While it remains a stand-alone document, ISO 13485 is generally harmonized with ISO 9001. A principle 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. Additionally, the ISO 9001https://texasqa.com/iso-9001-certified-quality-management-system/ requirements regarding customer satisfaction are absent from the medical device standard.

Other specific differences include:
1. the promotion and awareness of regulatory requirements as a management responsibility. Examples of market-specific regulatory requirements include 21 CFR 820, the Quality System Regulation for medical devices sold in the United States, enforced by the U.S. Food and Drug Administration (FDA), or the Medical Devices Directive 93/42/EEC, required for doing business in the European Union
2. controls in the work environment to ensure product safety
3. focus on risk management activities and design control activities during product development
4. specific requirements for inspection and traceability for implantable devices
5. specific requirements for documentation and validation of processes for sterile medical devices
6. specific requirements for verification of the effectiveness of corrective and preventive actions