ISO 13485:2003 - Quality Management System
ISO 13485:2003 specifically addresses Quality Management Systems related to the Medical Device Industry. The standard can be used by Medical Device manufacturers to demonstrate applicable regulatory requirements as well as by their suppliers and other supporting organizations.
A number of regulatory authorities have adopted ISO 13485 certification as part of their own requirement for allowing the sale of medical devices, including Health Canada (CMDCAS), the European Union (EU) to allow for CE marking, Taiwan Medical Device Regulations and Japan’s PAL.
LNE/G-MED provides auditing services to assess an organization's compliance with this standard by reviewing procedures and their implementation in the following areas:
- Quality management
- Management responsibility
- Resource management
- Product realization
- Measurement, analysis and improvement