Journey to Perfect: Mayo Clinic and the Path to Quality

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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 committees

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

(FDIS)

• 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 engagement

• More flexibility around documentation

• Improved applicability for service organizations

The 2015 revision: what to expect

• Use of new common structure for management system standards for smoother integration

– Standardized core text, structure, and definitions

– 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

2018)

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 organization?

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 asq.org/standards

-iso-9001-2015.html

Continue the discussion

Complete post-meeting survey or contact knowledgecenter@asq.org

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 standards?

Contact the ASQ standards team at standards@asq.org

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