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Rework Procedure - ISO 13485

Rework Procedure - ISO 13485

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ISO 13485: 2016 +A11 2021 

QMS.8.3.4 - QP – Rework 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 Rework Procedure?

  • Rework refers to the process of making changes to or reprocessing a product, either because it doesn’t meet specifications or because it is malfunctioning.
  • The purpose of a Rework Procedure is to establish and maintain processes for rework for your organisation, including retesting and revaluation of the non-conforming product after rework is complete.
  • Your organisation must also ensure that the product meets its current approved customer specifications and regulatory standards after rework.
  • The scope of the procedure should cover all products that are reworked after a non-conformity has been identified with them.

Why do I need a Rework Procedure?

  • You will need a reliable, consistent procedure for reworking any non-conforming product as an organisation.
  • The ISO 13485 standard requires that your organisation author a process for rework and perform rework in line with that procedure.
  • This template will help your organisation create a procedure that meets the requirements of the standard.

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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