Supplier Evaluation and Monitoring spreadsheet - ISO 13485

ISO 13485: 2016 +A11 2021

QMS.7.4.1.1 - LQR - Supplier Approval, On-boarding, Evaluation and Monitoring spreadsheet

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 keep an approved suppliers list?

• The ISO 13485 standard requires that organisation’s seeking certification shall establish criteria for the evaluation and selection of suppliers.
• Evaluating, on-boarding and continually monitoring suppliers will lead to selection of higher quality suppliers and elimination of unnecessary costs.
• 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.
• This template will help your organisation:
  • effectively evaluate, on-board and monitor suppliers
  • keep track of supplier status and performance
  • show compliance with the standard.

How should I evaluate and on-board 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.
• On-boarding suppliers should be determined as per the supplier category. This template will help you set supplier categories and determine on-boarding requirements for those categories.

If you would like further information on our wide range of templates or have any suggestions for improvements that requires 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.

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