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4.1 Understanding the organization and it context
4.2 Understanding the needs and expectations of
4.3 Determining the scope of the QMS
4.4 Quality Management System and its
6.1 Actions to address risks and
6.2 Quality objectives and planning to
6.3 Planning of Changes
6.1 Actions to address risks and opportunities
Consider the issues and determine the risks and opportunities
that need to be addressed to:
a. Give assurance that that the QMS can achieve intended
b. Prevent, or reduce undesired effects
c. Achieve continual improvement
- Actions to address these risks and opportunities
- How to integrate/implement actions into QMS
- Evaluation effectiveness of these actions
* Note: Options to address risks and
opportunities can include: avoiding risk,
taking risk in order to pursue an opportunity,
eliminating the risk source, changing the
likelihood or consequences, sharing risk, or
retaining risk by informed decision.
6.2 Quality Objectives
- similar to previous revision
- relevant and enhancement of customer satisfaction
- retain documented information on the quality
- What will be done, what resources, who will be
responsible, when completed, how evaluated.
6.3 Planning of changes: This is new
Changes (to QMS) shall be carried out in a planned
a) Purpose of the change and potential consequences
b) the integrity of the QMS
c) availability of resources
d) allocation or reallocation of responsibilities and
<Feedback loop Management Review 9.3.2.c.2>
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
Outputs: decisions and actions related to:
- Opportunity for improvement
- Changes to QMS
- Resource needs
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