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Document No: TR 14.

Issue No: 1

SADCAS POLICY – ISO/IEC 17025:2017 TRANSITION

Approval Date: 2018-01-31


Prepared by: Technical Manager Approved by: Chief Executive Officer
Effective Date: 2018-02-01
Document No: TR 14 Issue No: 1

Table of Contents
1. INTRODUCTION ...................................................................................................................................... 3

2. TRANSITION TO ISO/IEC 17025:2017 ..................................................................................................... 3

2.1 General ...................................................................................................................................... 3


2.2 Transition Plan .......................................................................................................................... 4
2.3 SADCAS Assessment for Purposes of Transition ....................................................................... 4
2.4 Nonconformities against New Standard ISO/IEC 17025:2017 ................................................. 4
2.5 Accreditation Certificate and Schedule .................................................................................... 5
2.6 End of Transition ...................................................................................................................... 5

3. CHANGES IN REQUIREMENTS ................................................................................................................ 5

APPENDIX A – SUMMARY OF CHANGES............................................................................................................. 6

APPENDIX B – CROSS REFERENCE…………………………………………………………………………………………………….7

APPENDIX C – AMENDMENT RECORD……………………………………………………………………………………………16

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Document No: TR 14 Issue No: 1

1. INTRODUCTION

ISO/IEC 17025:2017: General requirements for the competence of testing and calibration laboratories
was published on 30 November 2017.

On 4 November 2016, the International Laboratory Accreditation Cooperation (ILAC) published a


resolution on the transition period for the implementation of ISO/IEC 17025:2017.

The resolution is as follows:

ILAC Resolution GA 20.15: “As the revised version of ISO/IEC 17025 is scheduled for publication in
2017, the General Assembly endorses the recommendation of the AIC that a transition period of 3
years from the date of publication be adopted. At the end of the transition period, accreditation of a
laboratory to ISO/IEC 17025:2005 will not be recognized under the ILAC Arrangement.”

2. TRANSITION TO ISO/IEC 17025:2017

2.1 General

2.1.1 Any applications for accreditation in accordance with ISO/IEC 17025 submitted to SADCAS after 1 July
2018 shall be based on the latest version of the standard ISO/IEC 17025:2017.

2.1.2 For testing/calibration laboratories whose applications are received before 1 July 2018 and are
already being processed by SADCAS, the following shall apply:

• SADCAS shall not conduct assessments against the new standard ISO/IEC 17025:2017 before 30
November 2018.

• Between 1 February and 30 November 2018, SADCAS will continue to undertake assessments
against the old standard ISO/IEC 17025:2005 unless the testing/calibration laboratories explicitly
request that assessment be against the new standard ISO/IEC 17025:2017. The request should be
made when scheduling the assessment.

• After 30 November 2018, all assessments shall be conducted against the new standard ISO/IEC
17025:2017.

• All nonconformities raised during the transition period against the requirements of the new
standard ISO/IEC 17025:2017, that are also nonconformities against the old standard ISO/IEC
17025:2005 will require corrective actions from the testing/calibration laboratories. Refer to 2.4

• It is important that testing/calibration laboratories that have already applied for accreditation
from SADCAS and have not yet implemented the new standard do so as soon as possible. SADCAS
expects testing/calibration laboratories to establish an action plan for implementation of this
transition from the old version of the standard ISO/IEC 17025:2005 to the new version ISO/IEC
17025:2017.

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2.2 Transition Plan

2.2.1 Testing/Calibration laboratories that have already applied for accreditation from SADCAS and whose
application is progressing through the accreditation process shall provide SADCAS with a transition
plan.

2.2.2 The transition plan shall demonstrate that the testing/calibration laboratory has analyzed the new
standard and its implication for their management system and operations and shall enable the
testing/calibration laboratory to effectively implement all the changes needed to comply with the
new standard ISO/IEC 17025:2017 before 30 November 2020, the date set by ILAC.

2.2.3 As a minimum the transition plan shall include:

All specific actions to be taken to implement the changes;

The timelines and milestones for completion of actions;

The persons responsible for the actions; and means of monitoring progress and completion of the
actions.

2.2.4 Testing/Calibration laboratories that have already applied for accreditation from SADCAS and whose
application is progressing through the accreditation process shall provide SADCAS with the transition
plan before 30 November 2018.

2.3 SADCAS Assessment for Purposes of Transition

2.3.1 During the transition process, and after the testing/calibration laboratory has submitted its transition
plan, SADCAS shall review the plan to verify that the testing/calibration laboratory has analyzed the
impact of the new standard ISO/IEC 17025:2017 on its system and has developed the action plan.
Refer to 2.2.

