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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2000 – Major revision to ISO 9001 ISO 9002 and 9003 withdrawn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
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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
pecific
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
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 15 May 2015
THANK YOU!
(C) Nigel H Croft 2015 - All rights reserved 16 May 2015