WHAT IS ISO 13485?

ISO 13485 is an ISO standard which published in 2003 for a comprehensive quality management system for the design and manufacture of medical devices. We provide a full range of services including ISO 13485 Consultant.

While it remains a stand-alone document, ISO 13485 is generally harmonized with ISO 9001. A principal difference, however, is that ISO 9001 requires the organization to demonstrate continual improvement, whereas ISO 13485 requires only that the certified organization demonstrate the quality system is effectively implemented and maintained.

ISO 13485 focus on:

• • The promotion and awareness of regulatory requirements as a management responsibility.

• • Controls in the work environment to ensure product safety

• • Focus on risk management activities and design control activities during product development

• • Specific requirements for inspection and traceability for implantable devices

• • specific requirements for documentation and validation of processes for sterile medical devices

• • Specific requirements for verification of the effectiveness of corrective and preventive actions