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ISO 13485 is an ISO standard, published in 2003, that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. This standard supersedes earlier documents such as EN 46001 and EN 46002 (both 1997), the ISO 13485 published in 1996 and ISO 13488 (also 1996).
Though it is tailored to the industry's quality system expectations and regulatory requirements, an organization does not need to be actively manufacturing medical devices or their components to seek certification to this standard, in contrast to the automotive sector's ISO/TS 16949, where only firms with an active RFQ, or on the bid list, of an IATF supply chain manufacturer can seek registration.
While it remains a stand-alone document, ISO 13485 is generally harmonized with ISO 9001. A principal 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 9001 requirements regarding customer satisfaction are absent from the medical device standard.
Other specific differences include:
- 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 FDA, or the Medical Devices Directive 93/42/EEC, required for doing business in the European Union
- controls in the work environment to ensure product safety
- focus on risk management activities and design control 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 conformity of Medical Devices and In-vitro Diagnostic Medical Device according to EEC-decrees 93/42/EEC, 90/385/EEC and 98/79/EEC must be assessed before sale is permitted. The preferred method to prove conformity is the certification of the Quality Management System according ISO 9001 and/or ISO 13485 and ISO 14971 by a Notified Body. The result of a positive assessment is the certificate of conformity allowing the CE mark and the permission to sell the medical device in the European Union.
This standard adopted by CEN as EN ISO 13485:2003/AC:2007 is harmonized with respect to the European medical device directives 93/42/EEC, 90/385/EEC and 98/79/EC.
ISO 13485 is now considered to be inline standard and requirement for medical devices even with "Global Harmonization Task Force Guidelines" (GHTF). The GHTF guidelines are slowly becoming universal standards for design, manufacture,export and sales of various medical devices.
This standard adopted by CEN as EN ISO 13485:2012 is harmonized with respect to the European Medical Devices Directive 93/42/EEC.
- ISO Catalogue: ISO 13485:2003 Medical devices -- Quality management systems -- Requirements for regulatory purposes
- ISO/TS 16949:2002 Questions and answers
- Understanding ISO 13485
- Summary list of titles and references of harmonised standards related to medical devices - DG Enterprise & Industry. European Commission
- CEN/CLC/TC 3 Quality management and corresponding general aspects for medical devices--European Community for Electrotechnical Standardization
- Guide to ISO 13485
- ISO Organisation 13485 page
- Guidance MEDDEVs - Guidance for regulatory compliance for EU medical device manufacturers
- CFR - Code of Federal Regulations Title 21, FDA's Quality System Regulation