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Click WHATto editISMaster ISO & IEC
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ACRONYM for ISO – International Organization for Standardization
ISO is an independent,
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technical competence for specific
tests/ measurements, based on third party assessment based on
____ _____
ISO:17025-2017 standard.
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test report of laboratory global acceptance due to such
mutual recognition
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Click to edit Master title: style
MESSAGE FROM ISO 17025 2017
❖ toMESSAGE
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LINES FOR LABORATORIES
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• Continual improvement ____ _____
is the way of life
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Click to editOFMaster
BENEFITS
Click to edit Master title style ISO 17025 title
: 2017style
➢
Demonstrate that laboratory operate competently and generate
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level of confidence in Testing / Calibration data and
world. Increase
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instruments, preservation of test records etc.
Laboratory Accreditation provides formal recognition of competent
laboratories, to find reliable testing and calibration services.
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➢ It will give better image of laboratory as a Quality testing house in Global
QMS Advantage Case Study-1 Parameter Density
In roundClick to edit Master title style
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to editsurvey
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ASTM,
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lab has started ISO/IEC 17025 implementation, it becomes necessary to
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meter to prevent mistakes in the results reported after testing.
Lab has participated again in round robin test after compliance with the above
requirements and has got Z Score value of 0.2 amongst 352 laboratories of the world..
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•Second
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Why was it revised?
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ISO/IEC 17025
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2005 and, since then, market conditions and
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_____
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____ _____
• Support and guidance notes
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High Level Structure (HLS) of ISO/IEC 17025:2017
2.
1. Click to edit Master title style
Scope
Normative references
7. Process requirements
• Review of requests, tenders and contracts

3. Terms and definitions
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____ _____
• Improvement
• Externally provided products and • Corrective action
services • Internal audits
• Management reviews
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ISO/IEC 17025:2017 Requirements

4. General 5. Structural 6. Resource 7. Process 8. Management System
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6.6 Externally
provided products
and services
7.11 Control of
data –
Information
management
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conformity assessment activities), putting the emphasis on the
results of a process
and steps.
____
instead of _____
the detailed description of its tasks
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all standards dedicated to conformity assessment.
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Click toPhilosophical
changes


❖ Vocabulary:
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➢ otherwise it was moved to a requirement
____ _____
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Terms
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Preventive actions _____
-> risk and opportunities
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Click toChanges – Resources

❖ Personnel (6.2)
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services
❖ Metrological traceability (6.6)
➢ Clarified and moved____ much of_____
2005 content to Annex A
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ISO/IEC 17025:2017 - Impact on the ISO CASCO Toolbox
➢ClickPromoting
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➢ complaints and appeals,
➢ use of management systems
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9
Click Statements of Conformity
to edit Master title style

➢ Laboratories often make statements on conformity of
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traceabilitylevel
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device)
____ _____
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Requirements
Click to editforMaster
management systems
title style

➢ ISO/CASCO working groups had considered ISO 9001-2015

•Second
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the requirements clauses 4 to 7 of ISO/IEC
17025:2017
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Summary of Key changes
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Masteris the
titlelist of key changes and accordingly ISO/IEC 17025
style

Click toRevision had implication
edit Master title style to your laboratory management system
► Emphasis on the impartiality and confidentiality

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level
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approach- Risk and opportunities identification and control
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stylesof laboratory activities
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level or “technical manager” is removed
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materials and data, reagents, consumables or auxiliary apparatus
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results level
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IT: IMS to validate, data integrity, data security, data protection,
confidentiality, Immediate action on software failure, control on external
provider if externally managed
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Summary of Key changes (Continue)
► to
Click
"Decision
edit Master rules"titlefor style
passed/not passed {statement of conformity}. It has to

Clickbetocommunicated,
edit Master title documented
style and to be applied
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17034
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methods, procedures
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for result compromised in case of deviation
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► Use of statistical –» Methods( Control charts, Uncertainty records)
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► Management review to discuss risk, issues and monitoring activities
• Substantial impact on many other standards:
_____
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more than 300 ISO standards reference to ISO/IEC 17025
► Transitional period for accredited laboratories is already determined by ILAC
(3 years),
► Training is needed ____ _____
► Due to risk concepts, less "black and white" and more "grey" -> challenge
for
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Laboratory
Click to Process

