DIS ISO 17025 Status Maj 2017 1
Plan for udvikling/revision af ISO 17025 WD June 2015 CD1 August 2015 CD2 February 2016 DIS November 2016 (December 2016) FDIS draft July 2017 FDIS/Publication Autumn 2017 2
Forventninger Følgende afventer: Kommentarer indgives pr. 23 marts 2017 til ISO CASCO WG44. Drafting Committee mødes maj 2017 og bearbejder kommentarerne. WG44 mødes juli 2017 Der forventes ikke en FDIS da dette indebærer mindre end 75 % jastemmer til DIS eller substantielle ændringer. ILAC s kommentarer har ikke den karakter. Antallet af kommenterer er over 3000, så uagtet ISO s holdning ønsker convener ne en FDIS. 3
Krydsreferencer 4 General requirements 17025:2005 4.1 Impartiality 4.1.4+5 4.2 Confidentiality 4.1.5 c) 5 Structural requirements 4.1.5+6 6 Resource requirements - 6.1 General - 6.2 Personnel 5.2 6.3 Laboratory facilities and environmental 5.3 conditions 6.4 Equipment 5.5 6.5 Metrological traceability 5.6 6.6 Externally provided products and services 4.5 4
7 Process requirements 17025:2005 7.1 Review of requests, tenders and contracts 4.4 7.2 Selection, verification and validation of methods 5.4 7.3 Sampling 5.7 7.4 Handling of test or calibration items 5.8 7.5 Technical records 4.13 7.6 Evaluation of measurement uncertainty 5.4.6 7.7 Assuring the quality of results 5.9 7.8 Reporting of results 5.10 7.9 Complaints 4.8 7.10 Management of nonconforming work 4.9 7.11 Control of data Information management 5.4.7 5
8 Management requirements 8.1 Options 8.2 Management system documentation (Option A) 4.2 8.3 Control of management system documents (Option A) 4.3 8.4 Control of records (Option A) 4.13 8.5 Actions to address risks and opportunities (Option A) 4.10 8.6 Improvement (Option A) 4.7 8.7 Corrective action (Option A) 4.11 8.8 Internal audits (Option A) 4.14 8.9 Management reviews (Option A) 4.15 6
17025:2005 DIS 17025 4.1.4+5 Impartiality 4.1 4.1.5 c) Confidentiality 4.2 4.1.5+6 Structural requirements 5 4.2 Management system documentation (Option A) 8.2 4.3 Control of management system documents (Option A) 8.3 4.4 Review of requests, tenders and contracts 7.1 4.5 Externally provided products and services 6.6 4.7 Improvement (Option A) 8.6 4.8 Complaints 7.9 4.9 Management of nonconforming work 7.10 4.10 Actions to address risks and opportunities (Option A) 8.5 4.11 Corrective action (Option A) 8.7 4.13 Control of records (Option A) 8.4 4.13 Technical records 7.5 4.14 Internal audits (Option A) 8.8 4.15 Management reviews (Option A) 8.9 7
17025:2005 DIS 17025 5.2 Personnel 6.2 5.3 Laboratory facilities and environmental conditions 6.3 5.4 Selection, verification and validation of methods 7.2 5.4.6 Evaluation of measurement uncertainty 7.6 5.4.7 Control of data Information management 7.11 5.5 Equipment 6.4 5.6 Metrological traceability 6.5 5.7 Sampling 7.3 5.8 Handling of test or calibration items 7.4 5.9 Assuring the quality of results 7.7 5.10 Reporting of results 7.8 8
DANAK udarbejder: Krydsreferencelister (tovejs) Checklister for ny standard med markering af nye krav Tidsfrister for overgang, fx tidligst Maj 2018 senest 1. oktober 2020.* Nye rapportskabeloner for LA og TA. Træning samtlige LA og TA. Der udgives AML som informerer om alle dele af overgangsprocessen forventet ultimo 2017. *Beregnet fra mulig udgivelse ca.1.oktober 2017 9
Væsentligste ændringer Subcontracting Risk and opportunities Independence and impartiality (kap.4) Sampling stand alone Decision rules Chapter 8 A & B options 10
Subcontracting 6.6 Externally provided products and services 6.6.1 The laboratory shall assure the suitability of externally provided products and services that affect laboratory activities, 7.1.2 Externally provided laboratory activities 7.1.2.1The laboratory s procedure for the review of requests, tenders and contracts shall cover laboratory activities from external providers. 11
