ISO 9001:2015 Revision Luis Fonseca [email protected]

Report
ISO 9001:2015 Revision
Luis Fonseca
[email protected]
[email protected]
ISO 9001:2015 Revision, Luis Fonseca, [email protected]
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1. Introduction
• Many definitions of Quality;
• Gurus: Crosby, Deming, Juran, Feigenbaum, Ishikawa,
Taguchi, …;
• ISO 9000 standards;
• Excellence Models: EFQM, MBA, Deming Prize + 6 Sigma,
Lean Six Sigma, Kaizen, etc.;
• In summary: Ranging from Conformity to Standards (more
B2B) to Customer Satisfaction (more B2C).
ISO 9001:2015 Revision, Luis Fonseca, [email protected]
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1. Introduction
• Let´s discuss the rationale behind the ISO 9001:2015
revision and the status of this (still ongoing) process;
• Key Stakeholders have (and are still working) towards a
Quality Management Systems with less emphasis on
documentation and new/reinforced approaches like
consideration of organizational context, (relevant)
Stakeholders, risk based thinking and knowledge
management;
• The main question is how far ISO/TC 176 can go without
alienating the "traditional" user and at the same time
bonding Quality with Management.
ISO 9001:2015 Revision, Luis Fonseca, [email protected]
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1. Introduction
• Let´s discuss the rationale behind the ISO 9001:2015
revision and the status of this (still ongoing) process;
• WARNING! The current version of the standard is the DIS
(draft International Standard). Changes might happen to:
Content and Publication date• Why do standards change?
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ISO have a Directive governing the publication of standards
All full ISO standards require to be reviewed every 5 years
(ISO Directive Part 1, Cl. 2.9.1)
The review can confirm that there is no change … but normally
not.
ISO 9001:2015 Revision, Luis Fonseca, [email protected]
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1. Introduction
• Let´s discuss the rationale behind the ISO 9001:2015
revision and the status of this (still ongoing) process;
• ISO 9001 change process:
– ISO TC 176 – Structure: SC 1: Terms and Definitions,
SC2:
Quality Systems (WG 23: Implementation
Guidance; WG 24: Revision of ISO 9001); SC3:
Supporting Technologies
ISO 9001:2015 Revision, Luis Fonseca, [email protected]
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1. Introduction
User Survey: KEY AREAS IDENTIFIED
• 64% wanted enhancement (7918 responses)
• Concepts (top 5)
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Resource Management
Voice of Customer
Measures
Knowledge Management
Risk Management
• In addition there were free text comments which
concerned (top 5): Top management involvement; Risk
assessment; Business continuity / planning; Inclusion of finance:
Resources / competence / work environment.
ISO 9001:2015 Revision, Luis Fonseca, [email protected]
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1. Introduction: ISO Certificates wordwide
Source: ISO Survey 2012, acceded at www.iso.org/iso/iso-survey
ISO 9001:2015 Revision, Luis Fonseca, [email protected]
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1. Introduction: ISO Certificates In Portugal
Source: ISO Survey 2012, acceded at www.iso.org/iso/iso-survey
ISO 9001:2015 Revision, Luis Fonseca, [email protected]
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1. Introduction: ISO Certification value
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Information from research done by HBS among 1000 organizations, 500 with and
500 without QMS implemented and certified:
Turnover 9% higher.
Higher profit because of higher turnover.
More salary increase (7%).
More personnel needed (10%) because of higher turnover increase.
In combination with ISO 14001 less waste and less incidents.
Effects were much stronger in smaller organizations.
ISO 9001:2015 Revision, Luis Fonseca, [email protected]
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1. Introduction
Major Objectives:
• Performance Related
• What to achieve rather than “how”
• Consistently meeting customer requirements
• Widen appeal
• SME, services, R&D etc.
