Non-conformance Procedure - ISO 13485

ISO 13485:2016 +A11 2021 

QMS.8.3.2 - QP - Non-conformance procedure template

Our Medical Device Quality Assurance and Regulatory Affairs document templates have been created by fully qualified and experienced professionals at Patient Guard, a Quality Assurance and Regulatory Affairs Service provider. The templates have been specially written to ensure that they meet the basic requirements needed for each clause/section of the standard or regulation the templates relate to. We have carefully curated the templates to ensure they are easy to follow and adapt to make them specifically modified to your business needs. All the templates are fully editable Microsoft word documents allowing you to have complete control over the templates which can then be modified to suit your company branding/marketing requirements.

What is a Non-conformance?

• A non-conformance is a failure to meet one or more of the requirements in the standard.
• If your organisation finds or is issued with a non-conformance as part of a routine audit or otherwise, you are obligated to take immediate steps to rectify the issue.

What does the standard say about Non-conformances?

• The standard requires that your organisation identifies any medical device which does not conform to the requirements specified both within the standard and your organisation’s procedures.
• Non-conforming medical devices must be controlled to prevent unintentional use.
• Your organisation must document a procedure to define your process for detection, documentation, exclusion, appraisal and disposal of non-conforming product.

How will a Non-conformance Procedure help my organisation?

• The Non-conformance Procedure will help your organisation document a process for handling product that does not conform to the specified requirements.
• You will be able to ensure non-conforming products are prevented from unintended use, sale, or distribution.

If you would like further information on our wide range of templates or have any suggestions for improvements that require support in addition to our templates in the form of other Medical Device Quality Assurance or Regulatory Affairs services, contact us at qmsregs@patientguard.com.

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