TG 52-02

TRANSITIONAL GUIDELINES FOR ISO/IEC 17025:2017

TESTING AND CALIBRATION LABORATORIES

Approved By: Executive Accreditation: Mpho Phaloane

Revised By: Accreditation Manager: Shadrack Phophi
Date of Approval: 2018-09-19
Date of Implementation: 2018-09-19

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CONTENTS

1. Purpose and Background .......................................................................................... 3

2. SANAS Transitional Assessments ............................................................................. 3
3. Changes to the Certificate and Scope of Accreditation .............................................. 4
4. Overview of Changes in Requirements ..................................................................... 4
5. Existing Guidelines and Explanatory Documents....................................................... 4

Appendix A: Cross references between ISO/IEC 17025:2017 and ISO/IEC 17025:2005 ... 6
Appendix B: ISO/IEC 17025:2017 Transition Template.................................................... 10
ADDENDUM 1: Amendment Record .................................................................................. 16

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1. Purpose and Background

The purpose of this technical guidance document is to describe SANAS’ approach regarding the
processes of handling transition to, and effective implementation of ISO/IEC 17025:2017.

The new ISO/IEC 17025:2017 standard was published on the 30th November 2017 and will replace
ISO/IEC 17025:2005. The agreed transition period is 3 years from the date of publication. This means
that all Testing and Calibration laboratories will need to have successfully transferred to the new
standard within 3 years from the publication date.

SANAS has made an effort to identify the changes in the ISO/IEC 17025:2017 and this gap analysis is
appended to this document.

2. SANAS Transitional Assessments

2.1 Transitional assessments shall consist of at least an evaluation of the Conformity Assessment
Body’s (CAB) documented management system in line with the new ISO/IEC 17025:2017.

2.2 These transitional assessments will be performed as far as possible with the already scheduled
assessments in order to avoid extra costs for the CAB.

2.3 The following transitional provisions shall apply for the effective implementation of ISO/IEC
17025:2017:

i) All assessments scheduled to take place after 30 November 2018 will be conducted
against ISO/IEC 17025:2017;

ii) All findings raised against ISO/IEC 17025:2017 for the transitional period shall be handled
as non-conformances, where the submission of corrective actions to SANAS will be
required;

iii) As from 01 December 2018, SANAS will not accept applications of extension to scope to
ISO/IEC 17025:2005;

iv) As from 01 July 2018, SANAS will not accept new applications to ISO/IEC 17025:2005

v) CABs that will fail to transition to the ISO/IEC 17025:2017 within the given transition
period will be automatically suspended. Re-instatement will require an onsite visit to
confirm full compliance to the new standard.

2.4 It is the responsibility of the CAB to identify the impact of the changes between the two
standards to their management system and then make and implement any required alterations
as necessary. Details of alterations made to systems should be recorded in the transition
template and the completed template provided to SANAS (Refer to Appendix B) at least 2
months prior to the scheduled assessment taking place. Effective implementation will be
assessed at the site visit. If the CAB considers that it currently meets a changed requirement
and does not need to make changes to its system, then this should be stated in the template.

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2.5 In order to meet the set transition deadline, all accredited CABs are encouraged to put together
a transition action plan to enable them to monitor and track progress regarding the
implementation of the new requirements. The action plan should demonstrate how the CABs
have analysed the new standard and its implications to their management system and
operations. The action plan should also indicate how the CABs will effectively implement all the
changes, system and technical, needed to comply before the transition date. CABs are not
required to submit the action plan to SANAS.

As a minimum the plan should include:

i) All specific actions to be taken to implement the changes;

ii) The timelines and milestones for completion of actions;
iii) The persons responsible for the actions; and
iv) Ways to measure progress, implementation, effectiveness and completion of the actions.

2.6 All records and documented changes in line with the new standard will be assessed during the
scheduled visits and records shall demonstrate the following as a minimum:

i) the internal audit and management review findings are aimed at ensuring effective
implementation of ISO/IEC 17025:2017;
ii) the necessary changes made to documentation are implemented; and
iii) all changes are implemented in all fixed-office locations/branches, where applicable.

