Iso Iec 17025 2017 Transition Template 4u341o
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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 ed 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:
1.1
ISO/IEC 17025:2017
ISO/IEC17025:2005
CLAUSE
RELATED CLAUSE(S)
Staff Training
2.1
Staff
EXTENT OF CHANGE Major
TO BE COMPLETED BY LABORATORY CHANGES MADE & DOCUMENTATION SUPPLIED Policy and procedure to cover the increased
Page 1 of 8 ISO/IEC 17025:2017 – UKAS Transition Template – Version 2.1 June 2018
TO BE COMPLETED BY UKAS ASSESSORS COMMENTS ON COMPLIANCE & REF TO FINDINGS Comments:
ISO/IEC 17025:2017Transition Template ISO/IEC 17025:2017
ISO/IEC17025:2005
CLAUSE
RELATED CLAUSE(S)
(Example)
1.2
Independence (Example)
EXTENT OF CHANGE
Competence (Example)
2.2
Independence (Example)
Minor
TO BE COMPLETED BY LABORATORY CHANGES MADE & DOCUMENTATION SUPPLIED requirement to have demonstrated evidence of competence is covered in QM-1001 pages 67. 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) 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.
TO BE COMPLETED BY UKAS ASSESSORS COMMENTS ON COMPLIANCE & REF TO FINDINGS Finding Ref:
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: 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 Organisation Name UKAS Accreditation Number Completed by Date of Completion
1. 2. 3. 4.
ISO/IEC 17025:2017
ISO/IEC17025:2005
CLAUSE
RELATED CLAUSE(S)
Foreword Introduction Scope Normative references & Definitions General
1. 2. 3. -
Foreword Introduction Scope Normative References and Definitions -
TO BE COMPLETED BY UKAS ASSESSORS Assessment Manager Assessment Team & Roles Date(s) of review Issue Date
EXTENT OF CHANGE
TO BE COMPLETED BY LABORATORY
TO BE COMPLETED BY UKAS ASSESSORS
CHANGES MADE & DOCUMENTATION SUPPLIED
COMMENTS ON COMPLIANCE & REF TO FINDINGS
NEW NEW Minor Minor
Contains no mandatory requirements but should be considered by the laboratory when revising its management system
NEW -
N/A
Page 3 of 8 ISO/IEC 17025:2017 – UKAS Transition Template – Version 2.1 June 2018
N/A
ISO/IEC 17025:2017Transition Template
4.1
4.2
5.
6. 6.1
ISO/IEC 17025:2017
ISO/IEC17025:2005
CLAUSE
RELATED CLAUSE(S)
requirements Impartiality
Confidentiality
4.1
4.1
EXTENT OF CHANGE
Management requirements
Major
Management requirements
Minor
Organisation
Major
Structural Requirements
4.1
Resource Requirements General
-
-
4.1
Organisation
TO BE COMPLETED BY LABORATORY
TO BE COMPLETED BY UKAS ASSESSORS
CHANGES MADE & DOCUMENTATION SUPPLIED
COMMENTS ON COMPLIANCE & REF TO FINDINGS Comments: Finding Ref: Comments: Finding Ref: Comments: Finding Ref:
-
N/A
Minor
N/A Comments: Finding Ref:
6.2
Personnel
5.2
Personnel
Structural
Comments: Finding Ref:
6.3
6.4
Facilities and environmental conditions
5.3
Equipment
5.5
Accommodation and Environmental Conditions Equipment
Structural
Comments: Finding Ref:
Minor
Comments: Finding Ref:
6.5
Metrological traceability
5.6
Measurement Traceability
Structural
Page 4 of 8 ISO/IEC 17025:2017 – UKAS Transition Template – Version 2.1 June 2018
Comments: Finding Ref:
ISO/IEC 17025:2017Transition Template
6.6
7. 7.1.
7.2.
7.3.
ISO/IEC 17025:2017
ISO/IEC17025:2005
CLAUSE
RELATED CLAUSE(S)
Externally provided products and services Process Requirements Review of requests, tenders and contracts
4.6
5.10
Purchasing Services and Supplies -
Minor
Reporting the Results
Major
4.4
Review of Requests, Tenders and Contracts
Selection, verification and validation of methods
5.4
Sampling
5.7
Test and calibration methods and method validation Sampling
TO BE COMPLETED BY LABORATORY
EXTENT OF CHANGE
CHANGES MADE & DOCUMENTATION SUPPLIED
TO BE COMPLETED BY UKAS ASSESSORS COMMENTS ON COMPLIANCE & REF TO FINDINGS Comments: Finding Ref:
-
N/A
N/A Comments: Finding Ref:
Minor
Comments: Finding Ref:
Minor
Comments: Finding Ref:
7.4.
