Medical devices - Quality management systems - Guidance on the application of MS ISO 13485:2003
This Malaysian Standard provides guidance for the application of the requirements for the quality management systems contained in ISO 13485. It does not add to, or otherwise change, the requirements of ISO 13485. This standard does not include requirements to be used as the basis of regulatory inspection or certification assessment activities.
Published
• (none) / (none) / (none)
PDF
01/04/2019
111
NSC 18 - Medical Devices and Facilities for Healthcare
