QMS For Laboratories Testing and Calibration ISO 17025

GUIDANCE ON
QUALITY MANAGEMENT
SYSTEMS
FOR LABORATORIES
TESTING AND CALIBRATION
(ISO/IEC 17025)
Prepared by the
Caribbean Laboratory Accreditation Services (CLAS)
An European Union Funded Project
Obstacles are what you see when you take your eyes off the goal
November 2010 Edition 1
QUALITY MANAGEMENT SYSTEM GUIDANCE
PREAMBLE
This document is a consolidation of information and resources on the process of Developing a
Quality Management System for Testing Laboratories. Many resources were consulted in
preparation of the guide, and therefore contributed to its completion. Laboratories should
understand that there are many ways of accomplishing the goal of Accreditation and producing a
reliable output and therefore do not restrict themselves or their staff only to what pertains herein.
The development of this manual on Quality Management systems for Laboratories was supported
by the European Union through the 9th EDF Funded Caribbean Laboratory Accreditation Services
Project implemented by the CARICOM Regional Organisation for Standards and Quality (CROSQ).
This guidance manual is not used for commercial purposes.
For further information, please contact:
CARICOM Regional Organisation for Standards and Quality (CROSQ)

2nd Floor Nicholas House
29-30 Broad Street
Bridgetown
Barbados, W.I.
www.crosq.org
crosq.caricom@crosq.org
Authors
Giselle Guevara, BSc., MPhil, MBA
Project Coordinator
9th EDF Funded Caribbean Laboratory Accreditation Services Project (CLAS)
CROSQ
Bridgetown
Barbados
Ing. Manfred Kindler
Accreditation Expert and Consultant
Kindler International Division
Berlin, Germany
manfred@manfredkindler.de
Page 2 of 85
This Manual is dedicated to my colleague and dear friend

Bertha Munguia
Acknowledgements
The Authors are most grateful to the several persons who provided support, very useful input, feedback and
gave generously of their time in the development and production of this document. We especially wish to
thank those colleagues who reviewed the Manual and paused in their busy schedule to provide incisive
comments, helpful tips and stimulating input. Thank you for everyone who provided examples and ideas for
the content of this manual, sometimes without even knowing you were helping.
We are truly thankful and wish to recognise the contributions of Valerie Wilson and Wendy Kitson-Piggott as
Technical Editors, Michael Seepersaud, CROSQ-IDB Project Manager for assisting with the manual
publication. Thanks to Manfred Kindler who provided useful technical information, invaluable feedback and
assistance, in the preparation and compilation of this material.
We wish to thank CROSQ, the CARICOM Secretariat and the European Union funded CISP Project for their
contribution to the production of this guide. Preparation and Editing of this manual was a long and precise
task and we therefore wish to extend our special gratitude to all who assisted and facilitated the process.
Produced and Printed with support from the European Union under the 9th EDF Fund
Page 3 of 85
Table of Contents
FOREWORD.................................................................................................................................... 6
CHAPTER 1 LABORATORY QUALITY FUNDAMENTALS .................................................. 7
1.1
INTRODUCTION..................................................................................................... 7
1.2
QUALITY TERMS AND DEFINITIONS ..................................................................... 8
1.3
ACCREDITATION vs. CERTIFICATION ................................................................. 11
1.4
QUALITY MANAGEMENT SYSTEM ...................................................................... 13
1.5
DOCUMENT HIERARCHY .................................................................................... 14
1.6
A STEPWISE APPROACH TO DEVELOPING A QMS ............................................ 17
1.7
ACTION PLANNING USING THE MILESTONES .................................................... 20
1.8
CONTINUOUS QUALITY IMPROVEMENT ............................................................. 22
1.9
DOCUMENTATION PLAN..................................................................................... 29
CHAPTER 2 ELEMENTS OF THE QUALITY MANAGEMENT SYSTEM.............................. 35
2.1
THE QUALITY PLAN ............................................................................................ 35
2.2
STRUCTURING YOUR QUALITY MANAGEMENT SYSTEM ................................... 37
2.3
THE QUALITY POLICY STATEMENT.................................................................... 38
2.4
THE QUALITY MANUAL....................................................................................... 39
2.5
DOCUMENT CONTROL........................................................................................ 42
2.6
RECORDS ........................................................................................................... 46
CHAPTER 3 PROCEDURES............................................................................................ 47
3.1
PROCEDURE MANUAL........................................................................................ 47
3.2
OVERVIEW OF PROCEDURE WRITING................................................................ 47
3.3
ADVICE FOR WRITING PROCEDURES ................................................................ 48
3.4
ADMINISTRATIVE PROCEDURE OUTLINE........................................................... 49
3.5
OVERVIEW OF TECHNICAL PROCEDURES (SOPs)............................................. 53
3.6
DOCUMENTATION CHECKLIST ........................................................................... 57
3.7
USE OF FLOW DIAGRAMS .................................................................................. 58
CHAPTER 4 FAQs in LABORATORY QUALITY ............................................................... 61
CHAPTER 5 APPENDICES.............................................................................................. 67
REFERENCE DOCUMENTS ............................................................................................ 85
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List of Figures
Figure 1 Summary of the Application Process towards Accreditation ....................................12
Figure 2 Process Approach to Laboratory Quality Management..............................................13
Figure 3 Document Hierarchy ......................................................................................................15
Figure 4 Implementing a Quality Management System .............................................................16
Figure 5 The Twenty Milestones summarised............................................................................18
Figure 6 Milestone 1: Quality Policies........................................................................................20
Figure 7 Milestone 2: Management.............................................................................................21
Figure 8 Example of Responsibility Matrix for training .............................................................21
Figure 9 House of Accreditation ..................................................................................................17
Figure 10 The PDCA Model for QMS Improvement ....................................................................24
Figure 11 Example of a Quality Plan ...........................................................................................25
Figure 12 Diagram of QMS Process Activities............................................................................28
Figure 13 Documentation plan.....................................................................................................29
Figure 14 Quality Plan Outline .....................................................................................................36
Figure 15 Documentation Status .................................................................................................38
Figure 16 Example of Table of Contents for Manual.................................................................41
Figure 17 Example of Quality Manual Amendment table...........................................................42
Figure 18 Example of Master list (Document control log) .........................................................43
Figure 19 Example of Header/Footer combination.....................................................................44
Figure 20 Example of a Header ....................................................................................................44
Figure 21 Example of a Footer .....................................................................................................44
Figure 22 Example of Document control notes ..........................................................................45
Figure 23 Example Header/Footer with Document control note ...............................................45
Figure 24 Example of Record Management Database ...............................................................46
Figure 25. The Ps of Procedure writing......................................................................................48
Figure 26. Documentation Checklist for the QMS Program ......................................................57
Figure 27 Flowcharting Logic ......................................................................................................59
Figure 28 Flowchart symbols.......................................................................................................60
List of Appendices
Appendix 1 Summary of Clauses in ISO/IEC 17025............................................................. 67
Appendix 2 List of Policies in ISO/IEC 17025 ...................................................................... 70
Appendix 3 List of Procedures in ISO/IEC 17025 ................................................................ 71
Appendix 4 List of SHALLs in ISO/IEC 17025 .................................................................. 73
Appendix 5 Document Control Checklist ............................................................................ 78
Appendix 6 Example of a Flowchart ................................................................................... 79
Appendix 7 Checklist for reviewing Quality Management System Implementation ............. 80
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FOREWORD
aboratory accreditation is a formal process that recognizes the technical competence of a laboratory to
perform specific tests or calibrations. Accreditation requires laboratories to maintain a documented
quality management system (QMS) and personnel who are qualified and authorized to perform tasks
related to the scope of accreditation. The added value of accreditation far outweighs the necessary
investment in human resources, finances and time, since it is an independent method of monitoring
laboratory competence and performance, and assures the validity of results disseminated to users.
One very critical benefit of laboratory accreditation is that it provides assurance to trading partners that an
exporting country is competent to test or inspect to the trading partners requirements, while at the same
time addressing and assuring compliance with the World Trade Organisations (WTO) Technical Barriers to
Trade (TBT) Agreement.
The CLAS PROJECT (2008-2010) has sought to develop a framework that would facilitate co-ordination of
regional laboratory accreditation in a manner that would leverage regional capacity and harmonize
accreditation processes and procedures used across the Caribbean region while also addressing the need
for regional accreditation services to be cost-effective and internationally accepted. It was envisioned that
CLAS would create a platform for:
Strengthening regional communication through providing a mechanism for negotiation and

consensus building
Building the relevant human resource capacity
Forging strong linkages and relationships among regional stakeholders
Enabling the smaller countries of the region to participate in and more easily access expertise and
services to support their accreditation efforts.
Overall it strengthened and improved regional capacity for the continued functioning of the Laboratory
Accreditation infrastructure. More specifically, CLAS provided:
Assistance and support for the coordination of activities of the national accreditation bodies in the
region, aimed at avoiding duplication and promoting transfer of knowledge; and ensuring an
internationally recognized accreditation infrastructure in the Caribbean;
Interaction among the National Accreditation Focal points (NAFPs) for multiplication of benefits;
Access to international expertise by the NAFPs;
Access to proficiency testing programs by the NAFPs;
Access to training programs for Labs and Assessors;
A structure to uphold the principles of Cross frontier Accreditation (ILAC G21) and ensure that
confidence in the Caribbean Accreditation infrastructure is not eroded by extra-regional
Accreditation Bodies.
This manual has been developed to support the development of laboratory quality management systems in
regional laboratories and to build regional capacity to meet accreditation requirements.
Page 6 of 85
CHAPTER 1 LABORATORY QUALITY FUNDAMENTALS

1.1
INTRODUCTION
The International Standards ISO/IEC 17025 - General Requirements for the Competence of
Testing and Calibration Laboratories and ISO 15189 Medical Laboratories Particular
Requirements for Quality and Competence both respectively state that a laboratory shall establish,
implement and maintain a quality system appropriate to the scope of its activities including the
type, range and volume of testing and/or calibration activities it undertakes
Laboratory Accreditation is the formal recognition of a laboratorys technical competency to
perform specific tests, types of tests or calibrations. ISO/IEC 17025 and ISO 15189 1 requirements
are recognised internationally as defining and incorporating essential elements of a quality
management system for laboratories (ref: Appendix 1). The requirements for each stage of the
quality improvement process are described in the various clauses of the ISO/IEC 17025 and ISO
15189 2. Achieving compliance with the ISO/IEC 17025 and/or ISO 15189 Standard can be
achieved in a stepwise manner that ensures efficient use of resources.
Essential components of these standards include the following:
A laboratory that operates within a Quality Management System (QMS) will have a
single QUALITY MANUAL (ref: Section 2.4) hereafter referred to as the Manual, that
contains the documented policies for the laboratory and either includes or refers to the
processes, procedures and forms used by laboratory staff to implement the QMS
throughout all the disciplines in the laboratory.
A laboratory shall periodically and in accordance with a predetermined schedule and

procedure, conduct internal audits of its activities to verify that its operations continue
to comply with the requirements of the quality system and the Standard (ISO
17025/15189 clause 4.14).
Some laboratories have significant gaps in the required QMS documentation and as such
implementation of the QMS can at first appear to be a daunting task. However, if everyone in the
laboratory can be motivated and involved the task usually becomes easier. The Manual not only
serves as a guide for laboratory quality improvement but can also serve as a training manual for
new and existing staff because it outlines all the processes and procedures that must be executed
in the laboratory. Additionally, by describing all of the laboratorys processes and procedures, the
Manual allows laboratory staff to accurately identify the resources required for the laboratorys
operations.
1
This document references the ISO/IEC 17025:2005 General Requirements for the competence of Testing
and Calibration Laboratories
2
Please note that wherever Clause is mentioned in this document, it refers to a Clause of the ISO/IEC
17025 Standard
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In designing a quality plan (Figures 11 & 14), the laboratory establishes clear quality objectives that
ensure compliance with requirements of relevant regulatory authorities, clients and/or accreditation
bodies. The quality plan is intended to ensure that implementation of the QMS is efficient and costeffective.
The guidelines given in this publication are of a general nature. The complexity of a QMS depends
on the size, scope and organizational structure of the laboratory and many of the processes and
procedures described in this publication can be implemented in a simplified manner.
In order to master the process of Quality Management System implementation you must first
understand some related key concepts and definitions. These are described in the following
section.
Note
Essential areas of focus in your QMS include: organisation, personnel, equipment, purchasing and inventory,
process control, documents and records, information management, occurrence management, internal and
external assessment, process improvement, facilities and safety, customer service
1.2 QUALITY TERMS AND DEFINITIONS

a. Quality Management System
A program developed to support efficient and effective, high quality and appropriate
laboratory services (e.g. accurate and precise results, appropriate test selection, timely
reporting, and correct interpretation of results, clinical usefulness, and recommendations for
further tests).
Comprehensive and coordinated efforts (policies, processes and procedures) designed to
meet quality objectives, to direct and control an organization with regard to quality. The
system is comprised of the Quality Manual (Quality Policy, General policies, Organisational
Chart, etc), Administrative Procedures, Technical Procedures and Technical and Quality
Records.
b. Policy
Statement describing what is done and why.
c. Process
Series of inter-related steps involved in an activity or examination that uses resources and is
managed to transform inputs into outputs. Processes may often be linked since the output
of one process is often the input to the next. Rarely is there a process that is not linked to
some other.
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d. Procedure
Written work instructions that specify the way to carry out a step in the process, an activity or
examination. Procedures describe in detail exactly how one individual should perform an
activity.
e. Record
Any information that produces evidence (e.g. requisitions, examination results and reports,
instrument printouts, laboratory workbooks and worksheets, accession records, calibration
records, quality control records, records of audits, complaints and action taken, external
quality assessment records, instrument maintenance records, incident/accident reports, staff
training and competency records, personnel records).
f. Document
Any information that provides information (e.g. instructions including policy statements,
textbooks, reference intervals and their origins, procedures, specifications, calibration tables,
charts, posters, notices, memoranda, plans, software, drawings, regulations and standards).
g. Document Control
Is a system to regulate the handling and management (including archiving, storing and
destruction) of documents containing information that communicates policies, processes,
procedures as well as records. Usually pertains to documents that are part of the quality
management system
h. Audit
Systematic and independent examination to determine whether quality activities and related
results comply with planned arrangements and whether these arrangements are
implemented effectively and are suitable to achieve the objectives.
Note: In this document the term Internal Audit is used to emphasize that the audit is done
by the organization itself
i. Audit scope
The extent and boundaries of an audit. Usually established before the audit process begins
j. Audit plan
Description of the activities and arrangements for an audit
k. Management review
A formal evaluation by top management of the status and adequacy of the quality system in
relation to quality policy and objectives
l. Quality management
That aspect of the overall management function that determines and implements the quality
policy
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m. Quality manager
The staff member (by whatever title) who has responsibility for the laboratorys quality
system, its development, maintenance and ensuing implementation and who, in this
capacity, reports directly to top management.
n. Quality auditor
Person qualified to perform quality audits
o. Observation
A statement of fact made during an audit and substantiated by objective evidence.
p. Objective evidence
Qualitative or quantitative information, records or statements of fact pertaining to the quality
of an item or service or to the existence and implementation of a quality system element,
which is based on observation, measurement or test and which can be verified.
q. Audit findings
Results of the evaluation of the collected audit evidence against specified audit criteria.
r.Nonconformity
The non fulfillment of specified requirements.
s. Corrective Action
An action taken to eliminate the causes of an existing nonconformity, defect or other
undesirable situation, to prevent recurrence
t. Preventive Action
An action taken to eliminate the cause of a potentially undesirable result
u. Continuous Quality Improvement
The use of incremental and breakthrough quality management techniques to constantly
improve processes, products, or services provided to internal and external customers and
thus achieve higher levels of customer satisfaction
v. Quality Improvement Plan
A written description of the organizations quality improvement program that has been
approved by the management and is then periodically reviewed and updated, as necessary.
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1.3
ACCREDITATION vs. CERTIFICATION
Laboratory accreditation requires the use of criteria specifically developed to determine technical
competence. These criteria are based on the international standards ISO/IEC 17025 and ISO
15189, for Testing/Calibration and Medical Laboratories respectively. Accreditation bodies,
through specialist technical assessors, use these standards to conduct a thorough evaluation of all
factors relevant to the laboratorys competence and aim to ensure the laboratorys test data are
accurate and reliable.
The ISO 9001 standard is widely used in manufacturing and service organizations to evaluate their
system for managing the quality of their product or service. The ISO 9001, however, does NOT
assess the technical competence of the organisations operations. This standard is thus used for
certification and cannot be used for accreditation of laboratories.
Note
While laboratories may be certified to ISO 9001, such certification does not make any statement about the
technical competence of a laboratory as this standard does not contain technical requirements for laboratory
personnel and operations 3
Why Is a Laboratorys Technical Competence Critical?

