Control of Measuring and Monitoring Equipment Procedure - ISO 13485

ISO 13485:2016 +A11 2021

QMS.7.6.0 - QP - Control Measurement and Monitoring Equipment 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.

How will this template help my organisation?

• This template will help your organisation document a procedure that ensures appropriately calibrated equipment is always used for all components, manufacturing processes, subassemblies, and final assemblies that affect product quality measuring equipment.
• The template procedure will cover all equipment used in the product realisation of the organisation’s products held either by the organisation or its subcontractor manufacturers/suppliers.
  • The subcontractor/ supplier may provide a copy of their control of measurement and monitoring equipment which can be agreed to by both parties and fed into a quality agreement if applicable.
• Your organisation will be able to put procedures in place to ensure that equipment
  • be calibrated or verified, or both, at specified intervals and prior to use, against measurement standards,
  • be adjusted or re-adjusted as necessary,
  • be protected from damage and deterioration during handling, maintenance and storage.

What are the requirements of the standard?

• The standard requires that your organisation documents procedures that:
  • determine the monitoring and measurement to be undertaken,
  • determine the monitoring and measuring equipment needed to provide evidence of conformity of your medical device,
  • ensure that monitoring and measurement can be carried out and is in line with requirements,
  • ensure validation of the application of computer software used for the monitoring and measurement of requirements.

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.