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ISO 13485:2003

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ISO 13485:2003 is the quality management system for Medical Devices.


Compliance with ISO 13485:2003 is the first step in achieving compliance with European regulatory requirements for medical devices.  It helps to establish a Quality Management System necessary to pass an FDA audit in the United States.

In Europe, the conformity of medical devices according to EEC-decrees 93/42/EEC must be assessed before sale of a medical device is permitted.


The established assessment of a company’s Quality Management System according to ISO 13485:2003 by a Notified Body (such as Nemko) is necessary to obtain a certificate of conformity allowing CE marking and the permission to sell the medical device in the European Union.

How does the certification process work?


The certification process consists of two phases:



  • Phase 1 consists of a visit to the business in order to review the status of the organization, system documentation, infrastructure, etc. This assesses the maturity of the quality management system.

  • Phase 2 is the certification audit aiming to verify that the system documentation meets the requirements of ISO 13485:2003 standard. The certification audit will give feedback to the organization on issues that are not in conformance with the standard and that needs to be corrected before a certificate can be issued.
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