• Adaptive system
• Not static. Risk based
ISO 9001:2015 Revision, Luis Fonseca, [email protected]
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1. Introduction
Standardization versus Agility (flexibility, Innovation, Speed)
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ISO 9001:2015 Revision, Luis Fonseca,
[email protected]
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Process Reliability
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1. Introduction
Design Specification:
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Revised Quality Principles
User Survey
Wide applicability
Simplified language
Consistent language
Emphasis on Process Approach
Meet ISO Directives
ISO/TC176/SC2 Vision and Mission
ISO/TC 176/SC2 Strategic Objective
Annex SL to the ISO/IEC Directive Sanctioned interpretations
Frequently Asked Questions,
ISO 9001 for small businesses – What to do?
Drafts of ISO 14001, Annex A, as available
Drafts of ISO 37500 Outsourcing
Output of Auditing Practices Group
ISO 9001:2015 Revision, Luis Fonseca, [email protected]
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2. ISO 9001:2008 versus ISO/DIS 9001:2015
Quality Principles:
ISO 9001:2015 Revision, Luis Fonseca, [email protected]
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2. ISO 9001:2008 versus ISO/DIS 9001:2015
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ISO Directives Part 1, ANNEX SL:
Common structure for management systems;
Template for common requirements;
Allow better integration of MS;
POSSIBLY THE MOST MAJOR CHANGE;
Annex SL is also called “the high level text”, “the high
level structure (HLS)”;
No change allowed unless justified. Justification has to be
on the basis that the text will not work in the particular
context.
ISO 9001:2015 Revision, Luis Fonseca, [email protected]
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2. ISO 9001:2008 versus ISO/DIS 9001:2015
ISO Directives Part 1, ANNEX SL:
4: Context of the organisation
5: Leadership
6: Planning for the QMS
7: Support
8: Operation
9: Performance evaluation
10: Improvement
ISO 9001:2015 Revision, Luis Fonseca, [email protected]
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2. ISO 9001:2008 versus ISO/DIS 9001:2015
Headlines
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Consideration of organizational (relevant) Stakeholders;
Planning: Actions to address risks and opportunities;
Preventive Action: Now covered by Risk Based Thinking
Context , Clause 4.1, 4.2 and 4.3;
Quality Manual, no specific requirement;
Management Representative: Rewritten as clause 5.3, No
specific role but same responsibilities;
Objectives: More systematic approach;
Organisational Knowledge: Knowledge management;
Leadership: Better definition of top management
responsibilities;
Communication: Enhanced requirement
ISO 9001:2015 Revision, Luis Fonseca, [email protected]
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2. ISO/DIS 9001:2015 Process based QMS System
ISO 9001:2015 Revision, Luis Fonseca, [email protected]
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2. ISO 9001:2008 versus ISO/DIS 9001:2015
Headlines
ISO/TC 176/SC 2
Document N1224, July 2014
Correlation matrices between ISO 9001:2008 and ISO/DIS 9001
This document gives correlation matrices from ISO 9001:2008 to the current Draft
International Standard (DIS) of ISO 9001 (that is expected to be published in 2015) and vice
versa.
ISO/TC 176/SC2
Document N1222, July 2014
“RISK” IN ISO 9001:2015
ISO TS 9002:2015: There will be a guidance document (started 9 June 2014).
It is intended to be available when ISO 9001:2005 is published.
ISO 9001:2015 Revision, Luis Fonseca, [email protected]
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2. ISO 9001:2008 versus ISO/DIS 9001:2015 Correlation Matrix
ISO 9001:2015 Revision,
Luis Fonseca,
[email protected]
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2. ISO 9001:2008 versus ISO/DIS 9001:2015 Correlation Matrix
ISO 9001:2015 Revision,
Luis Fonseca,
[email protected]
20
2. ISO 9001:2008 versus ISO/DIS 9001:2015 Correlation Matrix
ISO 9001:2015 Revision, Luis Fonseca, [email protected]
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3 Conclusions
What about the feedback from ISO 9001 community?
• Some like very much the “Annex SL” approach, but other do not.
• Concerns that some requirements might being soft grading (e.g.,
Design & Development and Calibration).
• Concerns about “auditability” of some requirements (I agree this
might be a major challenge for Consultants and for Certification
Bodies Auditors).
• Some want more prescriptive requirements (e.g., Automotive
Sector).
