2017 新版 ISO/IEC 17025 對實驗室管理系統之應用

1 20190830/12017 ISO/IEC 17025 O 20190830/2 ISO/IEC 17025 20190830/3 ISO/IEC 17025 :2017 20190830/4 ISO/IEC 17025 : 2005 General requirements for the competence of testing and calibration laboratories ISO 17025 :200520190830/51999 2005 2017 ISO/IEC 17025 20190830/6 ISO17025:2005 ( ) 20190830 / ISO17025:2005 20190830/8 ISOCASCOC ommon StructureInformativePreliminaryTitle pageTable of contentsForewordIntroduction (including relationship to other standards)Normative GeneralTitleScope Normative referencesNormative TechnicalTerms and definitionsPrinciplesRequirementsStructu ral requirementsResource requirements (including Human resources)Process requirements (including operational functions)

2 Management system requirementsNormative annexesInformative supplementaryAny further explanations that are not part of the normative processInformative annexesBibliographyIndexesThe of QS-CAS-PROC01 states that it is strongly recommended that CASCO documents are developed in accordance with the common structure for CASCO documents endorsed in CASCO Resolution 12/2002, as follows: 20190830/9 ISO Committee on conformity assessment (ISO/CASCO) CASCO is the ISO committee that works on issues relating to conformity of reference To study means of assessing the conformity of products, processes, services and management systems to appropriate standards or other technical specifications. To prepare international guides and International Standards relating to the practice of testing, inspection and certification of products, processes and services, and to the assessment of management systems, testing laboratories, inspection bodies, certification bodies, accreditation bodies and their operation and acceptance.

3 To promote mutual recognition and acceptance of national and regional conformity assessment systems, and the appropriate use of International Standards for testing, inspection, certification, assessment and related is Conformity Assessment ? ISO/IEC 17000: demonstration thatspecifiedrequirements relating to a product, process, system, person or bodyare fulfilled as testing, inspection and certification as well as the accreditation of conformity assessment bodies 20190830/11 Conformity assessment involves a set of processes that show your product, service or system meets the requirements of a the conformity assessment process has a number of benefits: It providesconsumersand other stakeholders with added confidence. It gives yourcompanya competitive edge. It helpsregulatorsensure that health, safety or environmental conditions are main forms of conformity assessment are testing,certification, and addition, ISO has a committee,CASCO, that develops standards and addresses issues related to conformity is Conformity Assessment ?

4 20190830/12 Conformity Assessment Testing&Calibration Inspection Certification Product Management systems Personnel20190830/13 WTO TBT (TheAgreement on Technical Barriers to Trade) facilitating theconduct of international trade measures donot create unnecessary obstacles tointernational trade 20190830/14 Supplier OrganizationAccreditation bodiesAssess competenceConformity assessment bodiesAssess conformityAccredited Third-Party HierarchyAccreditation Bodies (ABs) assess the competence of Conformity Assessment Bodies (CABs) which assess conformance with standards20190830/15 Third Party Conformity Assessment StructurePersonnelCertifiersQMS/EMSC ertifiersProductCertifiersInspectionBodi esTestLabsProducts (Procedures, Services)PersonnelQMS/EMS (ISO 9000/ ISO 14000)Buildings, Facilities, Mines, Procedures, Services, etc.

