Corrective Action and Preventative Action (CAPA) Procedure - ISO 13485

ISO 13485: 2016 +A11 2021

QMS.8.5.2 - QP - Corrective & Preventative Action 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 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 Corrective & Preventative Action Procedure help my organisation?

• This procedure will help your organisation define a process for your own corrective and preventive action activities.
• This includes outlining the steps taken to:
  • analyse,
  • investigate root cause,
  • identify actions required to correct and prevent deficiencies or potential deficiencies related to products, processes or the quality management system,
  • verify and validate that the CAPA was effective and did not adversely affect the finished device.

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.