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Supplier Evaluation and Monitoring Procedure - ISO 13485

Supplier Evaluation and Monitoring Procedure - ISO 13485

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ISO 13485: 2016 +A11 2021

QMS.7.4.1 - QP - Supplier Evaluation and Monitoring Procedure

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.

Why do I need to evaluate my suppliers?

  • The ISO 13485 standard requires that organisation’s seeking certification shall establish criteria for the evaluation and selection of suppliers.
  • Evaluating suppliers will lead to selection of higher quality suppliers and elimination of unnecessary costs.
  • It can help you set and communicate clear expectations with your suppliers which in turn can create trust.
  • This template will help your organisation evaluate and keep records of supplier evaluation to show compliance with the standard.

How should I evaluate suppliers?

  • Evaluation of suppliers should be:
    • based on the supplier’s ability to provide product that meets your organisation’s requirements,
    • based on the performance of the supplier,
    • based on the effect of the purchased product on the quality of the medical device.
  • Your organisation should plan to monitor and re-evaluate suppliers on a regular basis.
  • This should include supplier performance in meeting requirements for the product/service you are purchasing.

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

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