Why you need a QM system

The quality management system is important

If you have a lean, precise and standards-compliant QM system, you will

  • survive audits and inspections without stress,
  • fulfill the prerequisite for the approval of your medical device,
  • work more smoothly and avoid unnecessary discussions and endless meetings,
  • develop your products to schedule and bring them to market,
  • be less dependent on the "heroic work" of individuals and
  • increase the value of your company.

You need to be aware of these regulatory requirements

The laws, directives and regulations oblige you to have a QM system. For example, Article 10 of both the MDR and the IVDR stipulates the requirement to establish and maintain a full QM system that covers "all parts and elements of the organization of a manufacturer involved in the quality of processes, procedures and products" . Annex IX of both regulations specifies further details.

Manufacturers usually use the harmonized standard EN ISO 13485:2019 to provide evidence for these requirements. Notified bodies check that these requirements are met in annual audits.

The FDA also insists on a QM system for most products. "Quality System Regulations" are described in 21 CFR part 820. The FDA reviews compliance with these requirements during regular inspections. However, it does not issue any certificates.


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