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- ISO 9001:2000 Quality Management Standard
- ISO 13485:2003 Medical Devices – Quality Management Standard
- ISO 14001:2004 Enviromental Management Standard
- Health & Safety Management
- Food Safety Management (HACCP)
ISO 13485:2003 is an ISO standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices. ISO 13485:2003 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
Whilst ISO 13485:2003 is a stand-alone certification standard, it is generally in-line with the requirements of ISO 9001:2000 but has a few extra medical specific elements included. The major differences are that ISO 13485:2003 requires the organisation to:
- Focus on risk management activities and design transfer activities during product development.
- Include specific requirements for inspection and traceability for implantable devices.
- Address specific requirements for documentation and validation of processes for sterile medical devices.
Download the Investrend Medical Devices – Quality Management Brochure