Anda di halaman 1dari 8

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 TO BE COMPLETED BY LABORATORY TO BE COMPLETED BY UKAS ASSESSORS


OF
CHANGES MADE & DOCUMENTATION COMMENTS ON COMPLIANCE & REF TO
CLAUSE RELATED CLAUSE(S) CHANGE
SUPPLIED FINDINGS
1.1 Staff Training 2.1 Staff Major Policy and procedure to cover the increased Comments:

Page 1 of 8
ISO/IEC 17025:2017 – UKAS Transition Template – Version 2.1 June 2018
ISO/IEC 17025:2017Transition Template

ISO/IEC 17025:2017 ISO/IEC17025:2005 EXTENT TO BE COMPLETED BY LABORATORY TO BE COMPLETED BY UKAS ASSESSORS


OF
CHANGES MADE & DOCUMENTATION COMMENTS ON COMPLIANCE & REF TO
CLAUSE RELATED CLAUSE(S) CHANGE
SUPPLIED FINDINGS
(Example) Competence requirement to have demonstrated evidence Finding Ref:
(Example) 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)
1.2 Independence 2.2 Independence Minor Review of the new standard identified the Comments:
(Example) (Example) change to be that relationships with third
Finding Ref:
parties must now be formally documented.
This was in place already within our
organisation and is documented in QM-1001
page 5.

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:

Page 2 of 8
ISO/IEC 17025:2017 – UKAS Transition Template – Version 2.1 June 2018
ISO/IEC 17025:2017Transition Template

 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 TO BE COMPLETED BY LABORATORY TO BE COMPLETED BY UKAS ASSESSORS


OF
CHANGES MADE & DOCUMENTATION COMMENTS ON COMPLIANCE & REF TO
CLAUSE RELATED CLAUSE(S) CHANGE
SUPPLIED FINDINGS
Foreword Foreword NEW
Introduction Introduction NEW
1. Scope 1. Scope Minor
Contains no mandatory requirements but should be considered by the
2. Normative 2. Normative Minor
references References laboratory when revising its management system
3. Terms & 3. Terms and NEW
Definitions Definitions
4. General - - - N/A N/A

Page 3 of 8
ISO/IEC 17025:2017 – UKAS Transition Template – Version 2.1 June 2018
ISO/IEC 17025:2017Transition Template

ISO/IEC 17025:2017 ISO/IEC17025:2005 EXTENT TO BE COMPLETED BY LABORATORY TO BE COMPLETED BY UKAS ASSESSORS


OF
CHANGES MADE & DOCUMENTATION COMMENTS ON COMPLIANCE & REF TO
CLAUSE RELATED CLAUSE(S) CHANGE
SUPPLIED FINDINGS
requirements
4.1 Impartiality 4.1 Management Major Comments:
requirements
Finding Ref:
4.2 Confidentiality 4.1 Management Minor Comments:
requirements
Finding Ref:
5. Structural 4.1 Organisation Major Comments:
Requirements
Finding Ref:
6. Resource - - - N/A N/A
Requirements
6.1 General 4.1 Organisation Minor Comments:
Finding Ref:
6.2 Personnel 5.2 Personnel Structural Comments:
Finding Ref:
6.3 Facilities and 5.3 Accommodation Structural Comments:
environmental and
Finding Ref:
conditions Environmental
Conditions
6.4 Equipment 5.5 Equipment Minor Comments:
Finding Ref:
6.5 Metrological 5.6 Measurement Structural Comments:
traceability Traceability
Finding Ref:

Page 4 of 8
ISO/IEC 17025:2017 – UKAS Transition Template – Version 2.1 June 2018
ISO/IEC 17025:2017Transition Template

ISO/IEC 17025:2017 ISO/IEC17025:2005 EXTENT TO BE COMPLETED BY LABORATORY TO BE COMPLETED BY UKAS ASSESSORS


OF
CHANGES MADE & DOCUMENTATION COMMENTS ON COMPLIANCE & REF TO
CLAUSE RELATED CLAUSE(S) CHANGE
SUPPLIED FINDINGS
6.6 Externally 4.6 Purchasing Minor Comments:
provided products Services and
Finding Ref:
and services Supplies
7. Process - - - N/A N/A
Requirements
7.1. Review of 5.10 Reporting the Major Comments:
requests, tenders Results
Finding Ref:
and contracts
4.4 Review of
Requests,
Tenders and
Contracts

