|Number of pages||94|
|Committee||Medische hulpmiddelen - horizontale onderwerpen|
This Technical Report provides guidance for the application of the requirements for quality management systems contained in ISO 13485. It does not add to, or otherwise change, the requirements of ISO 13485. This Technical Report does not include requirements to be used as the basis of regulatory inspection or certification assessment activities. This guidance can be used to better understand the requirements of ISO 13485 and to illustrate some of the variety of methods and approaches available for meeting the requirements of ISO 13485.
|Dutch title||Medische hulpmiddelen - Kwaliteitsmanagementsystemen - Leidraad voor de toepassing van ISO 13485:2003|
|English title||Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003|