8.4 Analysis of data 數據分析

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.

組織應當建相應的程序以確定、收集、分析相應的數據從而證明質量管理體系適宜性、充分性和有效性。程序應到包括適當的方法學，包括分析技術以及其使用的范圍。（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:

數據分析應當包括監控和測量過程中和來源于其他資源所產生的數據，同時包括最少來源于以下輸入的內容：

a) feedback; 反饋

b) conformity toproduct requirements;  符合產品要求；

c)characteristics and trends of processes and product, including opportunitiesfor improvement; 過程和產品的特性和趨勢，包括改進的條件。

d) suppliers; 供應商

e) audits; 審核（審計）

f) service reports, as appropriate.服務報告，如適用。（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.

如果數據分析顯示質量管理體系不適宜、充分和有效，組織應當將此分析作為改進（8.5項下要求）的輸入。（新增）

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

分析結果的記錄應當予以保留。（見4.2.5）