In the fields of medical products and in vitro diagnostics quality management systems are part and parcel. In Europe and in some other countries these products have been partially subject to conditions of the pharmaceutical law. Therefore the manufacturers had to comply to the requirements of the GMP (Good Manufacturing Practice). In other countries like the United States or Great Britain quality management systems as a market access are preconditions for a long time. In the meantime it is beyond dispute that a adequate quality management system, which is established in all relevant sectors, is an important element to improve the security and functionality of products and services.
Throughout the world ISO 9001 is the most common basis for quality management systems. This norm describes exemplary the entire quality management system. The principles of QM are customer orientation, responsibility of the management, involvement of the participating persons, process orientated approach, system orientated approach, continuous improvement, issue-related decision making approach, relationship to suppliers in view of a two-way advantage.
The EN ISO 13485:2003 "Medical products, quality management systems, requirements for regulatory purposes” has been released in November 2003 and harmonized 2004. Constitution and structure are based on the ISO 9001:2000. The norm EN ISO 13485:2000 and EN ISO 13485:2000 have been withdrawn by the 31st of July 2006 and replaced by the discrete norm EN ISO 13485:2003. As regards content it is widely conforming with ISO 9001:2000 but it is supplemented by the specifications for medical products. That’s why ISO 13485:2003 is much more extensive than ISO 9001:2000. The intention of ISO 13485:2003 is to achieve legal requirements, whereas the intention of ISO 9001:2000 is to improve efficiency.
The requests of ISO 13485:2003 are widely identical to ISO 13488:2000. The basis is the law of medical products and the guideline 93/42/EWG.
(source: mdc medical device certification GmbH)