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Corrective & Preventative Action Log - ISO 9001

Corrective & Preventative Action Log - ISO 9001

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ISO 9001:2015 - QMS.10.2.5 - QR - Corrective & Preventative Action log

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 log? 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 log the corrective and preventative actions, this allows an organisation to track and monitor corrective actions over time and allows the organisation to see when CAPAs are due and what the progress of implementation is.
  • This allows an easier way to summaries open corrective actions and feed this information back into other required areas such as Management Review Meetings.

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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