3. Changes to the Certificate and Scope of Accreditation

3.1 Once the laboratory has demonstrated successful transition and effective implementation of
ISO/IEC 17025:2017 and the decision by the SANAS Approval Committee is for the continuation
/ maintenance / renewal of accreditation, the Certificate and Scope of Accreditation will be
adapted to reflect accreditation to ISO/IEC 17025:2017.

3.2 The effective date on the certificate will be the date of the Approval Committee’s decision to
grant accreditation to the new standard.

3.3 It is important to note that the five (5) year assessment cycle will remain unchanged, i.e. a 5-year
cycle will not automatically commence on the date of accreditation to ISO/IEC 17025:2017. This
will only happen in the case of initial and reassessments.

4. Overview of Changes in Requirements

Appendix A of this document contains a summary of significant changes in ISO/IEC 17025:2017 as

compared to the 2005 version. This list can however not be considered a complete list of changes
because some clauses are not new but have significantly changed in wording. It remains the
responsibility of each CAB to investigate which changes in the standard are relevant and include these
in their transition plan.

5. Existing Guidelines and Explanatory Documents

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SANAS P 32 Transition to new standards

SANAS R 03 Nominated Representative and Signatories: Responsibilities, Qualifications & Approval
SANAS R 04 Conditions for use of Accreditation Symbols, Reference to Accreditation and Combined
Marks

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 Appendix A: Cross references between ISO/IEC 17025:2017 and ISO/IEC 17025:2005
Key - Extent of Change:
• Structural – Requirement remains the same but is under a new clause number
• Minor – Wording of the requirement has changed but overall intent is consistent
• Major – Changes will require the CAB to implement new or change existing practice
• New – New requirement(s)/concept(s) not in previous version of the standard
CLAUSE ISO/IEC 17025:2017 CLAUSE ISO/IEC 17025:2005 Change /Status Comments
Foreword Foreword NEW From the Foreword of ISO/IEC 17025:2017:
• the risk-based thinking applied in this edition has enabled some
reduction in prescriptive requirements and their replacement by
performance-based requirements;
• there is greater flexibility than in the previous edition in the
requirements for processes, procedures, documented information
and organizational responsibilities;
• a definition of “laboratory” has been added.
Introduction Introduction NEW • The standard contains requirements for laboratories to enable them
to demonstrate they operate competently, and are able to generate
valid results.
• It also requires the laboratory to plan and implement actions to
address risks and opportunities.
1. Scope 1. Scope Minor • This document specifies the general requirements for the
competence, impartiality and consistent operation of laboratories.
• This document is applicable to all organizations performing
laboratory activities, regardless of the number of personnel.
• Laboratory customers, regulatory authorities, organizations and
schemes using peer-assessment, accreditation bodies, and others
use this document in confirming or recognizing the competence of
laboratories.
2. Normative references 2. Normative References Minor No significant changes
3. Terms & Definitions 3. Terms and Definitions NEW New or modified definitions: laboratory, intra-lab, proficiency testing,
decision rules
4. General requirements - - -
4.1 Impartiality 4.1 Management Major Laboratory to identify risks to impartiality on an ongoing basis and come
requirements up with mitigation
4.2 Confidentiality 4.1 Management Major Stronger emphasis is on customer awareness and more detail regarding
requirements specific cases where confidentiality could be affected
5. Structural Requirements 4.1 Organisation Major Removed terms “technical management” and “quality manager”.
Introduced requirement for laboratory to identify range of laboratory
activities for which it conforms with ISO/IEC 17025. Restricts claims of

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CLAUSE ISO/IEC 17025:2017 CLAUSE ISO/IEC 17025:2005 Change /Status Comments

conformity to the defined range. Excludes externally provided laboratory
activities on an on-going basis
6. Resource Requirements - - -
6.1 General 4.1 Organisation Minor The laboratory shall have available the personnel, facilities, equipment,
systems and support services necessary to perform its laboratory
activities.”
Use of the term “available” indicates an approach in the revision to
focus less on the status or ownership of resources and more on the
relevant requirements for those resources

