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Medical Device Regulations

Quality system requirements

A Quality System is defined as the organizational structure, responsibilities, procedures, processes and resources needed to implement quality management. Quality system standards are “generic management standards” and are described in section 5.1.

The international quality system standards for medical devices are issued by the International Organization for Standardization (ISO) (ISO13485:1996 and ISO13488: 1996). ISO13485:1996 includes all the elements of ISO9001:1994 plus a set of minimum supplementary requirements for medical devices. The relationship between ISO9001:1994 and ISO13485:1996 is described in Annex 3. ISO13488:1996 is the same as ISO13485: 1994, but without the design control requirements. A new standard, ISO13485:200?, is currently being developed and will become the international reference standard for medical devices.

Regulations for quality systems may cover the methods, facilities and controls used by the manufacturer in the design, manufacture, packaging, labelling, storage, installation, servicing and post-market handling of medical devices. Therefore, quality system requirements can influence all phases in the medical device life span. Applicable requirements depend upon the risk class of the device and on the regulatory system of the country.

Design control is normally not required for regulatory scrutiny in medium- to low-risk devices.

When applied to the manufacturing process, quality system requirements impose strict quality assurance on every aspect of production. The result is a tightly controlled manufacturing system, commonly known as Good Manufacturing Practice (GMP), which reduces the likelihood of non-conforming products. This practice ensures consistency in the quality and provides the basis for greater reliability in device safety and performance. Elements of the quality system are periodically subject to audits, management review, and corrective or preventive actions that will maintain product quality. Continuous monitoring and corrective action requirements are interrelated to post-market surveillance previously described.

The key advantage regarding quality systems is that they represent a preventive approach to assuring medical device quality versus the previous reactive approach by inspection and rejection at the end of the manufacturing line. Prevention has been proven to be more efficient and cost effective in controlling manufacturing processes and maintaining medical device quality.

It is important to note that since the majority of medical devices are in the medium- to low-risk classes, their compliance with regulations often depends upon the declarations of manufacturers, thus the question of quality assurance naturally arises. This is why it is critical for manufacturers to conform with quality system standards and for this conformity to be subject to periodic audit by governmental or third party agencies.

All founding members of the GHTF have quality system requirements for their manufacturers, who are subject to periodic inspection by the government and/or accredited third party agencies. The applicable standard is determined by the risk class of the device and depends upon the regulatory system of the country or region.

Table 3. Quality system standards used by different authorities

Australia ISO13485 or EN46001*
ISO13488 or EN46002*
Government and Third party
Canada ISO13485, ISO13488 Third party
European Union EN46001* or ISO13485

EN46002* or ISO13488

Third party
Japan GMP #40 ordinance
GMPI #63 ordinance
QS Standard for medical
devices #1128 notice
United States QS (21 CFR part 820) Government

*EN46001 and EN46002 are being phased out by the end of March 2004.

With the rapid growth in the global market for medical devices, there is a need to harmonize national standards in order to minimize regulatory barriers and to facilitate trade. Harmonization also reduces the cost of local industry and government regulations.

The next chapter summarizes the work of the Global Harmonization Task Force to find common elements and ways to unify the different national standards and regulatory practices.