QMS Process Standards and Guidelines

Process Standards and Guidelines for medical devices MDs and IVDs

We present some QMS process standards and guidelines that don’t appear in any official standard list.

BUT, AND these QMS process standards are very important to understand the topic.

Why reinvent the wheel? Clearly, they can make your life easier. Especially when you’re a process owner or quality system responsible person.

Besides the here motioned standards you should also consider harmonised process standards here.

Medical devices – Post-market surveillance for manufacturers (ISO/TR 20416:2020)

Undoubtedly, this QMS process standard is an excellent description of the post market surveillance process. In fact, it takes the MDR and IVDR into account. Such as the post market surveillance plan and report. It also talk yout statistical methods.

Gap List

ISO/IEC Guide 63:2019 Guide to the development and inclusion of aspects of safety in International Standards for medical devices

Fully interpreted and ready to use in ColabON

This guide gives you much help when you define your risk management policy, risk acceptability. It is a must read for risk managers.

What is safe and what is risky?

This guide defines safety, safe, effective, and effectiveness.

What are proceed standards and process standards?

Clause 5.3 defines different types of standards. Excellent.

Gap List

ISO/TR 24971:2020 – Technical Report – Medical Devices Risk Management

This QMS process standard is fully interpreted and ready to use in ColabON. And it is essential for medical devices.

Intended Purpose = Intended Use

This is a absolute must have for medical devices. Because the MDR doesn’t define intended purpose well. But here it is.

Medical Devices Intended Purpose = Intended Use

MDCG 2020-6

All regulatory requirements with the topic intended purpose and intended use are identified in ColabON.

The MDR defines ‘intended purpose’, but not ‘intended use’. And this guidance document finally suggests that ‘intended use’ should be considered to have the same meaning as ‘intended purpose’.

Hence, you can follow the Definition of clause 5.2 form ISO/TR 24971:2020 – Technical Report – Medical Devices Risk Management.

In addition, we want to emphasis that the MDR device description lists all contents of the intended use separately. Hence, make sure that you don’t duplicate information.

Luckily, IVDs are better off. Because, the IVDR is very clear about the definition of intended purpose.

Clause 4.3 Competence of personnel

Most organizations struggle to describe roles in their quality management system. Therefore we find this clause very helpful. Where this clause includes competence examples of personnel.


State your companies global quality roles in ColabON. Define, roles, responsibilities, authority and competence at one place.