Organisations are required by ISO 9001:2015 to review and control changes for production or service provision (how you make your products or carry out your services), to the degree necessary to ensure continuing conformity with requirements.

Documented information (records) describing the results of the review of changes, the person or persons authorising the change, and any necessary actions arising from the review are also required.

Comment:

This clause applies to all the topics covered in the previous 8.5 prefixed (production and service provision) articles. Whilst the requirements are relatively straight forwards, they are arguably some of the most important in the standard as poorly controlled changes can have significant adverse impact on an organisations quality of product or service and ultimately, performance of the business.

It is therefore vital to ensure that a suitable process in is in place to manage changes. IE: To review and if valid, approve and communicate appropriately to ensure changes are implemented effectively. Implemented changes should also be validated to ensure quality is not adversely effected and appropriate actions taken if changes do not result in the expected outcomes. This may include appropriate corrective and preventive actions.

A process which includes the assessment of risk associated with the proposed changes and utilises the Plan, Do, Check, Act methodology (see article 6.1 Actions to address risks and opportunities) can be beneficial in ensuring changes are carried out in a controlled manner.

See also Design and Development changes (treated separately and discussed under article 8.3.6) and 6.3 Planning of Changes (to the Quality Management System.)

Audit Check:

As documented information describing results of review of changes, personnel authorising changes, and any necessary actions arising from reviews are required to be maintained, auditors will expect to see appropriate records covering all of these areas to an appropriate level depending on the specific organisation and level of change carried out.