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ISO 13485:2003

Medical Devices Quality Management System


ISO 13485:2003 Certification Medical Devices - Quality Management System is an international standard that defines quality management system requirements for manufacturers of medical devices. ISO 13485:2003 certification contains requirements essential for organizations operating at any tier in the medical devices and pharmaceutical supply chain. The primary objective of the standard is to facilitate harmonized medical device regulatory requirements and as a result, it includes some particular requirements for manufacture, installation and servicing such as added requirements on record-control, sterilization and risk management. ISO 13485 certification promotes harmonization of regulatory requirements for manufacturers of medical devices on an international scale. Though based on ISO 9001, 13485 removes 9001's emphasis on continual improvement and customer satisfaction. In its place is an emphasis on meeting regulatory as well as customer requirements, risk management and maintaining effective processes, namely the processes specific to the safe design, manufacture and distribution of medical devices. ISO 13485 is designed to be compatible with other management systems standards and specifications, such as ISO 9001, OHSAS 18001, ISO 22000, ISO 17025, ISO 27001, ISO 14001 Environment and other ISO standards. They can be integrated seamlessly through Integrated Management system approach.

 Responsibilities and authorities  Design and development
 Training procedures  Purchasing control, purchase traceability and verification
 Health, cleanliness & clothing  Labelling and packaging
 Environmental conditions  Installation and verification
 Control of contaminated products  Sterilization process validation
 Risk management  Preservation of product
 Customer requirements  Measurement and monitoring


 Customer satisfaction  Enhancing business reputation & corporate  image
 Reduced operating costs  Effective product traceability and recall  systems
 Improved Risk management  Compliance with statutory and regulatory  requirements
 Improved stakeholder relationships  Greater international acceptance and  competitive advantage
 Ensures product consistency  Delivers the benefits of an ISO 9001  Certification
 Improved operational efficiency  Improves Business Performance and Manages  Business Risks