Because it is important for laboratories to:
Minimise Risk
In the world today, customers seek reassurance that the products, materials or services they
produce or purchase meet their expectations or conform to specific requirements. This often
means the product is sent to a laboratory to determine its characteristics against a standard or a
specification. For the manufacturer or supplier, choosing a competent laboratory minimizes the
risk of producing or supplying a faulty product.
Avoid Expensive Retesting
Testing of products and materials can be expensive and time consuming, even when they are done
correctly the first time. If not done correctly, then the cost and time involved can be even higher if
the product has failed to meet specifications or expectations and re-testing is required. This can
negatively impact the reputation of a supplier or manufacturer. Additionally, the supplier can also
be held liable for any failure of the product, particularly if it involves public safety or financial loss to
a client. Choosing a competent laboratory thus minimises the chance of retesting being required,
increase in operational costs and/or exposure to legal action.
See ISO CASCO Communiqu on Accreditation vs. Certification and ILAC Publication on Laboratory
Accreditation or ISO 9001 Certification (www.ilac.org.tt)
Page 11 of 85
How does a Laboratory Apply for Accreditation?

Figure 1 summarises the steps in the accreditation process from the pre-audit visit to the final
award of the accreditation certificate.
Figure 1 Summary of the Application Process towards Accreditation
Accreditation Body Pre-Audit
External Audit by pre-Assessment Visit with Experts from

Accreditation Body
Corrective actions completed
Application to Accreditation Body

Complete Application process for Accreditation to ISO/IEC
17025
Accreditation Body Document Review On-site

Visit
Review of Documents forwarded by laboratory previously

On site Assessment by Assessor team
Laboratory Corrective Actions

Cause Analysis identify the source of Non conformances
and Confirm Corrective Actions
Accreditation
Accreditation Body -Vote on Accreditation Decision
Lab - Receipt of Accreditation Certificate
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1.4
QUALITY MANAGEMENT SYSTEM
Laboratory management, tasked with the responsibility for developing the QMS, must define the
policies under which the laboratory will operate. These policies are operationalised by defining the
processes and procedures (specific actions) that describe what must be done to implement the
policies (Appendix 2). Many laboratories may already be adhering to the best technical and
management practices and may only need to now document these practices. Some laboratories
may already have all or most of the documentation they need and all that is required is collation,
rationalization, and organization of the existing documentation with possibly some additional
documentation of the general administrative procedures (e.g. document control, purchasing of
supplies, retention of records, etc).
What is a Quality Management System (QMS)?
The procedures (activities, mechanisms, actions) that a laboratory uses to achieve and
demonstrate control over its system constitute the Quality Management System (QMS). Every
QMS is driven by an overarching quality policy (philosophy) from which a series of connected
processes and procedures are derived. These define the resources needed to provide the desired
laboratory outputs. The QMS outlines the inputs needed to produce the desired laboratory outputs
as well as the processes and procedures that transform these inputs into outputs. The laboratorys
input-output relationships are thus connected through the laboratorys processes and procedures
and collectively shape the laboratorys quality system (Figure 2).
The decision to implement a QMS has to be made by top management since managements
commitment is essential for the implementation and successful maintenance of the system. The
design and implementation of a QMS will vary depending on the type, size and output of the
laboratory with each one having its own objective. The QMS is often designed to align with the
requirements of an international standard. For laboratories, the standard commonly used is either
the ISO 17025 or ISO 15189.
Figure 2 Process Approach to Laboratory Quality Management
INPUT
PROCESS
OUTPUT
Personnel
Critical
process
necessary to
provide
reliable
output
Product or
Service
Environment
Methods
Equipment
Materials
Internal or
External
Customer
Satisfied or
Dissatisfied
Measures of performance (Time, quantity,

quality)
Page 13 of 85
What are Quality Objectives?

In order for a QMS to be effective, its quality objectives must be clearly defined and must reflect the
laboratorys overall service objectives. Objectives must also be practical, able to be regularly
reviewed and measured for effectiveness. All laboratory staff must be familiarized with these
quality objectives. Ongoing adjustments must be made to reflect major changes to the laboratory
and its practices.
What are Quality Documents?
A QMS consists of documented policies, processes and procedures for establishment and effective
implementation of the system, as well as records to provide evidence that the system is in
compliance. Key documents include the Quality Manual (which includes the quality policy or
philosophy of the laboratory and general policies); administrative and technical procedures
(specific work instructions), Test Methods (SOPs), and technical and quality records (proof).
1.5 DOCUMENT HIERARCHY

Figure 3 illustrates a typical document hierarchy. It shows that the laboratory must first establish
the Quality Policy (philosophy) for the organization, followed by the development of the more
general policies that reflect the overarching goals for every area of the laboratorys operations (a
list of policies from ISO/IEC 17025 are referenced at Appendix 2). Although very important, these
policies can be stated in a relatively simple way.
Administrative or operational processes and procedures that your organization performs to achieve
the goals or objectives expressed in the quality policies are then developed in addition to the
documentation of technical procedures that describe the specific analytical work performed in your
laboratory. These documents outline how you do things in your laboratory.
Finally the document hierarchy includes all the forms and records that are used to document the
results and activities of day-to-day operations. Records can be classified as either Quality or
Technical records, and as such the retention times and instructions for archiving both categories
should be documented. It is these records that are used as documented evidence of the work and
represent the proof of compliance with the standards requirements. All of these documents
collectively comprise the laboratorys QMS documentation.
The laboratorys safety management system, which will include policies, procedures and records,
can also be integrated into the Quality Management system.
Page 14 of 85
Figure 3 Document Hierarchy
What are the Benefits of a QMS?

Increases operational efficiency and productivity
Provides a system to enable control of all processes
Reduces costs and risks/errors
Provides ability to identify improvement opportunities
Provides employee participation and motivation of human resources
Increases customer satisfaction
Allows effective and efficient use of resources
Provides flexibility and ability to respond to market opportunities
Increases competitiveness and industry reputation
Implementing a Quality Management System who does what?
Successfully implementing a laboratory QMS needs careful planning, detailed identification of tasks
and clear guidance on the roles and responsibilities of the key stakeholders. Figure 4 details the
critical roles and responsibilities of management, the quality manager and the quality team.
Page 15 of 85

Figure 4 Implementing a Quality Management System
Responsibility
Management
Management/QM/QT
QM/QT
QM/QT/Management
Management
QM/QT
Management
QM/QT/Management
Tasks
Set objectives and goals of the QMS
Appoint a Quality Manager (QM) or Quality Team (QT) to develop and maintain
the QMS
Set timelines and project scope
Allocate resources required for the development, implementation and on-going
management of the system
Inform all staff and seek participation from all levels
Decide if a consultant is required for the project
Prepare a project plan an allocate resources
Develop a budget based on equipment, training, time and personnel required
Seek approval from management to procure required resources and execute
training
Assess method for documenting the QMS
Design templates and documentation
Set timelines for the various tasks
Schedule individual departments and positions for development of policies and
procedures
Develop QMS policies to reflect laboratory objectives
Start to develop procedures and work instructions (SOPs) with each
department
Report to management any risks and improvement opportunities that have
been found
Document any Quality Corrective Action Requests that might be identified
(identified risk areas that require management attention and improvements)
Approve and issue the QMS
Operate the QMS for a minimum period of 3 months
Carry out initial audits to ensure documentation matches processes
Ensure that you do what you say you do. If any deficiencies are found
change processes or QMS to reflect what is actually done
Assess the effectiveness of the QMS and implement any changes that might be
required.
Undertake management review of the QMS
Adjust resource requirements
Decide if accreditation assessment is required
Set accreditation assessment timelines
Appoint Accreditation Body
Continue to audit, review and assess the QMS at the agreed time intervals
Continue to assess risk areas and identify improvement opportunities
Continue to review policies and procedures and make amendments as required
Continue to measure effectiveness of QMS to the overall laboratory
performance
The ISO standards mention shall where it requires the laboratory to perform an activity without
question (i.e. all requirements that begin with shall are mandatory). Additionally, it mentions
Policy and Procedure wherever one of these documents is required. Where it does not require a
documented procedure, the standard may ask that the laboratory implement an activity.
Page 16 of 85

Naturally, if an activity is performed, records of its performance will be produced in a number of
different ways. Probably you will find that the most difficult task in implementing your QMS is
ensuring that all these activities are documented in one form or another and the records can be
retrieved when necessary.
Note
As stated in the standard, the establishment and effective implementation of the QMS Procedures
requires them to be documented. Quality Management System documents may be kept in various
forms, such as written on paper, in electronic format, photographic, or in any other media
1.6 A STEPWISE APPROACH TO DEVELOPING A QMS

HOUSE OF ACCREDITATION
(Model developed by Manfred Kindler, Berlin, Germany)
The following diagram illustrates how the 20 milestones can be put together in a systematic
pathway to achieve the desired endpoint, i.e. Accreditation for your laboratory. Let us picture a
house in which the policies are the foundation of the house, and the walls are comprised of the
documents and activities which make up the Management and Technical requirements of the
standard. The roof is the final pinnacle in the effort towards the achievement of accreditation. The
house is complete only after each brick has been laid.
Figure 5 House of Accreditation
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THE 20 MILESTONES FOR TESTING LABORATORIES

(Model developed by Manfred Kindler, Berlin, Germany 4)
Successful implementation of a QMS requires a structured and strategic approach. One such
approach entitled The Twenty Milestones to Accreditation is outlined in Figure 6. These
milestones present a stepwise approach that can be used to develop and implement a Quality
Management System and represent the actions you would undertake prior to applying for
Accreditation. The achievement of each milestone should signal the development and completion
of that particular aspect of the QMS. A timeline chart can be drawn using the milestones against
the estimated time allocated to conducting the activities. As each is completed it can be ticked off
(see example below).
Figure 6 The Twenty Milestones summarized
1.
Policies
Legal status established

Quality policy developed and documented
Quality goals agreed and documented
Quality Indicators determined and documented
General Policies developed and documented
Quality Plan developed and documented
2.
Management
3.
Scope
Description of Scope of tests for Accreditation
Procedures/Equipment/Personnel identified for test scope
Inventory of all Requirements for testing documented
4.
Quality System
Quality Manual Structure developed
Continuous Quality Improvement plan developed
5.
Procedures
Administrative Work Procedures developed and documented
Process for Control of Documents developed
Records identified and filed
6.
Test Methods
Instructions for Equipment operation documented
Examinations documented
Conflict of Interest Analysis conducted

Commitments from Top Management
Technical (testing staff) responsibilities developed and documented
Technical and Quality Responsibilities/Job Descriptions developed and documented
Kindler International Division manfred@manfredkindler.de
Page 18 of 85

7.
Sampling
Instructions for Pre-Analysis processes and procedures documented
Sampling procedures developed, and Sampling plan and processes documented
8.
Review Requests, Tenders and Contracts

Review Quality Manual
Review Requests and Contracts
Identify Process and procedures for Advisors
Evaluation of Subcontracting laboratories
9.
Quality Control
Reference Methods developed and documented
Internal and External Quality Control processes established
10. Validation
Verification Procedures developed and documented
Validation of new or modified Test Procedures documented
11. Work Conditions
Accommodation conditions documented and monitored
Facilities evaluated for suitability
Work Environment monitored
12. Literature
Review of current Standards
Research current Scientific Literature
13. Traceability
Check of Test Equipment
Calibration of Equipment
Reference Materials purchased and used
14. Uncertainty
Training in Estimation of Measurement Uncertainty
Calculation of Uncertainties
15. Training
Job Descriptions documented
Plan and Implement Staff continuing education
16. Monitoring
Monitoring System developed
Internal Audit plan and Schedule developed
17. Internal Audit
Training of Auditors
Internal Audit conducted
Audit Report prepared and evaluated
Page 19 of 85

18. Complaints
Complaint Management system implemented
Root Cause Analysis procedure implemented
Corrective Action procedure implemented
Preventive Action procedure implemented
19. Review Documents
Internal Review of Quality Documentation (Final review)
Review Manual, Procedures, Forms, Lists, Technical and Quality Records
20. Management Review
Management Review conducted,
Corrective Action plan implemented
Implementation and Control of Plan for Effectiveness
END OF THE SYSTEMS DEVELOPMENT PROCESS
1.7 ACTION PLANNING USING THE MILESTONES

Each of the twenty milestones can be broken down into the steps of an action plan, where each
action must end in a tangible result. In Figures 7 and 8 that follow, Milestone 1 and 2, for example,
are broken down into a series of 10 achievable steps with related laboratory and management staff
responsibilities. Each step yields a distinct result and responsibilities for achieving the result at
each step can be assigned to different persons. The responsibility matrix (Figure 9) can be used to
determine what each persons role is at each step.
Figure 7 Milestone 1: Quality Policies
Step
1
2
3
4
5
6
7
8
9
10
Action
Legal Status
Decide about Policy
Define Objectives
Determine Indicators
Create monitoring lists
General
management
Policies
General Technical Policies
Design Quality Plan
Issue Quality Records
Quality Report
HL
QM
TM
EP
SEC
Results
E
E
D
D
D
D
P
P
E
E
P
E
P
P
P
P
E
P
P
P
P
P
P
P
P
P
P
P
P
P
(Company) Registration
Quality Policy
List of Objectives
List of Indictors
Monitoring Procedure
Management policies
E
E
C
C
C
C
E
E
D
P
P
P
P
P
P
P
P
P
P
I
Technical Policies
Quality Plan
Quality Records
Report
Page 20 of 85
Figure 8 Milestone 2: Management
Step
Action
HL
QM
TM
EP
SEC
Results
1
2
Introduction Workshop
Conflict Analysis
D
D
E
E
P
P
P
P
P
P
3
4
5
Organisational Structure
Management Commitment
Clinical
interpretation
Responsibility
Technical Responsibility
Quality Responsibility
Job Descriptions
Final Check
Final Report
D
D
D
E
E
P
P
P
E
P
P
P
P
P
P
Agenda and Minutes

Structure,
Process,
Outcome Analysis, Risk
Matrix
Organisation Chart
Commitments in writing
List of Responsibilities
D
D
D
C
C
P
E
E
E
E
E
P
P
P
P
P
P
P
P
P
P
P
P
P
I
CVs, Job Descriptions
Checklist
Milestones Report
6
7
8
9
10
Responsibility Matrix
The following matrix is very useful for highlighting the responsible persons and the necessary
activities which must be performed in the normal conduct of daily operations for the laboratory.
The matrix can be used on its own or integrated into a procedure to illustrate the responsibilities
needed for effective implementation
Figure 9 Example of Responsibility Matrix for training
Activity
Assessment of training needs
Creation of a training plan
Interview of employees about training
Approving the training plan
Orientation of new staff
Technical training and exchange of experiences (seminar,
staff experiences)
Control of training activities
Key
HL Head of Lab
QM Quality Manager
TM Technical Manager
EP Employee
Sec Secretary
HL
D
D
P
D/E
D
D
P
E
P
I
E
P
D/E
QM
E
I
E
C
P
E
TM
E - Execute
P - Perform/Develop activities
C Cooperate/Assist
D - Decide
I - Informed
Page 21 of 85
EP
C
P
C
I
P
P
Secr
C
I
P
C
Staff competency is key to the quality of laboratory operations and thus the laboratory must also
ensure that the personnel they employ are:
Trained
Experienced and
Evaluated (to competently perform the tests which the laboratory offers.)
To ensure that well-trained and competent personnel are recruited the laboratory must develop
procedures which aim to:
Establish criteria for recruitment of staff
Develop appropriate job descriptions
Ensure that relevant qualifications are included in job descriptions
Develop orientation and continuing education programmes
Additionally, new and re-assigned staff must be properly supervised and trained before they are
allowed to perform tests on client samples. Competency evaluations should be performed and
documented. These records now serve as proof of the laboratorys confidence in the staffs ability
to perform testing independently. The laboratory can use several different techniques for evaluating
competence. These can include but are not limited to:
Testing of unknown samples
Testing using reference materials, and
Testing of replicate samples
Up to date training records must also be kept to prove that ALL staff have undergone initial
orientation, competency evaluation and participate regularly in continuing education. This can
easily be kept in a separate training file developed for each staff member (ISO/IEC 17025 Clause
5.2 Personnel).
Repeat the action plan format for each of the milestones (Figure 6 The Twenty Milestones ) above
and share it with staff. This can comprise the majority of the Labs quality plan, clearly outlining
what is to be done and by whom.
1.8 CONTINUOUS QUALITY IMPROVEMENT

