Goods In, Goods Out & Preservation of Product Procedure - ISO 13485

ISO 13485: 2016 +A11 2021 

QMS.7.4.3 - QP - Goods In, Goods Out & Preservation of Product Procedure

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 does my organisation need to inspect goods in?

• ISO standard 13485 requires that organisations set up and carry out the examination or other actions necessary for ensuring that product(s) you purchase from your suppliers meet the requirements you specified in your purchasing agreement, and that records of this must be maintained.
• The extent of this verification process should be based on your assessment of the supplier (see QMS.7.4.1 - QP - Supplier Evaluation and Monitoring and QMS.7.4.1.1 - QR - Supplier Evaluation Form Template)
• It should also be proportionate to the risks associated with the purchased product (see QMS.7.1.0 - QP - Risk Management).
• Independent of the standard, inspecting goods purchased from suppliers is recommended practice to eliminate divergent product from being used in your medical device and resulting in potentially costly amendments being made later or even consumer complaints and brand damage.

How should I inspect goods in?

• The template will help you to describe the process for checking incoming material(s) and product(s) received at your organisation.
• This will cover every step from receiving raw materials or products from suppliers through to processing non-conforming materials.
• You will also find an example process flow diagram within the document to use or customise to better suit your organisation’s procedures.

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.