Ensuring a Smooth ISO/IEC 17025

Accreditation Assessment

Tips on Reducing the Uncertainty and Anxiety

of an Upcoming Auditor Visit.

Roger Brauninger
American Association for Laboratory Accreditation
Frederick, Maryland
February 3, 2016 Government Food and Feed Accreditation meeting
 Topics

Pretest Exercise
What is Accreditation?
Preparing for assessment
Requirements, records & documentation
Gap & Preassessment audits
On-site assessment actions
Potential Rabbit Holes
Pretest Exercise
 Quizz
All of the questions in this quiz relate to requirements
of the current edition of ISO/IEC 17025.
Each question offers you four multiple-choice
answers (a, b, c, or d).
When ready hold up the colored card(s) which
correspond to the correct answer(s).
1. In what year was the current edition of ISO/IEC
17025 published?

a. 1982
b. 1999
c. 2005
d. 1990
1. In what year was the current edition of ISO/IEC
17025 published?

a. 1982
b. 1999
c. 2005
d. 1990
2. ISO/IEC 17025 requires the laboratory to conduct
audits of its activities______:

a. Every 6 months
b. At least once/year
c. At predetermined intervals decided by the
laboratory
d. Whenever testing problems are found
2. ISO/IEC 17025 requires the laboratory to conduct
audits of its activities______:

a. Every 6 months
b. At least once/year
c. At predetermined intervals decided by the
laboratory
d. Whenever testing problems are found
3. ISO/IEC 17025 requires that management reviews
are conducted_______:

a. Every 6 months
b. At least once/year
c. At predetermined intervals decided by the
laboratory
d. Whenever testing problems are found
3. ISO/IEC 17025 requires that management reviews
are conducted_______:

a. Every 6 months
b. At least once/year
c. At predetermined intervals decided by the
laboratory
d. Whenever testing problems are found
4. ISO/IEC 17025 requires the laboratory to notify the
client in writing if_______:

a. Any of the tests are to be subcontracted

b. The test item is unsuitable for testing
c. Audits reveal doubts about the test results
d. A non-standard test method is to be used
4. ISO/IEC 17025 requires the laboratory to notify the
client in writing if_______:

a. Any of the tests are to be subcontracted

b. The test item is unsuitable for testing
c. Audits reveal doubts about the test results
d. A non-standard test method is to be used
5. ISO/IEC 17025 does not require a laboratory to
document________:

a. Instructions for the operation of testing and

measuring equipment
b. Its procedures for purchasing and storing
laboratory consumables
c. Its procedures for subcontracting testing work
d. Its procedures for document control
5. ISO/IEC 17025 does not require a laboratory to
document________:

a. Instructions for the operation of testing and

measuring equipment
b. Its procedures for purchasing and storing
laboratory consumables
c. Its procedures for subcontracting testing work
d. Its procedures for document control
6. ISO/IEC 17025 requires a laboratory to keep records
of_______:

a. Customer complaints
b. Staff training
c. Results of audits
d. Management reviews
6. ISO/IEC 17025 requires a laboratory to keep records
of_______:

a. Customer complaints
b. Staff training
c. Results of audits
d. Management reviews
7. ISO/IEC 17025 requires the laboratory to ________:

a. Control access to testing and measurement

areas
b. Protect confidentiality of its test results
c. Comply with laws relating to laboratory safety
d. Have air conditioning which controls temperature
and humidity
7. ISO/IEC 17025 requires the laboratory to ________:

a. Control access to testing and measurement

areas
b. Protect confidentiality of its test results
c. Comply with laws relating to laboratory safety
d. Have air conditioning which controls temperature
and humidity
8. With respect to test equipment, a lab that complies
with ISO/IEC 17025 must________:

a. Ensure that all such equipment which affects

accuracy must be calibrated
b. Own and control all of the equipment that it uses
c. Attach a label to the equipment showing its
calibration status
d. Stop using the equipment if it is not operating
correctly
8. With respect to test equipment, a lab that complies
with ISO/IEC 17025 must________:

