Guidance

Check the results

The ISO Navigator™ database hyperlinks the ISO 9000 principles and the ISO 9001 requirements; and explains them in plain English with practical guidance.

ISO 9001: Control of non-conformances 8.3

No matter how you resolve a non-conformance, you must keep records of each non-conformance and how it was dealt with. By keeping records of your non-conformities and doing data analysis, it is easier to spot negative trends and examine the root cause, and eliminate the cause of your problems. This, in turn, should result in fewer defective products and more satisfied customers. Few other processes require as rigid adherence to procedures as controlling non-conforming products. There can be no room for deviation.

Corrective Action

If you have manufactured a product, inspected it and found it to be out of specification, it is most likely to be deemed non-conforming product. In some instances you will have to scrap the defective product but in other situations you may be able to do some remedial work and bring it back into specification.

The re-verification after remedial work might involve testing as well as inspection. The reason is not just to verify that the defect has been removed, but also to assure that fresh defects have not been introduced by the rework. Records would be as appropriate for the re-inspection or re-testing performed.

What the clause is telling us; is that the product should then be subject to further inspection to verify that it is now correct. As for records, if you documented the non-conformance there should normally be somewhere to verify that you successfully (or not) cured the problem and that it is now conforming.

Re-verification

Re-verification is equivalent to re-inspection and records could include a signature of approval or a more formal test report. Whichever format is chosen, it must defined in your control of non-conformances procedure.

Re-verification simply means that you cannot assume that because someone tells you they have corrected the problem then it is ok. The clause is asking you to re-verify by whatever means you originally chose. If you used inspection as a method of verification then re-inspect in the same method. If not, use whatever method suits you (or your customer). Just make sure it is ok before it leaves!

NCR documentation

You may need to supply new evidence of conformance to your customer along with any corrective/preventive action documentation if requested. The method that you use in either of these situations should be defined in your QMS and procedures, that way you relieve yourself and your auditor from guessing how you would address them.

Controlling non-conformances applies to services just as much as it does to tangible goods. Reports, data, test results and intellectual property, to name just a few service outputs, can all be potentially non-conforming, in which case all the disciplines of this process apply.

Non-conformance procedure

The controls and related responsibilities and authorities for dealing with non-conforming product should be defined in your control of non-conforming product procedure:

  1. Develop a procedure to control non-conforming products
  2. Define how non-conforming products are identified
  3. Define how non-conforming products are dealt with
  4. Remove or correcting non-conformities
  5. Prevent the delivery or use of non-conforming products
  6. Verify how non-conforming products were corrected
  7. Provide evidence that corrected product(s) now conform
  8. Keep records that catalogue non-conforming products

Looking for ISO 9001 mandatory procedure templates? Our quality manual template provides a great foundation for establishing, implementing and documenting the six mandatory procedures that are required by the standard.