Risk and opportunities 8.5 Actions to address risks and opportunities (Option A) 8.5.1 The laboratory shall consider the risks and opportunities associated with the laboratory activities. a) - d) 8.5.2 The laboratory shall plan: a) actions to address these risks and opportunities;. 8.5.3 Actions taken to address risks and opportunities shall be proportionate to the potential impact on the validity of laboratory results. 12
Independence and impartiality (kap.4) 4.1 Impartiality. Kommer fra ISO PAS som indgår I alle CASCO standarder. Risk indgår 5 gange I 4.1 og skal ja minimeres. 4.2 Confidentiality. Kommer ligeledes fra ISO PAS. 13
Sampling stand alone 3.6 laboratory body that performs one or more of the following activities: calibration testing sampling, associated with subsequent calibration or testing Dette emne har fyldt meget i diskussionerne i WG44. 14
Decision rules 7.1.1.3 When the customer requests a statement of conformity to a specification or standard for the test or calibration (e.g. pass/fail, in-tolerance/out-of-tolerance) the specification or standard, and the decision rule shall be clearly defined 7.8.5 Reporting statements of conformity 7.8.5.1 When a statement of conformity to a specification or standard for test or calibration is provided, the laboratory shall document the decision rule employed, taking into account the level of risk (such as false accept and false reject and statistical assumptions) associated with the decision rule employed and apply the decision rule. 15
Chapter 8 A & B options 8 Management requirements 8.1 Options 8.1.1 General The laboratory shall establish, document, implement and maintain a management syste that is capable of supporting and demonstrating the consistent achievement of the requirements of this International Standard and assuring the quality of the laboratory results.. the laboratory shall implement a management system in accordance with option A or option B. 16
Chapter 8 A & B options 8.1.2 Option A As a minimum the management system of the laboratory shall address the following: (8.2-8.9) 8.1.3 Option B A laboratory that has established and maintains a management system, in accordance with the requirements of ISO 9001, and that is capable of supporting and demonstrating the consistent fulfilment of the requirements of clauses 4 to 7 of ISO/IEC 17025 also fulfils at least the intent of the management system section requirements (8.2-8.9). 17
ILAC P15 Application of ISO 17020:2012 Management system requirements Options 8.1.3b Option B does not require that the inspection body's management system is certified to ISO 9001. However, when determining the extent of required assessment, the accreditation body should take into consideration whether the inspection body has been certified against ISO 9001 by a certification body accredited by an accreditation body which is a signatory to the IAF MLA, or to a regional MLA, for the certification of management systems. 18
DANAK AB 17 DANAK har i AB 17 (for inspektion) pkt. II skrevet følgende: DANAK s tolkning af disse punkter er, at kravene i DS/EN ISO/IEC 17020 pkt. 8.2 8-8 skal være opfyldt og DANAK vil bedømme dette. Hvis inspektionsorganet opfylder kravene i DS/EN ISO 9001 må det antages, at dette let kan demonstreres, da kravene i pkt. 8.2 8.8 er indeholdt i DS/EN ISO 9001. 19
Tolkning af P15 For lab med ISO 9000 certificerede ledelsessystemer (under akkreditering) vil fokus flytte over på, at dette leverer det ønskede output (i relation til laboratorieaktiviteterne), og at dette output demonstrerer laboratoriets kompetence. Dette betyder ikke, at der ikke kan komme afvigelser på mangler i ledelsessystemet. 20