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The primary objective of the ISO 13485:2003 standard is to facilitate world-wide harmonized medical device regulatory requirements for quality management systems. ISO13485 is based on the process approach as defined in the ISO9001:2000 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. The 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.