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Instructions for Using the TemplateFor 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 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 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 17025:2017ISO/IEC 17025:2005EXTENT OF CHANGETO BE COMPLETED BY LABORATORYTO BE COMPLETED BY UKAS ASSESSORSCLAUSERELATED CLAUSE(S)CHANGES MADE & DOCUMENTATION SUPPLIEDCOMMENTS ON COMPLIANCE & REF TO FINDINGS1.1Staff Training (Example)2.1Staff Competence (Example)MajorPolicy 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:1.2Independence (Example)2.2Independence (Example)MinorReview 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 ments: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 numberMinor – Wording of the requirement has changed but overall intent is consistentMajor – Changes will require the CAB to implement new or change existing practiceNew – New requirement(s)/concept(s) not in previous version of the standardTO BE COMPLETED BY LABORATORYTO BE COMPLETED BY UKAS ASSESSORSOrganisation NameAssessment ManagerUKAS Accreditation NumberAssessment Team Members & RolesCompleted byDate(s) of reviewDate of CompletionIssue DateISO/IEC 17025:2017ISO/IEC 17025:2005EXTENT OF CHANGETO BE COMPLETED BY LABORATORYTO BE COMPLETED BY UKAS ASSESSORSCLAUSERELATED CLAUSE(S)CHANGES MADE & DOCUMENTATION SUPPLIEDCOMMENTS ON COMPLIANCE & REF TO FINDINGSForewordForewordNEWContains no mandatory requirements but should be considered by the laboratory when revising its management systemIntroduction Introduction NEW1.Scope ScopeMinor2.Normative referencesNormative ReferencesMinor3.Terms & Definitions3.Terms and DefinitionsNEW4.General requirements---N/AN/A4.1Impartiality 4.1Management requirementsMajorComments:Finding Ref:4.2Confidentiality4.1Management requirementsMinorComments:Finding Ref:5.Structural Requirements4.1Organisation MajorComments:Finding Ref:6.Resource Requirements---N/AN/A6.1General4.1OrganisationMinorComments:Finding Ref:6.2Personnel5.2PersonnelStructuralComments:Finding Ref:6.3Facilities and environmental conditions 5.3Accommodation and Environmental ConditionsStructuralComments:Finding Ref:6.4Equipment5.5EquipmentMinorComments:Finding Ref:6.5Metrological traceability5.6Measurement TraceabilityStructuralComments:Finding Ref:6.6Externally provided products and services4.6Purchasing Services and SuppliesMinorComments:Finding Ref:7.Process Requirements---N/AN/A7.1.Review of requests, tenders and contracts5.104.4Reporting the ResultsReview of Requests, Tenders and ContractsMajorComments:Finding Ref:7.2.Selection, verification and validation of methods5.4Test and calibration methods and method validationMinorComments:Finding Ref:7.3.Sampling5.7SamplingMinorComments:Finding Ref:7.4.Handling of test or calibration items5.8Handling of test or calibration itemsMinorComments:Finding Ref:7.5.Technical records 4.13Control of recordsMinorComments:Finding Ref:7.6.Evaluation of measurement uncertainty5.4Test and calibration methods and method validationStructuralComments:Finding Ref:7.7.Ensuring the validity of results5.9Assuring the quality of test and calibration resultsMinorComments:Finding Ref:7.8.Reporting the results5.10Reporting the resultsMajorComments:Finding Ref:7.plaints4.8ComplaintsMajorComments:Finding Ref:7.10.Nonconforming work4.9Control of nonconforming testing and/or calibration workMinorComments:Finding Ref:7.11.Control of data and information management5.4Test and calibration methods and method validationMinorComments:Finding Ref:8.Management System Requirements4.0Management requirements-N/AN/A8.1.Options--NEWFindings:Actions:8.2.Management system documentation (Option A)4.2Management SystemStructuralComments:Finding Ref:8.3.Control of management system documents (Option A)4.3Document ControlStructuralComments:Finding Ref:8.4.Control of records (Option A)4.13Control of recordsStructuralComments:Finding Ref:8.5.Actions to address risks and opportunities (Option A)4.104.24.1ImprovementManagement SystemOrganisationNEWComments:Finding Ref:8.6.Improvement (Option A)4.104.7ImprovementServices to the CustomerMinorComments:Finding Ref:8.7.Corrective actions (Option A) 4.11Corrective actionMinorComments:Finding Ref:8.8.Internal Audits (Option A)4.14Internal AuditsMinorComments:Finding Ref:8.9.Management Review (Option A)4.154.2Management ReviewManagement SystemMajorComments:Finding Ref:Annex AMetrological traceability--NEWContains no mandatory requirements but should be considered by the laboratory when revising its management systemAnnex BManagement system options--NEWBibliography--BibliographyStructuralExecutive Summary:Recommendation: ................
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