ISO 13485:2003 is an International Organization for Standardization (ISO) standard, published in 2003, that sets forth the requirements for a comprehensive quality management system developed for the design, marketing, manufacture, and service of medical devices.
The standard supersedes previous documents such as EN 46001 and EN 46002 (both 1997), the ISO 13485 published in 1996 and ISO 13488 (also 1996).
While it is tailored to the industry’s quality system expectations and regulatory requirements, an organization need not be actively engaged in the manufacturing of medical devices or their components to seek certification to this standard.
Although it is a stand-alone document, ISO 13485 is generally harmonized with ISO 9001. One significant difference is that while ISO 9001 requires the organization to demonstrate continual improvement, ISO 13485 requires only that the certified organization demonstrate the quality system is effectively implemented and maintained. Furthermore, the ISO 9001 requirements regarding customer satisfaction are not included in the medical device standard.
Other specific differences include:
a) 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
b) controls in the work environment to ensure product safety
c) focus on risk management activities and design control activities during product development
d) specific requirements for inspection and traceability for implantable devices
e) specific requirements for documentation and validation of processes for sterile medical devices
f) specific requirements for verification of the effectiveness of corrective and preventive actions
Some see that compliance with ISO 13485 is often seen as the first step in achieving compliance with certain European regulatory requirements. For example, the conformity of Medical Devices and In-vitro Diagnostic Medical Devices 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. A result of the positive assessment is the certificate of conformity allowing the CE mark and the permission to sell the medical device in the European Union.
ISO 13485 is now considered to be in line with standards and requirements for medical devices including the “Global Harmonization Task Force Guidelines” (GHTF). The GHTF guidelines are slowly becoming universal standards for design, manufacture, export and sales of various medical devices.