《質(zhì)量管理體系文件》ISO9001_2015_中英文對(duì)照

1、 1 secretariat of iso/tc 176/sc 2 date: 3 june 2013 to the members of iso/tc 176/sc 2 - quality management and quality assurance/ quality systems iso/cd 9001 目錄目錄 1 scope 范圍 2 normative references 規(guī)范性引用文件 3 terms and definitions 術(shù)語和定義 4 context of the organization 組織的背景 4.1 understanding the organiz

2、ation and its context 理解組織及其背景 4.2 understanding the needs and expectations of interested parties 理解相關(guān)方的需求和期望 4.3 determining the scope of the quality management system 質(zhì)量管理體系范圍的確定 4.4 quality management system 質(zhì)量管理體系 5 leadership 領(lǐng)導(dǎo)作用 5.1 leadership and commitment 領(lǐng)導(dǎo)作用和承諾 5.2 quality policy 質(zhì)量方針 5.

3、3 organizational roles, responsibilities and authorities 組織的作用、職責(zé)和權(quán)限 6 planning 策劃 6.1 actions to address risks and opportunities 風(fēng)險(xiǎn)和機(jī)遇的應(yīng)對(duì)措施 6.2 quality objectives and planning to achieve them 質(zhì)量目標(biāo)及其實(shí)施的策劃 6.3 planning of changes 變更的策劃 7 support 支持 7.1 resources 資源 7.2 competence 能力 7.3 awareness 意識(shí)

4、7.4 communication 溝通 7.5 documented information 形成文件的信息 8 operation 運(yùn)行 8.1 operational planning and control 運(yùn)行的策劃和控制 8.2 determination of market needs and interactions with customers 市場需求的確定和顧客溝通 8.3 operational planning process 運(yùn)行策劃過程 28.4 control of external provision of goods and services 外部供應(yīng)產(chǎn)品和

5、服務(wù)的控制 8.5 development of goods and services 產(chǎn)品和服務(wù)開發(fā) 8.6 production of goods and provision of services 產(chǎn)品生產(chǎn)和服務(wù)提供 8.7 release of goods and services 產(chǎn)品和服務(wù)放行 8.8 nonconforming goods and services 不合格產(chǎn)品和服務(wù) 9 performance evaluation 績效評(píng)價(jià) 9.1 monitoring, measurement, analysis and evaluation 監(jiān)視、測(cè)量、分析和評(píng)價(jià) 9.2 i

6、nternal audit 內(nèi)部審核 9.3 management review 管理評(píng)審 10 continual improvement 持續(xù)改進(jìn) 10.1 nonconformity and corrective action 不符合和糾正措施 10.2 improvement 改進(jìn)附錄 a annex a quality management principles (informative)質(zhì)量管理原則文獻(xiàn) 1scope 范圍范圍 this international standard specifies requirements for a quality management sy

7、stem where an organization 本標(biāo)準(zhǔn)為有下列需求的組織規(guī)定了質(zhì)量管理體系要求： a）needs to demonstrate its ability to consistently provide goods and services that meet customer and applicable statutory and regulatory requirements, and 需要證實(shí)其具有穩(wěn)定地提供滿足顧客要求和適用法律法規(guī)要求的產(chǎn)品和服務(wù)的能力； b）aims to enhance customer satisfaction through the eff

8、ective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements 通過體系的的有效應(yīng)用， 包括體系持續(xù)改進(jìn)的過程，以及保證符合顧客和適用的法律法規(guī)要求，旨在增強(qiáng)顧客滿意。 注 1：in this international standard, the term “product” o

9、nly applies to 在本標(biāo)準(zhǔn)一中，術(shù)語“產(chǎn)品”僅適用于： a) goods and services intended for, or required by, a customer, and 預(yù)期提供給顧客或顧客所要求的商品和服務(wù)； b) any intended output resulting from the operational processes 運(yùn)行過程所產(chǎn)生的任何預(yù)期輸出。 注 2：statutory and regulatory requirements can be expressed as legal requirements 法律法規(guī)要求可稱作為法定要求。

10、2 normative references 規(guī)范性引用文件規(guī)范性引用文件 the following referenced documents are indispensable for the application of this document. for dated references, only the edition cited applies. for undated references, the latest edition of the referenced document (including any amendments) applies 下列文件中的條款通過本標(biāo)