QUALITY SYSTEMS PLANNING
The Continuous Quality Improvement process uses established incremental quality management
techniques to constantly improve processes, products and/or services provided to internal and
external customers towards achieving higher levels of customer satisfaction.
Continual improvement of the laboratory, its staff, and facilities and of course the QMS is vital to
the success of a laboratorys accreditation effort. A strong Quality Plan facilitates effective
communication with the parent organization, laboratory staff and clients about the laboratorys
Page 22 of 85

quality goals and operations. The purpose statement may be generated by using goals or
objectives previously defined by the parent organization and/or the laboratory, for example, in
Strategic planning. This will give guidance to decision making as the Plan is developed and
implemented.
What is a Quality Improvement Plan?
A written description of the organizations quality improvement program that has been approved by
the management and is then periodically reviewed and updated, as necessary.
What is a Purpose Statement?
A purpose statement will give guidance to the development and implementation of a quality plan.
Quality principles previously defined by the parent organization and/or the laboratory in, for
example, a strategic plan, can provide a foundation for the formulation of a purpose statement.
How will a Quality Plan Benefit the Laboratory?
It provides documentation of your commitment to quality improvement
It enables your laboratory to more efficiently use the resources available
It assists the staff and management to meet the requirements of accreditation bodies
How is a Quality Plan Developed?
There are several approaches to the development of quality plans, as there are for the
development of business plans. Figure 10 below illustrates how the Plan-Do-Check-Act (PDCA)
quality improvement model is applicable to the laboratorys quality planning and improvement
process and Figure 11 goes even further to outline an example of a quality plan drawn up by a
laboratory that is seeking to achieve accreditation.
Page 23 of 85

Figure 10 The PDCA Model for QMS Improvement
PLAN
Actions
Actions in
Define Procedures
Theory
Plan/Determine what will be done
Staff
responsible
Means of
Verification
How frequent?
Who is accountable?
DO
Actions in
Initiate Activities in plan
Practice
Perform processes
Gather data on performance
Execute training or improvement programs
CHECK
Review
Monitoring and evaluation of trends
and
Who is responsible for summarizing, reviewing

and reporting
Report results to the Quality Committee
Evaluation
How will this activity be considered for the

purposes of detecting patterns of problems and
opportunities for improvement, undertaking
quality interventions and corrective actions
ACT
Sustainable
Identification of indicators
Actions
The plan is modified as necessary

The process is implemented
A quality plan should clearly identify the laboratorys overall quality goals and the purpose of the
quality improvement effort. The plan should also detail the desired outcomes of the laboratorys
quality initiative and the activities that must be undertaken if these outcomes are to be realized.
Figure 11 outlines some of the outcomes and activities that a laboratory preparing for accreditation
may want to include in their quality plan.
Page 24 of 85

Figure 11 Example of a Quality Project Plan
Objectives
Success Measures
Verification
Assumptions
Customers have
increased confidence
and are satisfied with
reliable services
Less Customer
complaints
Evaluation Record of customer

complaints
Customers are willing to continue

working with the organization
More requests for

services/products
Client request data
Services offered meet the

customers needs
On site visit
conducted by
Accreditation
Assessors
Non conformance
report prepared with
findings of root cause
analysis
Assessor report
Lab pays Accreditation fees
Non conformance report and

supporting records
Root cause analysis finds and

eliminates non conformances
Goal
Purpose
Laboratory achieves
accreditation
Outcomes
1)Accreditation action
plan prepared and
responsibilities
identified
2) Quality Manual
written and approved
3) SOPs written and
implemented
4) Internal Audits
performed
Inputs
Staff trained in QMS,

20 Milestones, writing
documents
Quality system group trained and

staff sensitized
Action plan prepared and

approved
Quality Manual written

according to ISO
Standard requirements
Administrative and
Technical procedure
manuals prepared and
implemented
Audit program,
schedule and reports
prepared annually
Approved and Issued Quality

Manual
Quality Manager appointed
Approved and Issued Procedure

manuals
Consultant provides complete

documentation service
Internal Audit plan approved
Internal Auditors trained
Activities
Outcome 1: Accreditation Action plan prepared
Determine status of
QMS
Arrange training of
staff
Acquire standard and
determine scope
How
Who
When
Assumptions
Do lab self
Assessment
Do training needs
Assessment
Purchase standard and
review testing scope
Quality
Manager
Executive
Management
Management
First QMS action

plan prepared
While preparing
action plan
While preparing
action plan
Laboratory can get

Management commitment to
process
Page 25 of 85
Outcome 2: Quality Manual written and approved

How
Perform a GAP
analysis
Prepare report based
on findings
What do you
have?
What do you
need?
Who
When
Assumptions
Quality Manager
First month of action

plan
Within two weeks of
GAP Analysis
Laboratory can get

Management commitment to
process
Quality Manager
Prepare RIPOF
What is
Quality Manager
Analysis for Quality
missing?
team
Outcome 3: SOPs written and implemented
Fill in the GAPS

discovered in the
Gap analysis
Write Quality Manual
Write QMS
Administrative
Procedures
Write QMS Test

Procedures
Develop record
Management system
Within two weeks of

GAP Analysis report
How
Who
When
Assumptions
Develop policies,
processes and
procedures
Improve existing
policies,
processes and
procedures
Prepare/obtain
template for
Quality Manual
Develop policies
required by
standard and
Organization
Write Quality
Manual
Quality working
group
At working group
sessions
Quality systems
review group
At QMS review
meetings
Quality Manager has

sufficient knowledge to guide
team
Quality Manager
After GAP Analysis
Quality Manager
At QMS Document
writing meetings
Quality Manager
At Document writing
meeting
Prepare template
for SOPs
Quality Manager
After GAP Analysis
Distribute SOP
Template
Quality Manager
At QMS Document
writing meetings
Write
Administrative
procedures as
needed
Prepare template
for Test methods
Persons
responsible for
executing
procedure
Quality Manager
One procedure per

week at Document
writing meeting
Distribute
Template
Quality Manager
At QMS Document
writing meetings
Write Test
Methods as
needed
Prepare master
list of documents
Persons
responsible for
procedure
Quality Manager
One procedure per

week at Document
writing meeting
Updated as
procedures are
Page 26 of 85
After GAP Analysis
List of policies prepared and

available for use
List of Procedures prepared

and available for use
Reference documents
available

written
Outcome 4: Internal Audits performed

How
Who
When
Assumptions
Review system for

compliance
Perform internal
audit
Trainer/Quality
Manager
After GAP Analysis
Internal Audit team trained and

experienced
Evaluate system
routinely
Identify
opportunities for
continuous
quality
improvement
Prepare
Corrective
action plan
Management
review team
After internal Audit,

After Management
review
Management team participate

in meeting
Auditee and
Quality Manager
After the Internal audit
Non conformances are easy to

solve
Correct non
conformances
A flowchart of the QMS implementation process helps to simplify and clarify the laboratorys
planning and quality improvement process. In Figure 12 below, key activities, functions, duties and
responsibilities critical to the QMS planning and implementation process are detailed.
Page 27 of 85

Figure 12 Diagram of QMS Process Activities
Staff functions/Responsibilities/Duties
Clerical/administrative functions
Technical functions, Management functions
Quality Manager functions
Clerical/Administrative
Functions
Prepare lists of
Reference laboratories
Quality Control materials
Suppliers, Equipment
Staff
Tests offered
Arrange filing for

Package inserts
Reagent certificates
Reports
Other records
Activities:
Purchase the standard (ISO 17025)

Prepare staff orientation program, Assign computer access
Prepare a Safety plan (to include evacuation plan, fire and
biological hazards)
Prepare an accident report form
Set up housekeeping schedule and write procedures
Technical Functions:
Compile list of tests done, Collect and compile technical procedures

Review technical procedures to ensure that they are appropriate and complete
Prepare equipment records using equipment list, maintenance plans
Managerial Functions:
Review report format for conformance to standard

Prepare waste disposal plans, Arrange laboratory security
Decide on the Quality Policy
Appoint a Laboratory Director; Appoint a Quality Manager (however named),
Set Management review dates
Quality Manager Functions:
Prepare audit plan, and audit report forms, train internal auditors
Set quality indicators e.g. turnaround times
Review technical procedures to ensure they are appropriate and complete
Document any missing (outstanding) procedures
Set Retention time for - Records, Sample storage
Page 28 of 85
1.9 DOCUMENTATION PLAN

As described above, the ISO/IEC 17025 Standard require that the laboratory develop a
comprehensive Quality Management System that controls the daily operations of the laboratory
supported by a considerable amount of documentation. Every clause in these standards has
specific requirements in terms of the policies, procedures and records required to prove to
management, staff and clients that activities have been executed as needed. There are several
approaches or tools used to facilitate a laboratorys development of the QMS in preparation for
accreditation. One such tool is entitled The Twenty Milestones to Accreditation. This can be used
to define and track the documentation required for compliance with relevant standards. Figure 13
summarizes the documents needed to meet the requirements of the ISO/IEC 17025 standard using
the 20 Milestones tracking framework.
Figure 13 Documentation plan
Purpose: To facilitate the development of the Quality Management System by the Laboratory in preparation
for Accreditation
Milestone
1. Quality Policy
Clause #
4.1, 4.2
Legal Entity with Quality policy,

Quality Goals and Quality
Indicators, General Policies
2. Management
Conflict of Interest Analysis and

Commitments from Top
Management, Medical, Technical
and Quality Responsibilities/Job
Descriptions
Docs required
Policies and
procedures 4.1.5c,
4.1.5d, 4.2.3
Company
registration,
Quality Policy
statement and Goals
(SMART),
Quality indicators
4.2, 5.1
4.2.5 (Program),
5.1.1 Policy
Job Descriptions
QM & Deputies
Confidentiality
statements,
Application for
Registration
Organization Chart
Action (Output)
required
Records produced
Write policies, prepare

procedures
Policy and
Procedures
Register company,
Develop Quality Policy
statement and Quality
Manual
Develop Quality Team,
Host team meeting and
incorporate writing group
Registration
certificate,
Quality Policy
statement,
Indicator Monitoring
tools
List of team
members and
meeting minutes
Write policy and

procedure
Policy and procedure
Develop Job
Descriptions, Appoint
Quality Manager,
Meeting with Ministry,
Develop or review Org
Chart
Job Descriptions,
Signed Contracts,
Signed
Confidentiality
Statements
Meeting Minutes
Organization Chart
Page 29 of 85
Status
3. Scope
5.2.10, 5.3.11,
5.3.12, 5.3.13
Prepare procedures
Procedures
Revise procedures,
decide on scope
(selection of tests),
Check Equipment and
Maintenance records,
Authorize personnel and
perform competency
evaluation
Updated Technical
Procedures
Validation records
Training and
Competency records
Equipment and
Maintenance records
Description of Scope
(Procedures/Equipment/Personnel
and Analysis of all specific
Requirements)
5.3, 5.4, 5.5,

5.7
Technical
Procedures, List of
Equipment, List of
authorized
personnel,
QC Requirements,
Competency
Evaluation Forms
4. Quality System
4.2, 4.3,
4.12
4.3, Policy and

procedures
Prepare policies and

procedures
Policies and
Procedures
Quality Manual Structure,

Continuous Quality Improvement
Quality Manual
CQI Plan
SOP for SOPs
Develop Quality Manual

Develop CQI Plan
Prepare safety program,
waste disposal plan
Develop technical
requirements
Quality Manual,
Plan for
Improvements,
SOP,
Safety Manual
Disposal plan
5. Procedures
4.3.1, 4.3.2, 4.13.1,

4.3.13
Prepare policy and

procedure
Policy and
procedures
Develop Document
Master log,
Develop retention policy,
Prepare Archive system,
Prepare Backup system
for data, Develop record
management system
Updated Master
Document log,
Record management
procedure, Retention
policy,
Data Backup
medium (CDs, etc),
Prepare policy and

Procedures
Policy and
Procedures
Develop log of
Equipment,
Document or reference
applicable test methods,
Prepare Maintenance
logs,
Perform method
validation,
Analyze QC data and
trends,
Prepare reagent lists,
Execute training of staff
Equipment Records,
Technical Procedure
manual,
Maintenance and
calibration logs,
Validation procedure,
Validation records,
QC Data records,
Reagent lists,
Training records
Work Procedures /Control of

Documents and Records
4.3, 4.13,
5.5
Retention policy
Document control
procedure
Document master
Log
6. Test Instructions
5.4,
5.4.
Instructions for Equipment and

Procedures
5.5
Equipment Records
Technical
Procedures
Validation procedure
Page 30 of 85
7. Sampling
5.4, 5.7, 5.8
Instructions for collecting samples

and related
8. Review Contracts
4.4, 4.5, 4.7
Review Quality Manual, Requests,

Advisories, Contracts,
Subcontracting labs
9. Quality Control
Verification and Validation of Test

Procedures
Prepare Policies and

Procedures
Policies and
Procedures
Primary sample
collection,
Sample collection
procedure,
Result reports,
Prepare sample
collection instructions,
Prepare sample
collection procedure,
Perform Workflow
analysis,
sample collection
instructions,
Sample collection
procedure,
Result reports,
Corrective action
reports
Prepare Policy and

Procedure
Perform contract review,

Evaluate referral labs,
Conduct meetings of lab
advisors
Contract review
procedure,
Contract review
records,
Client contracts
(requisitions)
Register of
Subcontracting labs,
Meeting Minutes
Perform inventory of
reference materials,
Perform QC according
to requirements of test
procedures,
Monitor QC data,
Participate in PT,
Investigate bad PT
results, determine root
cause,
Do corrective actions
List of Reference
materials,
MSDS Sheets,
QC Data,
PT Reports,
Root cause
investigation,
Corrective Action
reports
5.5.1, 5.5.2
Prepare policy and

procedure
Validation
procedures
Perform validation
analysis
Verify calibrated
equipment
Validation procedure
Validation records
(X, SD, CV, TE, etc)
4.4.1, 4.5.1 Policy

and Procedure
Contract review
procedure
Requisition forms
Register of
Subcontracting labs
5.6
Reference Methods/Internal and

External Quality Control
10. Validation
5.4. 5.7, 5.8, 5.8, 5.8

(Policies)
5.4, 5.8, 5.8, 5.8.
(Procedures)
List of Reference
materials
QC Data,
PT reports
Corrective action
forms
5.5
Page 31 of 85
11. Work Conditions
5.2
Accommodation, Facilities and

Work Environment
12. Literature
Environmental logs,
Housekeeping
procedures,
Preventive
maintenance
procedures,
Disaster mitigation
procedure
4.3, 5.4, 5.5,

5.8
Check of current Standards and up

to date Scientific Literature
13. Traceability (Calibration)

Check of Test Equipment
(Calibration, Reference Materials)
5.2.4, 5.2.10
Perform environmental
monitoring,
Perform preventive
maintenance,
Safety audit,
Facility improvement
plan,
Ensure proper
arrangements for
possible disasters
Environmental logs,
Housekeeping
procedures,
Preventive
maintenance
procedures,
Preventive
maintenance
records,
Plan for facility
improvement,
Disaster mitigation
procedure
Ensure current and

effective examination
procedures are in use,
Verify suitability of
reporting format,
Ensure proper document
control,
Search scientific
literature on internet and
library,
Research innovations in
technology
Examination
procedures,
Reporting format
Prepare policy and

procedure
Prepare Calibration logs

Verify
calibration/reference
materials
Calibrate measuring
devices (test specific)
Produce secondary
reference materials,
Prepare calibration
curves
Calibration logs
Calibration
Certificates
Certificate of
Analysis, MSDS
Calibration curves
Secondary reference
materials procedure
4.3.1, 5.4.1,
5.5.1,5.5.2
Reference books
(e.g. Journals, kits
inserts, instruction
manuals)
5.6, 5.5
Prepare policy and

procedure
5.6,3, 5.5.1
Calibration
procedures
Calibration
certificates
List of Equipment
List of Reference
materials and
standards
Reference material
procedure
Page 32 of 85
14. Measurement Uncertainty
5.4
Training in Estimation of
Measurement Uncertainty
15. Training
Procedure for
Measurement
uncertainty
5.1
Job Descriptions, plan and

Implementation of Training
programme for the Lab Staff
16. Monitoring
Monitoring System and Internal

