Over deze norm
|Commissie||Medische hulpmiddelen - horizontale onderwerpen|
Provides guidance for the application of the requirements for medical device quality systems contained in ISO 13485 and ISO 13488. It does not add to, or otherwise change the requirements of ISO 13485 and ISO 13488. This guidance can be used to better understand alternative methods and approaches among many (not specifically included here) for applying the requirements of ISO 13485 and ISO 13488. The guidance provided by this Standard has value for: - suppliers seeking to implement and maintain quality systems that comply with ISO 13485 and ISO 13488, - organizations having the responsibility to assess the successful implementation and maintenance of such quality systems, and - regulatory bodies seeking to enforce regulatory requirements based on the requirements of ISO 13485 and ISO 13488. These organizations and regulatory bodies must understand the benefits of the guidance in this Standard and the special consultation associated with the use of these guidances.
|Nederlandse titel||Kwaliteitssystemen - Medische hulpmiddelen - Leidraad voor de toepassing van ISO 13485 en ISO 13488|
|Engelse titel||Quality systems - Medical devices - Guidance on the application of ISO 13485 and ISO 13488|