7.5.
7.6.
Handling of test or calibration items
5.8
Technical records
4.13
Evaluation of
5.4
Handling of test or calibration items Control of records Test and
Minor
Comments: Finding Ref:
Minor
Comments: Finding Ref:
Structural
Page 5 of 8 ISO/IEC 17025:2017 – UKAS Transition Template – Version 2.1 June 2018
Comments:
ISO/IEC 17025:2017Transition Template ISO/IEC 17025:2017
ISO/IEC17025:2005
CLAUSE
RELATED CLAUSE(S)
measurement uncertainty 7.7.
7.8.
7.9.
Ensuring the validity of results
5.9
Reporting the results
5.10
Complaints
4.8
calibration methods and method validation Assuring the quality of test and calibration results Reporting the results Complaints
TO BE COMPLETED BY LABORATORY
EXTENT OF CHANGE
CHANGES MADE & DOCUMENTATION SUPPLIED
Minor
TO BE COMPLETED BY UKAS ASSESSORS COMMENTS ON COMPLIANCE & REF TO FINDINGS Finding Ref:
Comments: Finding Ref:
Major
Comments: Finding Ref:
Major
Comments: Finding Ref:
7.10.
7.11.
8. 8.1.
Nonconforming work
4.9
Control of data and information management
5.4
Management System Requirements Options
4.0 -
Control of nonconforming testing and/or calibration work Test and calibration methods and method validation Management requirements
Minor
-
NEW
Comments: Finding Ref:
Minor
Comments: Finding Ref:
-
N/A
Page 6 of 8 ISO/IEC 17025:2017 – UKAS Transition Template – Version 2.1 June 2018
N/A Findings:
ISO/IEC 17025:2017Transition Template
8.2.
8.3.
8.4.
8.5.
8.6.
8.7.
8.8.
8.9.
ISO/IEC 17025:2017
ISO/IEC17025:2005
CLAUSE
RELATED CLAUSE(S)
Management system documentation (Option A) Control of management system documents (Option A) Control of records (Option A)
4.2
Actions to address risks and opportunities (Option A) Improvement (Option A)
4.10 4.2
Corrective actions (Option A)
4.11
Internal Audits (Option A)
4.14
Management
4.15
4.3
4.13
4.1 4.10 4.7
EXTENT OF CHANGE
Management System
Structural
Document Control
Structural
Control of records
Structural
Improvement Management System Organisation Improvement Services to the Customer Corrective action
TO BE COMPLETED BY LABORATORY CHANGES MADE & DOCUMENTATION SUPPLIED
TO BE COMPLETED BY UKAS ASSESSORS COMMENTS ON COMPLIANCE & REF TO FINDINGS Actions: Comments: Finding Ref: Comments: Finding Ref: Comments: Finding Ref:
NEW
Comments: Finding Ref:
Minor
Comments: Finding Ref:
Minor
Comments: Finding Ref:
Internal Audits
Minor
Comments: Finding Ref:
Management
Major
Page 7 of 8 ISO/IEC 17025:2017 – UKAS Transition Template – Version 2.1 June 2018
Comments:
ISO/IEC 17025:2017Transition Template ISO/IEC 17025:2017
ISO/IEC17025:2005
CLAUSE
RELATED CLAUSE(S)
Review (Option A) 4.2 Annex A Annex B Bibliography
Metrological traceability Management system options -
-
Review Management System Bibliography
EXTENT OF CHANGE
TO BE COMPLETED BY LABORATORY CHANGES MADE & DOCUMENTATION SUPPLIED
TO BE COMPLETED BY UKAS ASSESSORS COMMENTS ON COMPLIANCE & REF TO FINDINGS Finding Ref:
NEW NEW Structural
Executive Summary: Recommendation:
Page 8 of 8 ISO/IEC 17025:2017 – UKAS Transition Template – Version 2.1 June 2018
Contains no mandatory requirements but should be considered by the laboratory when revising its management system
1.1
ISO/IEC 17025:2017
ISO/IEC17025:2005
CLAUSE
RELATED CLAUSE(S)
Staff Training
2.1
Staff
EXTENT OF CHANGE Major
TO BE COMPLETED BY LABORATORY CHANGES MADE & DOCUMENTATION SUPPLIED Policy and procedure to cover the increased
Page 1 of 8 ISO/IEC 17025:2017 – UKAS Transition Template – Version 2.1 June 2018
TO BE COMPLETED BY UKAS ASSESSORS COMMENTS ON COMPLIANCE & REF TO FINDINGS Comments:
ISO/IEC 17025:2017Transition Template ISO/IEC 17025:2017
ISO/IEC17025:2005
CLAUSE
RELATED CLAUSE(S)
(Example)
1.2
Independence (Example)
EXTENT OF CHANGE
Competence (Example)
2.2
Independence (Example)
Minor
TO BE COMPLETED BY LABORATORY CHANGES MADE & DOCUMENTATION SUPPLIED requirement to have demonstrated evidence of competence is covered in QM-1001 pages 67. 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) 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.
