ISO 13485, while being an independent document, is generally in alignment with ISO 9001. A key distinction, however, lies in the fact that ISO 9001 mandates the organization to show continuous improvement, while ISO 13485 only necessitates that the organization proves the effective implementation and maintenance of the quality system. Moreover, the stipulations related to customer satisfaction in ISO 9001 are not present in the medical device standard.
There are other specific differences as well, such as:
- Emphasizing the importance of regulatory requirements as a managerial responsibility. Regulatory requirements specific to certain markets include 21 CFR 820, which is the Quality System Regulation for medical devices sold in the U.S., enforced by the U.S. Food and Drug Administration (FDA), or the Medical Devices Directive 93/42/EEC, necessary for conducting business in the European Union.
- Implementing controls in the work environment to guarantee product safety.
- Concentrating on risk management activities and design control activities during the product development phase.
- Establishing specific requirements for inspection and traceability for implantable devices.
- Setting specific requirements for documentation and validation of processes for sterile medical devices.
- Laying down specific requirements for verifying the effectiveness of corrective and preventive actions.
- Instituting specific requirements for ensuring the cleanliness of products.