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Product Identification & Traceability - ISO 13485

Product Identification & Traceability - ISO 13485

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ISO 13485:2016 +A 11 2021 

QMS.7.5.8 - QP - Product Identification & Traceability 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 are the requirements of ISO 13485 relating to Product Identification & Traceability?

  • The standard requires that your organisation documents procedures for product identification and that you identify your medical device by suitable means throughout the product realisation process.
  • Your organisation should also maintain the identification of your medical device’s status throughout production, storage, installation and servicing to ensure only product that has passed the required inspections and tests is dispatched, used or installed.
  • Your organisation may also need to assign unique device identification numbers (UDI’s) to the medical device if selling into the EU.
  • Your organisation must document procedures to ensure that any of your medical devices returned to you are identified and distinguished from conforming product.
  • Your organisation must also document procedures for traceability, defining the extent of traceability in accordance with applicable regulatory requirements.

How will the template help me meet the requirements of the standard?

  • The template will help your organisation create a procedure for establishing and maintaining product identification and traceability controls throughout product realization (i.e., receiving inspection, handling, production, storage, product returns etc).
  • The template covers:
    • Product status,
    • Ensuring the finished product is traceable to customer and to the Device History Records,
    • Contract Manufacturers requirements where applicable.

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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