TO BE COMPLETED BY UKAS ASSESSORS COMMENTS ON COMPLIANCE & REF TO FINDINGS Finding Ref:
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: 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 Organisation Name UKAS Accreditation Number Completed by Date of Completion
1. 2. 3. 4.
ISO/IEC 17025:2017
ISO/IEC17025:2005
CLAUSE
RELATED CLAUSE(S)
Foreword Introduction Scope Normative references & Definitions General
1. 2. 3. -
Foreword Introduction Scope Normative References and Definitions -
TO BE COMPLETED BY UKAS ASSESSORS Assessment Manager Assessment Team & Roles Date(s) of review Issue Date
EXTENT OF CHANGE
TO BE COMPLETED BY LABORATORY
TO BE COMPLETED BY UKAS ASSESSORS
CHANGES MADE & DOCUMENTATION SUPPLIED
COMMENTS ON COMPLIANCE & REF TO FINDINGS
NEW NEW Minor Minor
Contains no mandatory requirements but should be considered by the laboratory when revising its management system
NEW -
N/A
Page 3 of 8 ISO/IEC 17025:2017 – UKAS Transition Template – Version 2.1 June 2018
N/A
ISO/IEC 17025:2017Transition Template
4.1
4.2
5.
6. 6.1
ISO/IEC 17025:2017
ISO/IEC17025:2005
CLAUSE
RELATED CLAUSE(S)
requirements Impartiality
Confidentiality
4.1
4.1
EXTENT OF CHANGE
Management requirements
Major
Management requirements
Minor
Organisation
Major
Structural Requirements
4.1
Resource Requirements General
-
-
4.1
Organisation
TO BE COMPLETED BY LABORATORY
TO BE COMPLETED BY UKAS ASSESSORS
CHANGES MADE & DOCUMENTATION SUPPLIED
COMMENTS ON COMPLIANCE & REF TO FINDINGS Comments: Finding Ref: Comments: Finding Ref: Comments: Finding Ref:
-
N/A
Minor
N/A Comments: Finding Ref:
6.2
Personnel
5.2
Personnel
Structural
Comments: Finding Ref:
6.3
6.4
Facilities and environmental conditions
5.3
Equipment
5.5
Accommodation and Environmental Conditions Equipment
Structural
Comments: Finding Ref:
Minor
Comments: Finding Ref:
6.5
Metrological traceability
5.6
Measurement Traceability
Structural
Page 4 of 8 ISO/IEC 17025:2017 – UKAS Transition Template – Version 2.1 June 2018
Comments: Finding Ref:
ISO/IEC 17025:2017Transition Template
6.6
7. 7.1.
7.2.
7.3.
ISO/IEC 17025:2017
ISO/IEC17025:2005
CLAUSE
RELATED CLAUSE(S)
Externally provided products and services Process Requirements Review of requests, tenders and contracts
4.6
5.10
Purchasing Services and Supplies -
Minor
Reporting the Results
Major
4.4
Review of Requests, Tenders and Contracts
Selection, verification and validation of methods
5.4
Sampling
5.7
Test and calibration methods and method validation Sampling
TO BE COMPLETED BY LABORATORY
EXTENT OF CHANGE
CHANGES MADE & DOCUMENTATION SUPPLIED
TO BE COMPLETED BY UKAS ASSESSORS COMMENTS ON COMPLIANCE & REF TO FINDINGS Comments: Finding Ref:
-
N/A
N/A Comments: Finding Ref:
Minor
Comments: Finding Ref:
Minor
Comments: Finding Ref:
7.4.