a. Ensure that all such equipment which affects

accuracy must be calibrated
b. Own and control all of the equipment that it
uses
c. Attach a label to the equipment showing its
calibration status
d. Stop using the equipment if it is not operating
correctly
9. Before subcontracting any testing work to another
laboratory, a lab which complies with ISO/IEC
17025 must first _______:

a. Obtain a copy of the other laboratorys quality

manual
b. Ensure that the other laboratory is accredited to
ISO/IEC 17025
c. Ensure that the other laboratory is competent
d. Obtain a copy of the other laboratorys price list
9. Before subcontracting any testing work to another
laboratory, a lab which complies with ISO/IEC
17025 must first _______:

a. Obtain a copy of the other laboratorys quality

manual
b. Ensure that the other laboratory is accredited
to ISO/IEC 17025
c. Ensure that the other laboratory is competent
d. Obtain a copy of the other laboratorys price
list
10. A laboratory that complies with ISO/IEC 17025
would also meet the principles of______?

a. ISO 9001-2000 Quality Management Systems

b. EN45001-1989 General criteria for the operation of
testing laboratories
c. ANSI/ASQC Q.2-1991 Guidelines for Quality
Management and Systems
d. ISO/IEC 17011 General Requirements for
Laboratory Accreditation
10. A laboratory that complies with ISO/IEC 17025
would also meet the principles of______?

a. ISO 9001-2000 Quality Management Systems

b. EN45001-1989 General criteria for the
operation of testing laboratories
c. ANSI/ASQC Q.2-1991 Guidelines for Quality
Management and Systems
d. ISO/IEC 17011 General Requirements for
Laboratory Accreditation
WHAT IS ACCREDITATION?
 What is Accreditation?

Process, to determine an organizations

competence to carry out specific tasks:
By independent 3rd party accreditation body
Recognizes via a certificate and scope
Requires periodic monitoring of performance and regular
reassessment
Prerequisites: compliance with ISO/IEC 17025.
Accreditation Ten Second Tutorial

Doing what you say you are doing

And being able to prove it!

 Three Critical Thoughts

Does the laboratory say what they do?

Is there written documents (policies, procedures, arrangements)
that meet the requirements of ISO 17025?

Does the laboratory do what they say?

Are they in compliance with their own quality system, test methods
and ISO 17025?

And can they prove it with their records?

Ranging from having training records to standards preparation to
work books to client reports to audit reports and everything in
between?
 Scope of Accreditation
Although ISO 17025 is written as though all the methods used
by a laboratory are covered by the standard, this is rarely
the case.

Methods which are performed infrequently are difficult to

accredit
Hard to demonstrate a track record of performance.
In such cases a large level of quality control will be required by the
assessors.

Methods with little objective content are difficult to be able

to get accredited
Consistency in application cannot be guaranteed
 Quality Manual

Lays out Quality System roadmap

No set format required
Level of detail based on structure/ function of the
laboratory and its needs
Laboratorys policies must be included or referenced
Often follows 17025 sequence
 AOAC Guidelines
Started in 1998 with FLAWG precursor.

Additional criteria for:

Personnel
Equipment cal and verification
Reagents
Proficiency testing
Internal QC frequency
 Areas Needing Early Start...
Proficiency Testing data needed for:
Each major matrix of concern
For as many analytes/methods as possible
Estimates of Measurement Uncertainty
Develop Procedures, ID contributing factors
Training on calculation (e.g. LCS data)
Traceability of Calibrations, if in-house
Through an unbroken chain of comparisons, with each
step having stated uncertainties
Demonstrable competence performing calibration
 Preparing

Study to understand requirements

Review/ update all technical and quality procedures, QM

policies with technical staff

Get involvement from the technical staff in ensuring the

labs compliance to its QMS

Evaluate readiness with internal audits/ management

review or external help
Internal audits vs. management reviews
These are two distinct activities:

