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  ISO13485

Introduction: ISO13485 Chinese called "medical device quality management system" As the medical device is to save the disease, disease prevention and treatment of special products, according to the ISO9000 standard general requirements to regulate is not enough, for this ISO organization issued ISO13485: 1996 version of the standard (YY / T0287 and YY / T0288), the medical device manufacturing enterprises of the quality management system put forward special requirements for the quality of medical equipment to achieve safe and effective play a very good role in promoting.

Role

1, to manage the company management process, improve business performance;

2, to enhance product quality, strengthen the market competitiveness of enterprises;

3, for the outside world (including customers) to prove the company's standardized management and control capabilities;

4, used to meet customer audit requirements;

Certification conditions

1, with proof of identity: business license or business unit registration certificate;

2, the production of three types of medical equipment business, quality management system running time of not less than 6 months, the production and operation of other products business, quality management system running time of not less than 3 months;

3, has obtained a production license or other qualification certificate (national or departmental regulations are required);

4, the company normal operation.

5, within one year before the application for certification, the application of the organization's products without major customer complaints and quality accidents;

Applicable industry

1. medical product manufacturer

2. Medical product service provider;

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