2.3.2 Implementation of the transition plan shall be verified during assessments undertaken after 30
November 2018 when SADCAS shall review the changes in the documented system and progress in
the implementation of the transition plan.

2.4 Nonconformities against the New Standard ISO/IEC 17025:2017

2.4.1 Nonconformities raised against the requirements of the new standard ISO/IEC 17025:2017 that are
not nonconformities against the old version of the standard ISO/IEC 17025:2005 shall be recorded as
observations to highlight the gap identified. The testing/calibration laboratory shall have until 31 May
2020 to implement corrective actions and provide SADCAS with corrective action report. SADCAS shall
verify these actions before 30 June 2020 and take its decision before 31 July 2020.

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2.4.2 If by 31 July 2020 SADCAS cannot confirm compliance with the new version of the standard ISO/IEC
17025:2017, then accreditation against ISO/IEC 17020:2017 shall be suspended on 30 November
2020. No accreditation against ISO/IEC 17025:2017 shall be granted.

2.4.3 Nonconformities raised against the old version of the standard ISO/IEC 17025:2005 shall be dealt with
in accordance with the SADCAS normal processes and must be cleared within the set timelines before
accreditation can be granted.

2.5 Accreditation Certificate and Schedule

2.5.1 The accreditation certificate and schedule shall be adapted to reflect accreditation against the new
standard ISO/IEC 17025:2017 after assessment against the new standard has been successfully
completed and a decision has been taken to that effect by the Accreditation Approvals Committee.

2.5.2 The testing/calibration laboratory accreditation reference numbers shall remain the same.

2.5.3 The date on the certificate will be the date of decision to grant accreditation against the new standard.
The cycle shall remain as five years.

End of Transition

2.5.4 The three year transition period will conclude on 30 November 2020 and all testing/calibration
laboratories are expected to be in full compliance with the new standard ISO/IEC 17025:2017 and
have new accredited certificates issued.

2.5.5 If by 31 July 2020 SADCAS cannot confirm compliance with the new version of the standard ISO/IEC
17025:2017, then accreditation against ISO/IEC 17025:2005 shall be suspended on 30 November
2020. No accreditation against ISO/IEC 17025:2017 shall be granted.

3. CHANGES IN REQUIREMENTS

3.1 Appendix A of this document summarizes the significant changes in the new standard ISO/IEC
17025:2017. This summary does not contain all the changes made. The testing/calibration laboratory
is responsible to investigate all the changes in the new standard ISO/IEC 17025:2017 and their impact.

3.2 Appendix B contains the cross references between the new standard ISO/IEC 17025:2017 and the old
standard ISO/IEC 17025:2005.

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Document No: TR 14 Issue No: 1

APPENDIX A – SUMMARY OF CHANGES

Clause of ISO/IEC 17025:2017 Details of changes

1. Scope Laboratory activities (testing, calibration,


sampling with subsequent testing)

4.1 Impartiality Emphasis on “Impartiality” vs


“Independence”

7.1 Review of requests, tenders and contracts Process orientation

7.1 Review of requests, tenders and contracts Emphasis on result of a process instead of
detailed description of tasks and steps

4.1 Impartiality, sub clause 4.1.4 Risks and Opportunities


Actions to address risks and opportunities Recognition of risks at impartiality
(Option A) Consideration of risks and opportunities
associated to the laboratory activities

7.1 Review of requests, tenders and contracts, Scope vs “ongoing subcontracting”


sub clause 7.1.3 c) and
6.6 Externally provided products and services

7.11 Control of data and information management Information Technology: risks, data
integrity, confidentiality, validation of
software, considering electronic
documents

6. Metrological traceability Metrological traceability of measurement


results

7.1 and 7.8.6 Review of requests, tenders and contracts, Statement of conformity:
sub clause 7.1.3 and Decision Rules for pass/fail, in-
7.8.6 Reporting statement of conformity tolerance/out of tolerance

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APPENDIX B – CROSS REFERENCE

