Berlin/Germany. The German Medical Technology Association, BVMed, calls for a full integration of all quality management requirements including ISO 9001:2000 ("Quality management systems – Requirements") under the new international standard ISO 13485. BVMed succeeded in convincing the German standardisation body DIN to reject the current draft international standard (ISO DIS) 13485:2002 ("Quality systems – Medical devices) and instead to vote for the demanded integration. The new standard ISO 13485 will be substituting the European harmonised standard EN 46001 ("Quality systems - Medical devices - Particular requirements for the application of ISO 9001") in early 2004.

This means ISO 13485 shall additionally embody two of the ISO 9001 requirements, which are not yet part of the regulatory requirements for the medical device sector, here "costumers satisfaction" and "continual improvement". Today these two aspects are considered anyway by most of the medical device companies on a voluntary basis.

A full integration of  ISO 9001 under the new standard will help trade and industry to save time and money. The medical device sector as a whole will benefit from this development. Manufacturers supplying medical devices and other, non-medical devices may be forced to have both certificates. As a consequence medical device manufacturers and retailers will only need one audit and only one certification to comply with the European regulatory and the additional voluntary ISO 9001 requirements. The quantity of re-audits will be reduced by factor two and global market access in the medical device sector will be facilitated, said BVMed.

Experience shows that ISO 9001 certificates are still being asked for world wide. This applies in particular to public tenders. Another reason is the necessity to ensure the compatibility of quality assurance systems between manufacturers and their non medical suppliers on one hand and between manufacturers and their costumers on the other hand.

If the DIN proposal should be approved by the ISO/TC 210 (ISO TC 210: "Quality management and corresponding general aspects for medical devices") in September 2002 in Berlin, ISO 13485 certificates will demonstrate a much higher level of quality than ISO 9001 certificates do. A new standard ISO 13485 will prove that quality assurance systems in the medical device sector comply with much higher quality standards than other industrial goods. Notified bodies for medical devices will gain importance, as they will be the only test houses allowed to certify the new comprehensive quality system. Another consequence is that industry will be allowed to quote ISO 9001:2000 in their CE-conformity declarations, if the conformity assessment procedure is based on the new standard.

Some other European countries are supporting this demand. They understand that ISO 13485 and ISO 9001 are overlapping to a very high degree and that keeping them apart would conflict with the economical interests of the medical device trade and industry.

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