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The quality management system (QMS) according to ISO 13485


A quality management system QMS is a structured system that documents processes and responsibilities for planning and executing quality objectives and policies. The implementation and maintenance of a QMS is required when placing medical devices and in vitro diagnostic medical devices (IVDs) in the EU market according to the MDR (EU Medical Device Regulation 2017/745) and IVDR (EU IVD Regulation 2017/746) respectively.

ISO 13485 is a stand-alone quality management system (QMS) standard that is internationally recognized and accepted part of the quality management standard series. ISO 13485 Is built on the concepts from ISO 9001, but it offers a more defined and focused framework for medical device manufacturing.

The purpose of ISO 13485 is to ensure the consistent design, development, production, installation and delivery through to disposal of safe medical devices for their intended purpose. It was written to support medical device manufacturers in designing a QMS that establishes and maintains the effectiveness of their processes.


ISO 13485:2016 remains the expected standard for the QMS of medical devices being placed on the UK market.

Following the UK’s exit from the EU, ISO 13485:2016, among many other standards, was designated to the UK MDR 2002 – set out in regulation 3A

Whilst the use of the standard is not mandatory, if a manufacturer complies with the standard they will conform with the relevant parts of the current UK regulation, which remains based on the three EU Directives.

Why is QMS & ISO 13485 important?

ISO 13485 is important to medical device manufacturers and the CRO as they are critical service providers. It is not only about the manufacturer and how they document their processes. A strong QMS improves quality and supports consistency in medical devices – this ensures that products are effective and as safe as possible, and is therefore critical to patient safety.

The benefit of implementing ISO 13485 is not only the robust structure, increase consistency and quality, the standard also provides tool to audit the QMS to prove its effectiveness, this can provide a manufacturer with confidence in being able to maintain compliance with the standard. 


ECLEVAR Mas one of the leading EU Clinical research organisations and UK medical device CRO, can support medical device manufacturers to achieve CE and UKCA marking.

ECLEVAR MEDTECH selects and recruits professionals to conduct ISO 13485 mock audits gap assessment. Candidates must have design, manufacturing, or process knowledge in addition to general knowledge on use of medical devices. Our assessment staff come to ECLEVAR MEDTECH with exceptional real-industry experience. They then undergo rigorous internal training and ECLEVAR MEDTECH qualification processes, including best practice quality systems auditing techniques.

ECLEVAR MEDTECH quality consultants are experts in current state-of-the-art and are constantly trained on new requirements and future changes. ECLEVAR MEDTECH is always looking ahead to ensure that our clients are prepared and well-placed for future changes to compliance and the regulatory landscape.

ECLEVAR MEDTECH supports medical device manufacturers in developing and implementing a QMS under ISO 13485:2016 and is compliant with EU regulations.

Our services include :

  • Development of QMS documentation according to ISO 13485:2016
  • Full implementation of QMS according to ISO 13485:2016
  • Internal audits according to ISO 13485:2016
  • Gap assessments with prior ISO 13485 versions and EU requirements
  • Assistance in resolving gaps identified.