Purchasing Procedure - ISO 13485

ISO 13485: 2016 +A11 2021

QMS.7.4.2 - QP - Purchasing 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 Purchasing Procedure?

• The purpose of a Purchasing Procedure is to document the steps your company takes in support of purchasing items.
• This template will help you cover all activities in support of the procurement and assembly of finished product, including but not limited to:
• the purchasing of components and raw materials,
• the purchasing of all medical device products,
• the purchasing of labelling and marketing materials,
• the purchasing of all services affecting products or Quality Management System including, but not limited to:
  • product development,
  • product testing,
  • equipment calibration,
  • manufacturing,
  • warehousing,
  • distribution. 

Why does my organisation need a Purchasing Procedure?

• ISO 13485 requires that your organisation put in place procedures that will ensure products and services you purchase affecting or relating to your medical device conform to the purchasing information specified by the supplier.
• The purchasing information provided to your organisation by the supplier must describe or reference aspects of the product or service you will purchase.
• This template will help your organisation define these aspects and requirements in line with ISO 13485 in a way that benefits your company and demonstrates compliance with the standard.

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 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.