ISO 9001 - Clause 9: Performance Evaluation

Clause 9 of ISO 9001:2015, titled 'Performance Evaluation', sets out the requirements for monitoring, measurement, internal audit, and management review. Clause 9.1 necessitates determining what needs to be monitored and measured, the methods for doing so, and when these activities should be performed. Clause 9.2 necessitates regular internal audits by competent personnel, and the maintenance of documented information regarding the audit process. Lastly, Clause 9.3 stipulates that top management must periodically review the organization's Quality Management System to ensure its continuing suitability, adequacy, effectiveness, and alignment with the strategic direction of the organization.

Clause 9.1 - Monitoring and measurement

This clause focuses on monitoring, measurement, analysis, and evaluation. It requires organizations to determine what needs to be monitored and measured, the methods for monitoring, measurement, analysis, and evaluation, when the monitoring and measuring shall be performed, and when the results from monitoring and measurement shall be analysed and evaluated.

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Clause 9.2 - Internal Audit

Organization need to schedule internal audit at defined periodicity for example, some organization conduct internal audits once in a year or once in six months or on a quarterly basis. based on the importance of process, changes in organization and maturity of system. 
The schedule can be decided upon. Audit plan, shall be prepared.
Internal audit shall be conducted by competent person who are aware of ISO 9001 requirement and organization requirement. Also, internal auditor should not audit his or her own function to maintain impartiality. 
It is mandatory to maintain Documented information of Internal audit process. 
Examples of Documents in internal audit process are,
  1. Audit schedule
  2. Audit plan
  3. Audit report
  4. Non-conformity and corrective action ( if applicable )
  5. Competence record of Internal Auditor

Template - QMS Internal Audit Schedule

Template - QMS Internal Audit Plan

Template - QMS Internal Audit Summary

Template - QMS Internal Auditor List

Clause 9.3 - Management Review

Clause 9.3 of ISO 9001:2015 pertains to Management Review. This section stipulates that top management must periodically review the organization's Quality Management System (QMS) to ensure its continuing suitability, adequacy, effectiveness, and alignment with the strategic direction of the organization. This review should incorporate analysis of data from monitoring and measurement, audit results, and customer feedback, amongst other factors.

Management review