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ISO 13485 is an ISO standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices.
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, will providing resources and during reviews. An example of the market specific regulatory requirements is 21 CFR 820 Quality System Regulation for Medical Devices sold in the United States.
- controls in the work environment to ensure product safety
- focus on risk management activities and design transfer activities during product development
- specific requirements for inspection and traceability for implantable devices
- specific requirements for documentation and validation of processes for sterile medical devices
- specific requirements for verification of the effectiveness of corrective and preventive actions
Compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements. The preferred method to prove conformity is the certification of the Quality Management System according ISO 9001 and/or ISO 13485. The result of a positive assessment is the authorisation for the CE-identification and the permission to sell the high quality medical device in the European Union.
ISO 13485 is the Quality Management System for Medical Device Manufacturers. Released in the year 2003, it has become a regulatory requirement for medical device manufacturers in most countries across the globe.
The standard, ISO 13485:2003, was developed by International Orgnization for Standardization on the basis of it's popular quality management system standard, ISO 9001:2000. As opposed to ISO 9001, it contains more specific requirements for medical devices manufacturers to demonstrate their abilility to 'maintain' (and not 'improve') the quality management system.
Who can apply:
- Manufacturers of medical devices
- Consultants which design, manufacture, and assemble medical and in vitro diagnostic medical devices.
- Medical component manufacturers.
- Manufacturers of In Vitro Diagnostic Medical Devices that want to distinguish themselves, and prepare for future IVD regulatory obligations to enter the Europian Union.
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