Requirements for the Cleanliness of Product Procedure - ISO 13485

ISO 13485:2016 +A11 2021

QMS.7.5.2 - QP - Requirements for the Cleanliness of Product 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.

When do I need to establish requirements for the cleanliness of my medical device?

• The ISO 13485 standard requires that your organisation shall document requirements for the cleanliness of your product or contamination control of your product if:
  • the product requires cleaning by your organisation prior to sterilisation or use,
  • the product is supplied to users in a non-sterile condition but is required to undergo a cleaning process prior to sterilisation or use,
  • the product cannot be cleaned prior to sterilisation or use, but its cleanliness is of consequence when in use,
  • the product is supplied to customers to be used non-sterile, but its cleanliness is of consequence when in use,
  • process agents are to be removed from your product during manufacture.

How do I use this template?

• This template will help you produce a procedure that will establish your organisation’s requirements for the cleaning of products before use, depending on the type of device being provided to the end user.
• You can use information from your Design and Development Process (see QMS.7.3.0 – Design and Development Process) to establish the need for product cleanliness.
• You can establish requirements for and create work instructions or procedures to ensure the requirements for cleanliness are met.

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.

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