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Developed from ISO/TC 176/SC 2/WG23 N063, N064 & N065
ISO 9001:2015 Revision overview - Quality experts
Presented by
Jack West
January 2014
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Date:
ISO
/TC
176
/SC
2/W
G2
3 N
064
Purpose of presentation
The intention of this presentation is to:
To provide an overview of changes and likely impacts of the 2015 revision of ISO 9001
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/TC
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/SC
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Disclaimers
verbal statements made by the presenter may represent personal opinions and/or interpretations
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
you may wish to consider the changes as these occur and plan accordingly
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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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Revision intent
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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Main changes
use of the High Level Structure (HLS)
improved applicability for services
fewer prescribed requirements
increased emphasis on organizational context
boundaries of the QMS must now be defined
consideration of exclusions
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risk-based thinking throughout the standard supersedes a single clause on preventive action
the term ‘documented information’ replaces ‘documents and records’
the term ‘outsourcing’ is replaced by ‘external provision’
increased leadership requirements
no requirement for a management representative
Main changes
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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 context interested parties scope of QMS quality management system
5 Leadership general management commitment policy roles, responsibility and authority
6 Planning actions to address risks and opportunities objectives and plans to achieve them planning of changes
Structure 1/3
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7 Support resources competence awareness communication documented information
8 Operation operational planning and control determination of market needs and interaction with customers operational planning process control of external provisions of goods and services development of goods and services production of goods and provision of services release of goods and services non conforming goods and services
Structure 2/3
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9 Performance evaluation
monitoring, measurement, analysis and evaluation
internal audit
management review
10 Improvement
Non-conformity and corrective action
improvement
Structure 3/3
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QMS Structure
4 Context of the organization
Understanding of the organization and its context
Expectations of interested parties
Scope of management system
QMS
5 Leadership
Leadership and commitment
Quality policy
Roles, responsibilities and authorities
6 Planning
Actions to address risk and opportunity
Quality objectives
7 Support
Resources
Competence
Awareness
Communication
8 Operation
Operations of planning and control
Determination of market needs and interactions with customers
Operational planning process
Control of external provision of goods and services
Development of goods and services
9 Performance and evaluation
Monitoring, measurement, analysis and evaluation
Internal audit
Management review
10 Improvement
Nonconformity and corrective action
Continual improvement
PLAN DO CHECK ACT
Documented information
Planning of changes
Production of goods and provision of services
Release of goods and services
Nonconforming goods and services
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objectives must include reference to who, what, when
planning of changes
explicit reference to knowledge management
no need for a Quality Manual
operational planning includes addressing risks
greater emphasis on processes achieving requirements for goods or services and customer satisfaction
Changes to requirements
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control of changes
monitoring and measurement
internal audits now require the consideration of related risks
management review to take into consideration strategic direction of the organization
Changes to requirements
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ISO 9001:2015 “Risk Based Thinking” Most significant Change?
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Provide an overview of how the future ISO 9001:2015 standard addresses the topic of “risk”.
Purpose of presentation
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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
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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Risk in the clauses - Process Approach, Leadership, Planning
in Clause 4 the organization is required to determine the risks which can affect its ability to meet these objectives
in Clause 5 top management are required to commit to ensuring Clause 4 is followed
in Clause 6 the organization is required to take action to address risks and opportunities
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Risk in Clauses – Operation, Evaluation, Improvement
Clause 8 - the organization is required to have processes which identify and address risk in its operations
Clause 9 the organization is required to monitor, measure, analyse and evaluate the risks and opportunities
In Clause 10 the organization is required to improve by responding to changes in risk
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Why should I adopt “risk-based thinking”?
to improve customer confidence and satisfaction
to assure consistency of quality of goods 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 I 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 I do? (continued)
analyse and prioritize the risks and opportunities in your organization
what is acceptable?
what is unacceptable?
plan actions to address the risks
how can I avoid or eliminate the risk?
how can I 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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Additional updates and information will be made
available as the revision process proceeds
What is next?
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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
Draft DIS
NOW Jan 2014
Draft DIS
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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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/TC
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Updated information will be made available
as the revision process proceeds
What’s next?
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Thanks for your atttention
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