Professional Documents
Culture Documents
and Awareness of
ISO 9001:2015
Dr Nigel H Croft
Chair, ISO/TC176/SC2 (Quality Systems)
June 23, 2014
TÜV SÜD
Presenter
Dr Nigel H Croft
Chair, ISO/TC176/SC2 (Quality Systems)
E-Mail: nhc@tcaglobal.org
NOTE: Dr Croft is donating his professional fee for this Webinar to SOFT – Support
Organization for Trisomy (http://trisomy.org)
SC 1 SC 2 SC 3
WG 23 WG 24
WG 22
Communications Revision of
Interpretations
& Product Support ISO 9001
(C) Nigel H Croft 2014 - All rights reserved 8
ISO/TC176/SC2 Vision
“SC2’s products* are recognized and
respected worldwide, and used by
organizations as an integral component
of sustainable development”
Check Do
• Did things happen • Do what was
according to plan? planned
DESIRED
INPUTS OUTPUTS CUSTOMER
“Set of interrelated
activities” (Internal or external)
“PRODUCT”
Other Interested
Parties
• Effect on Product conformance
• Environmental Aspects / Impacts
• Health and Safety Risks UNDESIRED OUTPUTS
• Social implications (“WASTE” / “POLLUTION” etc.)
• Energy usage
• Etc etc
MONITOR/MEASURE
(C) Nigel H Croft 2014 - All rights reserved 16
Generic Process
How to carry out Process” – documented or not)
A
Extent of planning depends on RISK P
DESIRED
INPUTS OUTPUTS CUSTOMER
“Set of interrelated
activities” (Internal or external)
D “PRODUCT”
Other Interested
Parties
• Effect on Product conformance
• Environmental Aspects / Impacts
• Health and Safety Risks UNDESIRED OUTPUTS
• Social implications (“WASTE” / “POLLUTION” etc)
• Energy usage
• Etc etc
C MONITOR/MEASURE
(C) Nigel H Croft 2014 - All rights reserved 17
System of processes
A P
C D
Input E
PROCESS E
AA PP Ouput E
CC DD
Input A Output A
PROCESS A
AA PP
Input C Input D
CC DD Ouput D
PROCESS C PROCESS D
Output C
AA PP AA PP
CC DD CC DD
Input B Output
PROCESS B B
AA PP
Output F
CC DD Internal Input F Internal
PROCESS F
Customer Customer
AA PP
CC DD Feedback
Sustainable
(C) Nigel H Croft 2014 - All rights reserved Business 20
Life cycle events Road continuity
safety
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 2014 - All rights reserved 21
ISO Directives Part 1:2012 “Annex SL”
PREPARATION
SPECIFICATIONS
NEEDS &
EXPECTATIONS PROJECTS
DIS FDIS
WDs CD
VALIDATION
(C) Nigel H Croft 2014 - All rights reserved 25
High-Level Timing for ISO 9001:2015
Internal consensus Internal consensus
(ISO/TC176 experts) (within ISO) First “public airing”
June 2012 Nov 2012 Jun 2013 Apr2014 Nov 2014 Jan 2015 Sept2015
Draft Approved CD* for DIS* for Draft FDIS* for Publication
Design Spec Design Spec comment & ballot FDIS* ballot
& “WD0”* & WD1* ballot
Verification and
validation activities
• SC2 Strategic Plan
• Review of QMP’s Liaison with IAF & ISO/CASCO regarding transition
• User Survey
• TG Future Interactions with SC1 (ISO 9000) on * WD = Working Draft
Concept Papers terminology issues CD = Committee Draft
• ISO Directives DIS = Draft International Standard
Annex SL FDIS = Final Draft International Standard
4 Context of 9 Performance
5 Leadership 6 Planning 7 Support 8 Operation 10 Improvement
organization evaluation
Roles,
responsibilities Planning of Design and Management
Scope of the Awareness
and changes development review
QMS
authorities
Control of
externally provided
QMS and its Communication
products and
Processes
services
Production &
Documented
service
information
provision
Release of
products and
services
Control of
Nonconforming
(Slide Courtesy of Alan Daniels; Boeing) process outputs,
products and
services
5 Leadership
• Customer focus
• Quality Policy
• Roles &
responsibilities
Products &
Requirements Inputs 8 Operations Outputs services
nhc@tcaglobal.org
Must consider
the external and internal issues referred to in 4.1,
these processes;
risks and opportunities and plan and implement
appropriate actions to address them; NEW
is maintained;
the focus on enhancing customer satisfaction is maintained.
Plan:
a) actions to address these risks and opportunities, and
b) how to
integrate and implement these actions into the QMS processes
when to communicate
how to communicate”
Management review
Dr Nigel H Croft
Chair, ISO/TC176/SC2 (Quality Systems)
E-Mail: nhc@tcaglobal.org
info@tuvam.com