ISOIEC 17025 2017 Whats new IAEA SSDL and

ISO/IEC 17025: 2017 – What’s new IAEA – SSDL and Quality Management Training December 20, 2018 Stephen M. KEOCHAKIAN

New structure ISO/IEC 17025: 2005 1. Scope 2. Normative references 3. Terms and definitions 4. Management requirements 5. Technical requirements Annex A – Nominal crossreferences to ISO 9001: 2000 Annex B – Guidelines for establishing applications for specific fields ISO/IEC 17025: 2017 1. Scope 2. Normative references 3. Terms and definitions 4. General requirements 5. Structural requirements 6. Resource requirements 7. Process requirements 8. Management requirements Annex A – Metrological traceability Annex B – Management system 2

Why revise 17025? Align structure and content with other recently revised ISO standards To give laboratories more flexibility Update language to reflect current practices and technologies 3

What is different Different structure Ø But many requirements are unchanged New: You must manage your “risks” New flexibility: Ø “What to do and not how to do it” is no longer the intention Ø Disappeared: “quality manual”, “quality manager”, “subcontracting”, etc. ) ØYou can still use them! This talk will cover some of the major changes 4

New structure ISO/IEC 17025: 2005 1. Scope 2. Normative references 3. Terms and definitions 4. Management requirements 5. Technical requirements Annex A – Nominal crossreferences to ISO 9001: 2000 Annex B – Guidelines for establishing applications for specific fields ISO/IEC 17025: 2017 1. Scope 2. Normative references 3. Terms and definitions 4. General requirements 5. Structural requirements 6. Resource requirements 7. Process requirements 8. Management requirements Annex A – Metrological traceability Annex B – Management system 5

New terms 6

New terms 3. 6 Laboratory “Laboratory”/“Laboratory activities” used throughout the document and refers to testing, calibration and sampling… 7

New terms 3. 4 intralaboratory comparison tests on the same or similar items, within the same laboratory Relates to 7. 7, Ensuring the validity of results 3. 7 decision rule how to determine “Pass” or “Fail” taking into account uncertainties Relates to 7. 8. 6, Reporting statements of conformity 8

New items 9

Risk & Opportunities NEW Risks and opportunities associated with the laboratory activities must be considered in order to: give assurance the management system achieves its intended results; enhance opportunities to achieve the purpose and objectives of the laboratory; prevent or reduce negative impacts and potential failures in the laboratory activities; achieves improvement. What does this mean for you? 10

4 Impartiality NEW 4. 1. 4 The laboratory shall … On an ongoing basis, the laboratory must identify risks to impartiality, including those arising from its activities or relationships or the relationships of its personnel. What does this mean for you? 11

4 Confidentiality Major Ø Ø Stronger emphasis on confidentiality New clauses n o i t c Ø Laboratories are to advise customers of the e t o information they will make publically ravailable. P Ø Are you publishing reports and nota telling the customer? t a D 12

6. 2 Your Staff Your staff (either internal or external) must be “SQEP” Suitably Qualified and Experienced Person This was already found in the 1705: 2005 version New: Emphasis is now on staff’s ability to not only identify departures from procedures, but also to evaluate the significance of these. New: Staff must be authorized to validate a procedure, etc. as well as following a procedure New: Competence must be monitored continuously 13

6. 2 Monitoring staff competence How do you do this? • • • Witnessed measurements Results from participation in intra-laboratory comparisons Results from participation in inter-laboratory comparisons Measuring test samples/instruments Findings from internal audits 14

Traceability 15

6. 5 Metrological traceability 16

Questions? 17

Helpful links: UKAS Assessor tutorial: https: //www. ukas. com/download/general_docume nts/UKAS-January-2018 -training-v 9. pdf NATA Gap Analysis template: https: //www. nata. com. au/phocadownload/genaccreditation-criteria/17025 -2017 -Gap-analysis. pdf UKAS Transition template: https: //www. ukas. com/download/publications/pu blications-relating-to-laboratory-accreditation/ISOIEC-17025 -2017 -Transition-Template. docx 18

Stephen Keochakian Bureau International Poids et Mesures Quality, Health, Safety, Environment Sèvres, France Office: +33 1 45076258 Mobile: +33 7 89440933 stephen. keochakian@bipm. org www. bipm. org