ISO/IEC 17025:2017Transition Template

Instructions for Using the Template

For Testing and Calibration Laboratories:

This template identifies the clauses of ISO/IEC 17025:2017 and provides UKAS’ opinion on the broad extent of any changes in requirements from ISO/IEC 17025:2005. Details of the actual changes are not provided and as such the Laboratory will need to use this template in conjunction with copies of 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 theseon its systems, and thenmake andimplement any required alterations as necessary. Details of alterations made to systems should be recorded in this template and the completed template provided to UKAS (as an MS Word document) at least 1 month prior to the transition assessment taking place. The submission of the template should be supported by documentation demonstrating how new or changed requirements are met. 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.

The information provide to UKAS should be more than just a reference to the documented procedure and should explain what has been changed and actions taken by the laboratory. Examples of expected level of information expected from the laboratory for major and minor changes are provided below:

ISO/IEC 17025:2017 / ISO/IEC17025:2005 / EXTENT OF CHANGE / TO BE COMPLETED BY LABORATORY / TO BE COMPLETED BY UKAS ASSESSORS
CLAUSE / RELATED CLAUSE(S) / CHANGES MADE & DOCUMENTATION SUPPLIED / COMMENTS ON COMPLIANCE & REF TO FINDINGS
1.1 / Staff Training (Example) / 2.1 / Staff Competence (Example) / Major / Policy and procedure to cover the increased requirement to have demonstrated evidence of competence is covered in QM-1001 pages 6-7. Essentially staff will be 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) / Comments:
Finding Ref:
1.2 / Independence (Example) / 2.2 / Independence (Example) / Minor / Review of the new standard identified the change to be that relationships with third parties must now be formally documented. This was in place already within our organisation and is documented in QM-1001 page 5. / Comments:
Finding Ref:

For UKAS Assessors:

After reviewing the information and documentation supplied by the Laboratory and completing the assessment to confirm appropriate implementation,you should place your comments regarding the Laboratory’s conformity with the new requirements in this template, which forms the report for the transition. The level of comments provided should be similar to that provided in an assessment report. If any findings are raised relating to new or changed requirements these should be recorded in the IAR as normal but then cross-referenced in this template.

An Executive Summary and Recommendation on transition of accreditation to ISO/IEC 17025:2017 must be included at the end of this template.

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 LABORATORY / TO BE COMPLETED BY UKAS ASSESSORS
Organisation Name / Assessment Manager
UKAS Accreditation Number / Assessment Team Members & Roles
Completed by / Date(s) of review
Date of Completion / Issue Date
ISO/IEC 17025:2017 / ISO/IEC17025:2005 / EXTENT OF CHANGE / TO BE COMPLETED BY LABORATORY / TO BE COMPLETED BY UKAS ASSESSORS
CLAUSE / RELATED CLAUSE(S) / CHANGES MADE & DOCUMENTATION SUPPLIED / COMMENTS ON COMPLIANCE & REF TO FINDINGS
Foreword / Foreword / NEW / Contains no mandatory requirements but should be considered by the laboratory when revising its management system
Introduction / Introduction / NEW
1. / Scope / / Scope / Minor
2. / Normative references / / Normative References / Minor
3. / Terms & Definitions / 3. / Terms and Definitions / NEW
4. / General requirements / - / - / - / N/A / N/A
4.1 / Impartiality / 4.1 / Management requirements / Major / Comments:
Finding Ref:
4.2 / Confidentiality / 4.1 / Management requirements / Minor / Comments:
Finding Ref:
5. / Structural Requirements / 4.1 / Organisation / Major / Comments:
Finding Ref:
6. / Resource Requirements / - / - / - / N/A / N/A
6.1 / General / 4.1 / Organisation / Minor / Comments:
Finding Ref:
6.2 / Personnel / 5.2 / Personnel / Structural / Comments:
Finding Ref:
6.3 / Facilities and environmental conditions / 5.3 / Accommodation and Environmental Conditions / Structural / Comments:
Finding Ref:
6.4 / Equipment / 5.5 / Equipment / Minor / Comments:
Finding Ref:
6.5 / Metrological traceability / 5.6 / Measurement Traceability / Structural / Comments:
Finding Ref:
6.6 / Externally provided products and services / 4.6 / Purchasing Services and Supplies / Minor / Comments:
Finding Ref:
7. / Process Requirements / - / - / - / N/A / N/A
7.1. / Review of requests, tenders and contracts / 5.10
4.4 / Reporting the Results
Review of Requests, Tenders and Contracts / Major / Comments:
Finding Ref:
7.2. / Selection, verification and validation of methods / 5.4 / Test and calibration methods and method validation / Minor / Comments:
Finding Ref:
7.3. / Sampling / 5.7 / Sampling / Minor / Comments:
Finding Ref:
7.4. / Handling of test or calibration items / 5.8 / Handling of test or calibration items / Minor / Comments:
Finding Ref:
7.5. / Technical records / 4.13 / Control of records / Minor / Comments:
Finding Ref:
7.6. / Evaluation of measurement uncertainty / 5.4 / Test and calibration methods and method validation / Structural / Comments:
Finding Ref:
7.7. / Ensuring the validity of results / 5.9 / Assuring the quality of test and calibration results / Minor / Comments:
Finding Ref:
7.8. / Reporting the results / 5.10 / Reporting the results / Major / Comments:
Finding Ref:
7.9. / Complaints / 4.8 / Complaints / Major / Comments:
Finding Ref:
7.10. / Nonconforming work / 4.9 / Control of nonconforming testing and/or calibration work / Minor / Comments:
Finding Ref:
7.11. / Control of data and information management / 5.4 / Test and calibration methods and method validation / Minor / Comments:
Finding Ref:
8. / Management System Requirements / 4.0 / Management requirements / - / N/A / N/A
8.1. / Options / - / - / NEW / Findings:
Actions:
8.2. / Management system documentation (Option A) / 4.2 / Management System / Structural / Comments:
Finding Ref:
8.3. / Control of management system documents (Option A) / 4.3 / Document Control / Structural / Comments:
Finding Ref:
8.4. / Control of records (Option A) / 4.13 / Control of records / Structural / Comments:
Finding Ref:
8.5. / Actions to address risks and opportunities (Option A) / 4.10
4.2
4.1 / Improvement
Management System
Organisation / NEW / Comments:
Finding Ref:
8.6. / Improvement (Option A) / 4.10
4.7 / Improvement
Services to the Customer / Minor / Comments:
Finding Ref:
8.7. / Corrective actions (Option A) / 4.11 / Corrective action / Minor / Comments:
Finding Ref:
8.8. / Internal Audits (Option A) / 4.14 / Internal Audits / Minor / Comments:
Finding Ref:
8.9. / Management Review (Option A) / 4.15
4.2 / Management Review
Management System / Major / Comments:
Finding Ref:
Annex A / Metrological traceability / - / - / NEW / Contains no mandatory requirements but should be considered by the laboratory when revising its management system
Annex B / Management system options / - / - / NEW
Bibliography / - / - / Bibliography / Structural

Executive Summary:

Recommendation:

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ISO/IEC 17025:2017 – UKAS Transition Template – Version 2.1 June 2018