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Approved Supplier List - ISO 9001

Approved Supplier List - ISO 9001

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ISO 9001:2015 - QMS.8.4.1.1 - QR - Approved Supplier List

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. For updates on Regulatory and Quality Assurance news visit Patient Guards blogs.

Why do I need to keep an approved suppliers list?

  • The ISO 9001 standard requires that organisation’s shall establish criteria for the evaluation and selection of external providers.
  • Evaluating external providers will lead to selection of higher quality suppliers.
  • Maintaining a list of approved suppliers that is agreed upon by the company can be used to provide employees with a reference for which suppliers they can purchase/contract goods and services with, can prevent purchasing from un-evaluated sources and unnecessary expenditure or error.
  • This template will help your organisation keep track of supplier credentials and the agreements in place with your company 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 the effect of the purchased product on the quality of the product/ service
  • 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 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.

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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