11、準(zhǔn)的引用而構(gòu)成本標(biāo)準(zhǔn)的條款。凡是注日期的引用文件，只有引用的版本適用。凡是不注日期的引用文件，其最新版本（包括任何修訂）適用于本標(biāo)準(zhǔn)。 iso 9000:2015, quality management systems fundamentals and vocabulary gb/t19000- 2015 質(zhì)量管理體系 基礎(chǔ)和術(shù)語 3 3 term and definitions 術(shù)語和定義術(shù)語和定義 for the purposes of this document, the terms and definitions given in iso 9000 apply 本標(biāo)準(zhǔn)采用 gb/t19

12、000 中所確立的術(shù)語和定義。 4 context of the organization 組織的背景環(huán)境組織的背景環(huán)境 4.1 understanding the organization and its context 理解組織及其背景環(huán)境理解組織及其背景環(huán)境 the organization shall determine external and internal issues, that are relevant to its purpose and its strategic direction and that affect its ability to achieve the

13、intended outcome(s) of its quality management system 組織應(yīng)確定外部和內(nèi)部那些與組織的宗旨、戰(zhàn)略方向有關(guān)、影響質(zhì)量管理體系實(shí)現(xiàn)預(yù)期結(jié)果的能力的事務(wù)。 the organization shall update such determinations when needed 需要時(shí)，組織應(yīng)更新這些信息。 when determining relevant external and internal issues, the organization shall consider those arising from:在確定這些相關(guān)的內(nèi)部和外部事宜

14、時(shí)，組織應(yīng)考慮以下方面： a) changes and trends which can have an impact on the objectives of the organization可能對(duì)組織的目標(biāo)造成影響的變更和趨勢(shì)； b) relationships with, and perceptions and values of relevant interested parties 與相關(guān)方的關(guān)系，以及相關(guān)方的理念、價(jià)值觀； c) governance issues, strategic priorities, internal policies and commitments; a

15、nd 組織管理、 戰(zhàn)略優(yōu)先、內(nèi)部政策和承諾； d) resource availability and priorities and technological change 資源的獲得和優(yōu)先供給、技術(shù)變更。 注 1：understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, cultural, social, economic and natural environment, whether interna

16、tional, national, regional or local.外部的環(huán)境，可以考慮法律、技術(shù)、競爭、文化、社會(huì)、經(jīng)濟(jì)和自然環(huán)境方面，不管是國際、國家、地區(qū)或本地。 注 2：when understanding the internal context the organization could consider those related to perceptions, values and culture of the organization.內(nèi)部環(huán)境， 可以組織的理念、 價(jià)值觀和文化。 4.2 understanding the needs and expectations

17、of interested parties 理解相關(guān)方的需求和期望理解相關(guān)方的需求和期望 the organization shall determine 組織應(yīng)確定： a) the interested parties that are relevant to the quality management system, and 與質(zhì)量管理體系有關(guān)的相關(guān)方 b) the requirements of these interested parties 相關(guān)方的要求 the organization shall update such determinations in order to un

18、derstand and anticipate needs or expectations affecting customer requirements and customer satisfaction 組織應(yīng)更新以上確定的結(jié)果，以便于理解和滿足影響顧客要求和顧客滿意度的需求和期望。 the organization shall consider the following relevant interested parties 組織應(yīng)考慮以下相關(guān)方： a) direct customers 直接顧客 4b) end users 最終使用者 c) suppliers, distributo

19、rs, retailers or others involved in the supply chain 供應(yīng)鏈中的供方、分銷商、零售商及其他 d) regulators; and 立法機(jī)構(gòu) e) any other relevant interested parties 其他 注：note addressing current and anticipated future needs can lead to the identification of improvement and innovation opportunities應(yīng)對(duì)當(dāng)前的和預(yù)期的未來需求可導(dǎo)致改進(jìn)和變革機(jī)會(huì)的識(shí)別。 4.3

20、 determining the scope of the quality management system 確定質(zhì)量管理體系的范圍確定質(zhì)量管理體系的范圍 the organization shall determine the boundaries and applicability of the quality management system to establish its scope 組織應(yīng)界定質(zhì)量管理體系的邊界和應(yīng)用，以確定其范圍。 when determining this scope, the organization shall consider 在確定質(zhì)量管理體系范圍時(shí)

21、， 組織應(yīng)考慮： a) the external and internal issues referred to in 4.1, and 標(biāo)準(zhǔn) 4.1 條款中提到的內(nèi)部和外部事宜 b) the requirements referred to in 4.2 標(biāo)準(zhǔn) 4.2 條款的要求 the scope shall be stated in terms of goods and services, the main processes to deliver them and the sites of the organization included 質(zhì)量管理體系的范圍應(yīng)描述為組織所包含的產(chǎn)品、

