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Path to Continual Improvement: The Latest Development of ISO 9001, ISO 45001 and IMS HKQAA Symposium 2015 Dr Nigel H Croft (C) Nigel H Croft 2015 - All rights reserved 1 May 2015

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Path to Continual Improvement:

The Latest Development of ISO

9001, ISO 45001 and IMS

HKQAA Symposium 2015

Dr Nigel H Croft

(C) Nigel H Croft 2015 - All rights reserved 1 May 2015

May 2015 (C) Nigel H Croft 2015 - All rights reserved 2

ISO 9001 – evolution, not

revolution!

1987 – ISO 9001, 9002, 9003 published

1994 – Minor revision to ISO 9001, 9002, 9003

2000 – Major revision to ISO 9001 ISO 9002 and 9003 withdrawn

2008 – VERY minor revision to ISO 9001

2015 – Major revision to ISO 9001 Forecast life-span till 2030!

May 2015 (C) Nigel H Croft 2015 - All rights reserved 3

Bridging the gap.......

ISO 14001:1996

EMS

ISO 9001:1994

QMS

ISO 9001:2000

QMS

ISO 14001:2004

EMS

Note: ISO 9001 and ISO 14001 will remain as 2 separate standards

ISO 9001:2008

QMS

ISO 9001:2015

QMS

ISO 14001:2015

EMS

May 2015 (C) Nigel H Croft 2015 - All rights reserved 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 14001

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 45001

May 2015 (C) Nigel H Croft 2015 - All rights reserved 5

Health & Safety

BS 5750

QMS

BS 7750

EMS

ISO 9001

QMS

“OHSAS 18001”

BS 8750

H&SMS

BS 8800

Guidance X

ISO 14001

EMS

ISO 18001

H&SMS X (Occupational Health and Safety Assessment Series)

CERTIFICATION

BODIES

ISO 45001

HSMS

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 2015 - All rights reserved 6 May 2015

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 14001

(C) Nigel H Croft 2015 - All rights reserved 7 May 2015

“Matrix” structure of

Management System Standards

May 2015 (C) Nigel H Croft 2015 - All rights reserved 8

Core structure, format and text (“Annex SL”)

Quality (ISO 9001) Environment (ISO 14001) HSMS (ISO 45001) etc

Automotive Aerospace Telecomm Oil & Gas

Ford Peugeot BMW

etc

etc

+

+

+ Incre

asin

g s

pe

cific

ity

“Integrated Use of Management

Systems Standards”

May 2015 (C) Nigel H Croft 2015 - All rights reserved 9

• Currently being revised

• Scheduled publication

November 2015

• Takes into account

“Annex SL”

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 2015 - All rights reserved 10 May 2015

Some new requirements in ISO

9001:2015

New Clause 4.1 - “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 www.iso.org

Organizational knowledge

“Improving products and services to meet known and predicted requirements”

(C) Nigel H Croft 2015 - All rights reserved 11 May 2015

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 2015 - All rights reserved 12 May 2015

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 2015 - All rights reserved 13 May 2015

Timings……….

ISO 9001:2015

Technical work finalized

FDIS in preparation (forecast early July)

Formal ISO ballot July – Sept 2015

Expected publication Sept 15th 2015

ISO 45001

Technical consensus-building still ongoing (ISO/PC

283)

Currently at Committee Draft stage

Forecast publication 2016

May 2015 (C) Nigel H Croft 2015 - All rights reserved 14

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”

May 2015 (C) Nigel H Croft 2015 - All rights reserved 15

Conclusions

ISO is aligning its portfolio of management system standards

Aim is to facilitate integration

ISO 9001 undergoing a “major revision”

Scheduled publication Sept 15th 2015

Significant changes in structure and clause sequence

“Process Approach + PDCA + Risk-based thinking”

Some new requirements

ISO 45001 under development

Will replace OHSAS 45001

Scheduled publication 2016

Stay tuned to what’s happening via www.iso.org

Start preparing for the transition NOW! (C) Nigel H Croft 2015 - All rights reserved 16 May 2015

THANK YOU!

[email protected]

(C) Nigel H Croft 2015 - All rights reserved 17 May 2015