Audit plan and Schedule
5.4.6
4.14, 5.6,
4.9, 4.12,
4.6
Facilitate measurement
uncertainty training
courses,
Calculate Measurement
uncertainty, where
applicable
Monitor QC data and
analyze,
Perform statistical
Analysis on data
Procedure for
Measurement
uncertainty,
Measurement
uncertainty budget,
Statistical results and
calculations
5.1.1, 5.1.8
(Policies)
Prepare policies
Policies
Job descriptions
Training plan
Continuing
Education plan
Competency
evaluation forms
Prepare Job
Descriptions,
Determine criteria for
selecting staff
Perform competency
evaluations
Job descriptions
Training plan
Continuing
Education plan
Continuing
Education materials
Prepare Policy and

Procedures
Policy and
Procedures
Evaluate procedures
and testing process,
Appoint responsible
person for dealing with
non conformities in
testing,
Design or obtain
effective Information
Management system
(e.g. LIS)
Evaluate all suppliers
Appoint person to verify
purchased items
Procedure for
identifying non
conformities,
Record of non
conformities,
Supplier evaluation
Procedure,
Supplier evaluation
register,
Procedure for
purchase and
verification of
supplies and
services
4.9.1, 4.9.2, 4.9.3,

4.6.1 Policy and
Procedures
Procedure for
identifying non
conformities
Procedure for
evaluating suppliers
Procedure for
purchase and
verification of
supplies and
services
Page 33 of 85
17. Internal Audit
4.14, 4.10,
4.11
Training of Auditors and Internal

Audit, Audit Report
18. Complaints
4.8
Complaint Management, Cause

Analysis, Corrective and
Preventive Actions
19. Review Documents
Management Review, Corrective

Action plan, Implementation and
Control of Effectiveness
Prepare procedures
Procedures
Internal Audit
procedure
Corrective action
procedure
Preventive action
procedure
Select and Train internal

auditors,
Prepare criteria for
Auditors
Prepare internal Audit
schedule
Conduct internal audits
Address all non
conformances, and
determine root cause
Investigate opportunities
for Preventive action
Internal Audit
procedure, Internal
Auditor criteria,
Training certificate,
Internal Audit
schedule,
Internal Audit report,
Corrective action
procedure,
Corrective action
report,
Preventive action
procedure and plan
4.8 Policy and

Procedure
Prepare policy and

procedure
Resolution of
complaints
procedure
Review complaints,
Investigate root cause,
Perform corrective
actions
Develop preventive
action report
Feedback forms,
Complaints forms,
Corrective action
reports,
Preventive action
report
Document control
procedure,
Document Master
log
Record retention
policy
Perform scheduled
reviews of
documentation as
required,
Ensure obsolete
documents are removed
from general use and
archived
Updated procedures,
Updated document
master log
Record retention
policy,
List of obsolete
documents
Prepare procedure
Procedure
Determine date for MR

and invite attendees,
Prepare reports for
Management review,
Execute MR,
Prepare Action plan
coming out of
discussions
Management review
procedure
Meeting documents
(e.g. Agenda,
reports, etc)
Management review
Schedule
Meeting minutes and
Action plan
4.3, 4.13
Internal Review of Quality

Documentation (Manual,
Procedures, Forms, Lists,
Technical and Quality Records)
4.14.2, 4.10.1,
4.11.2 Procedures
4.15
Management review
procedure
Meeting documents
(e.g. Agenda,
reports, etc)
Page 34 of 85
CHAPTER 2 ELEMENTS OF THE QUALITY MANAGEMENT SYSTEM

2.1 THE QUALITY PLAN
Developing a quality plan is comparable to developing a business plan. This plan will serve as the
laboratorys blueprint for its quality management program and should outline the process and
details used to meet your objectives. It constitutes a concrete statement of purpose which
facilitates communication among the laboratorys management, staff and clients and will give
guidance to effective decision making.
Requirements for effective quality program functioning:
There is a written description of the quality program.
The program is reviewed annually and modified as appropriate.
A designated senior staff member is responsible for the quality program implementation.
Top management has substantial involvement and participates in quality improvement
activities.
There is an active quality systems committee with a defined role, structure and function.
The scope of the quality improvement program is comprehensive.
The quality assessment process and improvement are systematic.
These requirements dictate that the following elements should be addressed in your quality
plan:
The Quality Programs purpose, scope, goals and objectives
Completion of the quality management systems structure including a description of roles
for each staff member and function
Description of the process to be used for gathering feedback and conducting satisfaction
surveys
Description of the methods to be used for identifying non conformities, finding the root
causes and performing corrective and preventive actions
Development of a listing of the staff employed, tests performed and equipment used
Creation of records for each instrument and a description of how the laboratory will
reasonably ensure that its professionals are qualified to provide testing services to
customers
Identification of a mechanism to ensure that the Quality Systems Committees functioning
is conducted in a manner that protects the confidentiality and impartiality of the laboratorys
clients
Development of a process to be used by the Quality Systems Committee to present,
recommend and seek approval from management.
Development of a process to be used by the Quality Committee to report to the top
management and staff
Figure 14 provides a more detailed breakdown of the components to be considered in the process
of developing and implementing your quality plan and program.
Page 35 of 85

A critical initial step is the formation of a laboratory team that involves staff and management in the
quality improvement effort. Quantifying resources and devising strategies for mobilizing whats
needed is also critical to the laboratorys ultimate success. Identifying clear goals and objectives,
conducting periodic audits and continually taking corrective action is fundamental to success.
Figure 14 Quality Plan Outline
WHAT IS
The POLICY
The PLAN
The PROGRAM
Document expressing
managements commitment to
Quality in the laboratory
The strategy for developing

your laboratory Quality
Management plan and
program
The details and content of

your Quality Management
system
A. Develop the Plan
B. Develop the Program
1. Form a team (workers and management)

2. Analyze firms compliance with the standard
3. Review laboratory scope
4. Develop Quality objectives goals
5. Obtain senior management commitment
6. Develop a budget
7. Obtain necessary resources
8. Develop rules, practices & procedures
9. Get a professional review & evaluation
10.Quality System Committee
11. Decide on Responsibilities
12. Set timelines for the various tasks
1. Quality Policy Statement

2. Develop Training, Orientation & Communication
3. Assess method for documenting the QMS
4. Design templates and documentation
5. Develop QMS policies to reflect lab objectives
6. Schedule individual departments and positions
for development of policies and procedures
7. Start to develop procedures (SOPs) with each
department
8. Report to management any risks and
improvement opportunities
9. Document any Quality Corrective Action Requests
that might be identified (identified risk areas that
require management attention and improvements)
C. Implement the Program

1. Decide if a consultant is required for the project
2. Prepare a project plan an allocate resources
3. Assess an appropriate budget based on
equipment, training, time and personnel required
4. Seek approval from management to procure
required resources and attend any training
5. Instruct employees in their responsibilities
6. Provide guidance and follow-up
D. Evaluate the Program

1. Continue to audit, review and assess the QMS at
the agreed time intervals
2. Continue to assess risk areas and identify
improvement opportunities
3. Continue to review policies and procedures and
make amendments as required
4. Continue to measure effectiveness of QMS to
laboratory performance, review key elements
frequently
5. Identify weakness in the program
6. Ensure deficiencies corrected promptly
Page 36 of 85
2.2 STRUCTURING YOUR QUALITY MANAGEMENT SYSTEM

The first step in the structuring of your quality management system is achieving consensus among
key laboratory stakeholders - management & staff - on what processes and procedures are needed
to support the policies required by the standard (Appendix 2). Responsibilities for the development
of these documents should then be assigned. As each of these clauses is addressed, you should
assess the extent of your laboratorys compliance with the standard and seek the resources
needed to address the gaps and to fully comply. A periodic audit of progress towards the goal of
compliance is helpful to ensure that resources continue to be focused on the most important gaps.
Note
There are clauses of the standard not requiring a written policy or procedure, but these must be fully complied
with to ensure the efficiency and effectiveness of your system.
What should you include in documentation?
Efficient and effective documentation comprise the foundation of your QMS. The QMS itself must
include within its control all of the activities of the laboratory that influence or have the potential
to influence the validity of the test results or the satisfaction of clients. Hence some questions that
you may ask are:
If the activity were to be conducted incorrectly or inadequately would it impact the

result?
Can this problem occur under reasonably foreseeable circumstances if it were not
controlled within the QMS?
If the answer to any of the above questions is yes, the activity needs to be controlled within the
QMS. All activities within the QMS need to be documented to ensure effective control over the
activity concerned. Staff must be familiar with documentation and all documents must be available
when needed, must be complete, effective, easy to use, and consistently used whenever required.
Note
The name of the organization should at least appear on the first page of all documents developed by the
laboratory.
The laboratorys QMS documentation may include both internally and externally generated
documents. For most laboratories, the QMS will include both documentation generated in the
laboratory (for example the quality manual, administrative procedures, quality plans, technical
procedures, calibration procedures, reports, certificates), documentation used within the laboratory
but generated outside (for example contracts, requests, standards, specifications, client
correspondence), and records (for example worksheets, log books, environmental control records,
training records, test reports). The status of a laboratory document at any point in time must be
recorded and easily accessed. Figure 15 below illustrates the possible status of a document within
the laboratorys QMS.
Page 37 of 85

Figure 15 Documentation Status
2.3 THE QUALITY POLICY STATEMENT

The Quality Policy statement defines the laboratorys overall philosophy with respect to quality and
the aim or expected outcomes from the Quality Management System (Clause 4.2.2 of the ISO
17025). The Quality Policy statement is documented in the quality manual. This statement is used
to establish and reinforce the Managements commitment to the quality effort. Quality must enjoy
the same high priority as the laboratorys or parent organization's other major goals.
The policy should be
Issued under the authority of the Laboratory Director
Present in the quality manual
Clearly stated in terms that are easily understood
Posted in a conspicuous place and distributed and explained to all employees
Followed by every employee, including senior management, in all work activities
Reviewed annually to keep it up-to-date and in tune with current activities of the
laboratory and with the latest legislation.
Page 38 of 85
The policy statement should be readily available to appropriate personnel shall be

concise and shall include the following:
1. the scope of service the laboratory intends to provide;
2. the laboratory managements statement of the laboratorys standard of
service;
3. the laboratory management's commitment to good professional practice and
to the quality of its testing and calibration in servicing its customers;
4. the objectives and purpose of the quality management system related to
quality
5. a requirement that all personnel concerned with testing and calibration
activities familiarize themselves with the quality documentation and implement
the policies and procedures at all times in their work;
6. the laboratorys commitment to good professional practice, the quality of its
examinations, and compliance with the quality management system;
7. the laboratory managements commitment to compliance with this
International Standard and to continually improve the effectiveness of the
management system.
2.4 THE QUALITY MANUAL

AN OVERVIEW
The Quality Manual contains the laboratorys quality policy and objectives. The Quality Manual also
includes policies (Appendix 2) and general information about the laboratory including the testing
services, lists of major equipment, an illustration of the organisational structure, outline of
responsibilities and authority. Additionally, it should include how the elements of the QMS are
controlled. (All clauses are not mandated by a policy).
The quality manual should be used to inform staff members about the policies, and clients about
the laboratorys operation and structure. Confidential information need not be included. No format
is mandatory.
QUALITY MANUAL BASICS
The following should be considered when creating your quality manual:
It is the primary or foundation document of a quality management system and must
provide a thorough description of the quality management system and its policies
The size usually ranges from 20-50 pages although this may vary depending on the size
and scope of the laboratory and the amount of information included
Page 39 of 85
It may include processes, but does not usually include any administrative and technical
procedures. Procedures are referred to in the Quality Manual where appropriate (ref:
Chapter 2 Section 2.5 - Document control requirements)
It will reference your laboratorys supporting documentation: administrative and technical
procedures, records, forms, charts, etc. Some of the supporting documentation could be
included within the manual or as appendices
The Quality Manual should indicate where all documents are located (eg. Procedure
Manual)
It can be kept in either electronic or paper format
It must be easy for authorized personnel to update and easy for staff to access.
It is typically maintained and reviewed by a Quality Manager (however named)
STRUCTURE AND CONTENT OF THE QUALITY MANUAL
The exact format, structure and contents of the quality manual are at the discretion of each
laboratory. You have the freedom to design your manual in keeping with your laboratorys size and
complexity. The manual must, however, address every clause contained in the standard ISO
17025 or ISO 15189 unless the clause is not relevant to your laboratory (this is rarely the case). If
your manual format does not follow the layout/design of the standard then you should provide a
matrix that cross references the standards clauses to the manuals layout to facilitate ease of QMS
implementation and audits. In developing your quality manual content, remember that your quality
management system must encompass all management activities, technical activities and
processes relating to quality assurance. Organize the manual as you wish and at minimum include
the following:
Proper identification (title of document, organization name, page numbers)

A brief introduction (overview of the manual)
A description of the organization (name, address, brief history)
A quality policy statement (Clause 4.2.2 ISO 17025)
General Policies (as required by ISO/IEC 17025)
Policies of the Parent Organisation (e.g. policy on cell phone use)
Figure 16 below illustrates the typical contents page of a Quality Manual.
Page 40 of 85

Figure 16 Example of Table of Contents for Manual
Section
Number
Section Title
Introduction
Organisational Chart
Definitions/glossary of terms
Cross Reference table
Quality Policy Statement, Mission, Vision
General Organisational Policies
Personnel
Equipment
Purchasing and inventory
Process control, validation of processes,
Internal quality control and Proficiency testing
Documents and records
Information management
Investigation of non-conformities
Evaluation (includes the use of quality indicators and
internal audits)
Continual (process) improvement
Service and satisfaction
Facilities and safety
ISO Standard
Cross
Reference
Page
number
Note
Everyone in the laboratory must provide input into the development of the Quality Manual, and it is essential
that the entire staff is familiar with, and understands the contents of the Quality manual and its related
documentation
MAINTAINING THE QUALITY MANUAL

a. The quality manual shall be maintained current under the authority of an individual given
this responsibility by laboratory management, this could be the quality manager

(however named) (ISO/IEC 17025, clause 4.1.5)
b. All laboratory personnel shall be instructed on the use and application of the quality
manual.
c. The quality manual should be reviewed, approved and updated regularly, at a minimum
annually by the individual given this responsibility by top management.
d. All amendments to the manual must be authorised by agreed personnel. Figure 17 that
follows outlines an example of a documented amendment table
Page 41 of 85

Figure 17 Example of Quality Manual Amendment table
REVISION NO.
0
1
2
3
DATE OF CHANGE
4/10/09
25/11/09
AUTHORISED BY
Quality Manager
Quality Manager
PAGE AND TEXT AFFECTED
Initial Release
List of Tests amended Page 4
Note
This type of table reminds personnel to ensure that they are using the most up-to-date version of any
document and can be placed at the front of the binder.
2.5 DOCUMENT CONTROL

OVERVIEW
Your quality manual and ALL documents in your QMS will be considered controlled documents
(ref: Appendix 10document control checklist). Changes to documents must be controlled to
prevent irrelevant and unauthorised changes being introduced. The standard requires that
documents shall be reviewed and approved by the original reviewer(s) or by other authorized staff
thoroughly conversant with the background information on which the original documents were
based. In order to ensure that documents can be issued and withdrawn efficiently and accurately, a
control mechanism - such as a MASTER LIST - should be developed to record and identify
documents, their revision status and the document location. Requirements for document control
are as follows (ref: ISO 17025 Clause 4.3):
1.
Laboratory management shall define, document and maintain procedures to
control documents and records. Documents and records may be maintained and
stored on any appropriate medium that maintains its integrity (Paper or electronic).
2.
Authorized documents shall be available at all locations where operations
essential to the effective functioning of the laboratory are performed (e.g. within
easy reach of the work areas in the laboratory).
3.
All documents issued to laboratory personnel as part of the quality management
system shall be reviewed and approved for use by authorized personnel prior to
use.
4.
A MASTER LIST, also referred to as a DOCUMENT CONTROL LOG, that
identifies the current valid revisions and their distribution, must be maintained. An
example of a master list is provided in Figure 18 below.
Page 42 of 85

