Clause 9: Performance evaluation

This clause is sub-divided into the following: Let’s now look into each of these in detail …

9.1 Monitoring, measurement, analysis and evaluation

• 9.1.1 General
• 9.1.2 Customer satisfaction
• 9.1.3 Analysis and evaluation
9.2 Internal Audit
9.3 Management review
• 9.3.1 General
• 9.3.2 Management review inputs
• 9.3.3 Management review outputs

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9.1 Monitoring, measurement, analysis
and evaluation9.1.1 General

Organisations must determine: They must also evaluate the performance and the
effectiveness of the QMS and retain appropriate
documented information (i.e. records) as evidence of the
results.
what needs to be monitored and measured
the methods for monitoring, measurement, analysis and evaluation needed
to ensure valid results
when the monitoring and measuring must be performed
when the results from monitoring and measurement must be analysed and
evaluated

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9.1.2 Customer satisfaction

Examples of monitoring customer

Organisations must obtain, monitor and perceptions can include; customer surveys,
review customers’ perceptions of the customer feedback on delivered products
degree to which their needs and and services, meetings with customers,
expectations have been fulfilled. market-share analysis, compliments,
warranty claims and dealer reports.

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 • Organisations must analyse and evaluate
appropriate data and information arising from
monitoring and measurement. Evaluation needs to
include:
• conformity of products and services
• the degree of customer satisfaction
9.1.3 • the performance and effectiveness of the QMS
Analysis and • if planning has been implemented effectively

evaluation • the effectiveness of actions taken to address

risks and opportunities
• the performance of external providers
• the need for improvements to the QMS

 
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 9.2 Internal Audit

Organisations need to conduct internal They must plan, establish, implement and Organisations must also:
audits at planned intervals to provide maintain an audit programme(s) including
information on whether the QMS conforms the frequency, methods, responsibilities,
to: planning requirements and reporting,
which must take into consideration the
importance of the processes concerned,
changes affecting the organisation, and the
results of previous audits.
the organisation’s own requirements for its QMS define the audit criteria and scope for each audit
the requirements of the ISO9001:2015 standard select auditors and conduct audits to ensure
is effectively implemented and maintained objectivity and the impartiality of the audit process
ensure that the results of the audits are reported to
relevant management
take appropriate correction and corrective actions
without undue delay
retain documented information (i.e. records) as
evidence of the implementation of the audit
  programme and the audit results
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 9.3 • Top management must review their organisation’s
quality management system, at planned intervals,
Management to ensure its continuing suitability, adequacy,
effectiveness and alignment with the strategic
review direction of the organisation.

9.3.1 General

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9.3.2 Management review inputs

The management review must be planned The management review must be planned
and carried out taking into consideration: and carried out taking into consideration:
the status of actions from previous management reviews information on the performance and effectiveness of the
changes in external and internal issues that are relevant to QMS, including trends in:
the quality management system • non-conformities and corrective actions
information on the performance and effectiveness of the • monitoring and measurement results
QMS, including trends in: • audit results
customer satisfaction and feedback from relevant • the performance of external providers
interested parties the adequacy of resources
the extent to which quality objectives have been met the effectiveness of actions taken to address risks and
process performance and conformity of products and opportunities
services opportunities for improvement

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9.3.3 Management review outputs

The outputs of the management review must include Organisations need to retain documented information
decisions and actions related to: (i.e. records) as evidence of the results of management
reviews.
opportunities for improvement
any need for changes to the QMS
resource needs

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