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1 ISO/TC 176/SC 2/WG23 N063 ISO 9001:2015 Expected Changes Paula Fyda, Steve Sabo Innovative Quality Solutions Co.
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ISO/TC 176/SC 2/WG23 N063
ISO 9001:2015 Expected Changes Paula Fyda, Steve Sabo
Innovative Quality Solutions Co.
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Date:
ISO
/TC
176/S
C 2
/WG
23 N
063
To provide an overview of the proposed revision
of ISO 9001 which will be published in 2015
Purpose of presentation
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/TC
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Background to this presentation
Developed by the ISO sub-committee
responsible for communicating key information
about the current revisions to ISO 9001
Supplemented with insights provided by SQA
and Innovative Quality Solutions
“Risk-based Thinking”- a key aspect of ISO
9001:2015 incorporated
Information will be updated as the revision
progresses
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Disclaimers
The presentation includes information related to the revision process up to and including December 2013
Further changes are likely to occur as the revision process progresses
Final revision not scheduled for release until December 2015
Important to be aware of the proposed changes, but realize they may change
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ISO facts
ISO is “owned” by the International Organization for Standardization
ISO is based in Switzerland, over 160 nations participate with approximately 20,000 standards
all ISO standards are based on consensus
ISO standards are usually developed by Technical Committees (TCs) or their sub-committees, or by Project Committees
ISO work involves experts nominated by their national standards bodies
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ISO 9001:2015 development process an international ballot agreed the need for revision
there are several distinct stages when developing an ISO standard; the key ones being:
1. Working Drafts (WDs)
2. Committee Draft (CD)
3. Draft International Standard (DIS)*
4. Final Draft International Standard (FDIS)
5. International Standard (IS)
The standard is published after approval of the FDIS by participating national standards bodies and is then reviewed at regular intervals.
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Key perspectives
ISO 9001 needs to:
maintain relevance
integrate with other management systems
provide an integrated approach to organizational management
provide a consistent foundation for the next 10 years
reflect the increasingly complex environments in which organizations operate
ensure the new standard reflects the needs of all potential user groups
enhance an organization's ability to satisfy its customers
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What was considered?
the results of an extensive web-based user survey
the increasing diversity of ISO 9001 users
developments in knowledge and technologies
broader user interests
changes in industry
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an emphasis on risk-based thinking
increased emphasis on achieving value for the
organization and its customers
increased flexibility on the use of documentation
more readily applicable by “service” type
organizations
Main changes
customers remain the
primary focus
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General Still based on the Process Approach
Plan-Do-Check-Act cycle
Applied at process and system level
“Risk-based Thinking”
Effect of uncertainty on an expected result
Compatible with other Management System
Standards
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General
“ It is important to emphasize that organizations are
not required to follow an identical clause- by
clause sequence when defining their quality
management system, and they are encouraged to
use the Process approach as described”.
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High level structure
a new common format has been developed for
use in all management system standards
standardized core text and structure
standardized core definitions
Organizations implementing multiple management systems (e.g. quality,
environmental, information security) can achieve better integration and easier implementation
The high level structure and common text is public information and can be found in Annex SL of the
www.iso.org/directives
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1 Scope
2 Normative references
3 Terms and definitions
4 Context of the organization Understanding the organization and its context Needs and expectations of interested parties Scope of QMS QMS and its processes
5 Leadership General Commitment Quality policy Roles, responsibilities and authorities
Structure 1/3
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6 Planning for the QMS Actions to address risks and opportunities Objectives and plans to achieve them Planning of changes
7 Support Resources Competence Awareness Communication Documented information
8 Operation Operational planning and control Determination of requirements for products and services;
customer communication
Structure 2/3
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8 Operation (cont).
