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Corrective and Preventative Action (CAPA) Report Form - ISO 13485

Corrective and Preventative Action (CAPA) Report Form - ISO 13485

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ISO 13485: 2016 +A11 2021 

QMS.8.5.2.2 - QR - Corrective and Preventative (CAPA) Report 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 Corrective Action?

  • A Corrective Action is an action taken to reduce or eliminate the cause of a reported non-conformity or source of inefficiency and error within your Quality Management System and it’s associated processes.
  • Corrective Actions will also aim to prevent the recurrence of the undesirable event by establishing or updating procedures.

What is a Preventative Action?

  • A Preventative Action is an action taken to reduce or eliminate the chance of a non-conformity or source of inefficiency and error within your Quality Management System and it’s associated processes before it occurs or causes any harm.
  • Preventative Actions are normally taken as a result of risk analysis, GAP assessment or similar process that highlights a potential inadequacy within your Quality Management System.

How will the CAPA Report Form template help my organisation?

  • ISO 13485 requires that your organisation identify and implement any changes necessary to ensure and maintain effectiveness of and principles set out within the quality management system.
  • The CAPA Report Form template will allow your organisation to preform and record effective CAPAs in line with your Corrective & Preventative Action Procedure (see the QMS.8.5.2 template), as well as demonstrate compliance with the ISO 13485.

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.

Quality Management Support:

If you are looking for support with your QMS then Patient Guards consultancy services could be a cost effective solution for your organisation.

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