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ISO/DIS9001《質(zhì)量管理體系 要求》(2014國際標(biāo)準(zhǔn)草案)續(xù)

   日期:2024-10-25 21:22:21     來源:ISO9001認(rèn)證     作者:中企檢測認(rèn)證網(wǎng)     瀏覽:905    評(píng)論:0
核心提示:ISO/DIS9001《質(zhì)量管理體系 要求》(2014國際標(biāo)準(zhǔn)草案)續(xù)2015.3.12修訂9 Performance evaluation績效評(píng)價(jià)9

ISO/DIS9001《質(zhì)量管理體系 要求》(2014國際標(biāo)準(zhǔn)草案)續(xù)

2015.3.12修訂

9 Performance evaluation

績效評(píng)價(jià)

9.1 Monitoring, measurement, analysis and evaluation

監(jiān)視、測量、分析和評(píng)價(jià)

9.1.1 General

總則

The organization shall determine:

組織應(yīng)確定:

a) what needs to be monitored and measured;

監(jiān)視和測量對(duì)象

b) the methods for monitoring, measurement, analysis and evaluation, as applicable, to ensure valid results;

適用時(shí),監(jiān)視、測量、分析和評(píng)價(jià)方法,以確保結(jié)果有效

c) when the monitoring and measuring shall be performed;

確定監(jiān)視和測量的時(shí)機(jī)

d) when the results from monitoring and measurement shall be analyzed and evaluated.

確定對(duì)監(jiān)視和測量結(jié)果進(jìn)行分析和評(píng)價(jià)的時(shí)機(jī)

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(yīng)確保監(jiān)視和測量活動(dòng)按照確定的要求執(zhí)行,并應(yīng)保留適當(dāng)?shù)淖鳛榻Y(jié)果的證據(jù)的記錄信息。

The organization shall evaluate the quality performance and the effectiveness of the quality management system.

組織應(yīng)評(píng)價(jià)質(zhì)量績效和質(zhì)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(yīng)監(jiān)視顧客對(duì)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(yīng)獲得有關(guān)顧客對(duì)組織及其產(chǎn)品和服務(wù)的看法和意見的信息。

The methods for obtaining and using this information shall be determined.

應(yīng)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(guān)顧客的看法信息可以包括:顧客滿意度或意見調(diào)查、顧客關(guān)于交付的產(chǎn)品或服務(wù)質(zhì)量的數(shù)據(jù)、市場份額分析、贊美、索賠和經(jīng)銷商報(bào)告。

9.1.3 Analysis and evaluation

分析和評(píng)價(jià)

The organization shall analyse and evaluate appropriate data and information arising from monitoring, measurement and other sources.

組織應(yīng)分析和評(píng)價(jià)來自監(jiān)視、測量以及其他來源的適當(dāng)?shù)臄?shù)據(jù)和信息

The output of analysis and evaluation shall be used to:

分析和評(píng)價(jià)的輸出應(yīng)用于:

a) demonstrate conformity of products and services to requirements;

證實(shí)產(chǎn)品和服務(wù)符合要求

b) assess and enhance customer satisfaction;

評(píng)估和提高顧客滿意度

c) ensure conformity and effectiveness of the quality management system;

確保質(zhì)量管理體系的符合性和有效性

d) demonstrate that planning has been successfully implemented;

證實(shí)策劃已得到成功實(shí)施

e) assess the performance of processes;

評(píng)價(jià)過程績效

f) assess the performance of external provider(s);

評(píng)價(jià)外部供應(yīng)商的績效

g) determine the need or opportunities for improvements within the quality management system.

確定在質(zhì)量管理體系內(nèi)改進(jìn)的需求和機(jī)會(huì)

The results of analysis and evaluation shall also be used to provide inputs to management review.

分析和評(píng)價(jià)的結(jié)果也應(yīng)被用于提供管理評(píng)審的輸入

9.2 Internal audit

內(nèi)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(yīng)按策劃的時(shí)間間隔進(jìn)行內(nèi)部審核,以提供信息,關(guān)于質(zhì)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(duì)其質(zhì)量管理體系的要求

2) the requirements of this International Standard;

本標(biāo)準(zhǔn)的要求

b) is effectively implemented and maintained.

得到有效的實(shí)施和保持

9.2.2 The organization shall:

組織應(yīng)

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(shí)施和保持一個(gè)或多個(gè)審核方案,包括審核的頻次、方法、職責(zé)、策劃要求和報(bào)告,審核方案應(yīng)考慮質(zhì)量目標(biāo)、有關(guān)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(jié)果。

b) define the audit criteria and scope for each audit;

確定每次審核的準(zhǔn)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(shí)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(jié)果向相關(guān)管理者報(bào)告

e) take necessary correction and corrective actions without undue delay;

及時(shí)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(shí)施和審核結(jié)果的證據(jù)

NOTE See ISO 19011 for guidance.