• Click to edit Master text

Sample
Second level styles
Chemicals /
Laboratory Calibration Competent
•Click
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to
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Appropriate
Validated Control
Data Management
• Calibrated
____ _____
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Second level
•Click
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____ _____
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4 TIER DOCUMENTATION STRUCTURE FOR
Click to
LABORATORY
edit
title style
Master title style
UNDER ISO 17025:2017


Second level
Lab Quality
•Click
Click to edit Master text styles Manual
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Work Instruction/SOP/Process
flow charts/other documents
_____
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_____
Quality Records
Sample receipt Purchasing

____ _____
sampling Testing
Record
preparation
Dispatch Personnel & Trg.
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Developing ISO/IEC 17025 System

title style
In a Quality System, work activities are described in written
documents
Second level
andtext styles out in a planned way. The
carried structure
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ISO 17025 standards are:
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Quality – ••level
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Policy Third
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Description of quality system,
Quality Manual – »
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Fifth level
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policy
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____Describe
_____
level how processes which
affect quality are carried out
Work Instruction _____
FifthAdditional
level
_____ detail on how specific
jobs are carried out
Formats ____ Forms_____ to show evidence that
system is followed
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Department Procedure No. : PRO/OO/XY
NAME OF THE COMPANY

QUALITY PROCEDURE
Issue No. : 1.0
Date : DD-MM-YY

1.0 PURPOSE :
Give Statement of the Specific Purpose of the Procedure to Know Why This Procedure Is Being
Followed.
Second level
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SCOPE to : edit Master text styles
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Department and the Area of Personnel Where the Procedure Applies.
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RESPONSIBILITY :
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4.0 DESCRIPTION OF ACTIVITIES : level
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5.0 REFERENCE :
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This Section Should Contain Details of the Activities Step by Step With Sub Title of Paragraphs and
the Action to Be Taken. They Contain How the Actions Will Be Taken.
» Fifth level
Fourth
____ _____level
Give Reference of Internal and External Documents Used in Procedure
6.0 ENCLOSURES :
List Out Any Tables or Flowcharts Enclosed With the Procedure As a Part of Procedure.
7.0 FORMATS / EXHIBITS : _____
List Out Them in Proper Manner.
Fifth level
_____
Originator ____ _____
Approved By Signature Page
Of
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Procedures
Click to editrequired
Master
Click to edit Master title style by ISO/IEC 17025
title style
❖ Click to edit Master title style
List of Procedures:
➢Click to
6.2.5
edit MasterProcedure for personnel
text styles
➢Second level
•Second
Click6.3.3
Third
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to
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to__
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Second
Procedure
edit Master
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to maintain laboratory environmental conditions
text styles
Click text ____
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level for handling, transport, storage, use and planned
➢Fourth level Procedure
Fifth –
Third level
level ••Second
Third
Third
maintenance
level
level level of equipment
Second
Fourth level
➢ Fifth6.4.10
level• – ______level
Intermediate
Fourth
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checks procedure
➢ 6.5.2 –Documented
» Fifth risk management process
Fifth level
Fourth
➢ 6.5.3b_____
Third level
»
_____
Results
level
of reference
» Fifth level measurement procedures
➢
➢
6.6.2
7.1.1
Fourth
____ _____
level
Procedure for externally provided products and services
Procedure for the review of requests, tenders and contracts
➢ _____
7.2.1.1 Fifth level
_____
Procedure for evaluation of the measurement uncertainty
and use of statistical techniques for analysis of data.
____ _____
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Procedures
Click to editrequired
Master
Click to edit Master title style by ISO/IEC 17025
title style
❖
List of Procedures:
title style
➢Second 7.2.2.4
level Procedure for method validation
•Click
Click to
Click
____
➢Third – to
level
toedit
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edit
Second
7.4.1
Second Master
____ text
Master styles
_____
level
level Procedure text ____
styles
for the transportation, receipt, handling,
Fourth level protection, storage, retention, and disposal or return of test
Third level
level Second
Third level
Thirdor level items
calibration
level
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➢ Fifth7.7level• – Fourth
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–
Second
levellevel
Procedure
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levelfor ensuring the validity of results
➢ –Procedure
» Fifth
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Fourth
7.10 »
_____
Third level
_____
for Nonconforming work
level
» Fifth level
Fourth
____ _____ level
_____
Fifth level _____
____ _____
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Documents
Click required
to edit by ISO/IEC
Master 17025
title style

