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Corrective Action & Preventative Action form - ISO 9001

Corrective Action & Preventative Action form - ISO 9001

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ISO 9001:2015 - QMS.10.2.4 - QR - Corrective & Preventative Action Form

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 CAPA Form? Why do I need it in my Quality Management System (QMS)?

  • When a QMS Non-conformance has been identified and corrective or preventative action has been identified as a way of correcting the non-conformance a CAPA is raised. 
  • This template is used to detail the corrective action needed and record the full details of what the corrective action is and how it is being implemented within the organisation.
  • This shows evidence that the corrective action has been implemented properly and there is a paper (electronic) trail on how and why the organisation implemented the corrective action, and the results of the corrective action being implemented. 

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

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