The Standard ISO 13485:2004 is relative to the medical devices sector, and specifies the requirements for a quality management system for use by the companies responsible for the design and manufacture of devices as well as by the companies that design and deliver services related to them.
UNI EN ISO 13485:2004 is structured according to the scheme of standard ISO 9001 to facilitate the harmonisation of regulatory requirements for medical devices for the quality management systems.
The standard is applicable to:
The UNI EN ISO 13485 certification allows you to receive significant benefits:
The ANCCP Certification Agency certifies companies in accordance with UNI EN ISO 13485.
Harmonised standards relating to:
- OHSAS 18001/2007 "Requirements"
- OHSAS 18002/2008 "Guidelines"
- UNI EN ISO 14001/2004 "Environmental Management System/Requirements"
- UNI EN ISO 14004/2010 "Environmental Management System/Support Techniques"
- UNI EN ISO 9000/2005 "Quality Management Systems - Vocabulary"
- UNI EN ISO 9001/2008 "Quality Management Systems - Requirements"
- UNI EN ISO 19011/2012 "Guidelines for Auditing Management Systems"
- UNI EN ISO 3834 "Quality requirements for fusion welding of metallic materials"
Part 1: choice criteria;
Part 2: extended quality requirements;
Part 3: normal quality requirements;
Part 4: elementary quality requirements;
Part 5: documents to conform to for declaring conformity.