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Keep Calm and Prepare For Iso 9001 2015
Keep Calm and Prepare For Iso 9001 2015
CALM
AND
PREPARE FOR
ISO 9001:2015
Eight experts outline key changes
and how to handle them
ISO 9001:2015
September 2015 QP 19
DEANN DESAI is a project manager for Georgia Techs Enterprise Innovation Institute in Atlanta. She has a
masters degree in statistics and polymers from the Georgia Institute of Technology in Atlanta. An ASQ member,
Desai is an Exemplar Global-certified QMS lead auditor, energy management lead auditor and environmental
management systems lead auditor. Desai is a member of multiple ISO standards committees, including TAG 176
and the task force in the Joint Technical Coordination Group that wrote Annex SL and the associated guidance.
ALLEN GLUCK is president of ERM31000 Training and Consulting in Spring Valley, NY, and an adjunct professor
at Manhattanville School of Business in Purchase, NY. He has a masters degree in leadership from Bellevue
University in Nebraska. Gluck is an ASQ member and a member of TAG 176, which develops ISO 9001, and TAG
262, which develops ISO 31000.
PAUL PALMES is president and principal consultant with Business Systems Architects Inc. in Fargo, ND, and
Prescott, WI. He is a member of TAG 176 and chair of international ISO/TC 176, subcommittee 1, responsible for
the revision of ISO 9000. He has been international ISO/TC 176 liaison to the International Accreditation Forum
(IAF), co-chair of the IAFs ISO 9000 advisory group, and member of the Auditing Practices Group and the Accreditation Council of the ANSI/ASQ National Accreditation Board. Palmes is an ASQ-certified quality manager,
British Standards Institution-certified ISO 9001 auditor and has a masters degree in administration from Gonzaga University in Spokane, WA.
DENISE ROBITAILLE is the author of 12 books, including ISO 9001:2008 for Small and Medium-Sized Businesses (ASQ Quality Press, 2010), and an internationally recognized speaker and trainer. She is an active member
of TAG 176, where she has participated in the revision of multiple standards. Robitaille is an ASQ fellow, an
Exemplar Global-certified lead assessor and an ASQ-certified quality auditor.
JOHN E. JACK WEST is a member of Silver Fox Advisors in Houston. He is past chair of TAG 176 and lead
delegate of the committee responsible for the ISO 9000 family of quality management system standards. He is
an ASQ fellow and has co-authored several ASQ Quality Press books.
20 QP www.qualityprogress.com
ISO 9001:2015
structure:
1. Scope.
2. Normative references.
5. Leadership.
6. Planning.
7. Support.
8. Operation.
9. Performance evaluation.
al environmental MSS.
10. Improvement.
joint vision and high-level structure for all MSSs was de-
Clause titles.
Text.
These items are permitted to diverge among standards only where necessitated by specific differences in
managing the individual fields of application.
September 2015 QP 21
The issues identified by an organization and the relevant requirements of interested parties are linked to
new version.
22 QP www.qualityprogress.com
ISO 9001:2015
Technology trends.
go?
ance.
the organization.
REFERENCES
1. International Organization for Standardization, ISO/FDIS 9001:2015Quality
management systemsRequirements, clause 4.
2. International Organization for Standardization, ISO/FDIS 9001:2015Quality
management systemsRequirements, subclause 4.1.
3. International Organization for Standardization, ISO/FDIS 9001:2015Quality
management systemsRequirements, subclause 5.1.1.
4. International Organization for Standardization, ISO/FDIS 9000:2015Quality
management.
SMALL BUSINESS
CHALLENGE
September 2015 QP 23
Consider Risk
by Denise Robitaille
What is the change?
Many of the changes in ISO 9001:2015 will involve a
cause the QMS touches most processes and departments, the need to engage in risk-based thinking is
ISO 9001.
24 QP www.qualityprogress.com
Allen Gluck
REFERENCES
1. International Organization for Standardization, ISO 31000:2009Risk management
Principles and guidelines.
2. International Organization for Standardization, ISO/FDIS 9001:2015Quality management
systemsRequirements.
3. Ibid.
ISO 9001:2015
All of the language about the context of the organization is directly relevant to the conversation about risk.
working.
REFERENCE
1. International Organization for Standardization, ISO/FDIS 9001:2015Quality
management systemsRequirements, clause 4.
Leaders, Step Up
by Paul C. Palmes
What is the change?
an organization.
3. Ensuring the quality policy is communicated, understood and applied in an organization.
September 2015 QP 25
able.
7. Communicating the importance of effective quality
management and of conforming to QMS requirements.
requiring prepared materials to explain this fundamental concept to top management during these meetings.
11.
Supporting other relevant management roles to
venues for each requirement. Perhaps your organization routinely schedules an all-organization business
systems.
accustomed).
26 QP www.qualityprogress.com
REFERENCES
1. International Organization for Standardization, ISO/FDIS 9001:2015Quality
management systemsRequirements, subclause 5.1.1.
2. Stephen R. Covey, The Seven Habits of Highly Effective People, Free Press,
1989.
3. International Organization for Standardization, ISO/FDIS 9001:2015Quality management systemsRequirements, see reference 1.
ISO 9001:2015
Determine Your
Documentation Needs
by Bill Aston
What is the change?
necessary?
No, that is not the case. Consider the requirements
clause 8.4.1).
10. Traceability (subclause 8.5.2).
formed as planned.
Annex A, section A.6, provides guidance regarding
the references made to requirements throughout the
18.
Nonconformity and corrective action (subclause
10.2.2).
zation:
September 2015 QP 27
ISO 9001:2015
an organizations operation.
ISO 9001:2015.
its needs.
to ISO 9001:2015.
9001:2015. QP
REFERENCES
1. International Organization for Standardization, ISO/FDIS 9001:2015Quality
management systemsRequirements, subclause 4.4.2.
2. International Organization for Standardization, ISO/FDIS 9001:2015Quality
management systemsRequirements, Annex A, section A.6.
3. International Organization for Standardization, ISO 31000:2009Risk managementPrinciples and guidelines.
4. International Organization for Standardization, Technical Committee 176,
Subcommittee 2 (ISO TC/176/SC2) homepage, http://tinyurl.com/TCSC2.
5. International Accreditation Forum (IAF), IAF Informative Document 9: 2015
Transition Planning Guidance for ISO 9001:2015, Issue 1, Jan. 12, 2015.
28 QP www.qualityprogress.com
REVISION
RESOURCES