Internal audits verify conformance to the documented system

and confirms the management system is in compliance with
the standard

Management reviews determine if the management system

policies and procedures are suitable and effective in
generating quality data, meet the objectives of the
laboratory and if improvements to meet changing needs are
required
 Types of Preparation Audits
Gap Assessment (1st or 3rd party)
Prospective focus sets direction and planning.
Looks at A-Z / notes the degree of compliance and Identifies
corresponding actions to be taken.
Internal audit (1st or 3rd party)
Retrospective focus on compliance/gathering evidence.
Includes QMS, technical competence and ABs policies.
Multidimensional, looking at implementation.
Accreditation body Pre-assessment (3rd party)
Mix of both: prospective focus and on compliance.
Primary focus is not on technical.
 Pre-assessment:
Unplanned for scenario
During the assessment the assessor determines that there are
major non-compliances with the criteria that would lead to a
large number of significant deficiencies.
In this case, the assessor identifies the potential deficiencies and
suggests to the laboratory that the full formal assessment should
wait until the problems have been addressed.
This first identification of the problems would be considered a pre-
assessment and is optional (i.e., lab could decide to go ahead
anyway).
 Pre-assessment:
Planned Triggering scenario

During prior document review the assessor identifies major

gaps in QM/ lab documentation. The applicant is given time
to correct and full assessment follows later.
In this case, the assessor identifies the potential deficiencies and
suggests to the laboratory that the full formal assessment should
wait until the problems have been addressed.
 Pre-assessment:
Planned Triggering scenario

At time of application lab requests a pre-assessment

because it is unsure of its documentation or system.
In this case, the assessor identifies the potential deficiencies and full
formal assessment takes place after the problems have been
addressed.
Ideal time is after both a gap assessment and Internal audit.
 Pre-assessment: Report
Management System
ISO 17025 requirements explained,
Reviews the status of the labs preparations,
Responds to suggestions on bringing deficiencies into
compliance.
Technical
General technical capability evaluated,
Accommodations,
Environment,
Log books
INTERPRETING SOME ISO TERMS
 Definitions
Shall = imperative
Should = strong recommendation
Policy = rules the what
Procedure = step-by-step the how
Quality System = written policies, procedures,
arrangements, etc. (all of the documents)
 Records
ISO 17025 defines these words as records and specifies
needed evidence of how actions were done e.g. (the proof):

Record Evaluate
List In Writing
Register Monitor
Formulate Feedback
Validate
 Documents
ISO 17025 considers these words as those that describe how
activities are to be done (the what and how):

Document Define
Policy Specify
Procedure Pre-defined
Instruction Pre-determined
System Arrangement
Plan
 Weasel Words

Where practicable
Where necessary
Including but not limited to
Where appropriate
Where possible
Whenever reasonable
If relevant Where relevant
 Shall plus

Shall + include whatever is listed after must be in

the procedure or record. (unless it is accompanied
by a weasel)

Shall + ensure - The objective evidence

(outcome) must show that the stated goal listed in
the standard has been met.
 ISO/IEC 17025

Implementations
Records
Documentation
 4.1 - Organization
LABORATORY
Legal Entity
Conflicts of Interest

CLIENTS MANAGEMENT STAFF

Satisfy their needs Protect confidentiality Define the structure Sufficient Resources Avoid Free of Responsibility &
Inappropriate Undue Authority
Outside Pressures Clearly
Activities Defined

Conflict of Interest Org Charts

Technical Quality Agreement Available to
Management Manager Reviewed Annually all staff

Deputies Deputies
Green - 17025
Dk. Blue - 17025/Policies & Procedures
Lt. Blue - AOAC
 4.2 - Quality System
QUALITY
SYSTEM
All documents
for ex. procedures, regulations

QUALITY
MANUAL

Policy Statement on Outline (Reference) Defined role & Easily identifiable Annual retraining for
overall objectives Quality & responsibilities of sections for all personnel
Technical Quality Manager & multifunctional labs on Roles & Resposibilities
Procedures Technical Management

Commitment Management's
to Statement of
Testing Service & commitment
to ISO/IEC 17025

Lab's All personnel

Objectives are familiar
w/ the quality
system
Green - 17025
Dk. Blue - 17025/Policies & Procedures
Lt. Blue - AOAC
 4.3 - Document Control
QUALITY SYSTEM
all documents