注:作為指南,參見ISO19011

9.3 Management review

管理評(píng)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(yīng)按策劃的時(shí)間間隔評(píng)審組織的質(zhì)量管理體系,確保其持續(xù)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(píng)審策劃和實(shí)施時(shí)應(yīng)考慮:

a) the status of actions from previous management reviews;

以往管理評(píng)審的措施現(xiàn)狀

b) changes in external and internal issues that are relevant to the quality management system including its strategic direction;

與質(zhì)量管理體系包括其戰(zhàn)略方向有關(guān)的內(nèi)外部問題變化。

c) information on the quality performance, including trends and indicators for:

關(guān)于質(zhì)量績效的信息,包括以下方面的趨勢和指標(biāo)

1) nonconformities and corrective actions;

不符合和糾正措施

2) monitoring and measurement results;

監(jiān)視和測量結(jié)果

3) audit results;

審核結(jié)果

4) customer satisfaction;

顧客滿意度

5) issues concerning external providers and other relevant interested parties;

關(guān)于外部供應(yīng)商及其他相關(guān)方的問題;

6) adequacy of resources required for maintaining an effective quality management system;

維持有效的質(zhì)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(chǎn)品和服務(wù)的符合性

d) the effectiveness of actions taken to address risks and opportunities (see clause 6.1);

應(yīng)對(duì)風(fēng)險(xiǎn)和機(jī)會(huì)采取措施的有效性(見條款6.1)

e) new potential opportunities for continual improvement.

持續(xù)改進(jìn)的新的潛在的機(jī)會(huì)

9.3.2 The outputs of the management review shall include decisions and actions related to:

管理評(píng)審輸出應(yīng)包括以下相關(guān)的決定和措施

a) continual improvement opportunities;

持續(xù)改進(jìn)的機(jī)會(huì)

b) any need for changes to the quality management system, including resource needs.

對(duì)質(zhì)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(yīng)保持管理評(píng)審的結(jié)果的證據(jù)的記錄信息

10 Improvement

改進(jìn)

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(yīng)確定和選擇改進(jìn)的機(jī)會(huì),并采取必要的措施,以滿足顧客要求和增強(qiáng)顧客滿意度。

This shall include, as appropriate:

適當(dāng)時(shí),應(yīng)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(jìn)產(chǎn)品和服務(wù)來滿足已知和預(yù)期的要求

c) improving quality management system results.

改進(jìn)質(zhì)量觀管理體系的結(jié)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(jìn)可以是事后實(shí)現(xiàn)(例糾正措施)、漸進(jìn)型的(例,持續(xù)改進(jìn))、逐步改變(例,突破)、創(chuàng)造性(如創(chuàng)新)或重新組織(例如,轉(zhuǎn)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(dāng)發(fā)生不合格時(shí),包括哪些引起的抱怨,組織應(yīng):

a) react to the nonconformity, and as applicable:

適用時(shí),對(duì)不合格作出響應(yīng):

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(píng)價(jià)消除不合格原因的措施的需求,以便通過以下步驟不再發(fā)生和在其他區(qū)域發(fā)生:

1) reviewing the nonconformity;

評(píng)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(fā)生;

c) implement any action needed;

實(shí)施所需的任何措施

d) review the effectiveness of any corrective action taken;

評(píng)審每一個(gè)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(shí),對(duì)質(zhì)量管理體系進(jìn)行修改;

Corrective actions shall be appropriate to the effects of the nonconformities encountered.

糾正措施應(yīng)與所發(fā)生的不合格的影響相適應(yīng);

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(fù)發(fā)生的可能性到一個(gè)可接受的水平

10.2.2 The organization shall retain documented information as evidence of:

組織應(yīng)保持作為證據(jù)的記錄信息

a) the nature of the nonconformities and any subsequent actions taken;

不合格的性質(zhì)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(jié)果

10.3 Continual improvement

持續(xù)改進(jìn)

The organization shall continually improve the suitability, adequacy, and effectiveness of the quality management system.

組織應(yīng)持續(xù)改進(jìn)質(zhì)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(yīng)考慮分析和評(píng)價(jià)的輸出,和管理評(píng)審的輸出,以確定是否有應(yīng)解決的表現(xiàn)不佳或機(jī)會(huì)的領(lǐng)域,作為持續(xù)改進(jìn)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(shí),組織應(yīng)選擇和使用適用的工具和方法對(duì)表現(xiàn)不佳的原因調(diào)查和支持持續(xù)改進(jìn)。

以上全部結(jié)束,請各位批評(píng)指正!

2015.1.21

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