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Supplier Evaluation and Monitoring - ISO 9001

Supplier Evaluation and Monitoring - ISO 9001

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ISO 9001:2015 - QMS.8.4.1 - QP - Supplier Evaluation and Monitoring

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 9001 standard requires that organisations shall establish criteria for the evaluation and selection of external providers.
  • Evaluating external providers will lead to selection of more reliable and higher quality suppliers.
  • 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 external providers should be:
    • based on the supplier’s ability to provide product/ service that meets your organisation’s requirements,
    • based on the performance of the supplier,
    • based on performance measured against KPI’s set by your organisation
  • Your organisation should plan to monitor and re-evaluate suppliers on a regular basis, this can be done in line with your management review meetings
  • If any of your suppliers require a supplier audit this should be defined in your audit schedule.

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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