Master List Unique Document

or Identification Changes
Doc Control
Procedure

Current Distribution Date of Issue Total # Review and ID of

Revision of and/or of Pages Approval Altered or New
Status Documents Revision ID or Text
Ending Mark

Authorized Periodic Issueing Hand Amendments Computerized

Editions at Review Authority Are they allowed? Changes
All
Locations

Avoid Obsolete
Obsolete Documents
Documents Are Marked

Green - 17025
Dk. Blue - 17025/Policies & Procedures
4.4 - Review of Requests, Contracts, & Tenders
CLIENTS

REQUESTS,
TENDERS,
&
CONTRACTS

Procedure Differences with Records Deviations

for Contract are of
Review Resolved Reviews

Defined Capability Pertinent Subcontracted

Requirements and Discussions Work Amended
Resources Contracts

Appropriate
Test Method
Selected
Green - 17025
Dk. Blue - 17025/Policies & Procedures
White - 17025/Records
 4.5 - Subcontracting

CLIENTS

SUBCONTRACTING

Competent Responsibility Register Client Approval

Records
of
Compliance

Green - 17025
White - 17025/Records
 4.6 - Purchasing Services & Supplies
LABORATORY

PURCHASED
SUPPLIES
&
SERVICES

Policy & Procedure Procedure for Evaluation of Suppliers

for Selection & Purchasing the Purchase,
of quality-critical Reception,& Storage
Services & Supplies of Reagents & Consumables

Purchasing Documents Inspected Records List of

with Data Description for of the Approved
Compliance Evaluations

Records Program to Periodically

Reviewed Control Sample
of Periodically
and Testing or
Compliance Monitor
Approved Other System

Records of data
Green - 17025
Dk. Blue - 17025/Policies & Procedures Program to Periodically
Periodically
Monitor
White - 17025/Records
Lt. Blue - AOAC
4.6 - Purchasing Services & Supplies (cont.)
REVIEW ED
AND
APPROVED
SUPPLIES

PREPARED REAGENTS

Labelled Safety of Disposal

Individual Identify
Preparing Substance

Strength Solvent

Hazards Restrictions

Date of Prep Green - 17025

or
Exp Date Lt. Blue - AOAC
4.7 - Service to Client

CLIENTS

Cooperation for clarification

Monitor lab performance

Green - 17025
 4.8 - Complaints
CLIENTS & Other parties

COMPLAINTS

Resolution Policy Records

and
Procedure

All Complaints Investigations

Corrective
Actions
Green - 17025
Dk. Blue - 17025/Policies & Procedures
White - 17025/Records
4.9 - Control of Non-Conforming Work
TESTING
QUALITY
CLIENT

NON-CONFORMING
WORK

Policy
and
Procedure

Actions Defined & Evaluation

Responibilties of Significance
Designated

Possible Recurrence

Immediate Green - 17025

Corrective Action
Dk. Blue - 17025/Policies
Client Resumption & Procedures
Notification of
Work
 4.11 - Corrective Action
NON-CONFORMING WORK
COMPLAINTS
INTERNAL AUDIT FINDINGS

CORRECTIVE ACTION

Policy Identify Potential Document Monitor Internal Audit

and Problems Changes Results of
Implementation Procedure Appropriate Areas

Root Cause Select action

Analysis and
Eliminate problem

Green - 17025
Dk. Blue - 17025/Policies & Procedures
White - 17025/Records
 4.12 - Preventative Action

NEEDED IMPROVEMENTS
OF ANY NATURE

PREVENTIVE
ACTION

Procedure

Initiation of Actions Application of Controls

Green - 17025
Dk. Blue - 17025/Policies & Procedures
 4.13 - Records
QUALITY
TECHNICAL

RECORDS
Audit Trail Capabilities

Procedures for ID, Collection, Legible, Retrievable, Procedure to Protect and Mistakes
Indexing, Access, Storage, & Held Secure Back-up eRecords &
Maintenance, & Disposal Control Unauthorized Access

