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[sterilization packaging manufacturer] the difference between iso3485 certification and 9001 certification in medical device packaging industry

[sterilization packaging manufacturer] the difference between iso3485 certification and 9001 certification in medical device packaging industry

  • Categories:Industry news
  • Author:Baojie editor
  • Origin:Anqing Baojie packaging co.,ltd
  • Time of issue:2022-05-25
  • Views:639

(Summary description)ISO13485 is called "requirements of medical device quality management system for laws and regulations" in Chinese. As medical devices are special products for saving the lives and healing the wounded, preventing and treating diseases, it is not enough to regulate them only according to the general requirements of ISO9000 standard. Therefore, ISO has organized and issued iso13485:1996 standards (YY / T0287 and YY / t0288), which put forward special requirements for the quality management system of medical device manufacturers, It has played a good role in promoting the quality of medical devices to achieve safety and effectiveness. ISO9001 is not a standard, but a general term of a class of standards. It is all international standards formulated by TC176 (TC176 refers to the technical committee of quality management system). It is the best-selling and most common product among more than 12000 iso12000 standards.

ISO9001 quality management system certification standard is a summary of the development of management theory and management practice in many countries, especially developed countries. It embodies a management philosophy and quality management method and mode, which has been adopted by more than 100 countries and regions in the world.

[sterilization packaging manufacturer] the difference between iso3485 certification and 9001 certification in medical device packaging industry

(Summary description)ISO13485 is called "requirements of medical device quality management system for laws and regulations" in Chinese. As medical devices are special products for saving the lives and healing the wounded, preventing and treating diseases, it is not enough to regulate them only according to the general requirements of ISO9000 standard. Therefore, ISO has organized and issued iso13485:1996 standards (YY / T0287 and YY / t0288), which put forward special requirements for the quality management system of medical device manufacturers, It has played a good role in promoting the quality of medical devices to achieve safety and effectiveness. ISO9001 is not a standard, but a general term of a class of standards. It is all international standards formulated by TC176 (TC176 refers to the technical committee of quality management system). It is the best-selling and most common product among more than 12000 iso12000 standards.

ISO9001 quality management system certification standard is a summary of the development of management theory and management practice in many countries, especially developed countries. It embodies a management philosophy and quality management method and mode, which has been adopted by more than 100 countries and regions in the world.

  • Categories:Industry news
  • Author:Baojie editor
  • Origin:Anqing Baojie packaging co.,ltd
  • Time of issue:2022-05-25
  • Views:639
Information

As we all know, ISO13485 and ISO9001 are essential certification standards in the medical device industry. ISO13485:2003 is also called "medical device quality management system". This standard is formulated by SCA / tc221 medical device quality management and general requirements Standardization Technical Committee. It is an independent standard based on IS09001:2000. So what are the main differences between them? YINGSHUO packaging has sorted out the following points for you:

Differences between standard names:

1. ISO9001:2000 quality management system requirements

2. ISO13485: 2003 requirements of medical device quality management system for regulations

Difference in standard content: ISO9001:2000

1. The general requirements of ISO9001:2000 for quality system are applicable to all industries

2. Emphasize the continuous improvement of the system and enhance customer satisfaction

3. There are only 7 documented requirements in the standard

Differences in standard content: ISO13485:2003

1. Only applicable to medical device industry

2. Emphasize compliance with regulatory requirements

3. There are 26 requests for documentation and 40 requests for records

4. Emphasize the risk management in the process of product realization to ensure the safety and effectiveness of products

5. Special requirements for special products are put forward

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