❖ClickList
to edit
ofMaster title style
Document:
➢
Click to5.3 Define the scope with range
Second
edit Master
➢ Click6.2.2
level
text styles
document the competence requirements
• –Click
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➢ Second
to edit Master
Master
text styles
Click
____ to__
edit____ _____
Seconddocumentation
6.4.13 text ____
level styles of reference materials, results, acceptance
Fourth level criteria, relevant dates and the period of validity
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Third level
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Third level level
6.5.1Thirdmaintain
level
Fifth level
➢ Fourth Second
Fifth level• ––______level
Fourth
Third level
levellevel
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metrological traceability of its measurement results
➢ 7.1.1 Contract review requirements
–» Fifth
Fourth level
➢ 7.6 _____
Third level
_____
» Fifth level
decision
» Fifthrule to give statement of conformity to a
level
specification or standard
➢ Fourth
____ _____
7.8.7.1 level
document the basis upon which the opinions and
interpretations have been made.
➢
➢
7.11
8.1.1
_____
Fifth level
_____
Any changes in data to be documented and authorized
Document the system to plan and implement
➢ 8.2.1 ____ _____
document, and maintain policies and objectives
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Records
Click required
to edit by ISO/IEC
Master
title 17025
style
❖ Click to edit Master title style
List of records:
➢ 6.2.6 Records for determining the competence requirements;
Second level
1. Selection; 2. Training 3. Supervision 4. Authorization 5. Monitoring of
•Click
Click to editcompetence
Click
____
Third
➢ Second to
toedit
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edit
–6.3level
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Master text
Master
____ text
Master _____
of personnel
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text ____
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level conditions
Record environmental
level
Fourth
➢ Third
➢Fifth
– •Second
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level
level Equipment records with manufacturer details and acceptance criteria
6.6 •level
Third
Third level level
Recordlevel
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–
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Third Second
levellevel
Fourth
______ level
for externally provided product and services (Selection, evaluation,
Fifth level• reevaluation, order, inspection and action on providers )
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➢ 7.1.8 Records of contract reviews, discussions including any significant changes
–» Fifth
Fifth level
Fourth
➢
➢
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7.2.2.4
»
_____
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level
level
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Records of the verification of methods performance
» Fifth level
Records of the validation
➢
➢
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7.4.3
Fourth
____ _____level
Records of sampling data
Records of deviations of sample conditions on receipt and customer consultation
➢ 7.4.4 Environmental conditions monitoring records during storage
➢
➢
7.5.1
7.6
_____
Fifth level
_____
Original observations, data and calculations
Evaluation of measurement uncertainty and use of statistical
➢ 7.7.1
techniques
____ _____
Monitoring results and track the trend for the validity of results (QA)
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Records to edit Master
required
title 17025
by ISO/IEC style
❖
List of records:
title style
➢Click to7.8.1.2
Second to
edit Master
level
All text
issuedstyles
reports as technical records
•Click
➢ Click7.8.7.3
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➢ Second
level
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edit Master
toedit
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Second Master
____ text
Master
text and
Opinions
styles
_____
styles
text ____
interpretations dialogues, decision rule applied
styles
levelcomplaint records for tracking and recording complaints,
level Customer
Fourth level
Fifth –
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including actions undertaken to resolve them
level
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level level
➢ Fourth 7.10.2level
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Software
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of nonconforming work and action taken
validation, Data transfer checks and information
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» Fifth
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➢ 8.6.2
»
Customer _____
Third level
_____
» Fifthsatisfaction
level surveys, communication records
➢ 8.7.3 Report on nature of the nonconformities, cause(s) and any
➢ 8.7.3b
Fourth
____ _____
level
subsequent corrective action taken
Records for results of any corrective action
➢ 8.8.2e
_____
Fifth level
_____
Records of the implementation of the audit programme and the
audit results
➢ 8.9.2 &3 Inputs and output to management review
____ _____
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Second level
•Click
Click to
Click
____
Third to
– level
level
Second
toedit
__
edit
Second Master
____
level text
Master styles
_____
level text ____
styles
Fourth
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Fourth STEPS
