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ISO 9001:2015 Status of the Revision Work Anni Koubek ISO 9001 Revision 1 Innovations and Developments - Overview ISO 26000 ONR 192 500 ISO 14001 ISO 17021 ISO 9001 Anni Koubek ISO 50001 ISO 19011 EFQM Excellence Model ISO 9001 Revision ISO 31000 et seqq. OHSAS 18001 ISO Directives Annex SL ISO 29990 ISO 22301 ISO 17024 ISO 17065 ISO 17020 EN 15224 2 ISO 9001 Big revision in process Start in Bilbao in June 2012 First committee draft created Titel and purpose stay unchanged Simultaneous revision of ISO 9000 Anni Koubek ISO 9001 Revision 3 ISO 9001 Looking back: The Development of ISO 9001 1987 First edition Contractual standard 1994 Small revision State of the art 2000 Big revision Processes & Improvements 2008 Small revision Supply chain included Anni Koubek ISO 9001 Revision 4 ISO 9001 Preliminary Work on the Current Revision Preliminary studies on possible concepts have been completed at the end of 2010 A public survey of users has been carried out Systematic Review of ISO-full members; 15th of March, 2012: the majority has voted for revision of ISO 9001 The harmonized concept is mandatory (cf. “Annex SL” ISO Directives – about 40 % of the text will be affected) Anni Koubek ISO 9001 Revision 5 ISO 9001 Timetable of the Revision ISO 9001 First consolidated draft (CD) published in June 2013 First public draft (DIS) around the beginning of 2014 Planned date of issue: 2015 Anni Koubek ISO 9001 Revision 6 ISO 9001 The New Structure of Chapters 4. Context of the Organization 5. Leadership 6. Planning 7. Support 8. Operation 9. Performance Evaluation 10. Improvement Anni Koubek ISO 9001 Revision 7 ISO 9001 4.1 Understanding the Organization and its Context/Determining the Relevant Context of the Organization Only implicitly contained in 9001:2008 (0.1, 4.1, 5.3a) In future: clear requirements Context regarded as external environment, drivers and trends, and internal framework conditions Anni Koubek ISO 9001 Revision 8 ISO 9001 4.2 Understanding the Needs and Requirements of Interested Parties/Requirements of the Interested Parties Determining relevant interested parties and identifying their requirements Interested parties restricted to the objectives of the standard A chance for integrative quality management Anni Koubek ISO 9001 Revision 9 ISO 9001 Key Elements Process oriented approach A general overview presented (requirements of section 4) Risks and Opportunities System & processes planned according to risks of the specific organisations The term preventive actions has been dropped Anni Koubek ISO 9001 Revision 10 ISO 9001 7.5 Documented Information Familiar terms like “document”, “record”, “procedure” are not used in the common text. More self-responsibility, which information has to be present in documented form; No required documented procedures for control of documents or control of records Anni Koubek ISO 9001 Revision 11 ISO 9001 Further Approaches and Elements More focus on change management Development – broader interpreted with focus on development transfer alignment with the strategic focus of the organization as a requirement „internal and external sourcing“ replace the terms „purchasing“ and „outsourcing“ Knowledge management elements included Anni Koubek ISO 9001 Revision 12