Figure 18 Example of Master list (Document control log)
Document
number
Document
name
Issue
Date
ACME
P001
Document
control
procedure
1/4/09
Edition
no.
Prepared
by
Approved
by
Revision
status
Revision
date
31/3/10
Retention
time
Issued to
John Smith,
Senior
Technologist
5. Invalid or obsolete documents shall be promptly removed from all points of use, or
otherwise assured against inadvertent use.
6. A retention period for out of date documents shall be identified (this is defined by the
countrys regulations or laboratory policy)
7. Retained or archived out of date documents shall be appropriately identified to prevent
their inadvertent use (for example by labelling as obsolete)
8. Only currently authorized versions of appropriate documents must be available for active
use at relevant locations.
ELECTRONIC DOCUMENTS
Electronic files comprise Quality System documents, data from tests, staff records, inventory files
and client information among others. These must be protected from unauthorised changes and
deletions. Password protection, administrator privileges and limited access to confidential
information are techniques that can be employed to ensure the protection of important electronic
files.
DOCUMENT IDENTIFICATION
Unique identification numbers on documents should be easy to use, with a simple format followed
throughout the QMS and communicated to everyone involved in their use. An example of a
numbering system follows:
All documents relevant to the quality management system shall have a unique identification,
including:
a. Title (simple and relevant to the procedure)
b. Edition and/or current revision date or revision number (e.g. Edn 1 Revision 2)
c. Number of pages (e.g. Page 1 of 6)
d. Authority for issue (not necessarily a signature, e.g. Authorised by)
e. Location of documents (including electronic documents)
EXAMPLE OF A DOCUMENT IDENTIFICATION SYSTEM
The following is an example of a numbering system used by the GGMLab:
GGMLABX-000
P - Standard Operating Procedures (GGMLAB-P-001 series)
R Records (GGMLAB-R-001 series)
Page 43 of 85
T Test method Documents (GGMLAB-T-001 series)

E Equipment instructions (E-001 series)
L Lists (L-001 series)
F Forms (F-001 series)
EXAMPLES OF HEADERS AND FOOTERS
Figures 19-23 that follow present a variety of document identification examples including examples
of headers and footers that meet the standards requirements for document identification. Any of
these can be adapted for your quality manual and related documentation in your Quality
Management System. Note that pagination can either be continuous or sectioned. Additionally,
you should include a revision history for each individual policy and/or procedure as part of a
standard header or footer. The revision history indicates the date when the document was last
reviewed and what the current version is. This ensures that all persons have the same version and
obsolete versions of documents are not used in the laboratory.
Figure 19 Example of Header/Footer combination

Header:
Quality
Manual
Footer:
Prepared by
Approved by
Good Test Laboratories

Section 0.0
TABLE OF CONTENTS
Senior Technician
Lab Manager
Page 1 of 1
Revision date: Jan 31 2009
Issue Number
Issue Date
2
Jan 31, 2005
Figure 20 Example of a Header

Section 1.0 Quality Manual
Table of Contents
Revision 2
Date Issued: 21/01/09

Authorized by: Lab Manager
Approved by: Quality Manager
Page 1 of 1
Figure 21 Example of a Footer

Prep Date: 05/11/10,
Revision Date: 09/01/21
Authority for Issue: Quality Manager
Page 44 of 85
Quality manual
Pg 1 of 42
CONTROLLED AND UNCONTROLLED DOCUMENTS
All documents in the QMS should have some label or mark indicating whether they are controlled
under the Document control system. Figures 22 and 23 below provide examples of acceptable
control labelling. If the document is no longer under the control of the person responsible for
Quality or the document has left the supervision of that person it is considered to be uncontrolled.
For example, a document sent to a person outside of the lab for review, for information, as a
resource document, etc. This is applicable whether the QMS documents are in electronic or paper
format. If your quality manual and procedures are primarily electronic documents where
uncontrolled printed paper copies may exist, you can consider adding footers either electronically
or you may use a coloured rubber stamp on the bottom of the printed pages to identify these
documents
Figure 22 Example of Document control notes
NOTE: This is a CONTROLLED Document, as are all management system files on
this server. Any documents appearing in paper form are not controlled and should be
checked against the server file version prior to use.
Notice: The hard copy of this Document may be used for reference purposes only.
The on-line copy must be considered the current document
Figure 23 Example Header/Footer with Document control note
Header:
Good Test
Laboratory
Status: Approved
Quality Manual Section 5.1

Title: Document and Record Management Policy
Footer:
Prepared by: Senior Technician
Approved by: Lab Manager
Page 1 of 2
Version 2.0
Rev. Date: 2006/08/26
Effective Date: 2005/08/26
NOTE: This is a CONTROLLED document for internal use only. Any documents appearing in paper form are not controlled and should be checked
against the document (titled as above) on the file server prior to use.
Page 45 of 85
2.6 RECORDS
The Standard requires that the Laboratory keep detailed records of all the activities it performs as
proof that the activity has been completed, the data is correct or corrective actions have been
performed to improve the process. Examples of laboratory records required by the QMS are data
sheets, purchasing documents, training records, raw data from testing, sampling records and
equipment maintenance records.
All records must be kept in a safe location that allows them to remain legible and easily accessible
and able to be disposed of in a manner that maintains confidentiality. A reasonable retention time,
taking into account lab operations and storage options, should be established for each record. An
example of an appropriate record management database is illustrated in Figure 24 below
Figure 24 Example of Record Management Database
Record Management Database
Name of
Record
Type of
Record
Date
created
Retention
time
Date
deleted
Back up
Created
by
Page 46 of 85
Entered
by
Storage
Location
Reference
no
Comments

CHAPTER 3 PROCEDURES
3.1 PROCEDURE MANUAL
It is suggested that the quality system procedures be compiled into a manual to instruct those
involved in managing the process of transforming laboratory policies into laboratory outcomes i.e.
who, what, when, where, why and how the policies and objectives expressed in the quality manual
are to be addressed and achieved.
Your procedure manual outlines one or more procedures arising from the relevant policies laid out
in the quality manual. These define how individuals or groups of people in the same or different
departments will work to meet managements stated objectives for quality. The quality system
procedures must address each requirement of the relevant clause of the standard and
collectively they will define the organisations administrative operation, from receiving an enquiry to
delivering a completed product or service.
Note
It should be noted that the procedures do not have to be assembled into a manual, but it is quite likely that one
master set will be in the form of a manual, to facilitate control.
3.2 OVERVIEW OF PROCEDURE WRITING

Several procedures may be required in the conduct of any of the processes conducted in the lab
that arise from the laboratorys stated policies. If you do not have a written procedure, you may
start by simply writing down how you actually carry out the activity and then verify it works as you
have described. This outline may be prepared as a flow chart. Flow charting is a powerful
technique for generating a description of processes and is usually a good way to start (ref: Section
3.8). In documenting your administrative and technical procedures you may use the following
steps:
Step 1 Produce an outline of the procedure which should simply list:
I.
What is done?
II. When it is done?
III. Who does it?
IV. How is it done?
All other parts of the procedure can be included at a later time. This outline may be prepared as a
flow chart.
Step 2 When the procedure outline has been prepared it must be reviewed by several persons
who have to use it. The reviewers must check to make sure that the outline adequately describes
what is being done.
Page 47 of 85

Step 3 Once the details of the procedure are listed, then the document should be reviewed
following the questioning technique to evaluate the efficiency of the procedure outlined in Figure 25
below.
Figure 25 The Ps of Procedure writing
Purpose
Place
Progression
Person
Process/Method
What is done?
Where is it done?
When is it done?
Who does it?
How is it done?
What should be
done?
Why is it done?
Where should it be
done?
Why is it done there?
When should it be
done?
Why is it done then?
Who should do it?
What else might be

done?
Where else might it

be done?
When might it be
done?
How should it be
done?
Why is it done that
way?
How else might it be
done?
Why does that

person do it?
Who else might do
it?
Step 4 When the procedure has been reviewed and is found to be adequate, the team should
produce a draft procedure that is circulated for comment and, as well, should set and enforce a
deadline for responses.
Step 5 Comments are reviewed, suggested changes made and the procedure can then be issued
for use.
3.3 ADVICE FOR WRITING PROCEDURES
Procedures are short documents and should not exceed three pages if possible. If the
procedure is too long it should be split into two separate procedures
In each stage of a procedure each action should have a person responsible, e.g. Clerk
completes the request form
Procedures should be written with an eye to auditing. At every point the question should
be asked. How do you prove this has been done?
Procedures should be written in simple direct language, long sentences or unfamiliar
words cause misunderstandings and misinterpretations
The language used should be precise, there is no room for interpretation of the meaning of
a word in a procedure
Use verbs (active words) in the procedure description
Page 48 of 85
3.4 ADMINISTRATIVE PROCEDURE OUTLINE

For Administrative Quality System Procedures, the following headings are applicable.
3.4.1 Title
All procedures should have a title that clearly states the intent of the document. The title should be
concise and descriptive. E.g. Procedure for Purchasing Supplies and Services. Because a
procedure describes how to do something, the title should use direct language to declare what is
being done to what. A procedure titled "Laboratory Equipment" is not descriptive of the
procedure's content; a more appropriate title would be, "Procedure for Purchasing of Laboratory
Equipment."
3.4.2 Purpose
This section would outline the intention of the document. If a procedure were being written for
procedure writing the section would read as follows:
The purpose of this procedure is to define the steps to be taken in writing a procedure, to ensure
that all procedures written have been adequately reviewed and are consistent.
3.4.3 Scope
This section would outline the limits of applicability of the procedure. This section would indicate
the function, department or group to which the procedure is applicable.
This procedure is applicable to all staff of the stores department and is to be applied to all new
equipment delivered to the laboratory.
3.4.4 References
This section would list all the other documents referred to in the procedure or which have a bearing
on the activity. These could be legislation, standards or associated procedures.
3.4.5 Definitions
This section would list definitions of all acronyms, initials and abbreviations. It would also list
definitions of all words which have specific meaning in the context of the document.
3.4.6 Responsibility
This section would list persons with specific responsibilities under the procedure, Example:
The superintendent is responsible for reviewing all test data before incorporation into the test
report.
3.4.7 Process/Methods (Actions)
This section would describe the details of the activity as laid out during the review steps above
(Section 3.2 Procedure Writing).
3.4.8 Documents Generated (Records)
This section would list the documents generated by the procedure.
End of Outline
Page 49 of 85
Example of an Administrative Procedure

Prepared By:
Laboratory Technician
Date:
2009.05.01
Reviewed By:
Approved By:
Title:
Senior Laboratory Technician

Quality Manager
Procedure for controlling Documents
Date:
Date
2009.05.30
2009.06.01
Purpose
To control all quality system documents (internally generated and from external sources).
To identify changes made to documents including amendments by hand and electronically.
To control documents maintained in computerized systems.
To dispose of documents which are obsolete or irrelevant
Scope
This procedure applies to the Quality Manual, all Test Methods, Forms, Standards, Specifications,
Work Instructions, Registers and Standard Operating Procedures (SOPs).
The procedure ensures that:
authorized editions of appropriate documents are available at all locations where

operations essential to the effective functioning of the laboratory are performed
documents are periodically reviewed and where necessary revised to ensure continuing
suitability and compliance with applicable requirements
invalid or obsolete documents are promptly removed from all points of issue or use to
assure against unintended use
obsolete documents retained for either legal or knowledge preservation purposes are
suitably marked
documents are uniquely identified
documents are approved and issued by authorized laboratory personnel

Definitions and Acronyms
Quality manual a document stating the quality policy, quality system, and quality practices of an
organization
Standard operating procedure (SOP) a document that specifies or describes how an activity is
to be performed. It may include methods to be used and sequence of operations.
Test Methods a document that specifies activities performed in the determination of analyze(s)
in a specific test sample (s)
Responsibilities
Laboratory management ensures that this document control procedure is established, implemented
and maintained. The Quality Manager/Laboratory supervisor/Senior Laboratory technician
oversees the day-to-day operations of document control. Laboratory technical personnel are
responsible for following this procedure in its entirety.
Page 50 of 85

Laboratory technical personnel include Quality Manager, Technical Manager, Laboratory Manager
Laboratory Supervisor, Senior Laboratory technician and Laboratory technician.
Procedure
Note Documents in the QMS may consist of signs, flowcharts, pictures, drawings, sketches,
forms, and numbered lists. Regardless of the format, all quality system documents must be
controlled through this procedure
The Quality Manager develops and reviews a master list of all controlled documents (LAB-P001)
and circulates for comments to all staff.
Quality Manual:
1. The Quality Manual is approved by the ACME Lab Director, who signs the master copy.
2. Controlled hard copies are indicated by the Controlled Copy Number on the Title page of the
Manual.
Operating Procedures:
1. Test methods and standard operating procedures are controlled documents with limited
distribution, and working copies are kept in three-ring binders. The Table of Contents includes
all current procedures assigned to a given work area and the following information:
the code and title of each procedure
the revision number of each procedure
the effective date of each procedure
the issue date of each procedure
review date the date each procedure was last reviewed
total number of pages

2. Unique codes are assigned for each procedure.
3. Test methods are written with the following headings (as applicable):
Scope
Description of Test Items, Sample Identification, Holding Times
Quantities to be Tested
Materials and Equipment Required
Physical Environmental Conditions Required
Procedure
Safety Measures
Method for Data Analysis and Presentation
Sensitivity, Quality Control Plan
Reference Procedures
Documents Generated
Revision History
Appendix
4. SOPs are written with the following headings (as applicable):
Purpose
Scope
Definitions and Acronyms

Page 51 of 85
Responsibility
Materials Required
Procedure
References
Documents Generated
Revision History
Appendix
5. Procedures and Test Methods are prepared, reviewed by Laboratory technical staff authorized
by Quality Manager; copies are uniquely identified, and distributed to users, with a Controlled
Copy Number on the title page.
Note the issue date is the date the document was issued to the user for review. The effective
date is the date the document is effectively in place and followed.
6. Obsolete master copies are archived for at least five (5) years. All other draft copies and
obsolete versions are kept in LAB-OBS-07 Obsolete Document Folder.
7. The Quality Manager maintains the master copies of the current procedures.
8. The master list of procedures includes:
Code, copy number
title
revision number
review date
status (current, obsolete)
Document Review:
1. Quality manual is reviewed on an annual basis by the Quality Manager/Technical Manager.
Records are kept of this review and any changes made.
2. Written Administrative procedures and Test Methods are reviewed on a biennial basis. The
reviewer makes a record of this review, any required changes, and forwards to the Quality
Manager.
Document Changes:
If any changes are required for any Controlled Documents these are documented on the Change
Request Form outlining the description of the change and forwarded to the Quality Manager. This
form is held as a record.
1. Changes to the Quality Manual, Test Method or a procedure require the same review and
approval by technical laboratory personnel who performed the original review and approval.
2. Changes are indicated by typewritten bold italic font to the revised area. The master list is
updated to reflect the changes in revision status and revision release date.
3. Personnel affected by the issue of a revised procedure are informed in writing. Holders of
obsolete copies return them to the Quality Manager who ensures the updated version is placed
in the manual. A list of obsolete quality manual sections and procedures is maintained.
Page 52 of 85
Amendments by Hand:
1. Where permitted, hand written amendments in ink are clearly marked, initialed, approved
by Laboratory Supervisor/Senior Laboratory technician and dated on all copies. The
relevant changes are made at the next revision of the document.
Computerized Documents:
1. Electronic copies of documents are maintained under the authority of the Quality Manager.
2. Access to electronic copies is password protected and changes are made and controlled by
Laboratory manager/Quality Manager/Laboratory Supervisor.
3. Documents that are revised are maintained in a folder identified as current; the obsolete
version is moved to a folder identified as obsolete.
4. Relevant personnel are informed of any amendment(s)
Documents Generated
Document Change request Form
Document Master List
Approved master copies of Quality Manual and procedures
END OF EXAMPLE PROCEDURE
3.5 OVERVIEW OF TECHNICAL PROCEDURES (SOPs)

Technical procedures or Standard Operating Procedures (SOPs) describe or reference all activities
necessary to conducting tests and describe in detail how specific tests or calibrations are
conducted. While it is not necessary to transcribe the contents of a kit insert or manufacturers
procedure manual once the documented format is appropriate, however, these documents must
form part of the controlled documentation of the laboratory and be numbered appropriately. SOPs
could be presented as drawings, pictures, kit inserts, analytical methods and models. They may
originate within the organization, be provided by the customer or from international scientific
references.
TECHNICAL PROCEDURE/SOP OUTLINE
A technical procedure must normally be supplemented by additional information. It can be written
in a very condensed form with considerable cross-referencing. For Technical Procedures, the
following headings may be applicable:
Page 53 of 85

