8.4 Analysis of data 数据分析

The organizationshall document procedures to determine, collect and analyse appropriate data todemonstrate the suitability, adequacy and effectiveness of the qualitymanagement system. The procedures shall include determination of appropriatemethods, including statistical techniques and the extent of their use.

组织应当建相应的程序以确定、收集、分析相应的数据从而证明质量管理体系适宜性、充分性和有效性。程序应到包括适当的方法学，包括分析技术以及其使用的范围。（新增）

The analysis ofdata shall include data generated as a result of monitoring and measurement andfrom other relevant sources and include, at a minimum, input from:

数据分析应当包括监控和测量过程中和来源于其他资源所产生的数据，同时包括最少来源于以下输入的内容：

a) feedback; 反馈

b) conformity toproduct requirements;  符合产品要求；

c)characteristics and trends of processes and product, including opportunitiesfor improvement; 过程和产品的特性和趋势，包括改进的条件。

d) suppliers; 供应商

e) audits; 审核（审计）

f) service reports, as appropriate.服务报告，如适用。（新增）

If the analysis of data shows thatthe quality management system is not suitable, adequate or effective, theorganization shall use this analysis as input for improvement as required in 8.5.

如果数据分析显示质量管理体系不适宜、充分和有效，组织应当将此分析作为改进（8.5项下要求）的输入。（新增）

Records of theresults of analyses shall be maintained (see 4.2.5).

分析结果的记录应当予以保留。（见4.2.5）