This document discusses quality management system requirements including leadership commitment, customer focus, quality policy, organizational roles and responsibilities, and management review. It addresses leadership accountability for quality management system effectiveness, integrating the system into business processes, ensuring adequate resources, and promoting continual improvement. Customer requirements and regulatory compliance are also addressed. Quality objectives, management responsibilities, and review of quality performance data and opportunities for improvement are discussed.

1. LEADERSHIP and
Management Review
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2. Quality is Culture 2
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5.1 Leadership and Commitment
5.1.2 Customer Focus
5.2 Quality Policy
5.3 Organizational roles, responsibilities and
authorities
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5.1 Leadership and commitment
a) accountability for effectiveness of QMS
b) Policy and objectives are compatible with the
context and strategic direction
c) Integration of QMS into business processes
d) Promoting the use of the process approach
and risk-based thinking
e) Ensuring resources for QMS are available
f) Ensuring the importance of effective QMS and
of conformance to the QMS requirements (cont.)
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g) Ensuring the QMS achieves its intended
results
h) Engaging, directing, and supporting persons to
contribute to the effectiveness of the QMS
i) Promoting improvement
j) Support relevant managers to demonstrate
their leadership
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5.1.2 Customer Focus – Top Management demonstrate
leadership and commitment:
a. customer requirements and applicable statutory and
regulatory requirements are met
b. the risks and opportunities that can affect conformity of
products and services and the ability to enhance customer
satisfaction are determined and addressed
c. the focus on consistently providing products and
services that meet customer and applicable statutory and
regulatory requirements is maintained;
d. the focus on enhancing customer satisfaction is
maintained.
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5.2 Quality Policy
a. Appropriate to the purpose and context of the
organization
b. Framework for quality objectives
c. Commitment to satisfy requirements
d. Commitment to Continuous Improvement of QMS
*- shall be available as documented information
*- be communicated, understood, applied.
*- be available to relevant parties, as appropriate
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5.3 Organizational roles, responsibilities and authorities
Top management shall ensure that the responsibilities and
authorities for relevant roles are assigned, communicated and
understood within the organization.
a. Ensure the QMS confirms to ISO 9001
b. Ensure the processes are delivering their intended outputs
c. Reporting on the performance of the QMS and on
opportunities for improvement
d. Ensuring the promotion of customer focus throughout the
organization
e. Ensuring that the integrity of the QMS is maintained when
changes to the QMS are planned and implemented.
No requirement for a management representative
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9. Quality is Culture 9
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Management Review
process updates
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9.3 Management Review
a) Status of actions
b) Changes in external and internal issues that are relevant to the QMS
c) Information on the performance and effectiveness of the QMS, including trends
in:
- Customer satisfaction and feedback from relevant interested parties;
- The extent to which quality objectives have been met;
- Process performance and conformity of products and services;
- Nonconformities and corrective actions;
- Monitoring and measuring results;
- Audit results;
- The performance of external providers;
d) The adequacy of resources
e) The effectiveness of action taken to address risks and opportunities (see 6.1)
f) Opportunities for improvement
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11. Quality is Culture 11
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Outputs: decisions and actions related to:
-Opportunity for improvement
-Changes to QMS
-Resource needs
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