7.2. Selection, 5.4 Test and Minor Comments:


verification and calibration
Finding Ref:
validation of methods and
methods method
validation
7.3. Sampling 5.7 Sampling Minor Comments:
Finding Ref:
7.4. Handling of test or 5.8 Handling of test Minor Comments:
calibration items or calibration
Finding Ref:
items
7.5. Technical records 4.13 Control of Minor Comments:
records
Finding Ref:
7.6. Evaluation of 5.4 Test and Structural Comments:

Page 5 of 8
ISO/IEC 17025:2017 – UKAS Transition Template – Version 2.1 June 2018
ISO/IEC 17025:2017Transition Template

ISO/IEC 17025:2017 ISO/IEC17025:2005 EXTENT TO BE COMPLETED BY LABORATORY TO BE COMPLETED BY UKAS ASSESSORS


OF
CHANGES MADE & DOCUMENTATION COMMENTS ON COMPLIANCE & REF TO
CLAUSE RELATED CLAUSE(S) CHANGE
SUPPLIED FINDINGS
measurement calibration Finding Ref:
uncertainty methods and
method
validation
7.7. Ensuring the 5.9 Assuring the Minor Comments:
validity of results quality of test
Finding Ref:
and calibration
results
7.8. Reporting the 5.10 Reporting the Major Comments:
results results
Finding Ref:
7.9. Complaints 4.8 Complaints Major Comments:
Finding Ref:
7.10. Nonconforming 4.9 Control of Minor Comments:
work nonconforming
Finding Ref:
testing and/or
calibration work
7.11. Control of data 5.4 Test and Minor Comments:
and information calibration
Finding Ref:
management methods and
method
validation
8. Management 4.0 Management - N/A N/A
System requirements
Requirements
8.1. Options - - NEW Findings:

Page 6 of 8
ISO/IEC 17025:2017 – UKAS Transition Template – Version 2.1 June 2018
ISO/IEC 17025:2017Transition Template

ISO/IEC 17025:2017 ISO/IEC17025:2005 EXTENT TO BE COMPLETED BY LABORATORY TO BE COMPLETED BY UKAS ASSESSORS


OF
CHANGES MADE & DOCUMENTATION COMMENTS ON COMPLIANCE & REF TO
CLAUSE RELATED CLAUSE(S) CHANGE
SUPPLIED FINDINGS
Actions:
8.2. Management 4.2 Management Structural Comments:
system System
Finding Ref:
documentation
(Option A)
8.3. Control of 4.3 Document Structural Comments:
management Control
Finding Ref:
system documents
(Option A)
8.4. Control of records 4.13 Control of Structural Comments:
(Option A) records
Finding Ref:
8.5. Actions to address 4.10 Improvement NEW Comments:
risks and 4.2 Management
Finding Ref:
opportunities System
(Option A) 4.1 Organisation
8.6. Improvement 4.10 Improvement Minor Comments:
(Option A) 4.7 Services to the
Finding Ref:
Customer
8.7. Corrective actions 4.11 Corrective action Minor Comments:
(Option A)
Finding Ref:
8.8. Internal Audits 4.14 Internal Audits Minor Comments:
(Option A)
Finding Ref:
8.9. Management 4.15 Management Major Comments:

Page 7 of 8
ISO/IEC 17025:2017 – UKAS Transition Template – Version 2.1 June 2018
ISO/IEC 17025:2017Transition Template

ISO/IEC 17025:2017 ISO/IEC17025:2005 EXTENT TO BE COMPLETED BY LABORATORY TO BE COMPLETED BY UKAS ASSESSORS


OF
CHANGES MADE & DOCUMENTATION COMMENTS ON COMPLIANCE & REF TO
CLAUSE RELATED CLAUSE(S) CHANGE
SUPPLIED FINDINGS
Review (Option A) Review Finding Ref:
4.2 Management
System
Annex A Metrological - - NEW
traceability
Contains no mandatory requirements but should be considered by the
Annex B Management - - NEW
system options laboratory when revising its management system
Bibliography - - Bibliography Structural

Executive Summary:

Recommendation:

Page 8 of 8
ISO/IEC 17025:2017 – UKAS Transition Template – Version 2.1 June 2018

Anda mungkin juga menyukai