8.4 Analysis of data 數(shù)據(jù)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(yīng)當(dāng)建相應(yīng)的程序以確定、收集、分析相應(yīng)的數(shù)據(jù)從而證明質(zhì)量管理體系適宜性、充分性和有效性。程序應(yīng)到包括適當(dāng)?shù)姆椒▽W(xué)，包括分析技術(shù)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(shù)據(jù)分析應(yīng)當(dāng)包括監(jiān)控和測量過程中和來源于其他資源所產(chǎn)生的數(shù)據(jù)，同時包括最少來源于以下輸入的內(nèi)容：
a) feedback; 反饋
b) conformity toproduct requirements; 符合產(chǎn)品要求；
c)characteristics and trends of processes and product, including opportunitiesfor improvement; 過程和產(chǎn)品的特性和趨勢，包括改進(jìn)的條件。
d) suppliers; 供應(yīng)商
e) audits; 審核（審計）
f) service reports, as appropriate.服務(wù)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(shù)據(jù)分析顯示質(zhì)量管理體系不適宜、充分和有效，組織應(yīng)當(dāng)將此分析作為改進(jìn)（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(jié)果的記錄應(yīng)當(dāng)予以保留。（見4.2.5）