EN ISO 13485 standard version 2016

The new international standard for medical devices – Quality management systems (requirements for medical devices for regulatory purposes), was revised and published by ISO on 1st March 2016.
This revision provides an effective framework for meeting the general requirements of a quality management system for medical devices and takes into account changes in the medical device industry.

Extension of the scope: The new version extends its scope of application to all organisations and companies involved in the product’s life cycle (from design to end of life) and not only concerns manufacturers but also storage, distribution, installation, after-sales and technical support companies.

Roles and responsibilities exercised: The organisation must document the roles and responsibilities exercised in the frame of the applicable regulatory requirements, e.g., manufacturer, authorised representative, importer, or distributor.

The roles and responsibilities of each organisation within the distribution chain are clarified here; the organisation must clearly define its role to ensure that the legal manufacturer is properly identified.

Alignment with regulatory requirements: The obligation to comply with the applicable regulatory requirements is systematically recalled, for example for the quality system, the quality objectives, the Management reviews, the design, the corrective actions, or the handling of customer complaints.

Approximation with the FDA’s regulatory requirements