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Proficos PMZ Home About Formulation Filling News Medical Devices PMZ Group Jobs Contact Login Home Medical Devices ISO 13485 Standard ISO 13485 Standard EN ISO 13485 - MEDICAL DEVICES - Quality Management System requirements for regulatory purposes ISO 13485 is an ISO standard, published in 2003, that represents the requirements for a quality management system that can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services . This standard supersedes earlier documents such as EN 46001 and EN 46002 (both 1997), the ISO 13485 published in 1996 and ISO 13488 (also 1996). This standard adopted by CEN (European Commission for Standardization) as EN ISO 13485:2003/AC:2009 is harmonized with respect to the European medical device directives 93/42/EEC, 90/385/EEC and 98/79/EC. While it remains a stand-alone document, ISO 13485 is based on ISO 9001. There is however a fundamental different approach: ISO9001 is focusing on client satisfaction, while ISO13485 is focusing on safe and effective medical devices and protection of patient and public health. The main differences between ISO 13485: 2003 and ISO 9001: 2000 are in 5 key areas: 1. Product specific 2. Regulatory 3. Documentation 4. Customer satisfaction 5. Continual improvement Some specific differences include: Risk management has to be in place for all stages of product realisation Work environment – training and supervision of staff working in special conditions, and the prevention of contamination Clinical evaluation, as part of design and development validation, in line with regulatory requirements Cleanliness of products and contamination control Status of product with respect to monitoring and measurement Nonconforming product – authorised personnel must be identified, concessions must meet regulatory requirements, and the adverse effect of rework must be determined specific requirements for verification of the effectiveness of corrective and preventive actions Compliance with EN ISO 13485 is the first step in achieving compliance with European regulatory requirements ISO 13485 Certificate and Scope ISO 13485 Standard Filling - Production - Formulation Clean zone Proficos - Industriepark 33 Zone A - 2220 Heist op den Berg - Belgium Tel. : +32 15 25 81 40 - Fax : +32 15 24 29 21 - info@proficos.be