Retention Times Consistent w/ Cross out and corrected Not Deleted

Record Observations,
Client's
Data and
Requirements
Calculations

Initialed Backed-Up if
Electronic

Green - 17025 Dated

Dk. Blue - 17025/Policies & Procedures

White - 17025/Records
Lt. Blue - AOAC
 4.14 - Internal Audits

INTERNAL AUDIT

Pre-determined Quality & Technical Records Follow-up

Schedule and System Audit
Procedure

Area Findings Implementation Effectiveness

Corrective Actions

Green - 17025
Dk. Blue - 17025/Policies & Procedures
White - 17025/Records
 4.15 - Management Review
MANAGEMENT
REVIEW

Pre-Determined Findings and

Schedule & the Actions
Procedure Associated

Suitability of Mangerial & Personnel Appropriate

Policies & Procedures Reports Timescale

Internal Audit Corrective Action &

Preventative Action

External Assessments Proficiency Testing

Changes in Work Client Feedback

Complaints Other: Training, Green - 17025

Resources,etc.
Dk. Blue - 17025/Policies & Procedures
Responsible
Individuals/Min Rev. Freq. White - 17025/Records
(Documented)

Lt. Blue - AOAC

 5.2 - Personnel
MANAGEMENT

# of Personnel
Established by
Workflow

STAFF
(Employed or Contracted)

Training Policy Formulation Current Training Records

& Procedure of Goals Job Descriptions

Ensure Competency Initial & Ongoing Revelant Authorization Competence

Appropriate Supervision Competency of Staff w/ Date

Review of Testing Function Maintained

Training Records and Data
Periodically Procedural Oversight (records)
(documented)
Qualifications Training

Green - 17025
Dk. Blue - 17025/Policies & Procedures Skills & Experience Date of Authorization

White - 17025/Records
Lt. Blue - AOAC
 5.3 - Accommodation & Environmental
Conditions
LABORATORY

ENVIRONMENTAL

Facilitate Proper Technical Requirements Cross-Contamination Good Housekeeping Storage, Use, & Disposal
Performance of Chemicals,Reagents,
& Equipment
(Documented)

Monitor and Control Record Conditions Control all areas Where Necessary, MSDS's must be
Special Procedures available

Green - 17025
Dk. Blue - 17025/Policies & Procedures
White - 17025/Records
Lt. Blue - AOAC
 5.4 - Test and Calibration Methods
TEST METHODS
AND
VALIDATION

Standard Methods Non-Standard Methods

CLIENT APPROVAL

Deviations Validation Measurement Control of

Uncertainty Data

Documented Justified Results Procedure

Used Reasonable Appropriate Checks Automated Equipment
Estimation of Calculations &
Data Transfers
Authorized/Date (AOAC) Accepted Fit for Intended Use Relevant to
Statement Client's Needs Identified Previous Software Validated Protection of Data
Components Experience

Validation Operating Conditions

Data

Green - 17025
Dk. Blue - 17025/Policies & Procedures
White - 17025/Records
 5.5 - Equipment
EQUIPMENT

Uniquely Identifed

Calibration Verification/ Maintenance Safe Handling, Transport,

Intermediate Checks Storage, Use, and Planned
Maintenance

Calibration Calibration Label Checked Before Suspect Results: Identity Manufactorer's

Programmes Each Use Out of Service Name/ Type ID

Status Exp. Date Serial Number Check of Compliance

with Specification
Correction Factors Program meets
Clients Requirements
Current Location Manufactorer's Instructions

Refernence Materials must Volumetric Equipment per

be traceable to national SOP's Calibration Reports Maintenance Plan
or international standards

Damage, Malfunction, Program meets

Green - 17025 or Repair Clients Requirements

Dk. Blue - 17025/Policies & Procedures

White - 17025/Records
Lt. Blue - AOAC
 5.6 - Measurement Traceability
MEASURMENT TRACEABILITY

