ISO 13485 – (Customized ISO 9001 Standard for Medical Device Quality Management)

ISO 13485:2003 specifies requirements for a quality management system where an organization 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.

The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.

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

Other specific differences include:

  • 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 transfer activities during product development
  • specific requirements for implantable devices such as inspection and traceability
  • specific requirements for sterile medical devices such as documentation and validation of processes
  • specific requirements for verification of the effectiveness of corrective and preventive actions

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