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Home | ISO 13485:2016 – New requirements for the medical devices section
July 20, 2016

ISO 13485:2016 – New requirements for the medical devices sector Updating of standards for quality management systems

The production of medical devices is highly regulated, which is reflected particularly in EU regulations and standards.

If one of these standards is updated in response to rapid progress, it is crucial to react fast and to implement the required changes within the specified period. This has happened again:

The ISO 13485:2016 standard, published on March 2016, constitutes the first major update of one of the fundamental standards governing the production and trial of medical devices in 13 years. The 2003 version, which was valid until the recent update, regulates the requirements for comprehensive quality management systems used in companies developing, producing and marketing medical devices. The revised version has a considerably wider scope: regulations for quality management systems now affect all organizations that play a role in the life cycle of a medical device, including suppliers and service providers. Accordingly, the standard now applies all the way from the brainstorming stage to the disposal of a device.

Quality of Service

A shift in focus, divergences and approximations – some fundamental reforms:

  • Risk management plays a significantly more important role in the new version. The suitability test for computer systems has also arrived in the digital age and is now regulated more comprehensively: software with certain influence on the product must be validated before its first use.
  • Validation requirements for newly developed products have been rephrased such that the selection of a product which should be validated must be justified in detail. Similarly, the verification of newly developed products has been formulated in further detail.
  • The requirement of documenting the process, which ensures the capability, the necessary training and the quality awareness of the staff, has also been added to the standard. Therefore, medical device companies are faced with the demand of a verification process to make the success of trainings measureable.
  • The subchapter “quality manual” has been supplemented with the section “medical device file”, which marks the first time a demand on conformity with international standards and consonance with applicable regulatory requirements was added to the ISO standard.
  • The chapters “complaint handling” and “reporting to regulatory authorities” have been expanded and reveal, that the traceability of products is an increasing requirement for medical device companies. It is clearly recognizable that this is an approach towards requirements, which are a fixed component in the pharmaceutical-related quality management since many years.

Efficient planning is key for a successful Transition.

The update of ISO 13485, along with topics such as software validation, risk management and complaints handling, adapts first and foremost to a highly innovative sector. In order to keep up with technological developments, many small changes have been introduced alongside the major new topics, and the efforts involved in their implementation should not be underestimated. Organizations that are already certified have until 31 March 2019: a three-year period in which the transition to the new standard must be completed. Not least due to the high workload of the notified bodies, companies should start developing a concrete schedule for their reorganization as soon as possible.

Do you have any questions or do you need our expertise for adjusting your quality management system to the new standard?

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Stewart Spears

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