This standard, together with GB/T 19002-ISO 9002, specifies the quality system requirements for the production of medical devices and corresponding installation and service. This standard, together with GB/T 19002-ISO 9002, is applicable to the quality system evaluation of medical device suppliers. As part of regulatory requirements for evaluation by third parties, the supplier may be required to provide access to confidential information to third parties to demonstrate compliance with this standard. Suppliers may be required to produce these documents, but this standard does not require them to provide copies for their records.
YY/T 0288-1996 history
1996YY/T 0288-1996 Quality system.Medical devices.Particular requirements for the application of GB/T 19002.ISO 9002