Comparison between ISO/IEC 17025:2017 and ISO/IEC 17025:2005

ISO/IEC 17025:2017 ISO/IEC 17025:2005


Foreword Foreword
Introduction Introduction
1. Scope 1. Scope
2. Normative references 2. Normative references
3. Terms and definitions 3. Terms and definitions
3.1 Impartiality
3.2 Complaint
3.3 Inter laboratory comparison
3.4 Intra laboratory comparison
3.5 Proficiency testing
3.6 Laboratory
3.7 Decision rule
3.8 Verification
3.9 Validation
4. General requirements
4.1 Impartiality 4.1 Organization
4.1.1
4.1.2
4.1.3 4.1.4 and 4.1.5 (b)
4.1.4
4.1.5
4.2 Confidentiality
4.2.1 4.1.5 (c)
4.2.2
4.2.3
4.2.4
5. Structural requirements 4.1 Organization
5.1 4.1.1
5.2 4.1.5 (h)
5.3
5.4 4.1.2; 4.1.3
5.5
5.5 a) 4.1.5 (e)
5.5 b) 4.1.5 (f)
5.5 c) 4.2.1
5.6 4.1.5 (a)
5.7 4.1.6
5.7 a)
5.7 b) 4.2.7

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6. Resource requirements
6.1 General 5.1 General
6.2 Personnel 5.2 Personnel
6.2.1 5.2.3
6.2.2 5.2.1; 5.2.2
6.2.3 5.2.1
6.2.4
6.2.5 5.2.5
6.2.5 a)
6.2.5 b) 5.2.5
6.2.5 c) 5.2.2
6.2.5 d) 5.2.1; 5.2.3
6.2.5 f) 5.2.5
6.2.6 5.2.5
6.2.6 a) 5.2.5
6.2.6 b) 5.2.5
6.2.6 c) 5.2.5
6.3 Facilities and environmental conditions 5.3 Accommodation and environmental conditions
6.3.1 5.3.1
6.3.2 5.3.1
6.3.3 5.3.2
6.3.4
6.3.4 a) 5.3.4
6.3.4 b) 5.3.3
6.3.4 c) 5.3.3
6.3.5 5.3.1
6.4 Equipment 5.5 Equipment
6.4.1 5.5.1
6.4.2
6.4.3 5.5.6
6.4.4 5.5.1; 5.5.4
6.4.5 5.5.2
6.4.6
6.4.7 5.5.2
6.4.8 5.5.8
6.4.9 5.5.7
6.4.10 5.5.10
6.4.11 5.5.11
6.4.12 5.5.12
6.4.13 5.5.5
6.4.13 a) 5.5.5 a)

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6.4.13 b) 5.5.5 b)
6.4.13 c) 5.5.5 c)
6.4.13 d) 5.5.5 d)
6.4.13 e) 5.5.5 f)
6.4.13 f)
6.4.13 g) 5.5.5 g)
6.4.13 h) 5.5.5 h)
6.5 Metrological traceability 5.6 Measurement traceability
6.5.1 5.6.2.1.1
6.5.2 5.6.2.1.1
6.5.2 a) 5.6.2.1.1
6.5.2 b)
6.5.2 c)
6.5.2 – Note 5.6.2.1.1
6.5.3 5.6.2.1.2
6.5.3 a) 5.6.2.1.2
6.5.3 b) 5.6.2.1.2
6.6 Externally provide products and services 4.6 Purchasing supplies and services
6.6.1
6.6.2 4.6.1
6.6.2 a) 4.6.3
6.6.2 b) 4.6.3
6.6.2 c) 4.6.2
6.6.2 d) 4.6.3
6.6.3 4.6.3
7. Process requirements
7.1 Review of requests, tenders and contracts 4.4 Review of request, tender and contract
4.7 Service to customer
7.1.1 4.4.1
7.1.1 a) 4.4.1 a)
7.1.1 b) 4.4.1 b)
7.1.1 c) 4.4.1 c); 4.5.1; 4.5.2
7.1.1 d)
7.1.1 - Note 2 4.4.1 - Note 1
7.1.2
7.1.3
7.1.4 4.4.1
7.1.5 4.4.4
7.1.6 4.4.5
7.1.7 4.7.1
7.1.7 - Note 4.7.1 - Note 1

