ISO13485 and national GMP requirements.
ISO13485 Chinese called "medical device quality management system for regulatory requirements", because the medical device is to save lives, prevention and treatment of special products, only according to the ISO9000 standard general requirements to regulate is not enough, for this reason the ISO organization promulgated ISO13485: 1996 version of the standard (YY/T0287 and YY/T0288).
The quality management system of medical device manufacturers has put forward special requirements for the quality of medical devices to achieve safe and effective has played a good role in promoting.
The quality assessment indexes are implemented quarterly and annually. Each quality assessment items have reached the higher level of the assessment requirements before the completion of the quality assessment indicators. One to four quarters have reached the assessment indicators. For the completion of the quality assessment program, there are three quarters to meet the assessment indicators (must include the last quarter), for the basic completion of the quality assessment program; only two quarters to meet the nuclear indicators, for the failure to complete the quality assessment program.
Rotational production of products, if the production of all quarters to meet the assessment indicators, for the completion of the quality assessment program; more than half of the quarter to meet the assessment criteria (must include the last quarter) for the basic completion of the quality assessment program; only half or less than half of the quarter to meet the assessment indicators for the failure to complete the quality assessment program.
Products that have been rated as qualified or for qualified products, should be assessed finished product qualification rate (or qualified rate of finished product sampling). Has been rated first-class or for first-class products, should be assessed first-class rate of finished products (or finished product sampling rate of first-class). Has been rated as first-class products or for products rated first-class, should assess the rate of finished products (or finished product sampling rate of first-class).
Assessment of finished product superior rate (or finished product sampling superior rate), must be assessed at the same time the rate of finished product first-class (or finished product sampling first-class rate) and finished product qualified rate (or finished product sampling qualified rate); assessment of finished product first-class rate (or finished product sampling first-class rate), must be assessed at the same time the rate of finished product qualified (or finished product sampling qualified rate).
The equipment products should generally be assessed once the product pass rate, but do not assess the finished product rate. Non-equipment products of large quantities of a single piece of general assessment of the rate of finished products, but do not assess the rate of passing a product inspection.