[This series of articles tries to emphasize the benefits of ISO 9001, and how to yield results from each major clause of the standard.]


Clause 8.5.6 is called “Control of Changes.” Here, ISO is beginning to introduce the more complex discipline of “change management” to teh ISO 9001 standard, but only with a light touch.

The purpose of the clause is to ensure that operational changes — like those affecting manufacturing, for example — are done in a controlled manner. (A prior clause, 6.3 “Planning of Changes”, addressed the same topic but at a higher, organizational level.)

The thinking here is that if you are going to change manufacturing or service delivery methods, you have to make sure the changes still ensure you can meet your customer requirements. Some examples:

  • For companies that use routers or travelers, if you change them in the middle of a production run, would the change result in nonconformances of some sort?
  • If you opt to outsource a process that you had originally intended to do in-house, do you have the proper controls in place over the outsourced service provider to ensure quality?
  • If you change a raw material mid-stream, what problems might that raise?

In all cases, such changes should be done in a thoughtful manner, to ensure the changes don’t create more problems than they solve.

The only “hard” requirement in this clause is that you must retain records of the review of the change, who authorized it, and any other actions required (typically describing what was eventually done.)


When implemented properly, Clause 8.5.6 should result in the following tangible benefits for your company:

  1. You will prevent chaos. Unchecked changes can cause tremendous problems, and result in inconsistent quality and chaotic overall performance.
  2. Changes will be officially vetted and authorized before they are implemented. This can still be a 5-minute exercise, but ensuring changes are properly reviewed and approved — again — prevents chaos.
  3. With proper change control you are unlikely to introduce nonconformities,m even as you improve activities and processes for greater efficiency.
  4. With the records kept, you will be able to go back later and review what changes were made in the future. This can be helpful when trying to imitate a positive change, or tracking down a change that may have resulted in problems later on.

Click here for the full series of articles on The Benefits of ISO 9001:2015.



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