5 Products (Procedures, Services)ISO/IEC17024 ISO/IEC17021 ISO/IEC17065 ISO/IEC17025 ISO/IEC17020 ISO/IEC14065 Greenhouse Gas VerifiersGreenhouse Gas EmissionsAccreditation Bodies (ABs) ISO/IEC 1701120190830/16 IAF PAC ILAC APLAC ISO/IEC17011 ISO/IEC 17020 ISO/IEC 17065 ISO/IEC 17024 ISO/IEC 17021 ISO/IEC 27006 ISO/IEC 17021 ( ISO/IEC 17021) ISO/T S 22003 / ISO/IEC 17025 ISO 15189 ( ISO/IEC17021) ISO 9001 ISO 14001 ( ) ISO/IEC 27001 ISO 22000 OHSAS 18001 GP MS-080000QC-080000 TAF 20190830/174 5 6 7 8 ISO/IEC 17025 :201720190830/18 ISO/IEC 17025 :20174 5 6 20190830/19 ISO/IEC 17025 :20177 20190830/20 ISO/IEC 17025 :20178 ( A) ( A) ( A) ( A) ( A) ( A) ( A) ( A)20190830/21 ISO/IEC 17025 :2017 ISO/IEC 17025 :2005 ISO/IEC 17025 :2017 ISO/IEC 17025 :20054 4 , (b), (d) (c) 5 6 5 20190830/22 ISO/IEC 17025 :2017 ISO/IEC 17025 :2005 ISO/IEC 17025 DISISO/IEC 17025 .

6 20057 5 ( ) 20190830/23 ISO/IEC 17025 :2017 ISO/IEC 17025 :2005 ISO/IEC 17025 :2017 ISO/IEC 17025 :20058 4 ( A) ( A) ( A) ( A) ( A) ( A) ( A) ( A) 20190830/24 20190830/25 ISO/IEC 17025 20190830/26 20190830/27 ISO/IEC 17025 :2017 20190830/28 ISO/IEC 17025 :20174 20190830/29 20190830/30 Trust20190830/31 Process Resources Trust Org & Mgmt20190830/324 ISO/IEC 17025 :201720190830 ( ) ISO/IEC 17025 :201720190830/34 (impartiality)?

7 ISO/IEC 17025 1 2 ISO/IEC 17021-1 2015, 2013 10 13 .. OO 4 9 ..20190830/36 6 2010-09-02 .. 6 ..20190830/37 2018/07/09 19:50 Nissan NISSAN 5 1171 ..20190830/38 2015-10-01 980 .. 147 2016 10 26 47 5000 147 11 ..20190830/39 20190830/40.

8 2018 20190830/41 ISO9000:2015 (risk) (effect of uncertainty) 1 2 3 ISO 73 2009, ISO 73 2009, 4 ISO 73 2009, 5 6 ISO / IEC ISO 1 SL ISO 5 20190830/42 ISO31000:2018 (risk) (effect of uncertainty on objectives) 1 / 2 3 ( ) , ( ) , ( ) ( ) 20190830/43 1 2 3 4 20190830/44 20190830/45 ISO17021-1:2015 a) b) c) d) 20190830/4601.

9 (brainstorming)02. (structural or semi-structural interviews)03. (Delphi technique)04. (check-lists)05. (preliminary hazard analysis)06. (Hazard and operability study, HAZOP)07. (Hazard analysis and critical control point, HACCP)08. (Environmental risk assessment)09 - (structured what-if technique, SWIFT)10. (scenario analysis)11. (business impact analysis)12. (root cause analysis)13. (failure modes and effects analysis)14. (fault tree analyssi)15. (event tree analysis)ISO 31010:2009 20190830/4716. (cause-consequence analysis)17. (cause-and-effect analysis)18. (layers of protection analysis, LOPA)19. (decision tree analysis)20. (human reliability assessment)21.

10 (bow tie analysis)22. (reliability centred maintenance)23. (sneak circuit analysis)24. (Markov analysis)25. (Monte Carlo simulation)26. (Bayesian statistics and Bayes nets)27. (FN) (frequency-number (FN) curves)28. (Risk indices)29. (consequence/probabilitymatrix)30. / (cost/benefit analysis)31. (multi-criteria decision analysis, MCDA)ISO 31010:2009 20190830/4848 ISO 31010 Risk management Risk assessment techniques CNS 31010 / ISO 31010:200920190830/49 Risk and Return 20190830/50 M S P M x P S x P 20190830/51 5 X 4 X-X 3 X 2 1 20190830/52 5 80%4 60%~80%3 40%~60%2 20%~40%1 20%20190830/531 2 3 4 5 1 2 3 4 5 20190830/54 326 224 122 ?