29 IECQ報導年刊 - cteccb.org.tw

1 29 IECQ ISO 9001:2015 2015 9 23 ISO ISO 2000 ISO 9001:2015 (Transition) ISO/TC 176 ISO/CASCO IAF 3 IAF ID 9:2015 ISO 9001 ISO 9001:2008 ISO 9001:2008 (ABs) (CBs) ISO 9001 IAF ISO 9001 ISO 9001:2015 ISO 9001:2015 2008 ISO 9001:2015 ISO 14001:2005 ISO 45001:2016 OHSAS 18001:2007 ISO Annex SL (High Level Structure, HLS) (Sustainable Development, SD) (Global System) (Sub-system) ISO ISO 9001:2015 3 ( 3 core concepts) PDCA / ISO 9001:2015 ISO 9001:2008 30 IECQ ISO 9001(-1987, -1994, -2000, -2008, -2015) ISO 14001(-1996, -2004, -2015) ISO 45001/OHSAS 18001(-1999,-2007, -2016) ISO 9001:2015( ISO Annex SL ) ISO 9004.

2 2009 ISO 31000:2009 PDCA ISO 9001: 2008 ISO 9001:2015 (Context of organization) ISO 31000:2009 ISO 9004:2009 / / / ( ) (Business process) ISO 9001:2015 ISO Annex ISO 9001:2015 ISO 9001:2015 ISO Annex SL ISO Annex SL (HSL) 10 1. (Scope introduction)2. (Normative references)3. (Terms + Definitions)4. (Context of the organization)5.

3 (Leadership)6. (Planning)7. (Support)8. (Operation)9. (Performance evaluation)10. (Improvement) ISO 9001:2015 ISO 9001:2008 ISO 9004:2009 ISO 9004:2009 31 IECQ 32 IECQ ISO 9001:2015 ISO Annex SL Annex SL ISO 9001:2008 ISO 9001:2015 (2008) 9. 10. (2015) ISO 9004:2009 ISO 9001:2015 ISO 9001:2008 ISO 9004 ISO 9004 (complex) (demanding) (ever-changing) (sustained success) ISO 9004 ISO 9001 (organization environment) (changes) (risks associated) ( )ISO 9001:2008 (2009 ) ISO 9004:2009 ISO 31000:2009 / (organization context/environment) (risk management) ISO 9001:2015 ISO 9001:2008 ISO 9004:2009 ISO 31000:2009 ISO Annex SL ISO 9001.

4 2015 2008 (1) 2008 ( ) a) e) 5 2015 ( ) a) j) 10 b) ( ) ( ) / ( ) c) ( ) d) ( ) ( ) / ( ) ( , ) (engagement)[( a)~j)] ( ) ( ) ( ) (alignment) ( ) ( ) ( ) ( ) ( ) ( ) ( )33 IECQ (2) ( )2008 f) 7. 2015 ( ) 7.

5 / (3) e) (4) / ( )2008 4. 7. 2015 ( ) / ( ) / ( ) (5) ( ) (6) (Documented information)( ) 2008 2015 / / (operation documented information) (maintain) (evidence documented information) (retain) (7) ( ) ( ) 2015 34 IECQ (8) ( ) 7.

6 (9) / ( ) ( ) ( ) ( ) ( ) 2008 ( ) ( ) (10) 2008 2015 ( (6))(11) 2008 2015 UKAS Risk based thinking Organization context Effective leadership Audit QMS with less documentation Ability of QMS to support consistent provision of product and service ISO 9001:2015 ISO 9001:2015 2015 9 3 ISO 9001:2008 2018 9 IAF ISO 14001 ISO 45001 IECQ QC 080000 HSPM IAF IAF ID 9:2015 ISO 9001:2015 ( ) ( ISO 9001:2008 ) ( , , , ) ( ) ( ).

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