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level
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ISO :Fourth
17025-2017
____ _____
» Fifth level
level
ACCREDITATION
_____
Fifth level
_____
____ _____
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PROCESSES OF PROJECT FOR SCOPE EXPANSION AND
Click to edit Master title styleISO/IEC 17025-2017
A.
Gapto
Click Analysis – Diagnostic
edit Master Study of the existing processes & controls, Identification
title style
of Gaps w.r.t ISO 17025:2017 requirements
B. Training – Providing training on QMS awareness, QMS Documentation and QMS
ClickInternal
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level
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to identified core team personnel or cross functional Team (CFT).
•Click
Provide
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2. Internal auditing as per ISO/IEC 17025-2017 3. Documentation
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C. Third
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Documentation
level Third
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level level – Providing templates and necessary guidance in the
Fourth
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levellevel
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Fourth
______ level
level of documentation as required by the standards and to fulfill the
preparation
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QUALITY Management System. (1 Month)
Fifth
Fifth level
Fourth
D.
»
_____
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level
level
_____
Implementation of documented QMS – Providing guidance for the
» Fifth
implementation. (2 Month)
level training
E.
Fourth
____ _____level
Conducting Internal Audit and for conducting Management Review and provide
guidance for initiating corrective action for the reported audit findings. In (3rd
Month)
F. _____
Fifth level
_____
Mock audit and prepare the laboratory for final audit in accordance with the
requirements of the standards. In (3rd Month)
G. ____ _____
Certification Audit: Provide guidance for initiating corrective action for the external
audit (Initial visit and Certification audit) findings reported by the Accreditation body.
In 3rd Month)
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ISO:17025 -2017 Accreditation for Saudi Aramco
Click to edit
Master title
laboratories(YASREF) style
Click to edit
Master title style
❖ Following Phases are involved in actual implementation of ISO
Click17025:2017
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survey, gap analysis and ISO:17025 training to all,
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and change in system as per suggestions.(February 2018)
–» Fifth
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_____
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level
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_____
3. Phase-3 Implementation follow up, Internal auditor training, Document
» Fifth level
finalization (March 2018)
Fourth
____ _____level
4. Phase-4 1st Internal audit as per ISO17025. Uncertainty measurement; Inter lab
result analysis, 1st management review meeting. Action on Adequacy
audit report and witness testing for assessment agenda. (March 2018)
_____
Fifth level
_____
5. Phase-5 Mock audit and assess status of implementation and identify
problems if any . (April 2018)
____ _____
6. Phase-6 Final assessment by accreditation body. (April 2018)
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DELIVERABLES
Deliverables from Lab Team to FDS Team
➢ Appoint Quality Manager and technical Manager and deputy to them
➢ Providing
Click to edit Masternecessary inputs during gap analysis i.e. existing documented
text styles
Process
Second level / légal documents etc.
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➢Second
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____ text
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of QMS Scope, Policy, Objectives
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➢Third
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➢ Purchase of certified CRM
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______ level
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–» Fifth
Fifth level
Fourth
»
_____
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level
level
_____
the same. Implement all gap analysis points
» Fifth level
➢ ISO/IEC 17025 -2017 documents; review of their adequacy; Finalization and
release
Fourth
____ _____level
➢ Support Quality leader & core group during developing, implementation and
maintenance of QMS
_____
Fifth level
_____
➢ To qualify as internal auditors & Conduct one round of internal audit.
____ _____
➢ Report system audit findings to Quality Leader, and To Take Corrective and
Preventive Actions as per Internal Audit Report
➢ To Conduct MRM
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➢ Closing of CARs after Final accreditation Audit.
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Second level
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_____
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_____
Fourth
____ _____level
_____
Fifth level
_____
____ _____
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IAS Transition Policy for International
ClickStandard to
title style ISO/IEC 17025:2017