3.5.1 Title
All Test Methods should have a title that clearly states the intent of the document. The title should
be concise and descriptive. E.g. Determination of Calcium in drinking water
Because a procedure describes how to do something, the title should use direct language to
declare what is being done to what. A procedure titled "Maintenance Chemical Analyser" is not
descriptive of the procedure's content; a more appropriate title would be, "Preventive Maintenance
Procedure for the Photometer."
3.5.2 Principle of test
The scientific basis behind the reactions which occur in the test
3.5.3 Responsibility
Who is responsible for performing the work described? Who is responsible for reporting the work?
Are there special training or certification requirements? i.e., who will be qualified to perform the
work described?
3.5.4 Reagents and Media
The Method should include a list of the reagents or media used, which should include:
List of required reagents and/or media, Reagent name or chemical formula
Special safety requirements
Step-by-step instructions for reagent or media preparation
Degree of accuracy and any special handling instructions for measuring device
QC of reagents or media (e.g., pH testing or visual assessment)
Labelling requirements, including expiration, Storage requirements, including containers and
stability
Note
Only provide instructions for preparing reagents when the reagents are to be prepared each time the
procedure is performed
3.5.5 Equipment
Only include a list of equipment. Instructions for calibrations and maintenance are written as
separate procedures. They are only included in the technical procedure where they are performed
each time the procedure is done.
3.5.5.1 Procedures for equipment calibration should include the following:
Schedule for performing the calibration daily, weekly, monthly, semi-annually
Schedule for performing calibration verifications (Assaying of calibration materials in the same
manner as patient samples to confirm that the calibration of the instrument, kit or test system
has remained stable throughout the laboratorys reportable range for patient test results)
Calibration material specifications, preparation and storage
Source of the calibration material
Step-by-step instructions for performing the calibration, including expected readings
Troubleshooting guidelines
Documentation methods and storage requirements for calibration data
Page 54 of 85
3.5.5.2 Procedures for equipment maintenance should include the following:

Schedule for performing preventative maintenance daily, weekly, monthly, semi-annually
Step-by-step instructions for performing preventative maintenance or references to equipment
manuals containing instructions
Troubleshooting guidelines
Records for documenting results of maintenance
3.5.6 Supplies
The method should include a list of the supplies (consumables) used in performing the procedure.
E.g., disposable pipettes, pipette tips
3.5.7 Sample Information
The analytic procedure should include the following information regarding the sample required:
Sample type and source
Amount of sample required, including minimum requirements
Acceptable collection containers
Sample stability and storage requirements, Preservative/Additive
Criteria for acceptable samples and follow-up action
3.5.8 Special Safety Precautions
This is included when ADDITIONAL safety requirements - beyond the basic handling of hazardous
materials are necessary. They should include the following:
Engineering controls (E.g., Use of Fume hood)
Personal protective equipment (E.g., Respirators, gloves, face shields)
Work practice controls (E.g., Beginning a step only after certain conditions have been met or
precautions have been taken)
3.5.9 Quality Control
Instructions for QC are usually written as separate procedures. They are only included in the
technical procedure where they are performed each time the procedure is done.
QC procedures should include the following information:
Type of QC material to be used
Instructions for preparation and handling of control materials
Frequency with which controls must be run, number of controls to use
QC expected values and/or ranges
Explanation of control criteria (E.g., Accept or reject runs or batch criteria)
Corrective action, to be taken if controls do not meet the expected criteria
Instructions for documentation of QC data
Alternate QC measures (E.g. correlation)
3.5.10 Process/Method
Write in a step-wise fashion rather than lengthy paragraphs. Provide a COMPLETE listing of the
steps required to accomplish the analysis.
Page 55 of 85

3.5.11 Interpretation of Results
This section should include:
Comparison of the results to the expected values or to determine if the result is normal,
abnormal, or indeterminate. Follow-up for indeterminate results
Recognition of results that fall outside the reportable range, and reference back to the Method
Limitations section of the original procedure
Recognition and follow-up of results that exceed critical limits
3.5.12 Calculations (Quantitative procedures)
Quantitative analytic procedures should include the equations for calculations when they are
applicable to the test. Include:
The full equation
Step-by-step instructions to solve the equation, An example of how to solve the equation
Normal Values (Where applicable)
Include a range of expected values for the test result, where necessary or applicable.
Method Limitations
The limitations may be due to the method itself or interfering substances. Include the following:
Analytic sensitivity and specificity
Reportable range
Appropriate dilutions or reporting measures if the reporting range is exceeded
Interfering substances such as chemicals (E.g., Preservatives).
Procedure Notes (Hints, special precautions, comments)
Insert appropriate comments which could include special hazards in performing the test. If special
reporting of results is required it should be noted in this section.
3.5.13 References
Procedures should include the references that were used as the source of the information, when
applicable. References may originate from any of the following:
Manufacturers product literature
Text books
Published standards and guidelines
Laboratory policy manuals
Applicable regulations
3.5.14 Related Documents
Reference (List) other related procedures, e.g. Procedure for cleaning glassware
Records such as Forms used or data sheets produced
END OF PROCEDURE OUTLINE
Page 56 of 85
3.6 DOCUMENTATION CHECKLIST

The following checklist may be used to determine if you have developed the documents required for the
most crucial portions of the QMS. At minimum these documents will assist your system implementation and
ensure effective operation of the laboratory on a daily basis.
Figure 26 Documentation Checklist for the QMS Program
Do you have documentation to prove that these things have been done?
1. Policy Statement
The written policy statement has been:
Distributed to all employees
Yes
No
Yes
No
Properly explained to all employees

2. Responsibilities
Quality System responsibilities have been
communicated to:
Managers
Supervisors
Workers
Subcontractors
New managers have received a health and
safety orientation
3. Document control
Document control procedures are being
followed
4. Purchasing of Supplies
Items are inspected before use
Supplier Evaluations are performed
5. Non conformities
There are written procedures for
identifying and controlling NCs
There are written procedures for
performing corrective actions
6. Examination/Test Procedures
Examination/Test procedures have been
properly documented
Are available for use by relevant
employees
8. Quality Control
Procedures have been established and

implemented for Quality control
Trends are monitored and discordant
results are acted on
9. Training
Training records are kept for:
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Professional training
New worker orientation
Continuing education
First Aid training
All training sessions
Yes
No
Yes
No
Yes
No
10. Reporting & Investigating Accidents

Reports are kept for:
Critical injuries
Lost-time injuries
Medical aid injuries
Property damage
Accident investigations
Are Standard forms used
11. Internal Audits
Standard checklists are used
Planned audits are done as scheduled
Yes
No
Audit reports are kept

Deficiencies are corrected
Management Reviews are done
The recommendations are answered and an
action plan effected
Page 57 of 85

7. Accommodation and Environmental conditions
Yes
Environment suitable for testing
Proper housekeeping is performed
No
13. Personnel
Yes
Worker training records are kept

There are staff files/ records
3.7 USE OF FLOW DIAGRAMS

Flow charts are used to simplify a process by representing it in a diagrammatic fashion. They help
to clarify what outcomes are expected, and what should be done to provide better customer focus
and satisfaction. This is accomplished with an illustration of the sequence of steps that are
performed to produce an output. The output can be a product, service, information or a
combination of all three.
Many complex processes or procedures can best be illustrated by the use of flow diagrams.
Wherever possible, diagrams can form part of documented procedures and be used to simplify
complex text. It provides a simple mechanism for greater understanding of a process and better
identification of areas of variability, redundancy and potential waste and is an essential aid to
developing effective procedures.
You can prepare flowcharts for all processes and they can be used to identify the sequence of
activities involved in a process and to identify where documented procedures are needed to
describe a given task. The following is a listing of common flow chart symbols:
Page 58 of 85
No

Figure 27 Flowcharting Logic
To construct a List the steps
process flow chart
Sequence
the steps
Draw
appropriate
symbols
System Model
Check
Completeness
Determine the
boundaries
Use post-it
notes
so
you
can
move tasks
Do not draw
arrows until
later
Start with the

basic symbols
Draw charts using

system
(input
process-output)
approach
Input
use
information based
upon
people,
machines,
material, method
and environment
Ensure
document
control is Included and
complete, using title and
date for easy reference
Where does a
process begin?
Use a verb to
start the task
description
The flowchart
can either be
less
detailed
when providing
the information
to understand
the
general
process flow or
be very specific
and detail every
finite action and
decision
Process use
series
of
processes in steps
or parallel
Output use
outcomes
or
desired results
Where does a
process end?
Finalise the
flowchart
Ask if this
process is being
run the way it
should be
Are people
following
the process
as charted?
Do we have a
consensus?
Remove what is
redundant,
add
what is missing
Key to symbols:
Ovals show input to start the process or output at the end of the process
Boxes or rectangles show task or activity performed in the process
Diamonds show points in the process, where yes/no questions are asked or a decision is
required
Arrows show process direction flow, usually there is only one arrow out of an activity box.
If there is more than one arrow, a decision diamond is needed
If there are feedback arrows, make sure the feedback loop is closed, i.e. it should take you
back to an input box.
Small circles are connectors from one page to another
Flags contain a brief description of records generated while performing an action
Below are examples of the Flow chart symbols used in Quality Management. (See Appendix for example of
a flow chart)
Page 59 of 85
for

Figure 28 Flowchart symbols
An oval is used to show
the input to start the
process or the output at
the end of the process
Arrows show direction or the flow

taskprocess
or activity performed in the
of the
process
There is usually only one arrow

out of an activity. If there is more
than one arrow, you may need a
decision diamond
Make sure every feedback
loop is closed i.e. every path
takes you back or ahead to
another activity
A diamond shows
those points in the
process where a
yes/no question is
asked or a decision
is required
YES
An oval is used to show

the input to start the
process or the output at
the end of the process
Page 60 of 85
NO

CHAPTER 4 FAQs in LABORATORY QUALITY
What is Calibration?
Calibration is the process of comparing a measuring instrument against a measurement standard
to establish the relationship between the values indicated by the instrument and those of the
standard (standard in measurement is considered to be the reference base). The purpose of
calibration is to eliminate or reduce bias in your measurement system relative to the reference
base. The calibration procedure compares an "unknown" or test item(s) or instrument with
reference standards according to a specific algorithm.
Do all measuring instruments need to be calibrated?
All measuring devices usually need to be calibrated - whether they are simple devices or state-ofthe art systems - because certain characteristics change with time. There are situations where an
instrument need not be calibrated, for example where its readings are for information only and
their accuracy has little or no impact on the test, product or service being provided.
How often should an instrument be calibrated?
Calibration frequency can be established using manufacturers recommendations. In some cases,
commercial calibration laboratories can suggest intervals for particular instruments. There are two
main considerations when determining the calibration frequency. Firstly, the instruments
reproducibility should be taken into account - new devices should be calibrated frequently in order
to establish their reproducibility. Secondly, the required uncertainty of measurement should be
assessed. If the instruments reproducibility is shown, by successive calibrations, to be
substantially better than the uncertainty required then the interval between calibrations can be
extended. At the other extreme, where the instruments reproducibility approaches the uncertainty
needed, the calibration intervals should be much shorter.
To provide confidence in the accuracy of calibration results, the measurement must show
traceability. This means that all results associated with a calibration including those relating to
the calibration of the measurement standard used - must be traceable back to standards held at a
national measurement institute, through an unbroken chain of comparisons and where each link
has stated measurement uncertainties. In addition, it is important that appropriate equipment and
procedures are used in the calibration process, in that they are used by trained and authorized
personnel operating in an experimental environment.
Why perform calibrations?
To improve the measurement accuracy and reliability of the instrument
To reduce the number of end-products rejected because they are outside acceptable
tolerances
To provide products with reduced and more competitive tolerances, better reliability, and
access to quality-conscious markets
To minimize unnecessary rework and delays, resulting in customer dissatisfaction
To eliminate health and safety, legal and regulatory issues
Page 61 of 85

What is Traceability?
Traceability is the property of the result of a measurement whereby it can be related to appropriate
measurement standards, generally international or national standards, through an unbroken chain
of comparisons (traceability chain) in which all uncertainties are indicated. It should be noted that
the instrument itself is not traceable, but the result produced by the instrument is! Traceability
applies to both physical and chemical measurements. The standard referred to is a material
measure, measuring instrument, reference material or measuring system that define, realize,
conserve or reproduce a unit, or one or more values of a quantity to serve as a reference.
What is Traceability to international standards?
Representatives of seventeen nations signed the Metre Convention treaty which provided the
foundation for the establishment of the International System (SI) Units. Since then, national
standards laboratories have cooperated in the development of measurement standards that are
traceable to the SI.
The units of measurement with the highest accuracy are realized by international measurement
standards. The value of the international standard is usually determined by comparison of national
standards of the highest quality, or in the case of the kilogram by the mass of the International
Prototype. National measurement standards, maintained in a National Metrology Institute (NMI) are
compared with these international standards before they are used as a reference for calibration of
standards of lower precision. Therefore it is possible to demonstrate an unbroken chain of
comparisons that ends at a national standards body.
What is the traceability chain?
It is a series of comparisons between the device under test to a reference. The final comparison in
the chain is made using the International System (SI) units as a reference. Each comparison is a
link in the chain and the uncertainty of each comparison (link) must be known and documented.
NMIs provide the ultimate measurement references for their country. The intent of all NMIs is to
realize the SI units as closely as possible so that traceability to the SI can be established by
comparing to an NMI that in turn compares its references to the SI.
SI UNITS
Primary National Standard

NMI
Secondary Standards
NMI
Working Standards
NMI or other
Calibration of instrument
Page 62 of 85
What are the benefits of Traceability?

Allows you to be competitive and operate in the global environment thus reducing technical
barriers to trade
It provides another way of guaranteeing a measurements accuracy.
It is an essential element of quality control systems

It links people, organizations, documents, techniques and measurements within a large and
diverse measurement community
What is Measurement Uncertainty?

Test or calibration measurements are subjected to imperfections in each step of the process from
sampling to final measurement. Measurement uncertainty (also referred to as uncertainty of a
measurement) is the term used to describe this imperfection, and is defined as the parameter
associated with the result of a measurement, that defines the range of the values that could
reasonably be attributed to the measured quantity. This indicates the interval within which the true
value of the quantity being measured is expected to lie with a stated level of confidence.
How is measurement uncertainty evaluated?
Measurement uncertainty is evaluated by quantifying and combining a number of uncertainty
components, which can be:
Random Effects e.g., fluctuations in temperature, humidity, air-pressure, variability in
performance of the measurement, sampling.
Systemic Effects e.g., offset of measuring instruments, drift in its characteristics between
calibrations, personal bias in reading an analogue scale or uncertainty of the value of a
reference standard.
The components are quantified either by evaluation of the results of several repeated
measurements, or by estimation based on data from records, previous measurements, knowledge
of the equipment and experience of the measurement. The evaluation from repeated
measurements is done by applying a mathematical formula derived from statistical theory. The
parameter determined is the standard uncertainty expressed as a standard deviation.
Measurement uncertainty is usually written as an expanded uncertainty and provides an interval
within which the value of the measurand is believed to lie with a higher level of confidence. It is
obtained by multiplying the combined standard uncertainty by a coverage factor (k); where k is
based on the level of confidence desired. For a level of confidence of 95%, k is 2.
Why is measurement uncertainty important?
It provides laboratories and customers with valuable information about the accuracy and reliability
of test or calibration data.
It tells how well the results represent the value of the quantity being measured.
It gives confidence in comparability of results (which help to reduce barriers to trade).
It shows whether the result is within the acceptable limits or outside of it.
It is a requirement of ISO 17025:2005 (5.4.6).
Page 63 of 85

What is quality control (QC)?
Quality control (QC) is an integral part of a laboratorys operation. It is defined as the observation
techniques and activities used to fulfill requirements for quality. The control can be a substance,
sample or procedure intended to verify performance characteristics of a system. QC should not be
confused with quality assurance (QA), which encompasses everything a laboratory does to assure
high quality services to its customers.
Why establish a QC program?
Your QC program should be a monitoring system that provides immediate information about the
acceptability of results, as well as a method for evaluating data over time. Most control material is
accompanied by stated target values for the mean and standard deviations (S.D.). These stated
values may be used if they correspond to the methodology and instrumentation employed by the
laboratory. If they are not provided, then calculate the parameters after a statistically significant
number of control determinations have been completed (repetitions of 20 or more). Develop control
charts using the mean and S.D. to record the results of the control. Establish criteria for
acceptability, e.g. by applying Westgard rules to analyze the data. Also, develop policies and
procedures for remedial action for QC failures and apply them as needed to maintain accurate and
reliable test results.
What to look for on QC charts?
1.
Excessive scatter points are widely scattered above and below the mean. It shows poor
reproducibility of results. Common cause is operator variability in pipetting or inattention to
critical steps in the procedure.
2.
Bias majority of points fall either above or below the mean. The two most common
causes are an error in calibration or an error in reconstituting a control material.
3.
Drift or trend QC results move away from the mean in a particular direction over an
extended period of time. Causes are outdated reagents, deterioration in reagents or
instrument is losing its calibration.
4.
Shift controls suddenly change from moving above and below the mean to a line that is
either always above the mean or always below the mean. Common causes are:
recalibration was just performed; change in reagent lot; sudden deterioration of reagent
(possibly not refrigerated overnight); new analyst; major change instrument performance.
What are the benefits of QC?
Demonstrates analytical capability of laboratory personnel.
Monitors the stability of test methods or systems.
Assesses the accuracy and precision of test results and test methods.
Alerts the analyst if there is a problem with the reagent, test method, or instrument.
Allows the laboratory to track the overall performance of a test procedure over time.
Detects random and systemic errors.
Page 64 of 85

