ISO/DIS9001《質量管理體系 要求》（2014國際標準草案）續
2015.3.12修訂
9 Performance evaluation
績效評價
9.1 Monitoring, measurement, analysis and evaluation
監視、測量、分析和評價
9.1.1 General
總則
The organization shall determine:
組織應確定：
a) what needs to be monitored and measured;
監視和測量對象
b) the methods for monitoring, measurement, analysis and evaluation, as applicable, to ensure valid results;
適用時，監視、測量、分析和評價方法，以確保結果有效
c) when the monitoring and measuring shall be performed;
確定監視和測量的時機
d) when the results from monitoring and measurement shall be analyzed and evaluated.
確定對監視和測量結果進行分析和評價的時機
The organization shall ensure that monitoring and measurement activities are implemented in accordance with the determined requirements and shall retain appropriate documented information as evidence of the results.
組織應確保監視和測量活動按照確定的要求執行，并應保留適當的作為結果的證據的記錄信息。
The organization shall evaluate the quality performance and the effectiveness of the quality management system.
組織應評價質量績效和質量管理體系的有效性。
9.1.2 Customer satisfaction
顧客滿意
The organization shall monitor customer perceptions of the degree to which requirements have been met.
組織應監視顧客對其要求已得到滿足的感知程度。
The organization shall obtain information relating to customer views and opinions of the organization and its products and services.
組織應獲得有關顧客對組織及其產品和服務的看法和意見的信息。
The methods for obtaining and using this information shall be determined.
應確定獲取和利用這些信息的方法
NOTE Information related to customer views can include customer satisfaction or opinion surveys, customer data on delivered products or services quality, market-share analysis, compliments, warranty claims and dealer reports.
注：有關顧客的看法信息可以包括：顧客滿意度或意見調查、顧客關于交付的產品或服務質量的數據、市場份額分析、贊美、索賠和經銷商報告。
9.1.3 Analysis and evaluation
分析和評價
The organization shall analyse and evaluate appropriate data and information arising from monitoring, measurement and other sources.
組織應分析和評價來自監視、測量以及其他來源的適當的數據和信息
The output of analysis and evaluation shall be used to:
分析和評價的輸出應用于：
a) demonstrate conformity of products and services to requirements;
證實產品和服務符合要求
b) assess and enhance customer satisfaction;
評估和提高顧客滿意度
c) ensure conformity and effectiveness of the quality management system;
確保質量管理體系的符合性和有效性
d) demonstrate that planning has been successfully implemented;
證實策劃已得到成功實施
e) assess the performance of processes;
評價過程績效
f) assess the performance of external provider(s);
評價外部供應商的績效
g) determine the need or opportunities for improvements within the quality management system.
確定在質量管理體系內改進的需求和機會
The results of analysis and evaluation shall also be used to provide inputs to management review.
分析和評價的結果也應被用于提供管理評審的輸入
9.2 Internal audit
內部審核
9.2.1 The organization shall conduct internal audits at planned intervals to provide information on whether the quality management system;
組織應按策劃的時間間隔進行內部審核，以提供信息，關于質量管理體系是否：
a) conforms to:
符合
1) the organization’s own requirements for its quality management system;
組織自身對其質量管理體系的要求
2) the requirements of this International Standard;
本標準的要求
b) is effectively implemented and maintained.
得到有效的實施和保持
9.2.2 The organization shall:
組織應
a) plan, establish, implement and maintain an audit programme(s) including the frequency, methods, responsibilities, planning requirements and reporting, which shall take into consideration the quality objectives, the importance of the processes concerned, customer feedback, changes impacting on the organization, and the results of previous audits;
策劃、建立、實施和保持一個或多個審核方案，包括審核的頻次、方法、職責、策劃要求和報告，審核方案應考慮質量目標、有關過程的重要性、顧客的反饋、影響組織的變化和以往審核的結果。
b) define the audit criteria and scope for each audit;
確定每次審核的準則和每次審核的范圍
c) select auditors and conduct audits to ensure objectivity and the impartiality of the audit process;
選擇審核員和實施審核以確保審核過程的客觀性和公正性。 [??m?pɑ:??'?l?t?]
d) ensure that the results of the audits are reported to relevant management;
確保審核結果向相關管理者報告
e) take necessary correction and corrective actions without undue delay;
及時采取必要的糾正和糾正措施
f) retain documented information as evidence of the implementation of the audit programmer and the audit results.
保持記錄信息，作為審核方案實施和審核結果的證據
NOTE See ISO 19011 for guidance.
注：作為指南，參見ISO19011
9.3 Management review
管理評審
9.3.1 Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability [?sju:t?'b?l?t?], adequacy ['?d?kw?s?], and effectiveness.