22、服務(wù)、主要過程和地點(diǎn)。 when stating the scope, the organization shall document and justify any decision not to apply a requirement of this international standard and to exclude it from the scope of the quality management system. any such exclusion shall be limited to clause 7.1. 4 and 8 and shall not affect th

23、e organizations ability or responsibility to assure conformity of goods and services and customer satisfaction, nor can an exclusion be justified on the basis of a decision to arrange for an external provider to perform a function or process of the organization.描述質(zhì)量管理體系的范圍時(shí)，對(duì)不適用的標(biāo)準(zhǔn)條款，應(yīng)將質(zhì)量管理體系的刪減及其理由

24、形成文件。刪減應(yīng)僅限于標(biāo)準(zhǔn)第 7.1、 4 和 8 章節(jié)， 且不影響組織確保產(chǎn)品和服務(wù)滿足要求和顧客滿意的能力和責(zé)任。過程外包不是正當(dāng)?shù)膭h減理由。 注：an external provider can be a supplier or a sister organization (such as a headquarters or alternate site location) that is outside of the organizations quality management system.外部供應(yīng)商可以是組織質(zhì)量管理體系之外的供方或兄弟組織。 the scope shall b

25、e available as documented information 質(zhì)量管理管理體系范圍應(yīng)形成文件。 4.4 quality management system 質(zhì)量管理體系質(zhì)量管理體系 4.4.1 general 總則總則 the organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their interactions, in accordance with th

26、e requirements of this international standard.組織應(yīng)按本標(biāo)準(zhǔn)的要求建立質(zhì)量管理體系、過程及其相互作用，加以實(shí)施和保持，并持續(xù)改進(jìn)。 4.4.2 process approach 過程方法過程方法 the organization shall apply a process approach to its quality management system. the 5organization shall:組織應(yīng)將過程方法應(yīng)用于質(zhì)量管理體系。組織應(yīng)： a) determine the processes needed for the quality

27、management system and their application throughout the organization;確定質(zhì)量管理體系所需的過程及其在整個(gè)組織中的應(yīng)用; b) determine the inputs required and the outputs expected from each process;確定每個(gè)過程所需的輸入和期望的輸出； c) determine the sequence and interaction of these processes;確定這些過程的順序和相互作用； d) determine the risks to conformi

28、ty of goods and services and customer satisfaction if unintended outputs are delivered or process interaction is ineffective;確定產(chǎn)生非預(yù)期的輸出或過程失效對(duì)產(chǎn)品、服務(wù)和顧客滿意帶來的風(fēng)險(xiǎn)； e) determine criteria, methods, measurements, and related performance indicators needed to ensure that both the operation and control of these

29、 processes are effective 確定所需的準(zhǔn)則、方法、測(cè)量及相關(guān)的績效指標(biāo)，以確保這些過程的有效運(yùn)行和控制； f) determine the resources and ensure their availability 確定和提供資源； g) assign responsibilities and authorities for processes 規(guī)定職責(zé)和權(quán)限； h) implement actions necessary to achieve planned results 實(shí)施所需的措施以實(shí)現(xiàn)策劃的結(jié)果； i) monitor, analyse and chang

30、e, if needed, these processes ensuring that they continue to deliver the intended outputs; and 監(jiān)測(cè)、分析這些過程，必要時(shí)變更，以確保過程持續(xù)產(chǎn)生期望的結(jié)果； j) ensure continual improvement of these processes.確保持續(xù)改進(jìn)這些過程。 5 leadership 領(lǐng)導(dǎo)作用領(lǐng)導(dǎo)作用 5.1leadership and commitment 領(lǐng)導(dǎo)作用與承諾領(lǐng)導(dǎo)作用與承諾 5.1.1 leadership and commitment with respect

31、 to the quality management system 針對(duì)質(zhì)量管針對(duì)質(zhì)量管理體系的領(lǐng)導(dǎo)作用與承諾理體系的領(lǐng)導(dǎo)作用與承諾 top management shall demonstrate leadership and commitment with respect to the quality management system by 最高管理者應(yīng)通過以下方面證實(shí)其對(duì)質(zhì)量管理體系的領(lǐng)導(dǎo)作用與承諾： a) ensuring that quality policies and quality objectives are established for the quality mana