Design and development Control of externally provided products and services Production and service provision; changes Release of products and services Nonconforming process outputs, products, services
9 Performance evaluation
Monitoring, measurement, analysis and evaluation (including customer satisfaction)
Internal audit
Management review
10 Improvement
Nonconformity and Corrective Action
Continual improvement
Structure 3/3
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Supporting documents
certification transition plan and timeframe
guidance documents on specific topics, e.g. the
process approach
comparison of ISO 9001:2008 and 9001:2015
frequently asked questions
ISO website updates
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ISO 9001:2015 Timeline
June 2013 CD
(Committee Draft)
April 2014 DIS
(Draft International Standard)
July 2015 FDIS
(Final Draft International Standard)
September 2015
Published International Standard
2015 2014 2013
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ISO 9001:2015 Timeline
Draft has been developed and submitted to the ISO and CEN member bodies for a 5 month parallel review
Should the draft be accepted, a Final Draft, established on the basis of comments received, will be submitted to a parallel 2 month approval vote in ISO and formal vote in CEN
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ISO 9001:2015 Certification Transition Timeline
September 2015 start of 3 years transition period to September 2018
2018 2017 2016 2015
September 2015
Published International Standard
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The revision of ISO 9001 will impact other related standards and documents.
Expect changes to:
- industry-specific standards
- supporting documents
Other Important Information
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Ensure our organizations are aware of the key
changes
understand the key concepts
plan to implement the new requirements
stay informed as the revision proceeds
take full advantage of the revision of ISO 9001
What should we do…
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Provide an overview of how the future ISO 9001:2015 Standard addresses the topic of “risk”
Risk-based Thinking
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Risk-based Thinking
One of most significant changes to the ISO 9001
Standard
Beneficial to any type, size of organization
Remember that proposed document is still in
“draft” form and subject to change
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What is “Risk-based Thinking”?
Risk-based thinking is something we all do automatically and often sub-consciously
The concept of risk has always been implicit in ISO 9001 – this revision makes it more explicit and builds it into the whole management system
Risk-based thinking is already part of the process approach
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What is “Risk-based Thinking”? (cont).
Risk-based thinking makes preventive action part of the routine
Risk is often thought of only in the negative sense
Risk-based thinking can also help to identify opportunities. This can be considered to be the positive side of risk
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Where is risk addressed in
the current draft of
ISO 9001:2015?
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The main objectives of ISO 9001
to provide confidence in the organization’s ability to consistently provide customers with conforming goods and services
To enhance customer satisfaction
The concept of “risk” in the context of ISO 9001 relates to the uncertainty in achieving these objectives
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Where is Risk addressed in the ISO 9001:2015 Draft?
Clause 4- Context of the Organization
the organization is required to determine the risks which can affect its ability to meet its objectives
Clause 5- Leadership
Top management are required to commit to ensuring Clause 4 is followed
Clause 6- Planning for the QMS
the organization is required to take action to address risks and opportunities
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Where is Risk addressed in the ISO 9001:2015 Draft?
Clause 8- Operation
the organization is required to have processes which identify and address risk in its operations
Clause 9- Performance Evaluation
the organization is required to monitor, measure, analyse and evaluate the risks and opportunities
Clause 10- Improvement
the organization is required to improve by responding to changes in risk
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Why should we adopt “Risk-based Thinking”?
to improve customer confidence and satisfaction
to assure consistency in the quality of products and services
to establish a proactive culture of prevention and improvement
Successful companies intuitively take a risk-based approach
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What should You do?
Use a risk-driven approach in your organizational processes
identify what the risks and opportunities are in your organization – it depends on context
ISO 9001:2015 will not automatically require you to carry out a full, formal risk assessment, or to maintain a “risk register”
ISO 31000 (“Risk management — Principles and guidelines”) will be a useful reference (but not mandated)
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What should You do? (cont’d)
analyse and prioritize the risks and opportunities in your organization
what is acceptable?
what is unacceptable?
plan actions to address the risks
how can we avoid or eliminate the risk?
how can we mitigate the risk?
implement the plan – take action
check the effectiveness of the actions – does it work?
learn from experience – continual improvement
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Summary
Draft Standard is out for vote until 10-10-14
Expected to be published 09-2015
Three year transition to 09-2018
Important to be aware of proposed changes but
realize this is only a draft
Benefit from proposed changes
* Risk-based thinking
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Questions and Answers
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Contact Information
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Paula Fyda: 330.725.9927
Steve Sabo: 614.208.7226
www.iqsconsulting.net