What is Method Validation?
Method validation is defined as the confirmation, through the provision of objective evidence, that
the requirements for a specific intended use or application have been fulfilled. The aim is to
establish the operational limits and performance characteristics of a new, modified or otherwise
inadequately characterised test method.
When is Method Validation done?
Test methods should be validated when:
a new test method is being developed
an established test method is modified
QC indicates that an established method is changing with time
demonstrating the equivalence between two methods, e.g. a new method and a standard
method.
How is Method Validation done?
The experiments used to determine method performance characteristics should be conducted with
equipment that is within specification, working correctly and adequately calibrated. The analyst
carrying out the experiments must be competent in the field of study and capable of making
appropriate decisions from the data produced during the study.
The following are common characteristics tested during method validation studies:
Specificity/selectivity ability to accurately measure the analyte in the presence of
interferences.
Linearity - ability of an analytical method to produce test results which are proportional to
the concentration of analyte in samples within a given concentration range.
Accuracy closeness of the measured value to the true value for the sample.
Range the concentration interval over which acceptable accuracy, linearity and precision
are obtained.
Precision (Repeatability & Reproducibility) the amount of scatter in the results obtained
from multiple analyses of a homogeneous sample.
Detection Limit lowest concentration of the analyte that can be confidently detected by
the method.
Quantization Limit strictly the lowest concentration that can be determined with an
acceptable level of repeatability, precision and trueness.
Robustness ability of the test method to remain unaffected by small but deliberate
changes, e.g. temperature.
Recovery assesses the efficiency of the method in detecting all of the analyte present.
Why is Method Validation necessary?
To provide objective evidence that the results are accurate and reliable
To demonstrate that a test method is fit for purpose
Validation data can be used to design QC programs
Page 65 of 85

What is Verification?
Test method verification is a simplified validation process employed to check or verify a test
methods performance characteristics. It typically includes a subset of the parameters evaluated
when a complete validation is performed, and asks the question Does this new test method
perform to its specification in my laboratory?
When is Verification done?
It should be done before a new externally validated test method is employed by the laboratory to
report results.
How is Verification done?
The laboratory should:
Develop a clear, detailed verification procedure that defines the parameters to be
evaluated.
Define and approve the acceptance criteria (e.g., manufacturers package insert) to be
used in analyzing the results.
Compare experimental results to the previously established performance characteristics.
Based on the results, accept or reject the test method.
Summarize the data collected from the verification study in a final report.
The following is the most common subset of characteristics used in verification studies:
Characteristics Analyzed
Accuracy
Precision
Reportable range of test results for the
test method
Manufacturers reference intervals
(medical laboratories)
Types of Experiments Performed

Comparison of methods to estimate inaccuracy or
bias
Replication experiment to estimate imprecision
Linearity type experiment to estimate imprecision
and to determine reportable range
Collecting reference values to verify the established
reference range
Why is Verification necessary?

To provide objective evidence that your laboratory has the ability to achieve acceptable
results for a given test method.
To prove that an externally validated test method is acceptable for its intended use.
Page 66 of 85

CHAPTER 5 APPENDICES
Appendix 1 Summary of Clauses in ISO/IEC 17025
General Requirements for Quality and Competence in Testing and Calibration Laboratories.
Following is a summary of its requirements:
MANAGEMENT REQUIREMENTS
4.1
Organization
Laboratory management shall have responsibility for the design, implementation, maintenance and
improvement of the quality management system.
4.2
Management system (QMS)

The QMS shall have all its procedures documented. It shall include internal quality control and
participation in interlaboratory comparisons. A quality policy statement and a documented quality
manual are needed.
4.3
Document control
Define, document and maintain procedures to control all documents and information. Define retention
periods and archive documents for later reference.
4.4
Review of Request, tenders and contracts

Ensure that all parties understand and abide by the provisions made in contracts. Keep records of all
reviews, including significant changes and maintain these records.
4.5
Subcontracting of tests and calibrations

Have procedures for evaluation and selection of subcontracted laboratories and consultants. Maintain
a register of all subcontractors used.
4.6
Purchasing External services and supplies

Ensure external services, equipment and consumable supplies consistently meet the laboratorys
standards. Have an inventory control system and quality records of external commodities purchased.
4.7
Service to the client

Clients shall be afforded consideration to verify their samples are appropriately handled and analyzed.
Confidentiality shall be maintained.
4.8
Complaints
Keep records of any complaints or feedback and of investigations or corrective action taken by the
laboratory.
4.9
Identification and control of non-conformities

When a non-conformity is detected: a) Personnel must be designated for problem resolution; b)
Corrective action must be defined and taken immediately; c) The deviation must be documented, and
reviewed by staff.
4.10 Improvement
Review all procedures at regular intervals to identify any potential source of non-conformance. Action
plans must be developed, documented and implemented as appropriate.
Page 67 of 85

4.11 Corrective Action
Carry out investigations to determine the root causes of problems. Document and implement any
changes made to procedure. Review all procedures regularly and take action to improve the system.
4.12 Preventive Action
Identify any necessary improvements and areas of non-conformities, either technical or concerning
the management system. Develop action plans and procedures to reduce the likelihood of potential
non-conformities.
4.13 Control of records
Establish procedures for
Identification
Collecting, Indexing, Access
Maintenance
Safe disposal of quality and technical records
4.14 Internal Audits
Formally and periodically carry out internal audits to ensure that the QMS is maintained.
4.15Management review
Laboratory management must periodically review the QMS to maintain and improve the system.
Findings must be recorded and any corrective action needed must be taken immediately.
TECHNICAL REQUIREMENTS
5.1
5.2
General
Personnel
Define qualifications and duties for all personnel. Implement the Quality Management System (QMS)
and procedures.
5.3
Accommodation and environmental conditions

Ensure the facilities for examination allow for correct performance of tests and reliability of results.
5.4
Test and Calibration Methods and Method validation

Use only relevant, validated, documented procedures which meet the needs of the users of the
laboratorys services. Record any deviations or changes in procedure.
5.5
Equipment
Provide the laboratory with relevant, functioning and calibrated equipment. Ensure authorized
personnel operate equipment in a safe working environment.
5.6
Measurement Traceability
The laboratory must have documented evidence that measurements made by the laboratory can be
traced to the International System of Units (SI). Calibration certificates issued by or to laboratories
shall contain the measurement results, including the measurement uncertainty or a statement of
compliance with an identified metrological specification.
5.7
Sampling
Sampling plans should be based on sound statistical sampling techniques. The laboratory must be
sure that there is a good understanding and agreement between the customer and the laboratory as
Page 68 of 85

to how the sampling process is to be carried out. It must be properly documented and carried out
according to an authorized sampling plan and its associated procedures.
5.8
Handling of Test and Calibration items

Authorized personnel must review results and determine reliability before releasing results. Disposal
of samples must be in accordance with local standards.
5.9
Assuring the Quality of test and calibration results

Establish quality control methods to verify attainment of quality results. Document, record and retain
records of results. Take action if results are suspected to be incorrect.
5.10 Reporting results

Results must be reported legibly, unambiguously and in an identifiable manner. Use an audit log if the
present reporting system cannot capture changes or alterations
Page 69 of 85

Appendix 2 List of Policies in ISO/IEC 17025
Policy Name (Description)
ISO 17025
Clause Number
For ensuring the protection of confidential information
4.1.5c
For avoiding involvement in activities that would

diminish confidence in its competence, impartiality,
judgment or operational integrity
4.1.5 d
Quality Policy Statement
4.2.2
For conducting review of requests, tenders and

contracts
For the selection and purchasing external services and
supplies, equipment and consumable supplies that
affect the quality of Tests and Calibrations
4.4.1
For the resolution of complaints
4.6.1
4.8
To identify and control nonconformities when they

occur
To designate appropriate authorities for implementing
corrective actions
For identifying training needs and providing personnel
training
Page 70 of 85
4.9.1
4.11.1
5.2.2
Section in Quality
Manual
Done
Not
Done

Appendix 3 List of Procedures in ISO/IEC 17025
Procedure Name (Description)
For ensuring protection of confidential information
ISO
17025
Clause
Number
4.1.5c
For avoiding involvement in any activities which would diminish

confidence in its competence, impartiality, judgment, or
operational integrity
4.1.5d
To control all documents
4.3.1
Approval and issue of documents
4.3.2.2
For hand amendments of documents pending re-issue (if

allowed)
To describe changes in documents maintained in the
computerized systems are made and controlled
4.3.3.3
4.3.3.4
For review of requests, tenders and contracts
4.4.1
For the selection and purchasing external services and supplies

that affect the quality of tests and calibrations
4.6.1
For the resolution of complaints
4.8
To identify and control nonconformities when they arise
4.9.1
To designate appropriate authorities for implementing corrective

actions
4.11.1
To identify, document and eliminate the root cause(s) of

nonconformities
4.11.2
For initiating and monitoring preventive actions
4.12.2
For identification, collection, indexing, access, storage,

maintenance and safe disposal of records
4.13.1.1
To protect and back up records stored electronically
4.13.1.4
For internal audits which include the types of audit, frequencies,

methodologies and required documentation
4.14.1
For conducting Management reviews
4.15.1
For checking that the environment does not adversely affect the
performance of specimen collection and equipment
5.2.2
To ensure good housekeeping
5.3.5
Test and Calibrations methods
5.4.1
Procedure for validating test methods
5.4.5.2
For estimating uncertainty of measurement for calibration labs
5.4.6.1
For estimating uncertainty of measurement for testing Labs

performing calibrations
5.4.6.2
For protecting the integrity of (electronic/computer) data at all
5.4.7.2b
Page 71 of 85
Section in
Quality/Procedure
Manual
Done
Not
Done

times
Up to date instructions on the use and maintenance of equipment
5.5.3
For safe handling, transport, storage and use of equipment
5.5.6
For performing intermediate checks to maintain confidence in the

calibration status of equipment
5.5.10
For ensuring correction factors are correctly updated
5.5.11
For calibration of equipment
5.6.1
For calibration of reference standards
5.6.3.1
For intermediate checks to maintain confidence in the calibration

status of reference, primary, transfer or working standards and
reference materials
5.6.3.3
For safe handling, transport, storage and use of reference

standards
For sampling performed by the lab
5.6.3.4
5.7.1
For recording relevant data and operations relating to sampling
5.7.3
For transportation, receipt, handling, protection, storage,

retention and/or disposal of test/calibration items
5.8.1
For avoiding deterioration, loss or damage to the test or

calibration item during storage, handling and preparation.
5.8.4
Quality control procedures for monitoring the validity of tests

and calibrations undertaken
5.9.1
Page 72 of 85

Appendix 4 List of SHALLs in ISO/IEC 17025
Requirement
Met
Not Met
N/A
Clause
The laboratory shall be an entity that can be held legally

responsible.
The laboratory management system shall cover all work carried
out in permanent and mobile facilities
4.1.1
If personnel do perform other activities than testing, e.g.

consulting, the organization shall be defined in order to identify
conflicts of interest
4.1.4
4.1.3
The laboratory shall have personnel and resources needed to

carry out its duties according to its scope of accreditation
4.1.5.a
The laboratory shall have arrangements to avoid that their

personnel are not influenced of internal / external pressure that
could influence the quality of their work, e.g. paid by the number
tests performed
The laboratory shall have policy and procedures to avoid
involvement in anything that could diminish its confidence
4.1.5.b
The laboratory shall define its organization and management

structure and the relationships in the in the organization, e.g. by
using an organization chart.
4.1.5.e
The laboratory shall specify the responsibility, authority and

interrelations of personnel that could influence the test results.
4.1.5.f
The laboratory shall provide supervision of testing staff, including

trainees, by competent personnel.
4.1.5.g
The laboratory shall have technical management with the

competence and resources needed with the overall responsibility
for the quality.
4.1.5.h
The laboratory shall appoint a Quality Manager.
4.1.5.i
The laboratory shall appoint deputies for key personnel.
4.1.5.j
The laboratory shall establish, implement and maintain an

appropriate quality system for its activities.
4.2.1
The laboratorys quality system and policies shall be defined in a

named Quality Manual.
4.2.2
The quality policy statement shall be signed by the management.
4.2.2.a-e
The Quality Manual shall make references to supporting document

systems and outline the structure of the system.
Page 73 of 85
4.1.5.d
4.2.3

The roles of responsibilities of the Technical Management and
Quality Manager shall be defined.
4.2.4
The laboratory shall include / make references to external and

internal documents in the quality system.
4.3.1
All documents issued as part of the quality system shall be

reviewed and approved. A master list (or equivalent) shall outline
the documented quality system and be used to control the
documents.
The procedures adopted shall ensure that:
-
Authorized documents are available where needed
Documents are periodically reviewed and if necessary
4.3.2.1
4.3.2.2
Replaced
-
Invalid/obsolete documents are removed and marked as such
Quality system documents generated by the lab shall have id,

page numbering, and information if they are valid and be
authorized.
Changes to documents shall be reviewed and approved by the
same function that made the original.
4.3.2.3
Altered text in documents shall if possible be identified in the

revised document.
4.3.3.2
If the laboratory allows that changes are made by hand in

documents, that procedure must be documented.
4.3.3.3
If changes to electronic documents are allowed, that procedure

must be documented.
4.3.3.4
The laboratory shall have procedures for the review of requests,

tenders and contracts.
4.4
Records of reviews (including subcontractors) shall be

maintained.
When the laboratory is going to use a subcontractor, it shall use a
competent one.
4.3.3.1
4.4.2 / 4.4.3
4.5.1
The laboratory shall inform the client if the laboratory uses

subcontractors
4.5.2
The laboratory shall maintain a register with its approved

subcontractors and their competence.
4.5.4
The laboratory shall have a policy and procedure for the selection
of purchasing of services and supplies and a procedure for the
approval of bought goods.
The laboratory shall offer its clients service.
Page 74 of 85
4.6.1 / 4.6.2
4.7

The laboratory shall have a policy and procedure for complaints
and a list of received complaints.
4.8
The laboratory shall have a policy and procedure to control non

conforming work.
4.9.1
The laboratory shall monitor the effect of any corrective action.
4.10.4
When there is a doubt that the laboratory does not follow its own
procedures, the laboratory shall perform an internal audit:
4.10.5
If there is the need / opportunity to perform a preventive action the

laboratory shall do that.
4.11
The laboratory shall have a system for archiving of its documents.
4.12
Each observation etc. shall be documented in such a way making

it possible to identify the responsible person, and if of importance,
the time.
4.12.2.1
Mistakes shall not be tippexed or erased, the wrong note shall

be over-lined, dated and signed together with the correct result.
4.12.2.3
The laboratory shall have a procedure and a predetermined

schedule for internal audits covering the whole quality system.
4.13
The management shall periodically, according to a schedule,

perform management reviews.
4.14
The laboratory shall ensure the competence of its personnel. That

competence shall be documented.
5.2.1
The laboratory shall have a policy about training/competence and

a procedure to detect the need of training.
5.2.2
The laboratory shall have up-dated documented job descriptions.
5.2.4
The laboratory shall have documented authorizations for

personnel to perform specific tasks, e.g. signing of test reports.
5.2.5
The laboratory must have facilities and environment that does not
affect the test result.
5.3.1
The laboratory shall, if necessary monitor, control and record

environmental conditions.
5.3.2
The laboratory shall use appropriate test methods and laboratory

specific SOPs where needed.
The laboratory shall inform the client of the appropriate method to
meet the clients needs; the lab shall choose international,
regional or national methods or methods published in reputable
organizations / technical journals or methods proposed by the
manufacturer of the equipment used.
Non standard methods shall be validated before use.
5.4.1
Page 75 of 85
5.4.2
5.4.4 / 5.4.5.2

