8.0 Operation

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8.5 Product and Service Provision

8.5.6 Control of Changes

This is a new requirement for the organization to implement a process for responding to unplanned changes that are considered essential in order to ensure that products or services continue to meet their specified requirements, in such a way that conformity with requirements is maintained. Changes should be documented and information retained about the changes, including who authorized the change and the actions arising from the change.

In the olden days of ISO 9001:2008 this would have been addressed by Clause 7.3.7 Design and Development Outputs. ISO 9000:2015 Term 3.3.10 defines change control as ‘activities for the control of the output after formal approval of its product configuration information’. The clause requires an organization to make changes in a thoughtful manner and to consider the potential impact to other process, products and possibly the customer. Key items to consider are:

  1. Is the impact of the change evaluated to determine its affects to work in process or products already delivered?
  2. What process control documentation (procedures, travellers, forms, etc.) will need updating as the result of change to be implemented?
  3. Was the change approved prior to implementation including, where applicable, approval by the customer, statutory or regulatory authority?
  4. Does retained documented information indicate the source of change and information on necessary actions and approvals?

You should seek objective evidence that your organization has implemented a process to control unplanned changes in accordance with the requirements set out above.

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