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Process Validation Procedure Template - ISO 13485

Process Validation Procedure Template - ISO 13485

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ISO 13485: 2016 +A11 2021 

QMS.7.5.6 - QP - Process Validation 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 Process Validation?

  • Process Validation is the analysis of data gathered during designing and manufacturing your medical device, to confirm that the process you have put in place is reliable and meets the requirements of the ISO 13485 standard.
  • This is an ongoing process that you should be regularly adapting, considering feedback from manufacturing and consumer sources.
  • 7.5.6 - QP - Process Validation is a template that will help your organisation to define your own methodology for process validation.

How will Process Validation help my organisation?

  • Good Process Validation will ensure the steps involved in the manufacture of your medical devices are consistent and high quality.
  • The quality of your finished medical device cannot always be adequately determined by finished-product inspection, therefor adopting an end-to-end validation of manufacture procedures is crucial in establishing product quality and the efficacy of your processes.

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

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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