7.5.
7.6.
Handling of test or calibration items
5.8
Technical records
4.13
Evaluation of
5.4
Handling of test or calibration items Control of records Test and
Minor
Comments: Finding Ref:
Minor
Comments: Finding Ref:
Structural
Page 5 of 8 ISO/IEC 17025:2017 – UKAS Transition Template – Version 2.1 June 2018
Comments:
ISO/IEC 17025:2017Transition Template ISO/IEC 17025:2017
ISO/IEC17025:2005
CLAUSE
RELATED CLAUSE(S)
measurement uncertainty 7.7.
7.8.
7.9.
Ensuring the validity of results
5.9
Reporting the results
5.10
Complaints
4.8
calibration methods and method validation Assuring the quality of test and calibration results Reporting the results Complaints
TO BE COMPLETED BY LABORATORY
EXTENT OF CHANGE
CHANGES MADE & DOCUMENTATION SUPPLIED
Minor
TO BE COMPLETED BY UKAS ASSESSORS COMMENTS ON COMPLIANCE & REF TO FINDINGS Finding Ref:
Comments: Finding Ref:
Major
Comments: Finding Ref:
Major
Comments: Finding Ref:
7.10.
7.11.
8. 8.1.
Nonconforming work
4.9
Control of data and information management
5.4
Management System Requirements Options
4.0 -
Control of nonconforming testing and/or calibration work Test and calibration methods and method validation Management requirements
Minor
-
NEW
Comments: Finding Ref:
Minor
Comments: Finding Ref:
-
N/A
Page 6 of 8 ISO/IEC 17025:2017 – UKAS Transition Template – Version 2.1 June 2018
N/A Findings:
ISO/IEC 17025:2017Transition Template
8.2.
8.3.
8.4.
8.5.
8.6.
8.7.
8.8.
8.9.
ISO/IEC 17025:2017
ISO/IEC17025:2005
CLAUSE
RELATED CLAUSE(S)
Management system documentation (Option A) Control of management system documents (Option A) Control of records (Option A)
4.2
Actions to address risks and opportunities (Option A) Improvement (Option A)
4.10 4.2
Corrective actions (Option A)
4.11
Internal Audits (Option A)
4.14
Management
4.15
4.3
4.13
4.1 4.10 4.7
EXTENT OF CHANGE
Management System
Structural
Document Control
Structural
Control of records
Structural
Improvement Management System Organisation Improvement Services to the Customer Corrective action
TO BE COMPLETED BY LABORATORY CHANGES MADE & DOCUMENTATION SUPPLIED
TO BE COMPLETED BY UKAS ASSESSORS COMMENTS ON COMPLIANCE & REF TO FINDINGS Actions: Comments: Finding Ref: Comments: Finding Ref: Comments: Finding Ref:
NEW
Comments: Finding Ref:
Minor
Comments: Finding Ref:
Minor
Comments: Finding Ref:
Internal Audits
Minor
Comments: Finding Ref:
Management
Major
Page 7 of 8 ISO/IEC 17025:2017 – UKAS Transition Template – Version 2.1 June 2018
Comments:
ISO/IEC 17025:2017Transition Template ISO/IEC 17025:2017
ISO/IEC17025:2005
CLAUSE
RELATED CLAUSE(S)
Review (Option A) 4.2 Annex A Annex B Bibliography
Metrological traceability Management system options -
-
Review Management System Bibliography
EXTENT OF CHANGE
TO BE COMPLETED BY LABORATORY CHANGES MADE & DOCUMENTATION SUPPLIED
TO BE COMPLETED BY UKAS ASSESSORS COMMENTS ON COMPLIANCE & REF TO FINDINGS Finding Ref:
NEW NEW Structural
Executive Summary: Recommendation:
Page 8 of 8 ISO/IEC 17025:2017 – UKAS Transition Template – Version 2.1 June 2018
Contains no mandatory requirements but should be considered by the laboratory when revising its management system
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