Professional Documents
Culture Documents
ISO 9001:2015
Introduction
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ISO 9001 revision process
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ISO Mission
Develop, maintain and support products* that enable organizations worldwide to improve
their performance by establishing generic QMS requirements providing guidance and
support.
* ISO 9000, ISO 9001, ISO 9004 & other guidance documents
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Worldwide ISO 9001 survey
A worldwide ISO 9001 survey was conducted. The survey questioned what the most
important concepts were to follow for a successful QMS. The results were based on 6,299
answers and the top 6 concepts are as followed:
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Key Inputs
Set of stable requirements to last 10 years, 2015 until 2025.
Incentivate process approach and effective process
management.
INPUT Process OUTPUT
Changes in practices to QMS and technology.
Facilitate implementation in any organisation.
Effective verification by first, second and third party
organizations.
Simplified language and text
Quality Management Principles – Process approach include
concept of “system”
Simpler language for better understanding.
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‘High Level Structure’
Alignment of management systems standards
Identical titles and core text
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‘High Level Structure’
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‘High Level Structure’
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‘High Level Structure’
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Key Changes in ISO 9001:2015
Exclusions
No text for possible exclusions of requirements Intent remains
as per clause 1.2 of present standard
Leadership
•Role of “Management Representative” eliminated Quality policy
/ objectives compatible with strategic direction
• Integration of QMS requirements into business processes
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Key changes
Reduction of the prescriptive nature of some Requirements
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Key changes
Significant changes
Process approach
•New clause: Process approach
•Determination of risk to conformity of goods and services and to
customer satisfaction
Knowledge as a resource
•Determine the knowledge necessary for the operation of the QMS and its processes
•Knowledge shall be maintained, protected and made available as necessary
•Foresee the need for changes in knowledge and the risk of not acquiring it in a planned
and timely manner.
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Key changes
Documented information
•No mention of a “Quality Manual”
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What is “risk-based thinking”?
Something we all do automatically and often Subconsciously
Risk-based thinking
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Where is risk addressed in ISO
9001:2015?
Main objectives of ISO 9001:
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Where is risk addressed in ISO 9001:2015?
In Clause 4 > the In Clause 8 > the
organization is required organization is required
to determine risks that to have processes which In Clause 10 > the
can affect its ability to identify and address organization is
meet objectives” risk in its operations required to improve
by responding to
changes in risk and
In Clause 5 > top opportunities
In Clause 9 > the
management are
organization is required
required to commit to
to consider risks and
ensuring Clause 4 is
opportunities when
followed
determining what
needs to be monitored,
measured, analyzed and
In Clause 6 > the evaluated
organization is required
to plan and take action
to address risks and
opportunities
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What should you do?
Implementation of the High-Level
Structure
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Implementation of the High-Level
Structure
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Implementation of the High-Level
Structure
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Implementation of the High-Level
Structure
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Implementation of the High-Level
Structure
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Model of a process-based QMS
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Single process within the system
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ISO 9001:2015 High Level Structure
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Leadership
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Leadership
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ISO 9001:2015 High Level Structure
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Planning
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Planning
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ISO 9001:2015 High Level Structure
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Support
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Support
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Support
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Support
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ISO 9001:2015 High Level Structure
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Operation
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Operation
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Operation
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Operation
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Operation
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Operation
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Operation
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ISO 9001:2015 High Level Structure
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Performance evaluation
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Performance evaluation
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ISO 9001:2015 High Level Structure
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ISO 9001:2015 High Level Structure
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ISO 9001:2015 High Level Structure
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Conclusions
More leadership and commitment from top management
Documented information
Performance evaluation
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