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Introduction
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
Key Inputs
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Key changes
Reduction of the prescriptive nature of some
Requirements
Monitoring and measuring equipment
Evidence of fitness for purpose
Development of goods and services
Processes for the development
Control of development processes
Development transfer
Necessary documented information
Context of the organization
Two new clauses:
4.1 Understanding the
organization and its
context
4.2 Understanding the needs
and expectations of
interested parties
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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
Outsourcing of goods and services
Control of external provision of goods and services
Risk-based approach to determine
type and scope of controls
Risk and preventive action
Key purpose of a management system is to act as
preventive tool
Risk-based thinking introduced in all clauses
* Risk = effect of uncertainty
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Leadership
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Leadership
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Planning
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Planning
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Support
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Support
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Support
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Support
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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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Performance evaluation
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Performance evaluation
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Conclusions
More leadership and commitment from top management
Process approach as a requirement
Risk definition and management
Quality objectives at relevant functions, levels and Processes
Organizational knowledge as a resource
Documented information
Planned and controlled operation
Performance evaluation
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