1. PERFORMANCE EVALUATION
AND IMPROVEMENT
Quality is Culture 1 November 2016

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9.1 Monitoring, evaluation, analysis and
evaluation
(similar to para. 8.2.1 and para. 8.4, ISO 9001:2008)
9.2 Internal Audit (similar to para. 8.2.2)
9.3 Management review process (similar to 5.6)
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9.1 Monitoring, evaluation, analysis and evaluation
* 9.1.1 Determine what needs to be monitored and
measured; which methods; when to monitor,
measure, analyze and evaluate.
* 9.1.2 Customer Satisfaction: monitor perceptions
* 9.1.3 Analysis and Evaluation requirements:
conformity to products and services, customer
satisfaction, QMS effectiveness, planning
effectiveness, effectiveness of risks and opportunities
actions, performance of external providers
(suppliers), need for improvement
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9.2 Internal Audit
* Conduct at planned intervals
* Conforms to QMS and ISO 9001:2015
* Effectively implemented
* Include frequency, methods, responsibilities, planning, and
reporting
* Consider processes, changes affecting the organization, results
of previous audits
* Define audit criteria and scope
* Select auditors for objectivity and impartiality
* Report results to management
* Correction/Corrective action without undue delay
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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
Outputs: decisions and actions related to:
- Opportunity for improvement
- Changes to QMS
- Resource needs
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10.1 General
-Products, services, future needs and expectations
-Correcting, preventing or reducing undesired effects
-Improving the performance and effectiveness of the QMS
10.2 Nonconformity and corrective action
(similar to ISO 9001:2008, para. 8.5.2)
With enhancements:
- Deal with the consequences
- Determine if similar nonconformities exist, or could potentially occur
- Update risks and opportunities determined during planning
- Make changes to QMS, if necessary
10.2 Continual Improvement (similar to ISO 9001:2008, para. 8.5.1)
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