Path to Continual Improvement: The Latest Development of ISO 9001, ISO and IMS

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1 Path to Continual Improvement: The Latest Development of ISO 9001, ISO and IMS HKQAA Symposium 2015 Dr Nigel H Croft (C) Nigel H Croft All rights reserved 1

2 ISO 9001 evolution, not revolution! 1987 ISO 9001, 9002, 9003 published 1994 Minor revision to ISO 9001, 9002, Major revision to ISO 9001 ISO 9002 and 9003 withdrawn 2008 VERY minor revision to ISO Major revision to ISO 9001 Forecast life-span till 2030! (C) Nigel H Croft All rights reserved 2

3 Bridging the gap... ISO 9001:1994 QMS ISO 14001:1996 EMS ISO 9001:2000 QMS ISO 14001:2004 EMS ISO 9001:2008 QMS ISO 9001:2015 QMS ISO 14001:2015 EMS Note: ISO 9001 and ISO will remain as 2 separate standards (C) Nigel H Croft All rights reserved 3

4 Health & Safety Currently no ISO standard OHSAS 18001:2006 first published by BSI in 1999 Aimed at eliminating or minimizing risk to employees and other interested parties Similar model to ISO Includes requirements for hazard identification, risk assessment and risk control Supported by OHSAS 18002:2000 (Guidelines for implementation) Currently being used as basis for ISO (C) Nigel H Croft All rights reserved 4

5 Health & Safety BS 5750 QMS BS 7750 EMS X BS 8750 H&SMS BS 8800 Guidance CERTIFICATION BODIES OHSAS (Occupational Health and Safety Assessment Series) ISO 9001 QMS ISO EMS X ISO H&SMS ISO HSMS (C) Nigel H Croft All rights reserved 5

6 Need for Alignment of management system standards! ISO Joint Technical Coordination Group ( JTCG ): Joint vision for management system standards High level structure for all ISO management systems standards Identical sub-clause titles under the high level structure Generic core vocabulary for management system standards Aim is to make life easier for those who wish to have a single management system (C) Nigel H Croft All rights reserved 6

7 ISO Directives Part 1:2012 Annex SL Incorporates the recommendations of the JTCG work Defines the common structure and format for all new ISO management system standards and revisions to existing standards Common text (approx 30% or more of each standard will be identical text) Significant impact on revisions of ISO 9001 and ISO (C) Nigel H Croft All rights reserved 7

8 Increasing specificity Matrix structure of Management System Standards Core structure, format and text ( Annex SL ) + Quality (ISO 9001) Environment (ISO 14001) HSMS (ISO 45001) etc + Automotive Aerospace Telecomm Oil & Gas etc + Ford Peugeot BMW etc (C) Nigel H Croft All rights reserved 8

9 Integrated Use of Management Systems Standards Currently being revised Scheduled publication November 2015 Takes into account Annex SL (C) Nigel H Croft All rights reserved 9

10 Some changes to ISO 9001 Complete reformatting to align with Annex SL Products and services instead of product More requirements for top (and other) management External provision of products and services instead of purchasing includes outsourced processes Documented information instead of Documented procedures and records (C) Nigel H Croft All rights reserved 10

11 Some new requirements in ISO 9001:2015 New Clause Context of the Organization What are the external and internal factors? Identification of interested parties Relevant needs and expectations of the relevant Interested parties? Customer continues to be the primary (but not the only!) interested party Actions to address risks & opportunities Guidance document available on Organizational knowledge Improving products and services to meet known and predicted requirements (C) Nigel H Croft All rights reserved 11

12 Some deleted requirements... Elimination of the term preventive action the concept still remains, and is actually reinforced throughout the standard (by addressing risk ) Elimination of specific (prescriptive) requirements for A Quality Manual A Management representative (C) Nigel H Croft All rights reserved 12

13 Some Post-DIS changes Terms and definitions will go out of ISO 9001 ISO 9000 will become a normative reference Simplification of Introduction New, simpler Figures A lot of discussion about how to address the question of innovation ISO 9001 must not inhibit innovation Should encourage innovation BUT Must not require innovation (C) Nigel H Croft All rights reserved 13

14 Timings. ISO 9001:2015 Technical work finalized FDIS in preparation (forecast early July) Formal ISO ballot July Sept 2015 Expected publication Sept 15 th 2015 ISO Technical consensus-building still ongoing (ISO/PC 283) Currently at Committee Draft stage Forecast publication 2016 (C) Nigel H Croft All rights reserved 14

15 And finally.. ISO/TC176 will hold its 2015 Plenary meeting in Hong Kong in November Work will begin on the revision of ISO 9004 Managing for the sustained success of an organization A quality management approach (C) Nigel H Croft All rights reserved 15

16 Conclusions ISO is aligning its portfolio of management system standards Aim is to facilitate integration ISO 9001 undergoing a major revision Scheduled publication Sept 15 th 2015 Significant changes in structure and clause sequence Process Approach + PDCA + Risk-based thinking Some new requirements ISO under development Will replace OHSAS Scheduled publication 2016 Stay tuned to what s happening via Start preparing for the transition NOW! (C) Nigel H Croft All rights reserved 16

17 THANK YOU! (C) Nigel H Croft All rights reserved 17

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