EN ISO 13485:2016

Certification of quality management systems of medical device manufacturer

Incentive

The conformity of medical devices must be assessed under EU Directives 93/42/EEC before they are placed on the market. One part of the conformity assessment can be the certification of the QM system according to ISO 13485 by a Conformity Assessment Body (CAB) or Notified Body (NB). A positive assessment leads to the authorisation to use the CE mark and to place medical devices on the market. The manufacturer must provide evidence of the conformity of the product with the essential requirements set out in the directives and in the harmonised standards.

Outcome

The general concern is to manufacture safe and high-quality medical devices. Manufacturer of medical devices are obliged to set up and maintain a quality control system and, where applicable, to go through a conformity assessment process for medical devices.

Target groups

ISO 13485 is compatible with ISO 9001 (quality management), ISO 14001 (environmental management) and OHSAS 18001 (occupational health and safety).

Validity

3 years - there is an annual audit to ensure that standards are being maintained and a recertification audit after 3 years.

Recognition

SQS is registered as a Notified Body under number 1250. The SQS certificates according to the Directives 93/42/EEC are internationally valid. The SQS certificate ISO 13485 offers international validity and is recognised worldwide through the IQNet partnership.

Combinations

ISO 13485 is compatible with ISO 9001 (quality management), ISO 14001 (environmental management) and OHSAS 18001 (occupational health and safety).

Daniel Taddeo