When calibrating, the uncertainty shall be estimated.
5.4.6.1
Testing laboratories shall have procedures to estimate its

uncertainty.
5.4.6.2
Calculations and data transfers shall be checked periodically.
5.4.7.1
The laboratory shall validate own developed software and have

procedures to protect data stored electronically, e.g. log in / user
name and backups.
The laboratory shall have the equipment needed to perform the
tests.
Used equipment shall have the quality needed and shall be
appropriate calibrated.
5.4.7.2
The equipment shall be operated by competent persons;

instructions shall be available where needed.
5.5.1
5.5.2
5.5.3
Each item of equipment shall be identified and properly

documented.
Equipment suspected to function incorrect shall be prevented for
unintended use.
5.5.4 / 5.5.5
When intermediate checks (verifications) are needed to guarantee

the function of a piece of equipment those checks shall be
performed according to a defined plan and procedure.
5.5.10
The laboratory shall have a program for calibration of its

equipment.
5.6.1
5.5.7
When necessary the testing laboratory shall have traceability to SI

units for the physical factors in question.
5.6.2.2
The laboratory shall have a program and procedures for the

calibration of its reference standards.
5.6.3.1
Reference material shall be traceable to SI units or to certified

reference material if possible.
5.6.3.2
The laboratory shall have procedures to ensure the calibration

status of its standards and reference material.
5.6.3.3
The laboratory shall have procedures for the handling of its

standards and reference materials.
5.6.3.4
If the laboratory carries out sampling, it shall have a plan and

procedure for that.
5.7
The laboratory shall have procedures for receipt, transport, pretreatment labeling / identification etc. of test items.
5.8.1 / 5.8.2
If any abnormal is detected upon receipt of a test item that shall

be recorded and noted in the test report.
5.8.3 /
5.10.3.1.a /
5.10.3.2.e
Page 76 of 85

The laboratory shall have plans and procedures for monitoring the
validity of its results. Systems shall be used in order to detect
trends, e.g. the use of statistical evaluations.
5.9
The result shall be presented in a calibration certificate or test

report fulfilling the requirements in ISO 17025.
5.10
If opinions and interpretations are included in the report, the basis

of that must be explained and clearly separated from the result.
5.10.5
If subcontractors have been used that must be clear from the

report.
In the case of electronic transmission of results that must be
agreed (in writing) with the client and the requirements in ISO
17025 must be met.
5.10.6
Additions or corrections to a test report can only be made by a

new document with an explanation.
5.10.9
Page 77 of 85
5.10.7

Appendix 5 Document Control Checklist
Instructions - If the laboratory has implemented the action, process or procedure referred to, the auditor will
tick YES and state in the Proof/Comments column what was seen to verify or prove implementation. If not,
then tick NO and include any relevant and useful comments
Yes
No
Proof/Comments
1. Is there an up to date SOP for document control?
2. Is the document current and within review date?
3. Is there evidence that the document has been prepared,
checked and approved by a suitably qualified member
of staff?
4. Does the document have the necessary information
such as version number, unique identification, title,
review dates, etc.?
5. Is there evidence of cross referencing to other
documents?
6. Is there evidence that documents are accessible and
secure?
7. Is there evidence of appropriate document distribution?
8. Is there evidence that this is working?
9. Is there evidence of a process for document change?
10. Is there evidence of a backup procedure for the
document control system?
11. Is there evidence that previous versions of documents
have been archived?
12. Are previous versions of documents available for
retrieval?
13. Is there evidence that staff adhere to the document
control procedure?
14. Is there evidence that out of date documents are being
withdrawn from circulation?
15. Are out of date documents reviewed?
16. Are they in date, appropriately formatted etc?
17. Is there evidence of regular document review?
18. When was the last document review?
19. Is staff trained in document control?
20. Do they have documented evidence of the training?
21. Is their adequate back-up of documents?
22. Is staff informed when documents are updated and
available?
Page 78 of 85
Appendix 6 Example of a Flowchart
Responsibilities
Quality
Manager
Quality
Manager
START
Identify persons to train as auditors
Documents
Generated
List of Trainee
Internal Auditors
Identify facilitator and establish

bj i
Training Proposal
Trainer
Develop training materials
Training Manual
Human
Resources
Schedule and organize training
Training Schedule
Trainer
Conduct training
Attendance
Register
Evaluation Forms
Quality
Manager
Is the
training
effective?
No
Conduct
investigation
& document
findings
Competency
Evaluation
Investigation
Report
YES
Quality
Manager
Quality
Manager
Update training records
Personnel Records
Plan and execute Audits
Audit plan and

schedule
END
Page 79 of 85

Appendix 7 Checklist for reviewing Quality Management System Implementation
This checklist will be used to review the Quality Management Implementation process being conducted by
the Lab against ISO/IEC 17025. Items from this checklist are discussed in detail in the standards. If the
item is present simply tick
the checkbox, otherwise leave it blank if element is not available.
Note that all items below must be included in a QMS. If an item is not relevant, an explanation must be
provided. Also note that the process may either be described or referenced in the Quality Manual; however,
all references should be readily accessible within the organization and provided to the Staff.
Lab Name:
Lab Address:
Country :
Tel:
Quality Manager:
Fax:
Email:
Yes
ORGANIZATION
1.
Is Legal status of Laboratory identified and available (e.g. Company

registration certificate, etc)?
2.
Are arrangements for confidentiality and impartiality outlined?
3.
Is there a description of the process for resolving disputes?
4.
Is there a statement of the organization's Quality policy?

4a. Q policy statement includes general objectives/goals?
4b. Q policy statement includes requirements from standard?
5.
Is organizational chart available?

5a. Organizational chart identifies all important Managerial/Technical
positions of the organization?
5b. Organizational Chart identifies position of QA manager and lines of
reporting?
6.
Does it include authorities and independence of the QA manager and

staff?
7.
Describes procedures to ensure QA staff has access to appropriate levels

of management?
Page 80 of 85
Comments/Page(s)

Yes
8.
Discusses how management assures understanding and implementation in

all programs?
9.
Identifies how internal coordination of QA and QC activities is performed?
QUALITY SYSTEM COMPONENTS

11. Describes principal quality system components (e.g., quality manual,
administrative procedures, test procedures, records management
system, annual reviews and planning, project-specific quality
documentation? (Please identify the components in Comments section.)
12. Description of components includes how they are implemented and
responsibilities of management and staff??
13. Lists responsibilities for implementing each component (e.g., Quality
Systems Audits, Training Plans, Management review?
14. Identifies review and approval procedures?
QUALIFICATIONS AND TRAINING
15. Is there a policy regarding Quality training for management and staff?
16. Does it describe the process for identifying, maintaining, ensuring, and
documenting that personnel have necessary quality-related
qualifications?
16a Have records of competency analysis been prepared?
17. Is there a process for identifying the need for quality-related retraining
based on changing requirements and the roles, responsibilities, and
authorities for these processes?
PROCUREMENT OF ITEMS AND SERVICES
18. Is there a process for reviewing and approving all purchase agreements?
18a. The process ensures documents are complete and accurate and
agreement clearly describes the item or service needed?
18b. The process ensures agreement describes the associated technical
and quality requirements?
18c. The process ensures agreement describes the quality system
elements for which the supplier is responsible?
18d. The process ensures that the suppliers conformance to the
customers requirements will be verified?
19. Describes process for reviewing and approving applicable requisitions to
ensure that they satisfy all technical and quality requirements?
19a. Review process ensures the review of evidence of the suppliers
capability to satisfy quality requirements?
Page 81 of 85
Comments/Page(s)

Yes
19b.Review process ensures procured items and services are
acceptable?
20. Describes process for review and approval of suppliers quality-related
documentation (e.g., QA Project Plans and QMPs)?
21. Describes roles, responsibilities, and authorities for the above processes
process to ensure policies are satisfied?
DOCUMENTS AND RECORDS
24. Describes process for identifying quality-related documents and records
(including electronic) requiring control?
25. Describes procedure for preparing, reviewing, approving, issuing, using
and revising documents and records?
26. Describes process for maintaining documents and records including
confidentiality, transmittal, distribution, retention, access, preservation,
traceability, retrieval, removal of obsolete documentation, and disposal?
26a. Have all test methods been documented?
27. Does it describe the roles, responsibilities, and authorities for the above
processes?
COMPUTER HARDWARE AND SOFTWARE
28. Describes process for developing, installing, testing, using, maintaining,
controlling, and documenting computer hardware and software?
29. Describes process for assessing and documenting the impact of changes
to user requirements and/or the hardware and software on performance?
30. Describes process for evaluating purchased hardware and software?
31. Describes process for ensuring that data and information produced from or
collected by computers is backed up and secured?
32. Describes the roles, responsibilities, and authorities for the above
processes?
PLANNING
33. Includes a description of the systematic planning process for operations
and identification and involvement of all customers and suppliers?
34. Does process include specification of needed QA and QC activities to
assess the quality performance criteria?
35. Does process include specification of performance criteria for measuring
quality (e.g. Control chart)?
processes?
Page 82 of 85
Comments/Page(s)

Yes
IMPLEMENTATION OF WORK PROCESSES
37. Describes process for ensuring that work is performed according to
planning and technical documents?
38. Describes the roles, responsibilities and authorities for the above process?
AUDIT
39. Describes the process for assessing the adequacy of the quality system at
least annually?
40. Describes the process for planning, implementing and documenting audits
and reporting results to management?
40a. Process includes selecting an audit tool, the expected frequency,
and the roles and responsibilities of assessors?
40b.Process includes determining the level of competence, experience
and training needed for audit personnel?
40c. Process includes ensuring that personnel have no real or perceived
conflict of interest, and have no direct involvement or
responsibility for the work being assessed?
40d.Process includes ensuring that personnel conducting audits have
sufficient authority, access to programs and managers, access to
documents and records?
41. Describes process for managements review of, and response to findings?
42. Describes process for identifying how and when corrective actions are to
be taken in response to the findings of the audit?
42a. Process includes ensuring corrective actions are made promptly
and actions documented?
42b.Process includes confirming the implementation and effectiveness of
any corrective action?
43. Are past QS management audit findings resolved? (Put date of Final Report
in Column 3.)
processes?
QUALITY IMPROVEMENT
44. Describes process for ensuring that conditions adverse to quality are
prevented, identified promptly, corrected promptly and that actions are
taken toward prevention, documented and actions tracked to closure?
45. Describes process for encouraging staff to establish communications
between customers and suppliers, identify process improvement
opportunities, and identify and propose solutions for problems?
46. Describes the roles, responsibilities and authorities for the above
processes?
Page 83 of 85
Comments/Page(s)

Yes
OTHER REVIEW CRITERIA
47. Have all administrative procedures as required by standard been
documented and implemented?
48. Has scope of testing been defined and documented?
49. Have staff been trained in use of the QMS documentation?
50. Has a Quality team been designated?
Page 84 of 85
Comments/Page(s)
REFERENCE DOCUMENTS
Preparing For Accreditation: Guidance on Implementation of Quality Management Systems (QMS) for Medical
Laboratories. A QMS How To Guide. Edition 1 December 2006 Strengthening Of Medical Laboratory Services In The
Caribbean. A CARIFORUM Project Funded by the European Union (CAREC EU Project)
Estimation of uncertainty of measurement in Medical Laboratories, 12th September 2006. European Diagnostic
Manufacturers Association Position paper. www.edma-ivd.be
M3003 The Expression of Uncertainty and Confidence in Measurement, Edition 2 August 2006 United Kingdom
Accreditation Service www.ukas.com
Uncertainty of Measurement in Clinical
www.ifcc.org/ejifcc/vol13no4/130401006
Microbiology.
Fuentes-Arderiu
X,
eJIFCC
vol
13
no.
International Laboratory Accreditation Cooperation (ILAC) Documents www.ilac.org

ILAC G2 Traceability of Measurement
ILAC G9 Guidelines for the Selection and Use of Certified Reference Materials
ILAC G13 Guidelines for the requirements for the Competence of Providers of Proficiency Testing Schemes
Clinical laboratory testing and in vitro diagnostic test systems
ISO 15189:2003
Medical laboratories Particular requirements for quality and competence
ISO 15190:2003
Medical laboratories Requirements for safety
ISO/TR 22869:2005
Medical laboratories Guidance on laboratory implementation of ISO 15189:2003
Quality Management Standards
ISO/IEC 17025:2005
General requirements for the competence of testing and calibration laboratories
ISO/IEC 17043
Conformity Assessment General Requirements for Proficiency testing
ISO/IEC Guide 2:2004
Standardisation and related activities General Vocabulary
ISO/IEC 17000
Conformity Assessment - General Vocabulary
ISO 19011:2002
Guidelines for quality and/or environmental management system auditing
ISO/TR 10013:2001
Guidelines for Quality Management System documentation
ISO 10002: 2004
Quality Management Customer Satisfaction Guidelines for complaints handling in

organisations
ISO 10002: 2004
Quality Management Customer Satisfaction Guidelines for complaints handling in

organizations
ISO 9000
Quality Management Systems Fundamentals and vocabulary
ISO 9001
Quality Management Systems Requirements
Page 85 of 85
4.

QMS For Laboratories Testing and Calibration ISO 17025

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GUIDANCE ON

QUALITY MANAGEMENT SYSTEM GUIDANCE

CARICOM Regional Organisation for Standards and Quality (CROSQ)

QUALITY MANAGEMENT SYSTEM GUIDANCE

This Manual is dedicated to my colleague and dear friend

QUALITY MANAGEMENT SYSTEM GUIDANCE

QUALITY MANAGEMENT SYSTEM GUIDANCE

QUALITY MANAGEMENT SYSTEM GUIDANCE

Strengthening regional communication through providing a mechanism for negotiation and

QUALITY MANAGEMENT SYSTEM GUIDANCE

CHAPTER 1 LABORATORY QUALITY FUNDAMENTALS

A laboratory shall periodically and in accordance with a predetermined schedule and

QUALITY MANAGEMENT SYSTEM GUIDANCE

1.2 QUALITY TERMS AND DEFINITIONS

QUALITY MANAGEMENT SYSTEM GUIDANCE

QUALITY MANAGEMENT SYSTEM GUIDANCE

QUALITY MANAGEMENT SYSTEM GUIDANCE

ACCREDITATION vs. CERTIFICATION

Why Is a Laboratorys Technical Competence Critical?

QUALITY MANAGEMENT SYSTEM GUIDANCE

How does a Laboratory Apply for Accreditation?

External Audit by pre-Assessment Visit with Experts from

Application to Accreditation Body

Accreditation Body Document Review On-site

Review of Documents forwarded by laboratory previously

Laboratory Corrective Actions

QUALITY MANAGEMENT SYSTEM GUIDANCE

QUALITY MANAGEMENT SYSTEM

Measures of performance (Time, quantity,

QUALITY MANAGEMENT SYSTEM GUIDANCE

What are Quality Objectives?

1.5 DOCUMENT HIERARCHY

QUALITY MANAGEMENT SYSTEM GUIDANCE

Figure 3 Document Hierarchy

What are the Benefits of a QMS?

QUALITY MANAGEMENT SYSTEM GUIDANCE

QUALITY MANAGEMENT SYSTEM GUIDANCE

1.6 A STEPWISE APPROACH TO DEVELOPING A QMS

(Model developed by Manfred Kindler, Berlin, Germany)

QUALITY MANAGEMENT SYSTEM GUIDANCE

THE 20 MILESTONES FOR TESTING LABORATORIES

Legal status established

Conflict of Interest Analysis conducted

Kindler International Division manfred@manfredkindler.de

QUALITY MANAGEMENT SYSTEM GUIDANCE

Review Requests, Tenders and Contracts

QUALITY MANAGEMENT SYSTEM GUIDANCE

1.7 ACTION PLANNING USING THE MILESTONES

Figure 7 Milestone 1: Quality Policies

QUALITY MANAGEMENT SYSTEM GUIDANCE

Figure 8 Milestone 2: Management

Agenda and Minutes

QUALITY MANAGEMENT SYSTEM GUIDANCE

1.8 CONTINUOUS QUALITY IMPROVEMENT

QUALITY MANAGEMENT SYSTEM GUIDANCE

QUALITY MANAGEMENT SYSTEM GUIDANCE

Plan/Determine what will be done

Initiate Activities in plan

Monitoring and evaluation of trends

Who is responsible for summarizing, reviewing

How will this activity be considered for the

The plan is modified as necessary