9.1 Monitoring, measurement, analysis and evaluation
The organization shall determine:
a) what needs to be monitored and measured;
b) the methods for monitoring, measurement, analysis and evaluation needed to ensure valid results;
c) when the monitoring and measuring shall be performed;
d) when the results from monitoring and measurement shall be analysed and evaluated.
The organization shall evaluate the performance and the effectiveness of the quality management system.
The organization shall retain appropriate documented information as evidence of the results.
9.1.2 Customer satisfaction
The organization shall monitor customers’ perceptions of the degree to which their needs and expectations have been fulfilled. The organization shall determine the methods for obtaining, monitoring and reviewing this information.
NOTE Examples of monitoring customer perceptions can include customer surveys, customer feedback on delivered products and services, meetings with customers, market-share analysis, compliments, warranty claims and dealer reports.
9.1.3 Analysis and evaluation
The organization shall analyse and evaluate appropriate data and information arising from monitoring and measurement.
The results of analysis shall be used to evaluate:
a) conformity of products and services;
b) the degree of customer satisfaction;
c) the performance and effectiveness of the quality management system;
d) if planning has been implemented effectively;
e) the effectiveness of actions taken to address risks and opportunities;
f ) the performance of external providers;
g) the need for improvements to the quality management system.
NOTE Methods to analyse data can include statistical techniques.
9.2 Internal audit
9.2.1 The organization shall conduct internal audits at planned intervals to provide information on whether the quality management system:
a) conforms to:
1) the organization’s own requirements for its quality management system;
2) the requirements of this International Standard;
b) is effectively implemented and maintained.
9.2.2 The organization shall:
a) plan, establish, implement and maintain an audit programme(s) including the frequency, methods, responsibilities, planning requirements and reporting, which shall take into consideration the importance of the processes concerned, changes affecting the organization, and the results of previous audits;
b) define the audit criteria and scope for each audit;
c) select auditors and conduct audits to ensure objectivity and the impartiality of the audit process;
d) ensure that the results of the audits are reported to relevant management;
e) take appropriate correction and corrective actions without undue delay;
f ) retain documented information as evidence of the implementation of the audit programme and the audit results.
NOTE See ISO 19011 for guidance.
9.3 Management review
Top management shall review the organization’s quality management system, at planned intervals, to ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the organization.
9.3.2 Management review inputs
The management review shall be planned and carried out taking into consideration:
a) the status of actions from previous management reviews;
b) changes in external and internal issues that are relevant to the quality management system;
c) information on the performance and effectiveness of the quality management system, including trends in:
1) customer satisfaction and feedback from relevant interested parties;
2) the extent to which quality objectives have been met;
3) process performance and conformity of products and services;
4) nonconformities and corrective actions;
5) monitoring and measurement results;
6) audit results;
7) the performance of external providers;
d) the adequacy of resources;
e) the effectiveness of actions taken to address risks and opportunities (see 6.1);
f ) opportunities for improvement.
9.3.3 Management review outputs
The outputs of the management review shall include decisions and actions related to:
a) opportunities for improvement;
b) any need for changes to the quality management system;
c) resource needs.
The organization shall retain documented information as evidence of the results of management reviews.