Journey to Perfect: Mayo Clinic and the Path to Quality

ISO 9001:
Countdown to 2015
Preparing for the next revision of the ISO 9001 standard
on quality management systems
Agenda—Countdown to 2015
Impact and relevance of standards
ISO 9001 facts
Standards development process
ISO 9001 timeline
Transition from 2008 to 2015
Discussion and networking
Impact of standards like ISO 9001
• Standards are “enablers for other major
business processes.”
– The Boeing Company
• “The more standardized components we
can use to deliver reliable functionality, the
less we, and our customers, have to pay.”
– Deere & Company
• “Standards influence the design,
development, manufacturing, and
marketing of many products worldwide.”
– Motorola
ISO 9001 facts
• International standard for quality
management systems (QMS)
• Originally published in 1987
• Underwent major revision in 2000
• Applies to any organization regardless of
size or industry
• Implemented by more than one million
organizations in over 170 countries
Reasons for 2015 revision
• Maintain relevance for increasing diversity
of 9001 users
• Facilitate integration with other
management system standards
The standards development process
• ISO standards are based on consensus
• National standards institutes from more
than 160 countries participate
• Experts are nominated by these standards
bodies to work on technical committees
(TCs), subcommittees, or project
Standards development process
• An industry sector, consumer group, or
other stakeholder group identifies need
• A national member body proposes the new
working item to ISO
• Working groups define technical scope
• Consensus-building on specifications
• Approval of draft international standard
• Publication of international standard
Stages in development process
• Working Drafts (WDs)
• Committee Draft (CD)
• Draft International
Standard (DIS)
• Final Draft
International Standard
• International
Standard (IS)
ISO 9001:2015 timeline
June 2013: Committee Draft (CD)
Mid 2014: Expected publication of Draft
International Standard (DIS)
Mid 2015: Expected publication of Final Draft
International Standard (FDIS)
End 2015: Publication of International
Standard as ISO 9001:2015
The 2015 revision: what to expect
• More emphasis on
– risk-based thinking
– getting value out of QMS
– organizational context and leadership
• More flexibility around documentation
• Improved applicability for service
The 2015 revision: what to expect
• Use of new common structure for
management system standards for
smoother integration
– Standardized core text, structure, and
– Increase from 8 clauses to 10
Currently certified to ISO 9001:2008?
• Transition period begins when new revision
is published
• Expect to have three years before ISO
9001:2008 becomes out of date
• Certify to
ISO 9001:2015
before transition
period ends
(expected late
Conversation starter: preparing for 2015
What ideas do you have for
helping your organization prepare
for the upcoming changes?
How will you…
• Engage leadership?
• Mobilize key staff?
• Communicate to the
rest of the
Conversation starters—new opportunities
What new opportunities for quality
in your organization can you find
in the upcoming changes?
What can you do
to unlock them?
Conversation starters: your QMS
How do you define the value
proposition of your current
quality management system?
Why should your
customers care if your
organization is ISO
9001 certified?
Keep talking about ISO 9001:2015
Continue the discussion
Complete post-meeting survey or contact
[email protected] to:
• Offer feedback
• Recommend topics for your meetings
• Get help finding content
Get involved in standards development
Want to have a voice
in the ongoing
development of
ISO 9001 or other
Contact the ASQ standards team at
[email protected]

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