The primary objective of the ISO 13485 standard is to facilitate worldwide harmonized medical device regulatory requirements for quality management systems. ISO13485 is based on the process approach as defined in the ISO 9001 standard (and includes the old ISO 13488) but it has several key differences. Continuous improvement and customer satisfaction are de-emphasized while regulatory and safety requirements are emphasized. Long term, the 2 standards are so similar that eventually they may become one standard. Although continuous improvement is not  required by ISO 13485, it is still a best practice in the medical industry so hopefully it will be in future versions. Depending on the organization, many ISO 9001 certified or compliant companies  already comply with the majority of the 13485 standard.

The 13485 standard include increased emphasis on:

  • Cleanliness/sterility in the production area
  • Product and component labeling
  • Tractability of product and components (including recall procedures)
  • Validation and verification (testing) of products
  • Food and Drug Administration (FDA) or similar approval

The standard includes 8 sections, which describe the intent and the requirements for compliance. All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.