Preferred SI Units

Calibration Program Provide Measurement

& Procedure Uncertainty Needed

Equipment Reference Standards

Intermediate Checks Transport and

Storage

Procedure Schedule

Labeled Records of
Receipt

ID Scheme Date Received/Exp Chemical Name Manufacturers Lot #

Assigned Lab # Date Received

Manufacturer's Exp Date Discard Date

Green - 17025
Initials of Receiver
Dk. Blue - 17025/Policies & Procedures
Lt. Blue - AOAC
 5.7 - Sampling
SAMPLING

Plan and Procedure Data Collection Field Samples Sub-Sampling or

Homogenization
Procedures

Statistical All Factors Procedure for Must Comply with

Methods Considered Recording Data Established
Procedures

Changes
Records

ID of Sampler Env Conditions

Deviations Additions

Exclusions Diagrams of Statistics

Sampling Location
Green - 17025
Dk. Blue - 17025/Policies & Procedures
White - 17025/Records
Lt. Blue - AOAC
 5.8 - Handling of Test Items
TEST ITEMS

Transportation, Receipt, Identification

Handling, Protection,
Storage, Retention,
Preparation & Disposal

Integrity Safety Hazards Unique ID for it's entire

life span

Clean Storage Area Undamaged Packages

Env Conditions Controlled Package Label Maintained

Abnormalities Trained Staff

Green - 17025

Client notification
Dk. Blue - 17025/Policies & Procedures
with nonsuitability
White - 17025/Records
Lt. Blue - AOAC
 5.9 - Assuring Quality of Test Results
QUALITY CONTROL
PT

Monitoring the
Validity of the Results

Detectable Trends Planned & Reviewed Activity

Internal QC Interlab Comparison

PT Program Replicate Tests

Retesting of Retained Items Correlation of Results

Batch of Samples Daily QC Checks on Media, DPCCs

with Regular Use of CRMs, etc.

QC Procedures for A&P QCS and a control or Replicate Testing with RM's
sample duplicate 20 samples
or less

Control Charts for the QCS Upper and Lower Control

sample and duplicate Limits for Acceptance
analyses Criteria Green - 17025
Corrective Action for all
QCS outside of the accuracy
Dk. Blue - 17025/Policies &
Daily Control Using Procedures
an RC (pos. culture) Concurrently
with All Tests
White - 17025/Records
Lt. Blue - AOAC
 Additional PT Requirements

PROFICIENCY
TESTING

Prior to Accreditation

External Programs Internal Programs

Green - 17025
Lt. Blue - AOAC
 5.10 - Test Results

TEST DATA

Client Request Method Info

Minimize Misunderstanding 21 CFR

Test Report Test Report with Test Report with Amendments

Interpretations Needed Sampling

Title Name, Address, Date of Sampling ID of Product Sampled

& Location Test Results Statement - "Supplement
to Test Report"
Unique ID of Report Client Name & Address Location of Sampling Reference to Sampling
w/ identifier of each page Deviations, Additions, Measurement Uncertainty Plan & Procedure
Exclusions
Method ID ID, Description, Condition Details of Env Conditions Specification for the
of Tested Item Statement of Compliance Special Test Conditions Sampling Method

Tested Item Date of Sampling Plan

Reciept & Performance & Procedures Additional Info Opinions & Interpretations

Test Results ID of Personnel

Documented Basis

Statement - Results relate ID of Subcontractors

Green - 17025
only to items tested

Dk. Blue - 17025/Policies & Procedures

White - 17025/Records
Typical Findings
 Criteria used

Only ISO/IEC 17025 accredited or applicant labs

considered.

There were a total of 7,800 cited deficiencies that was

gathered from individual accreditation assessments of
laboratories performed by A2LA over the last 4 years.

Includes data for deficiencies against the clauses of ISO/IEC

17025, relevant test methods and specific program
documents (e.g. AOAC Food Testing Requirements).
 Deficiencies for All Labs

Top ten Deficiencies represent over 75% of all types of Non-

conforrmances (NCs).

67% are technical in nature. Rest are related to labs

management system or A2LA policies.

10% of assessments have no NCs.

Average number per assessment = 7.