6.2 Personnel 5.2 Personnel Structural Terminology and requirements have been updated and reorganized in
the revision
6.3 Facilities and 5.3 Accommodation and Structural Terminology and requirements have been updated and reorganized in
environmental conditions Environmental the revision
Conditions
6.4 Equipment 5.5 Equipment Minor The laboratory shall have access to equipment that is required for the
correct performance of laboratory activities and that can influence the
results.
6.5 Metrological traceability 5.6 Measurement Structural Terminology and requirements have been updated in the revision to
Traceability reflect current practice in traceability
Reduced the number of Notes compared to 2005 version. Additional
explanatory information included in Annex A
6.6 Externally provided 4.6 Purchasing Services Minor Combines 4.5 Subcontracting and 4.6 Purchasing services and supplies
products and services and Supplies from 2005 version
7. Process Requirements - - -
7.1. Review of requests, 4.4 Review of Requests, Major 7.1.3 requires statements of conformity and associated decision rules
tenders and contracts Tenders and Contracts be addressed during contract review
7.1.4 states that deviations requested by the customer shall not impact
5.10 Reporting the Results the integrity of the laboratory or the validity of the results
7.2. Selection, verification and 5.4 Test and calibration Minor Terminology and organization of clause updated from 2005 version.
validation of methods methods and method Note after 7.2.1.1 clarifies that “method” as used in this document can
validation be considered synonymous with the term “measurement procedure” as
defined in ISO/IEC Guide 99.
7.3. Sampling 5.7 Sampling Minor Definition of laboratory (3.6) clarifies that the sampling activity is
associated with subsequent testing or calibration
7.4. Handling of test or 5.8 Handling of test or Minor 7.4.3 includes a new requirement: “When the customer requires the
calibration items calibration items item to be tested or calibrated acknowledging a deviation from specified
conditions, the laboratory shall include a disclaimer in the report
indicating which results may be affected by the deviation.”
7.5. Technical records 4.13 Control of records Minor Technical records placed in this clause as process requirements. Other

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CLAUSE ISO/IEC 17025:2017 CLAUSE ISO/IEC 17025:2005 Change /Status Comments

types of records (e.g., management system records) addressed in
Clause 8
7.6. Evaluation of 5.4 Test and calibration Structural 7.6.1 requires all laboratories to identify contributions to measurement
measurement uncertainty methods and method uncertainty
validation 7.6.2 requires evaluation of measurement uncertainty for all calibrations,
including those a laboratory performs on its own equipment (i.e. “in-
house” calibrations)
7.7. Ensuring the validity of 5.9 Assuring the quality of Minor Clause separates requirements for monitoring done within the
results test and calibration laboratory (7.7.1) and those involving comparison with other
results laboratories (7.7.2)
Data from internal activities (7.7.1) required to be recorded such that
trends can be detected and, where practicable, statistical techniques
applied
7.8. Reporting the results 5.10 Reporting the results Major New/updated requirements
7.8.2.2 addresses data provided by a customer, including a disclaimer
when those data can affect validity of results
7.8.5 reporting sampling
7.8.6 reporting statements of conformity
7.9. Complaints 4.8 Complaints Major New/updated requirements
7.9.2 requires a description of the complaints handling process be
available to any interested party upon request
7.9.6 requires the outcomes to be communicated to the complainant be
made by, or reviewed and approved by, individual(s) not involved in the
original laboratory activities in question
7.10. Nonconforming work 4.9 Control of Minor No significant changes to this clause compared to the 2005 version
nonconforming testing
and/or calibration work
7.11. Control of data and 5.4 Test and calibration Minor Extends and updates 5.4.7 in the 2005 version to address current
information management methods and method laboratory practice
validation 7.11.2 Note 1 clarifies that use of the term “laboratory information
management system(s)” in this document includes both computerized
and non-computerized systems
7.11.4 requires laboratory to ensure that off-site or external providers of
information management comply with applicable requirements of
ISO/IEC 17025
8. Management System 4.0 Management - The revision now provides two distinct options (A or B) for establishing a
Requirements requirements management system
8.1. Options - - NEW Option A: As a minimum the management system of the laboratory
shall address the requirements in clauses 8.2 to 8.9
Option B: Establish and maintain a management system in accordance

