ISO 13485 contains requirements that are essential for any organization operating at any tier in the medical device and pharmaceutical supply chain. It is especially relevant to manufacturers that wish to demonstrate applicable regulatory requirements, and by organizations whose services support medical device manufacturers.
ISO 13485 is the de facto standard for a comprehensive management system for the design and manufacture of medical devices. It is often seen as the first step towards achieving compliance with European, Canadian and other regulatory requirements for medical device manufacturers and/or service companies for this industry. ISO 13485, published in 2003, and now fully recognized in many countries, is basedn the ISO 9001 process model approach. These standards provide a good base model, recognized by the Global Harmonization Task Force (GHTF), for compliance with the European Union (EU) CE marking medical device directives, Health Canada CMDCAS, Taiwan Medical Device Regulations, Japan JPAL and other international requirements.
ISO 13485 is based on the ISO 9001 process model approach and is a management systems standard specifically developed for the manufacture of medical devices. Its primary objective is to facilitate harmonized medical device regulatory requirements.The standard contains specific requirements for manufacture, installation and servicing and calls for: Implementation of a Quality Management System with several enhancements, Risk Management approach to product development and product realisation, Validation of processes, Compliance with statutory and regulatory requirements and Effective product traceability and recall systems