32、gement system and are compatible with the strategic direction of the organization;確保質(zhì)量方針和質(zhì)量目標(biāo)得到建立，并與組織的戰(zhàn)略方向保持一致； b) ensuring the quality policy is understood and followed within the organization;確保質(zhì)量方針在組織內(nèi)得到理解和實(shí)施； c) ensuring the integration of the quality management system requirements into the org

33、anizations business processes;確保質(zhì)量管理體系要求納入組織的業(yè)務(wù)運(yùn)作； d) promoting awareness of the process approach;提高過程方法的意識(shí)； e) ensuring that the resources needed for the quality management system are available;確保質(zhì)量管理體系所需資源的獲得； f) communicating the importance of effective quality management and of conforming to the

34、 quality management system requirements and the requirements of goods and services;傳達(dá)有效的質(zhì)量管理以及滿足質(zhì)量管理體系、產(chǎn)品和服務(wù)要求的重要性； g) ensuring that the quality management system achieves its intended outcomes outputs;確保質(zhì)量管理體系實(shí)現(xiàn)預(yù)期的輸出； h) engaging, directing and supporting persons to contribute to the effectiveness

35、of the quality 6management system 吸納、指導(dǎo)和支持員工參與對(duì)質(zhì)量管理體系的有效性作出貢獻(xiàn)； i) promoting continual improvement and innovation; and 增強(qiáng)持續(xù)改進(jìn)和創(chuàng)新； j) supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.支持其他的管理者在其負(fù)責(zé)的領(lǐng)域證實(shí)其領(lǐng)導(dǎo)作用。 5.1.2leadership and co

36、mmitment with respect to the needs and expectations of customers 針針對(duì)顧客需求和期望的領(lǐng)導(dǎo)作用與承諾對(duì)顧客需求和期望的領(lǐng)導(dǎo)作用與承諾 top management shall demonstrate leadership and commitment with respect to customer focus by ensuring that 最高管理者應(yīng)通過以下方面， 證實(shí)其針對(duì)以顧客為關(guān)注焦點(diǎn)的領(lǐng)導(dǎo)作用和承諾： a) the risks which can affect conformity of goods and se

37、rvices and customer satisfaction are identified and addressed;可能影響產(chǎn)品和服務(wù)符合性、顧客滿意的風(fēng)險(xiǎn)得到識(shí)別和應(yīng)對(duì)； b) customer requirements are determined and met;顧客要求得到確定和滿足； c) the focus on consistently providing goods and services that meet customer and applicable statutory and regulatory requirements is maintained;保持以穩(wěn)

38、定提供滿足顧客和相關(guān)法規(guī)要求的產(chǎn)品和服務(wù)為焦點(diǎn)； d) the focus on enhancing customer satisfaction is maintained;保持以增強(qiáng)顧客滿意為焦點(diǎn)； 注：reference to “business” in this international standard should be interpreted broadly to mean those activities that are core to the purposes of the organizations existence.本標(biāo)準(zhǔn)中的“業(yè)務(wù)”可以廣泛地理解為對(duì)組織存在的目的很

39、重要的活動(dòng)。 5.2quality policy 質(zhì)量方針質(zhì)量方針 top management shall establish a quality policy that:最高管理者應(yīng)制定質(zhì)量方針，方針應(yīng)： a) is appropriate to the purpose of the organization;與組織的宗旨相適應(yīng)； b) provides a framework for setting quality objectives;提供制定質(zhì)量目標(biāo)的框架； c) includes a commitment to satisfy applicable requirements, an

40、d 包括對(duì)滿足適用要求的承諾； d) includes a commitment to continual improvement of the quality management system.包括對(duì)持續(xù)改進(jìn)質(zhì)量管理體系的承諾。 the quality policy shall:質(zhì)量方針應(yīng)： a) be available as documented information;形成文件； b) be communicated within the organization;在組織內(nèi)得到溝通； c) be available to interested parties, as appropri

41、ate; and 適用時(shí)，可為相關(guān)方所獲??； d) be reviewed for continuing suitability.在持續(xù)適宜性方面得到評(píng)審。 注：quality management principles can be used as the basis for the quality policy.質(zhì)量管理原則可作為質(zhì)量方針的基礎(chǔ)。 5.3 organizational roles, responsibilities and authorities 組織的作用、職責(zé)和權(quán)限組織的作用、職責(zé)和權(quán)限 top management shall ensure that the resp

