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ISO 13485:2003 - Medical devices -- Quality management systems

ISO 13485:2003 - Medical devices -- Quality management systems -- Requirements for regulatory purposes specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.
ISO 13485

 All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.

If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity with ISO 13485:2003 reflect exclusion of design and development controls.

If any requirement(s) in Clause 7 of ISO 13485:2003 is(are) not applicable due to the nature of the medical device(s) for which the quality management system is applied, the organization does not need to include such a requirement(s) in its quality management system.
The processes required by ISO 13485:2003, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system.

Who is certified to these standards?
? Companies, who design, manufacture, distribute, install and service medical devices for the European and World markets.
? Companies who manufacture OEM products, which are sold under other, company names.
? Companies who design and/or manufacture medical device components or raw materials for the medical device market.
? Companies selling, installing or servicing medical devices.
? Consultants providing design services to the medical device market.
? Companies providing services to the medical device market such as sterilisation, cleaning, testing, etc.

What does each standard mean?

ISO 9001 is a quality system standard applicable to many industries. ISO 13485 is a standard specific to medical device quality systems that supplement the ISO 9001 standard. Some of the additional requirements relate to design controls, risk management, environmental controls, special processes (e.g. software validation), traceability, record retention, and regulatory actions (such as vigilance), which are more critical for the medical device industry.

Formal certification of your quality management system, specifically for medical devices, to ISO 13485:2003 proves advantageous, and in many cases essential, for medical companies which export their products to the global market.
In the European Union, the fulfilment of EU Directives (e.g. Active Implantable Medical Devices Directive, Medical Devices Directive and In Vitro Diagnostic Directive) allows the free trade of medical devices. A significant portion of demonstrating compliance with the EU Directive requirements is the establishment and independent assessment of the quality system meeting the requirements of ISO13485.
ISO 13485: 2003 has been harmonised against the three medical device directives. This means that compliance with this standard automatically demonstrates compliance with the specific parts of the directives that require a quality management system.
When manufacturers are active in the world market, the focus on global or international standards such as ISO13485:2003, is not only advantageous - it may be stipulated by certain countries. For example, Canada requires that medical device manufacturers marketing their products in Canada must have a quality system certified to ISO 13485 by an SCC accredited certification body.
In the U.S., the revised Quality System Regulation (21 CFR 820, Oct. 7, 1996) was based on the ISO 9001 and ISO 13485 quality system standards. US manufacturers in compliance with the FDA Quality System Regulations can assume that their quality system is close to meeting the requirements of the ISO 9001/ISO 13485 standards.