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CLAUSE ISO/IEC 17025:2017 CLAUSE ISO/IEC 17025:2005 Change /Status Comments

with the requirements of ISO 9001
Both options require that the management system is capable of
supporting and demonstrating the consistent achievement of the
requirements of ISO/IEC 17025 clauses 4 to 7 and assuring the quality
of the laboratory results.
Laboratories need only conform to one of the options (not both)
8.2. Management system 4.2 Management System Structural No significant changes, similar to 2005 version
documentation (Option A)
8.3. Control of management 4.3 Document Control Structural No significant changes, similar to 2005 version
system documents
(Option A)
8.4. Control of records (Option 4.13 Control of records Structural No significant changes, similar to 2005 version
A)
8.5. Actions to address risks 4.10 Improvement NEW Revision incorporates “risked-based thinking”
and opportunities (Option 4.2 Management System Introduction and Note after 8.5.2 include two important points:
A) 4.1 Organisation There is no requirement for formal methods for risk management or a
4.12 documented risk management process
The laboratory is responsible for deciding which risks and opportunities
need to be addressed
8.6. Improvement (Option A) 4.10 Improvement Minor Aligned with ISO 9001:2015
4.7 Services to the
Customer
8.7. Corrective actions (Option 4.11 Corrective action Minor Aligned with ISO 9001:2015
A)
8.8. Internal Audits (Option A) 4.14 Internal Audits Minor Aligned with ISO 9001:2015
8.9. Management Review 4.15 Management Review Major Aligned with ISO 9001:2015
(Option A) 4.2 Management System
Annex Metrological traceability - - NEW This annex provides additional information on metrological traceability
A
Annex Management system - - NEW More information on the two options (A & B)
B options
Bibliogr - - Bibliography Structural
aphy

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Appendix B: ISO/IEC 17025:2017 Transition Template

Instructions for Using the Template

For Testing and Calibration Laboratories:

This template identifies the clauses of ISO/IEC 17025:2017 and provides SANAS opinion on the broad extent of any changes in requirements from
ISO/IEC 17025:2005. Granular details of the actual changes are not provided and accordingly the Laboratory will need to use this template in conjunction
with its GAP analysis (self-assessment) done against the ISO/IEC 17025:2017 and ISO/IEC 17025:2005.

It is the responsibility of the Laboratory to identify the changes between the standards, determine the impact of these on its systems, and then make and
implement any required alterations as necessary. Details of alterations made to systems should be recorded in this template and the completed template
provided to SANAS (as an MS Word document) at least 2 months prior to the scheduled assessment taking place. Effective implementation will be
assessed at the site visit. If the Laboratory considers that it currently meets a changed requirement and does not need to make changes to its system,
then this should be stated in the template.

For SANAS Assessors:

After verifying the implementation (on-site) of what the laboratory documented in this template, objective evidence gathered regarding the Laboratory’s
conformity with the new requirements must be documented in the updated SANAS assessment checklists (i.e. F48, F49 and F44). The level of comments
provided should sufficiently detailed to allow for intelligent interpretation. If any findings are raised relating to new or changed requirements these should
be recorded in the F03 as normal.

Key - Extent of Change:

• Structural – Requirement remains the same but is under a new clause number
• Minor – Wording of the requirement has changed but overall intent is consistent
• Major – Changes will require the CAB to implement new or change existing practice
• New – New requirement(s)/concept(s) not in previous version of the standard

TO BE COMPLETED BY CONFORMITY ASSESSMENT BODY

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Conformity Assessment Body Name:

SANAS Accreditation Number
Completed by
Date of Completion

ISO/IEC 17025:2017 ISO/IEC 17025:2005 EXTENT TO BE COMPLETED BY LABORATORY

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CLAUSE RELATED CLAUSE(S) CHANGE CHANGES MADE TO MANAGEMENT SYSTEM

1.1 Staff Training 2.1 Staff Major Policy and procedure to cover the increased requirement to have demonstrated
(Example) Competence evidence of competence is covered in QM-1001 pages 6-7. Essentially staff will be
(Example) required to demonstrate competence via analysis of samples of known value or via
witnessed audit from an existing competent staff member.

