ISO 9001:2015

Status of the Revision Work

Anni Koubek ISO 9001 Revision 1

Innovations and Developments - Overview

Anni Koubek ISO 9001 Revision 2

ISO 9001

ISO 14001 OHSAS 18001

ISO 17021 ISO 19011

ISO 31000 et seqq. ISO 26000ONR 192 500

ISO 50001

ISO Directives Annex SL

EN 15224

ISO 17024ISO 17065ISO 17020

ISO 29990EFQM Excellence Model

ISO 22301

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

1987 First edition Contractual standard

1994 Small revision State of the art

2000 Big revision Processes & Improvements

2008 Small revision Supply chain included

Looking back: The Development of ISO 9001

Anni Koubek ISO 9001 Revision 4

ISO 9001

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)

Preliminary Work on the Current Revision

Anni Koubek ISO 9001 Revision 5

ISO 9001

Timetable of the Revision ISO 9001

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

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 integrativequality 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

ISO 9001