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What is ISO13485?
ISO13485 based on the ISO9001 process method for the medical device industry quality management system for regulatory requirements,
ISO 13485 contains special requirements for the manufacture, installation, service and recall of medical devices to facilitate:
Improve quality management system
Control the use of risk management in the implementation of the product
Verification of the process
meet the requirements of laws and regulations
Effective control of product risk and recall management
ISO13485 scope of application:
The requirements of ISO 13485 are applicable to organizations engaged in the design and development, production, storage and distribution of medical devices, installation, maintenance and final disposal and disposal;
The requirements of ISO 13485 apply to suppliers or other external parties that provide products for such organizations (eg raw materials, components, components, medical equipment, sterilization services, calibration services,
distribution services, maintenance services)
ISO13485 certification benefits
help to eliminate the technical barriers in international trade, is to enter the international market pass
Improve the management of the organization
Improve business reputation
Improve the level of product quality assurance
is conducive to enhancing the competitiveness of enterprises
perfect internal management of the organization
ISO13485: 2016 version was officially released on March 1, 2016,
ISO13485 is the medical device industry quality management system standard, it is on the basis of ISO9001 to increase the special requirements of the medical device industry, product identification, process control and other
aspects of the more stringent control requirements. Through this certification can enhance the medical workers and end users of the ultimate trust of enterprise products.
With ISO13485 certification, you can:
Improve and improve the management level of enterprises, improve the visibility of enterprises;
Is conducive to the elimination of trade barriers, access to the international market access permit;
Is conducive to enhancing the competitiveness of products, improve product market share.
ISO13485 based on the ISO9001 process method for the medical device industry quality management system for regulatory requirements,
ISO 13485 contains special requirements for the manufacture, installation, service and recall of medical devices to facilitate:
Improve quality management system
Control the use of risk management in the implementation of the product
Verification of the process
meet the requirements of laws and regulations
Effective control of product risk and recall management
ISO13485 scope of application:
The requirements of ISO 13485 are applicable to organizations engaged in the design and development, production, storage and distribution of medical devices, installation, maintenance and final disposal and disposal;
The requirements of ISO 13485 apply to suppliers or other external parties that provide products for such organizations (eg raw materials, components, components, medical equipment, sterilization services, calibration services,
distribution services, maintenance services)
ISO13485 certification benefits
help to eliminate the technical barriers in international trade, is to enter the international market pass
Improve the management of the organization
Improve business reputation
Improve the level of product quality assurance
is conducive to enhancing the competitiveness of enterprises
perfect internal management of the organization
ISO13485: 2016 version was officially released on March 1, 2016,
ISO13485 is the medical device industry quality management system standard, it is on the basis of ISO9001 to increase the special requirements of the medical device industry, product identification, process control and other
aspects of the more stringent control requirements. Through this certification can enhance the medical workers and end users of the ultimate trust of enterprise products.
With ISO13485 certification, you can:
Improve and improve the management level of enterprises, improve the visibility of enterprises;
Is conducive to the elimination of trade barriers, access to the international market access permit;
Is conducive to enhancing the competitiveness of products, improve product market share.