➢ This policy applies to all IAS-accredited Testing and Calibration Laboratories

➢Click
Second
to edit Master
IAS-accredited
policy level
to
TLs text
maintain
and styles
CLs are required to comply with the requirements of this
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Fourth level
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levellevel
Fourth level
______ level
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Fifth level
Fourth
»
_____
Third
level
_____
Fourth
____ _____level
_____
Fifth level
_____
____ _____
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Assessment and Documentation

title style
➢ From February 1, 2018, IAS will accept requests for accreditation to the new
2017
Click
Second
version
to edit
level
of text
Master the ISO/IEC
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➢•Click
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➢ Any noncompliance(s) _____
Fifth
Third
raised duringlevel
level
» Fifth level _____
assessments conducted during the
transition period against requirements of the new 2017 international
Fourth
____actions
standard will require corrective _____
level
within 30 days of the assessment.
➢ Laboratories that have not demonstrated full compliance with ISO/IEC
_____
17025:2017 international Fifth
standard level
_____
by December 1, 2020, are subject to
suspension and their accreditation certificate is removed
____ _____
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Guidance on transition process for laboratories
Click to edit
Master title style
Click
➢ Click
Plan your
to
to
edittransition
edit
process
Master title
Master title style
style to the new version of the standard
➢ Personnel responsible for transition and implementation of their laboratory
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system to the ISO/IEC 17025 -2017 standard will need to be
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Fourth
»
➢ Update laboratory _____
Third
management
_____
system documentation including existing
policies and procedures as required.
➢ Establish an internalFourth
____
training plan_____level
and schedule awareness trainings for
relevant laboratory personnel as well as internal auditor training for
_____
auditors as per ISO/IEC Fifth level
17025-2017. _____
➢ Contact IAS to arrange for a transition assessment visit.
Note: Assessment visits ____relating to _____
transitioning can be combined with the
laboratory scheduled reassessments if they are within accepted time frames as
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stated in this policy.
Application for Accreditation

Accreditation
(by Laboratory)

Click to edit Master title styleAcknowledgement & Scrutiny of
Procedure
Application (by accreditation body
Secretariat) Feedback

Second level Adequacy of Quality Manual
to
Laboratory
•Click
Click to edit Master text styles (by Lead Assessor)
Click
____
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Second level Stage 1 audit of Laboratory
Fourth level
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level ••Second
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and
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–
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levellevel
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______ level
level Final Assessment of Laboratory Necessary
(by Assessment Team)
–» Fifth
Fifth level
Fourth
_____
Third level
_____
Corrective
» level Action
» Fifth level Scrutiny of Assessment Report by
(by accreditation body Secretariat)
Laboratory
Fourth
____ _____level Recommendations for
Accreditation (by Accreditation
_____
Fifth level
_____ Committee)
Approval for Accreditation

(by Chairman, accreditation body)
____ _____ Issue of Accreditation Certificate

(by accreditation body Secretariat)
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ISO 17025:2017
Click IS NOT FOR
to edit Master
titleTHOSE
style
Who Hate Documentation
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SecondWho level
Resist Assessment
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a “PROBLEM” in Every “SOLUTION”
Who Identify
»
_____
Fifth
Third
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_____
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Fourth
____ _____ level
Whom “WHO IS WRONG” Is More Important Than “WHAT IS
WRONG” _____
Fifth level
_____
Whom “RESULTS” Are More Important Than “PROCESSES”
____ _____
Whom “TEAM WORK” Means “YES” Master
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Click to edit
Connectivity Master title
of laboratory style
practices
Click to edit
Master
and confirmative assessment as per
title style
•Second
ISO:17025
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Fourth
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+ Facility
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Fourth
____ _____
level
+ Personnel
_____
Fifth level
_____
= confidence
____ _____
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Challenges
•Second
•Click
–Click
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Second____
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Fourth
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long-term
Fifth level level
_____
success.
Fourth
____ _____
level
_____
Fifth level
_____
____ _____
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Thank
•Second
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Click level
text styles for your attention
•Click
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_____
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_____
Fourth
____ _____ level
_____
Fifth level
_____
____ _____
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