iso 13458（ISO 13458）.docVIP

iso 13458（ISO 13458） ISO13485 authentication ISO13485 Chinese called medical quality management system, as the medical device is a special product to heal and prevent diseases, only according to the general requirements of the ISO9000 standard specification is not enough, so ISO has issued a ISO13485:1996 version of the standard (YY/T0287 and YY/T0288), put forward special requirements for medical device manufacturing enterprise quality management system. The quality of medical devices to achieve a very good role in promoting safe and effective. With the development of history, the ISO organization revised the standard on the basis of ISO13485:1996 and upgraded to ISO13485:2003. Most of the current medical equipment manufacturers in the establishment of quality management system, as a package of solutions to begin to ISO9001:2000 version of the +ISO13485:2003 version of CE certification to consider. The medical equipment industry has been the ISO 13485 standard (equivalent conversion standard YY / T0287) as the basis for quality management system certification. This standard is based on the ISO 9001:1994 standard, increased the special requirements of the medical equipment industry, formulated, that is, the so-called 1+1 standards. Therefore, meeting the ISO 13485 standard meets the requirements of the ISO 9001:1994 standard. After the promulgation of the ISO 9001:2000 standard, ISO / TC 210 has promulgated the new ISO 13485:2003 standard (our country is equivalent to the conversion of YY / T 0287-200X standards, is for approval). ISO13485 certification profile The full name of the ISO13485:2003 standard is the system-Requirements (Medical device-Quality management for regulatory) for medical device quality management system. This standard is formulated by SCA/TC221 medical equipment quality management and general requirements Standardization Technical Committee, and it is the independent standard based on ISO9001:2000. The standard specifies the requirements for th