Iso 13485 Certification Service

Iso 13485 Certification Services
This is an industry specific management standard specially developed for medial devices manufacturing industry. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems.

ISO 13485: 2003 represents the requirements that medical device manufacturers must incorporate into their management systems. ISO 13485:2003 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 of ISO 13485 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.

ISO 13485:2003 is also known as quality management system for medical device industry. Here device is a broad term & includes every medical product except pharmaceuticals.