All trainers and section managers have been made aware of and given an update on the
changes (see document XYZ-001 attached)
1.2 Independence 2.2 Independence Minor Review of the new standard identified the change to be that relationships with third
(Example) (Example) parties must now be formally documented. This was in place already within our
organisation and is documented in QM-1001 page 5.

ISO/IEC 17025:2017 ISO/IEC 17025:2005 EXTENT TO BE COMPLETED BY LABORATORY

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Foreword Foreword NEW

Introduction Introduction NEW
1. Scope 3. Scope Minor
Contains no mandatory requirements but should be considered by the laboratory when
2. Normative 4. Normative Minor
revising its management system
references References
3. Terms & 3. Terms and NEW
Definitions Definitions
4. General - - - N/A

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requirements
4.1 Impartiality 4.1 Management Major
requirements

4.2 Confidentiality 4.1 Management Minor

requirements

5. Structural 4.1 Organisation Major

Requirements

6. Resource - - - N/A
Requirements
6.1 General 4.1 Organisation Minor

6.2 Personnel 5.2 Personnel Structural

6.3 Facilities and 5.3 Accommodation Structural

environmental and
conditions Environmental
Conditions
6.4 Equipment 5.5 Equipment Minor

6.5 Metrological 5.6 Measurement Structural

traceability Traceability

6.6 Externally 4.6 Purchasing Minor

provided Services and
products and Supplies
services
7. Process - - - N/A

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Requirements
7.1. Review of 5.10 Reporting the Major
requests, Results
tenders and
contracts 4.4 Review of
Requests,
Tenders and
Contracts

7.2. Selection, 5.4 Test and Minor

verification and calibration
validation of methods and
methods method
validation
7.3. Sampling 5.7 Sampling Minor

7.4. Handling of test 5.8 Handling of test Minor

or calibration or calibration
items items
7.5. Technical 4.13 Control of Minor
records records

7.6. Evaluation of 5.4 Test and Structural

measurement calibration
uncertainty methods and
method
validation
7.7. Ensuring the 5.9 Assuring the Minor
validity of quality of test
results and calibration
results
7.8. Reporting the 5.10 Reporting the Major
results results

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7.9. Complaints 4.8 Complaints Major

7.10. Nonconforming 4.9 Control of Minor

work nonconforming
testing and/or
calibration work
7.11. Control of data 5.4 Test and Minor
and information calibration
management methods and
method
validation
8. Management 4.0 Management - N/A
System requirements
Requirements
8.1. Options - - NEW

8.2. Management 4.2 Management Structural

system System
documentation
(Option A)
8.3. Control of 4.3 Document Structural
management Control
system
documents
(Option A)
8.4. Control of 4.13 Control of Structural
records (Option records
A)
8.5. Actions to 4.10 Improvement NEW
address risks 4.2 Management
and System
opportunities 4.1 Organisation
(Option A)

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8.6. Improvement 4.10 Improvement Minor

(Option A) 4.7 Services to the
Customer
8.7. Corrective 4.11 Corrective action Minor
actions (Option
A)
8.8. Internal Audits 4.14 Internal Audits Minor
(Option A)

8.9. Management 4.15 Management Major

Review (Option Review
A) 4.2 Management
System
Anne Metrological - - NEW
xA traceability
Anne Management - - NEW
xB system
options
Biblio - - Bibliography Structural
grap
hy

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ADDENDUM 1: Amendment Record

Proposed By: Section Change

AM Appendix B Transition Template added

QM 2.4 Reference to Appendix B added
QM 3 Schedule of Accreditation change to Scope of Accreditation

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