Requirements for Product Installation Activities Procedure - ISO 13485

ISO 13485: 2016 +A11 2021 

QMS.7.5.3 - QP - Requirements for Product Installation Activities 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.

Why do I need to establish Requirements for Installation Activities of my medical device?

• The ISO 13485 standard requires that:
  • your organisation shall document requirements for medical device installation and acceptance criteria for verification of installation, as appropriate.
  • If the agreed customer requirements allow installation of the medical device to be performed by an external party other than the organisation or its supplier, the organisation shall provide documented requirements for medical device installation and verification of installation.
  • records of medical device installation and verification of installation performed by the organisation, or its supplier shall be maintained.
• If your medical device has no installation requirements, then this part of the standard is not applicable.

How do I use this template?

• This template will help you produce a procedure that will establish your organisation’s requirements for installation of your medical device products.
• These specifications and installation requirements will form part of the design and development process (see QMS.7.3.0 - QP - Design and Development Procedure).
• You will set requirements for the product to operate in normal conditions of use, such as:
  • The space required for the product to operate safely, considering Health and Safety legislation for where and how it is to be installed.
  • The type of environment the product requires for operation.
  • The availability of sources of energy or utilities required to operate the product, with the appropriate voltages, pressures etc. taken into consideration.
  • Any IT infrastructure required to operate the product such as network integration, Wi-Fi connection, etc.

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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