A good QMS will not function or improve without adequate audits and reviews.
Audits are carried out to ensure that actual methods are adhering to the documented procedures, whilst
system reviews should be carried out periodically and systematically, to ensure the system achieves the
There should be a schedule for carrying out audits, with different activities possibly requiring different
frequencies. An audit should not be conducted just with the aim of revealing defects or irregularities – they
are for establishing the facts rather than finding faults. Audits do indicate necessary improvement andcorrective actions, but must also determine if processes are effective and that responsibilities have beencorrectly assigned. The emphasis on process improvement and enhancing customer satisfaction in therevised standard will require a more thoughtful approach to auditing.
The generic steps involved in an audit are:
Review of documentation
Examination and evaluation
Close the meeting with the auditee
A quality management system review should take place, possibly once a year, which should cover:
- Results of audits
- Customer feedback
- Process and product conformity
- Status of preventative and corrective actions
- Follow up actions from previous management reviews
- Changes that could effect the QMS
- Recommendations for improvements
Outputs should include:
- Improvements to the QMS and processes
- Improvements of a product related to customer requirements
- Resource needs
In addition, the procedures for conducting audits and reviews and the results from them should be documented, and also be subject to review. Internal system audits and reviews should be positive and conducted as part of the preventative strategy, and not as a matter of expediency resulting from problems.