AS ISO 13485-2003 PDF

Specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The primary objective is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001. It is identical with and reproduced from ISO 13485:2003.

Edition :	2nd
File Size :	1 file , 1.1 MB
ISBN(s) :	0733757154
Note :	This product is unavailable in Ukraine, Russia, Belarus
Number of Pages :	57
Product Code(s) :	10139590, 10139554, 10139568
Published :	01/01/2003