FDA QSR820_CN课件.pptVIP

QSR820 框架 Subpart A--General Provisions ???§ 820.1 - Scope. ???§ 820.3 - Definitions. ???§ 820.5 - Quality system. Subpart B--Quality System Requirements ???§ 820.20 - Management responsibility. ???§ 820.22 - Quality audit. ???§ 820.25 - Personnel. Subpart C--Design Controls ???§ 820.30 - Design controls. Subpart D--Document Controls ???§ 820.40 - Document controls. Subpart E--Purchasing Controls ???§ 820.50 - Purchasing controls. Subpart F--Identification and Traceability ???§ 820.60 - Identification. ???§ 820.65 - Traceability. Subpart G--Production and Process Controls ???§ 820.70 - Production and process controls. ???§ 820.72 - Inspection, measuring, and test equipment. ???§ 820.75 - Process validation. Subpart H--Acceptance Activities ???§ 820.80 - Receiving, in-process, and finished device acceptance. ???§ 820.86 - Acceptance status. Subpart I--Nonconforming Product ???§ 820.90 - Nonconforming product. Subpart J--Corrective and Preventive Action ???§ 820.100 - Corrective and preventive action. Subpart K--Labeling and Packaging Control ???§ 820.120 - Device labeling. ???§ 820.130 - Device packaging. Subpart L--Handling, Storage, Distribution, and Installation ???§ 820.140 - Handling. ???§ 820.150 - Storage. ???§ 820.160 - Distribution. ???§ 820.170 - Installation. Subpart M--Records ???§ 820.180 - General requirements. ???§ 820.181 - Device master record. ???§ 820.184 - Device history record. ???§ 820.186 - Quality system record. ???§ 820.198 - Complaint files. Subpart N--Servicing ???§ 820.200 - Servicing. Subpart O--Statistical Techniques ???§ 820.250 - Statistical techniques. 章节A 概述--820.1 范围 适用性 本质量体系本法规不适用于最终产品的部件或零件制造商，但鼓励这类制造商把本法规的适当规定作为指南来使用。人血和血器官制造商不受本部分法规的限制，但应遵循本章606部分法规的要求。 （2） 本部分的规定适用于本部分定义的应用于人体的所有最终产品设备，不论其在美国本土制造还是进口的产品。 （3） 在本法规中“适用时”（where appropriate）出现过多次。当要求根据“where appropriate”被认为是合格时，其要求应被认为是“适用的”（appropriate），除非组织能提供文件证明其理由。如果不执行导致产品不符合其特定的要求，或组织未执行必要的纠正措施，那么要求就是适用的（appropriate）。 章节A 概述--