ISO13485 medical device quality management system

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1. Introduction to ISO13485 certification
The full name of the ISO13485:2003 standard is "Medical device-Quality management system-requirements for regulatory". This standard was developed by the SCA/TC221 Medical Device Quality Management and General Requirements Standardization Technical Committee and is an independent standard based on ISO 9001:2000. The standard specifies the quality management system requirements for the relevant organization, but it is not the implementation guide for the ISO9001 standard in the medical device industry.
Since its publication in 1996, the standard has been widely implemented and applied worldwide. The new ISO13485 standard was officially released on July 3, 2003. Unlike the ISO9001:2008 standard, ISO13485:2003 is a management standard applicable to the regulatory environment: it is clearly defined as the quality management system requirements for the regulations. Medical devices are not only the general listed products operating in the commercial environment, but also subject to the supervision of national and regional laws and regulations, such as the US FDA, the EU MDD (European Medical Device Directive), and the Chinese medical Device Regulations. Therefore, the standard must be legally bound to operate in a regulatory environment, and must fully consider the risks of medical device products, and require risk management throughout the process of implementing medical device products. Therefore, in addition to the special requirements, it can be said that ISO13485 is actually ISO9001 under the medical device regulatory environment.
At present, the United States, Canada and Europe generally use ISO 9001, EN 46001 or ISO 13485 as the requirements of the quality assurance system, and the establishment of medical device quality assurance systems is based on these standards. Medical devices that enter markets in North America, Europe, or different Asian countries should comply with applicable regulatory requirements.

2. Characteristics of ISO13485:2003 standard

1. The standard is an independent standard with strong professionalism applicable only to the medical device industry;
2. Put the requirements of medical device regulations into a prominent position;
3. The standard continues to clarify the documentation requirements;
4. The standard emphasizes the specific requirements for medical devices;
5. ISO13485 standard is a supplement to the technical requirements of the product;
6. Give special provisions for the deletion;
7. The standard attaches importance to risk management requirements;
8. The definition of the concept of “medical devices” is further clarified;
9. Although this standard has not been adopted by the FDA, a company that meets the requirements of ISO13485:2003 can easily meet the requirements of FDAQSR;
10. This standard is compatible with other "non-quality" management systems such as ISO14001 and OHSAS18001.

3. The significance of ISO13485 certification

1. Improve and improve the management level of enterprises, avoid legal risks, and increase the visibility of enterprises;
2. Improve and ensure the quality level of products, so that enterprises can obtain greater economic benefits;
3. It is conducive to eliminating trade barriers and obtaining passes to enter the international market;
4. It is conducive to enhancing the competitiveness of products and increasing the market share of products.
5. Effective risk management to effectively reduce the risk of product quality accidents or adverse events.
6. Improve employee responsibility, enthusiasm and dedication.

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