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5 质量记录及控制质量体系应要求保存足够的记录,以证明符合质量控制的规定要求,并验证质量体系的有效运行。通过对质量记录的分析,还可为纠正和改进措施的制定提供重要信息。5.1 质量记录的内容、建立及储存质量记录的内容包括:检验报告、试验数据、鉴定报告、确认报告、考察和审核报告、不合格品评审报告、校准数据及质量成本报告等。质量记录可以是任何媒
5 The quality records and control quality system shall require that sufficient records be kept in order to demonstrate compliance with the requirements of quality control and to verify the effective operation of the quality system. An analysis of quality records can also provide important information for corrective and improvement actions. 5.1 Contents of quality records, records of establishment and quality of storage include: inspection reports, test data, identification reports, confirmation reports, inspection and audit reports, nonconforming product assessment reports, calibration data and quality cost reports. Quality records can be any medium