 Tenth Most Cited Deficiency

Laboratories were cited for deficiencies against ISO/IEC 17025,

section 4.11 Corrective action.
Not establishing a policy and a procedure or designating
appropriate authorities,
Lacking an investigation to determine the root cause(s) and
Not monitoring the results to ensure that the corrective actions
taken have been effective.
 Ninth Most Cited Deficiency

Laboratories were cited for deficiencies against R103 General

Requirements: Proficiency Testing for ISO/IEC 17025 Laboratories.
Lack details in documented proficiency plan.
PT results are not being provided within 30 days upon receipt;
and
Failure to meet the minimum proficiency testing participation
frequency established.
 Eighth Most Cited Deficiency
Laboratories were cited for deficiencies against ISO/IEC 17025,
section 5.6: Measurement Traceability & A2LA P113 policy.
Using non-accredited calibration laboratories.
Lack of accreditation body endorsement on calibration
certificates.
Improper reference standards for in-house calibrations.
Lack of procedures for the safe handling, transport, storage and
use of reference standards/materials.
 Seventh Most Cited Deficiency
Laboratories were cited for deficiencies against ISO/IEC 17025,
section 5.9: Assuring the Quality of Test and Calibration Results.
Failure to participate in available and relevant commercial PT
programs.
PT Plan not complete or current and/or PT Schedule not being
followed.
PT Data records incomplete.
Lack of quality control procedures /Failure to perform qc checks
on accredited tests.
Lack of corrective action response to outliers.
 Sixth Most Cited Deficiency
Laboratories were cited for deficiencies against ISO/IEC 17025,
section 4.14: Internal Audits.
Inadequate procedure.
Lack records of findings.
Not recording area of activity audited.
Failure to meet audit schedule.
No corrective actions for IA findings.
Not verifying continued compliance with all elements of their
activities.
Lacking evidence of internal auditor training and qualified to
perform the audit.
 Fifth Most Cited Deficiency
Laboratories were cited for deficiencies against ISO/IEC 17025,
section 5.5: Equipment.
Equipment not uniquely IDed/labeled with calibration
status/calibrated before placed into service.
Lacking records of calibrations & maintenance.
Defective/suspect equipment not sequestered.
Intermediate checks not performed after calibration,
maintenance or repair.
Calibration cycles have been extended and not properly
documented.
 Fourth Most Cited Deficiency
Laboratories were cited for deficiencies against ISO/IEC 17025,
section 4.13: Control of Records.
Failure to record original observations.
Failure to retain adequate records to establish an audit trail.
Procedures lacking all of the required record traceability
requirements.
Inadequate protection of electronic records.
Records with information made illegible or scratched out and/or
alterations to the records were not signed or initialed.
 Third Most Cited Deficiency
Laboratories were cited for deficiencies against ISO/IEC 17025,
section 4.3: Document Control.
Lacking defined control procedure.
Documents not undergoing periodic review.
Use of obsolete/uncontrolled instructions.
Failure to control external documents.
Master list of documents not current or complete.
Lacking record trail for archived documents.
Documents not uniquely identified and/or did not include all the
required identification.
 Second Most Cited Deficiency
Laboratories were cited for deficiencies against ISO/IEC 17025,
section 5.4: Test (and Calibration) Methods and Method
Validation.
Modification to method not validated.
Method not confirmed prior to use.
Did not follow method procedure as written.
Measurement uncertainty: Improper or incomplete estimate.
Lacking a procedure for estimation for in-house calibrations.
Failure to validate in-house software.
 #1 Most Cited Deficiency

Laboratories were cited for deficiencies against Specific

Program Requirements, such as AOAC requirements.
Lacking records of yearly staff training on QMS.
No microbiological QC activities.
Table 1 equipment calibration/ verification requirements not
being followed.
Media records not complete.

15% of the total were in areas specific to these.

Questions / Comments
 For Further Information

Contact: Roger M. Brauninger

Phone: 301 644 3233
Email: rbrauninger@a2la.org

American Association for Laboratory Accreditation

5301 Buckeystown Pike, Suite 350
Frederick, MD 21704

www.a2la.org