EN ISO 13485:2016 Certification of the quality management systems of medical device manufacturers, their suppliers and other players in the medical device environment

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Incentive

An efficient and standard-compliant quality management system is of crucial importance in the medical technology sector. Certification according to EN ISO 13485:2016 confirms compliance with the highest standards and significantly contributes to strengthening the trust of your stakeholders.

Outcome

The aim is to produce safe and high-quality medical devices. Medical device manufacturers and their suppliers must set up and maintain a quality assurance system and, if necessary, have it certified by an independent body.

Target groups

Industrial- and service companies in the medical device sector.

Validity

3 years - in the sense of continuous further development, a surveillance audit takes place annually and a recertification audit after 3 years.

Recognition

The SQS certificate ISO 13485 is internationally valid and recognised worldwide through IQNET membership.

Combinations

ISO 13485 is compatible with, among others, ISO 9001 (quality management), ISO 14001 (environmental management) and ISO 45001 (occupational health and safety).