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7.1.7 - Note a) 4.7.1 Note 1 a)
7.1.7 - Note b) 4.7.1 Note 1 b)
7.1.8 4.7.1 Note 2
7.2 Selection, verification and validation of 5.4 Test and calibration methods and method
methods validation
7.2.1 Selection and verification of methods 5.4.1 General
5.4.2 Selection of methods
7.2.1.1 5.4.1
7.2.1.2 5.4.1
7.2.1.3 5.4.2
7.2.1.3 – Note 5.4.1 – Note
7.2.1.4 5.4.2
7.2.1.5 5.4.2
7.2.1.6 5.4.3
7.2.1.7 5.4.1
7.2.2 Validation of methods 5.4.5 Validation of methods
7.2.2.1 5.4.5.2
7.2.2.1 – Note 1 5.4.5 – Note 1
7.2.2.1 – Note 2 5.4.5 – Note 2
7.2.2.2 5.4.5 – Note 3
7.2.2.3 5.3.5.4
7.2.2.4 5.4.5.2
7.3 Sampling 5.7 Sampling
7.3.1 5.7.1
7.3.2 5.7.1 – Note 2
7.3.3 5.7.3
7.3.3 a) 5.7.2; 5.7.3
7.3.3 b)
7.3.3 c)
7.3.3 d) 5.7.3
7.3.3 e)
7.3.3 f) 5.7.3
7.3.3 g)
7.3.3 h) 5.7.3
7.4 Handling of test or calibration items 5.8 Handling of tests and calibration items
7.4.1 5.8.1; 5.8.4
7.4.2 5.8.2
7.4.3 5.8.3
7.4.4
7.5 Technical records 4.13.2 Technical records
7.5.1 4.13.2.1; 4.13.2.2

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7.5.2 4.13.2.3
7.6 Evaluation of measurement uncertainty 5.4.6 Estimation of uncertainty of measurement
7.6.1
7.6.2 5.4.6.1
7.6.3 5.4.6.2; 5.4.6.3
7.6.3 – Note 1 5.4.6.2 – Note 2
7.6.3 – Note 2
7.6.3 – Note 3
7.7 Ensuring the validity of results 5.9 Assuring the quality of test and calibration
results
7.7.1 5.9.1
7.7.1 a) 5.9.1 a)
7.7.1 b) 5.9.1 b)
7.7.1 c)
7.7.1 d)
7.7.1 e)
7.7.1 f) 5.9.1 c)
7.7.1 g) 5.9.1 d)
7.7.1 h) 5.9.1 e)
7.7.1 i)
7.7.1 j)
7.7.1 k)
7.7.2 5.9.1 b)
7.7.3 5.9.2
7.8 Reporting of results 5.10 Reporting the results
7.8.1 General 5.10.1 General
7.8.1.1 5.10.1
7.8.1.1 – Note 1 5.10.1 – Note 1
7.8.1.1 – Note 2 5.10.1 – Note 2
7.8.1.2 5.10.1
7.8.1.3 5.10.1
7.8.2 Common requirements for reports (test, 5.10.2 Test report and calibration certificates
calibration or sampling)
7.8.2.1 5.10.2
7.8.2.1 a) 5.10.2 a)
7.8.2.1 b) 5.10.2 b)
7.8.2.1 c)
7.8.2.1 d) 5.10.2 c)
7.8.2.1 e) 5.10.2 d)
7.8.2.1 f) 5.10.2 e)
7.8.2.1 g) 5.10.2 f)

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7.8.2.1 h) 5.10.2 g)
7.8.2.1 i)
7.8.2.1 j)
7.8.2.1 k) 5.10.2 h); 5.10.2 j)
7.8.2.1 l)
7.8.2.1 m) 5.10.2 i)
7.8.2.1 n) 5.10.3.1 a)
7.8.2.1 o) 5.10.2 k)
7.8.2.1 p) 5.10.5
7.8.2.2 5.10.2 – Note 2
7.8.3 Specific requirements for test reports 5.10.3
7.8.3.1 5.10.3.1
7.8.3.1 a)
7.8.3.1 b) 5.10.3.1 b)
7.8.3.1 c) 5.10.3.1 c)
7.8.3.1 d) 5.10.3.1 d)
7.8.3.1 e) 5.10.3.1 e)
7.8.3.1 f)
7.8.3.2
7.8.4 Specific requirements for calibration 5.10.4 Calibration certificates
certificates
7.8.4.1 5.10.4 .1
7.8.4.1 a) 5.10.4 .1 b)
7.8.4.1 b) 5.10.4 .1 a)
7.8.4.1 c) 5.10.4 .1 b)
7.8.4.1 d) 5.10.4.3
7.8.4.1 e) 5.10.4.2
7.8.4.1 f) 5.10.4.2
7.8.4.2 5.10.4.2
7.8.4.3 5.10.4.4
7.8.5 Reporting sampling – specific requirements 5.10.3.2
7.8.5 a) 5.10.3.2 a)
7.8.5 b) 5.10.3.2 b)
7.8.5 c) 5.10.3.2 c)
7.8.5 d) 5.10.3.2 d)
7.8.5 e) 5.10.3.2 e)
7.8.6 Reporting statements of conformity 5.10.4 Calibration certificates
7.8.6.1 5.10.4.2
7.8.6.2 5.10.4.2
7.8.6.2 a) 5.10.4.2
7.8.6.2 b) 5.10.4.2

