ISO 13485 is compatible with ISO 9001 (quality management), ISO 14001 (environmental management) and ISO 45001 (Occupational Health and Safety Management). The SQS certificate ISO 13485 offers international validity and is recognised worldwide through the IQNet partnership. The SQS certificates according to the Directives 93/42/EEC are internationally valid. SQS is registered as a Notified Body under number 1250. Validityģ years - there is an annual audit to ensure that standards are being maintained and a recertification audit after 3 years. ISO 13485 is compatible with ISO 9001 (quality management), ISO 14001 (environmental management) and OHSAS 18001 (occupational health and safety). 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. The general concern is to manufacture safe and high-quality medical devices. 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. A positive assessment leads to the authorisation to use the CE mark and to place medical devices on the market. The NSAI Medical Device department has just completed its latest Roadshow on ISO. 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). ISO 13485 quality management systems for medical devices. The conformity of medical devices must be assessed under EU Directives 93/42/EEC before they are placed on the market. Certification of quality management systems of medical device manufacturer Incentive
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