What is iso13485 certification what does it mean

ISO 13485 is a specialized quality management system standard for the international medical device industry. Many people may not be too clear what this is a certification standard, today I will give you an introduction to iso13485 certification, I hope to help you!

The standard since its release in 1996, has been widely implemented and applied around the world, the new version of the ISO13485 standard in July 3, 2003 was officially released. Unlike the ISO9001:2000 standard, ISO13485:2003 is a management standard applicable to regulatory environments: it is clear from its name that it is a quality management system requirement for regulatory purposes. Medical devices in the international are not only general listed commodities operating in the business environment, it also subject to national and regional laws and regulations of supervision and management, such as the U.S. FDA, the European Union's MDD (European Union Medical Devices Directive), China's "Medical Devices Regulatory Regulations". Therefore, the standard must be bound by law and operate in a regulatory environment, and at the same time, it must give full consideration to the risks of medical device products and require risk management in the whole process of medical device product realization. Therefore, in addition to the specialized requirements, it can be said that ISO13485 is actually ISO9001 in the medical device regulatory environment.

At present, the United States, Canada and Europe generally to ISO 9001,, EN 46001 or ISO 13485 as a quality assurance system requirements, the establishment of the medical device quality assurance system are based on these standards. To enter the North American, European, or Asian markets, medical devices must comply with the appropriate regulatory requirements.

With the development of history, the ISO organization on the basis of this standard has been revised, upgraded to ISO13485:2003. At present, most of the medical device manufacturers in the establishment of the quality management system, began to put the ISO9001:2000 version of +. ISO13485:2003 + CE certification as a package solution to consider. The medical device industry has been using the ISO 13485 standard (China's equivalent conversion standard number is YY/T0287) as the basis for quality management system certification. This standard is formulated on the basis of ISO 9001: 1994 standard with the addition of the special requirements of the medical device industry, which is also known as 1+1 standard. Therefore, to meet the ISO 13485 standard also meets the requirements of ISO 9001: 1994 standard. ISO 9001: 2000 standard promulgated after the promulgation of ISO/TC 210 and promulgated a new ISO 13485: 2003 standard (China's equivalent conversion of YY/T 0287-200X standard is being submitted for approval).

This standard applies to the design and development of medical devices, the production, installation and service or related services design, development and provision of related industries.

A medical device, as defined in the standard, is an instrument, apparatus, appliance, machine, appliance, implant, in vitro reagent or calibrator, software, material, or other similar or related article, the intended use of which by the manufacturer is to be used in human beings, either singly or in combination, for one or more of the following specified purposes. These purposes are:

- the diagnosis, prevention, guardianship, treatment, or alleviation of disease;

- the diagnosis, guardianship, treatment, alleviation, or compensation of injury;

- the -Study, substitution, or regulation of anatomical or physiological processes;

-Support or maintenance of life;

-Pregnancy control;

? -Sterilization of medical devices;

? -Medical information by means of in vitro examination of samples taken from the human body.

Its primary design action on the human body surface or in the body is not obtained by pharmacological, immunological or metabolic means, but these may be involved and play a supporting role.

1, to improve and improve the management level of enterprises, to avoid legal risks, and increase the visibility of the enterprise;

2, to improve and ensure the level of quality of the product, so that the enterprise to obtain a greater economic benefits;

3, is conducive to the elimination of barriers to trade, and access to the international market

4, is conducive to enhancing the competitiveness of the product, increase the market share of the product.

5, through effective risk management, effectively reduce the risk of product quality accidents or adverse events.

6, improve the sense of responsibility, enthusiasm and dedication of employees.