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7.8.6.2 c) 5.10.4.2
7.8.7 Reporting opinions and interpretations 5.10.5 Opinions and interpretations
7.8.7.1 5.10.5
7.8.7.2
7.8.7.3 5.10.5 – Note 3
7.8.8 Amendments to reports 5.10.9 Amendments to test reports and calibration
certificates
7.8.8.1
7.8.8.2 5.10.9
7.8.8.3 5.10.9
7.9 Complaints 4.8 Complaints
7.9.1
7.9.2
7.9.3
7.9.4
7.9.5
7.9.6
7.9.7
7.10 Nonconforming work 4.9 Control of nonconforming testing and/or
calibration work
7.10.1
7.10.1 a) 4.9.1 a)
7.10.1 b) 4.9.1 a)
7.10.1 c) 4.9.1 b)
7.10.1 d) 4.9.1 c)
7.10.1 e) 4.9.1 d)
7.10.2
7.10.3 4.9.2
7.11 Control of data and information management 5.4.7 Control of data
7.11.1
7.11.2 5.4.7.2; 5.4.7.2 a)
7.11.3 4.13.1.4; 5.4.7.2 b)
7.11.3 a) 4.13.1.4
7.11.3 b) 4.13.1.4
7.11.3 c) 5.4.7.2 c)
7.11.3 d) 5.4.7.2 c)
7.11.3 e)
7.11.3 - Note 2 5.4.7.2 - Note
7.11.4
7.11.5 4.2.1
7.11.6 5.4.7.1

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8. Management system requirements 4.2 Management system
Introduction
8.1 Options
8.1.1 General 4.2.1
8.1.2 Option A
8.1.3 Option B
8.2 Management system documentation
(Option A)
8.2.1 4.2 Management system
4.2.2 d)
8.2.2 4.2.2
8.2.3 4.2.3
8.2.3 e) 4.3.2.3
8.2.4 4.2.5
8.2.5
8.3 Control of management system documents 4.3 Document control
(Option A)
8.3.1 4.3.1
8.3.1 (Note) 4.3.1 (Note)
8.3.2 4.3.2.2
8.3.2 a) 4.3.2
8.3.2 b) 4,3.2.2 b)
8.3.2 c) 4.3.2
8.3.2 d) 4.3.2.2 a)
8.3.2 f) 4.3.2.2 c); 4.3.2.2 d)
8.4 Control of records (Option A) 4.13 Control of records
8.4.1 4.13.1.1; 4.13.1.2
8.4.2 4.13.1.2; 4.13.1.3
8.5 Actions to address risks and opportunities 4.12 Preventive action
(Option A)
8.5.1 4.12.1
8.5.1 a) 4.12.1; 4.12.2
8.5.1 b) 4.12.2
8.5.1 c) 4.12.1
8.5.1 d) 4.12.2
8.5.2
8.5.3
8.6 Improvement (Option A) 4.10 Improvement
8.6.1
8.6.2 4.7.2
8.7 Corrective actions (Option A) 4.11 Corrective action

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8.7.1 4.11.1
8.7.1 a) 4.11.2
8.7.1 b) 4.11.2
8.7.1 c) 4.11.3
8.7.1 d) 4.11.4
8.7.1 f) 4.11.3
8.7.2 4.11.3
8.7.3
8.8 Internal audits (Option A) 4.14 Internal audit
8.8.1 4.14.1
8.8.2 4.14.1
8.8.2 a) 4.14.1
8.8.2 b)
8.8.2 c)
8.8.2 d) 4.14.2
8.8.2 e) 4.14.13
8.9 Management reviews (Option A) 4.15 Management Review
8.9.1 4.15.1
8.9.2 4.15.1
8.9.3 4.15.2

Annex A (informative) Metrological traceability


A.1 General
A.2 Establishing metrological traceability
A.2.1
A.2.2
A.2.3
A.3 Demonstrating metrological traceability
A.3.1
A.3.2
Annex B (informative) Management system
options
B.1
B.2
B.3
B.4
B.5

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APPENDIC C – AMENDMENT RECORD

Revision status Change Effective


Approved by
Page No. Clause Description of change Date

Issue no.1 - - - CEO 2018-02-01

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