最高管理者應按策劃的時間間隔評審組織的質量管理體系，確保其持續的適宜性、充分性和有效性。
The management review shall be planned and carried out taking into consideration:
管理評審策劃和實施時應考慮：
a) the status of actions from previous management reviews;
以往管理評審的措施現狀
b) changes in external and internal issues that are relevant to the quality management system including its strategic direction;
與質量管理體系包括其戰略方向有關的內外部問題變化。
c) information on the quality performance, including trends and indicators for:
關于質量績效的信息，包括以下方面的趨勢和指標
1) nonconformities and corrective actions;
不符合和糾正措施
2) monitoring and measurement results;
監視和測量結果
3) audit results;
審核結果
4) customer satisfaction;
顧客滿意度
5) issues concerning external providers and other relevant interested parties;
關于外部供應商及其他相關方的問題；
6) adequacy of resources required for maintaining an effective quality management system;
維持有效的質量管理體系所需的足夠的資源
7) process performance and conformity of products and services;
過程績效、產品和服務的符合性
d) the effectiveness of actions taken to address risks and opportunities (see clause 6.1);
應對風險和機會采取措施的有效性（見條款6.1）
e) new potential opportunities for continual improvement.
持續改進的新的潛在的機會
9.3.2 The outputs of the management review shall include decisions and actions related to:
管理評審輸出應包括以下相關的決定和措施
a) continual improvement opportunities;
持續改進的機會
b) any need for changes to the quality management system, including resource needs.
對質量管理體系變更的任何需求，包括資源需求
The organization shall retain documented information as evidence of the results of management reviews.
組織應保持管理評審的結果的證據的記錄信息
10 Improvement
改進
10.1 General
總則
The organization shall determine and select opportunities for improvement and implement necessary actions to meet customer requirements and enhance customer satisfaction.
組織應確定和選擇改進的機會，并采取必要的措施，以滿足顧客要求和增強顧客滿意度。
This shall include, as appropriate:
適當時，應包括：
a) improving processes to prevent nonconformities;
改善過程來防止不合格；
b) improving products and services to meet known and predicted requirements;
改進產品和服務來滿足已知和預期的要求
c) improving quality management system results.
改進質量觀管理體系的結果
NOTE Improvement can be effected reactively (e.g. corrective action), incrementally (e.g. continual improvement), by step change (e.g. breakthrough), creatively (e.g. innovation) or by re-organization (e.g. transformation).
注：改進可以是事后實現（例糾正措施）、漸進型的（例，持續改進）、逐步改變（例，突破）、創造性（如創新）或重新組織（例如，轉換）。
10.2 Nonconformity and corrective action
不合格和糾正措施
10.2.1 When a nonconformity occurs, including those arising from complaints, the organization shall:
當發生不合格時，包括哪些引起的抱怨，組織應：
a) react to the nonconformity, and as applicable:
適用時，對不合格作出響應：
1) take action to control and correct it;
采取措施控制和糾正不合格；
2) deal with the consequences;
處理后果
b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere, by:
評價消除不合格原因的措施的需求，以便通過以下步驟不再發生和在其他區域發生：
1) reviewing the nonconformity;
評審不合格
2) determining the causes of the nonconformity;
確定不合格的原因
3) determining if similar nonconformities exist, or could potentially occur;
確定是否存在類似的不合格，或可能潛在發生；
c) implement any action needed;
實施所需的任何措施
d) review the effectiveness of any corrective action taken;
評審每一個采取糾正措施的有效性
e) make changes to the quality management system, if necessary.
如果必要時，對質量管理體系進行修改；
Corrective actions shall be appropriate to the effects of the nonconformities encountered.
糾正措施應與所發生的不合格的影響相適應；
NOTE 1 In some instances, it can be impossible to eliminate the cause of a nonconformity.
注1：在某些情況下，它可以是不可能消除不合格的原因。
NOTE 2 Corrective action can reduce the likelihood of recurrence [r??k?r?ns] to an acceptable level.
注2：糾正措施可以減少重復發生的可能性到一個可接受的水平
10.2.2 The organization shall retain documented information as evidence of:
組織應保持作為證據的記錄信息
a) the nature of the nonconformities and any subsequent actions taken;
不合格的性質以及隨后所采取的任何措施；
b) the results of any corrective action.
任何糾正措施的結果
10.3 Continual improvement
持續改進
The organization shall continually improve the suitability, adequacy, and effectiveness of the quality management system.
組織應持續改進質量管理體系的適宜性、充分性和有效性。
The organization shall consider the outputs of analysis and evaluation, and the outputs from management review, to confirm if there are areas of underperformance or opportunities that shall be addressed as part of continual improvement.
組織應考慮分析和評價的輸出，和管理評審的輸出，以確定是否有應解決的表現不佳或機會的領域，作為持續改進的一部分。
Where applicable, the organization shall select and utilise applicable tools and methodologies for investigation of the causes of underperformance and for supporting continual improvement.
適用時，組織應選擇和使用適用的工具和方法對表現不佳的原因調查和支持持續改進。
以上全部結束，請各位批評指正！
2015.1.21
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