• Introduction of the concept of “Relevant Interested parties” and
“Risk Based Approach” is a new reality.
• Elimination of usual terminology and requirements like
“Preventive action”; “Management Representative”, “Quality
Manual” still not liked by all.
ISO 9001:2015 Revision, Luis Fonseca, [email protected]
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3 Conclusions
What does the author thinks?
• It should not be a major source of concern for the ISO 9001:2015
should not be a major source of concern, for the more than 1
Million certified organizations and the many Quality Professionals
and Scholars that work with it.
• It will have major benefits for Quality Management Systems
with less emphasis on documentation and new/reinforced
approaches like consideration of organizational context and
(relevant) Stakeholders, risk based thinking and knowledge
management.
• The author thinks one of the major changes will be that
organizations have to be clearer about what they say they are
going to offer and the main question is how far ISO/TC 176 can
go without alienating the "traditional" user.
ISO 9001:2015 Revision, Luis Fonseca, [email protected]
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3 Conclusions
What should you do know?
Stay tuned to what’s happening with the revision to ISO
9001.
Get familiar with the concepts of “Risk-based thinking” and
“Relevant interested parties”.
Follow into www.iso.org. since periodic updates will be
made available by ISO/TC176/SC2/WG23.
Look into the DIS (Draft International Standard) and start
working on understanding and incorporating the changes.
DIS will be followed by FDIS (Final Draft Standard) and
finally IS (international Standard).
ISO 9001:2015 Revision, Luis Fonseca, [email protected]
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3 Conclusions
What should you do know?
• Is your organization pleased with your present Quality
Management System? Is it really a lean process based
system? Does it integrates and supports your business well?
• Depending on you the answer, some organizations should
consider the 2015 ISO 9001 revision as a great opportunity
to reviews and reignite theirs systems. If the system is
working well, maybe just adjust it to the new ISO 9001.2015
changes.
ISO 9001:2015 Revision, Luis Fonseca, [email protected]
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4 References
ISO TC/176, accessed at www.iso.org/iso/iso_technical_committee?commid=53882
ISO Survey 2012, accessed at www.iso.org
Boiral, O., 2012, ISO 9000 and Organizational Effectiveness: A Systematic Review, QMJ, Vol 19, and N º 370)
Croft, N.H., 2013, ISO 9001:2015, from CD to DIS, DNV Webinar
Hadfield R., Fonseca L., 2014, ISO9001:2015, APQ, ANO XLIII, Edição 01,pp32-36
IATF, 2014, accessed at ww.iatfglobaloversight.org.
ISO, 2014, ISO/TC 176/SC 2/N 1147, 2013, ISO/CD 9001.
ISO 2014, ISO/TC 176/SC 2/WG 24/N 112, 2014, ISO/DIS 9001. This document is presently under ISO copyright and should
not be forwarded to, or made available to, any 3rd Party -This document is a draft circulated for comment and approval. It is
therefore subject to change and may not be referred to as an international standard until published as such.
Lee, H., L., 2004, Harvard Business Review, October 2004.
Levine D., Toffel, M.W., 2010, Quality Management and Job Quality: How the ISO 9001 Standard for Quality Management
Systems Affects Employers and Employees, Harvard Business School.
Nascimento J.C., 2013, Norma ISO 9001:2015, Panorama e tendência da revisão 2015, ABNT, Exponorma.
O’Byrne, F., Tighe, J., 2013, NSAI Consultants Forum.
Sá, J.G., 2014, Workshop ISO 9001:2015 perspetivas futuras, Ponta Delgada.
Karapetrovic, S., 2002, Strategies for integration of management systems and standards, TQM Magazine, 14(1) pp. 61-67).
ISO 9001:2015 Revision, Luis Fonseca, [email protected]
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Q&A and Thanks
• For more details please see full article.
• Quality: a major source of value.
Thank You Very Much
Q&A most welcomed
Luis Fonseca
[email protected]
[email protected]
paginas.isep.ipp.pt/lmf/
http://pt.linkedin.com/in/luismiguelciravegnafonseca
ISO 9001:2015 Revision, Luis Fonseca, [email protected]
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