42、onsibilities and authorities for relevant roles are assigned and communicated within the organization.最高管理者應(yīng)確保組織內(nèi)相關(guān)的職責(zé)、權(quán)限得到規(guī)定和溝通。 7 top management shall be accountable for the effectiveness of the quality management system and shall assign the responsibility and authority for:最高管理者應(yīng)對(duì)質(zhì)量管理體系的有效性負(fù)責(zé)，并規(guī)定

43、職責(zé)和權(quán)限以便： a) ensuring that the quality management system conforms to the requirements of this international standard and,確保質(zhì)量管理體系符合本標(biāo)準(zhǔn)的要求； b) ensuring that the processes interact and are delivering their intended outputs;確保過程相互作用并產(chǎn)生期望的結(jié)果； c) reporting on the performance of the quality management syst

44、em to top management and any need for improvement, and 向最高管理者報(bào)告質(zhì)量管理體系的績效和任何改進(jìn)的需求； d) ensuring the promotion of awareness of customer requirements throughout the organization.確保在整個(gè)組織內(nèi)提高滿足顧客要求的意識(shí)。 6 planning 策劃策劃 6.1actions to address risks and opportunities 風(fēng)險(xiǎn)和機(jī)遇的應(yīng)對(duì)措施風(fēng)險(xiǎn)和機(jī)遇的應(yīng)對(duì)措施 when planning for the

45、quality management system, the organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed to 策劃質(zhì)量管理體系時(shí)，組織應(yīng)考慮 4.1 和 4.2 的要求，確定需應(yīng)對(duì)的風(fēng)險(xiǎn)和機(jī)遇，以便： a) assure the quality management system can achieve it

46、s intended outcome(s);確保質(zhì)量管理體系實(shí)現(xiàn)期望的結(jié)果； b) assure that the organization can consistently achieve conformity of goods and services and customer satisfaction;確保組織能穩(wěn)定地實(shí)現(xiàn)產(chǎn)品、服務(wù)符合要求和顧客滿意； c) prevent, or reduce, undesired effects, and 預(yù)防或減少非預(yù)期的影響； d) achieve continual improvement.實(shí)現(xiàn)持續(xù)改進(jìn)。 the organization sh

47、all plan:組織應(yīng)策劃： a) actions to address these risks and opportunities, and 風(fēng)險(xiǎn)和機(jī)遇的應(yīng)對(duì)措施； b) how to 如何 1) integrate and implement the actions into its quality management system processes (see 4.4), and 在質(zhì)量管理體系過程中納入和應(yīng)用這些措施（見 4.4） 2) evaluate the effectiveness of these actions.評(píng)價(jià)這些措施的有效性 any actions taken

48、to address risks and opportunities shall be proportionate to the potential effects on conformity of goods and services and customer satisfaction.采取的任何風(fēng)險(xiǎn)和機(jī)遇的應(yīng)對(duì)措施都應(yīng)與其對(duì)產(chǎn)品、服務(wù)的符合性和顧客滿意的潛在影響相適應(yīng)。 注：options to address risks can include for example risk avoidance, risk mitigation or risk acceptance可選的風(fēng)險(xiǎn)應(yīng)對(duì)措施包

49、括風(fēng)險(xiǎn)規(guī)避、風(fēng)險(xiǎn)降低、風(fēng)險(xiǎn)接受等。 6.2quality objectives and planning to achieve them 質(zhì)量目標(biāo)及其實(shí)施的策劃質(zhì)量目標(biāo)及其實(shí)施的策劃 the organization shall establish quality objectives at relevant functions, levels and processes. the quality objectives shall:組織應(yīng)在相關(guān)職能、層次、過程上建立質(zhì)量目標(biāo)。質(zhì)量目標(biāo)應(yīng)： a) be consistent with the quality policy;與質(zhì)量方針保持一致 b)

50、 be relevant to conformity of goods and services and customer satisfaction;與產(chǎn)品、服務(wù)的 8符合性和顧客滿意相關(guān) c) be measurable (if practicable);可測(cè)量（可行時(shí)） d) take into account applicable requirements,考慮適用的要求 e) be monitored,得到監(jiān)測(cè) f) be communicated, and 得到溝通 g) be updated as appropriate.適當(dāng)時(shí)進(jìn)行更新 the organization shall

51、 retain documented information on the quality objectives.組織應(yīng)將質(zhì)量目標(biāo)形成文件。 when planning how to achieve its quality objectives, the organization shall determine:在策劃目標(biāo)的實(shí)現(xiàn)時(shí)，組織應(yīng)確定： a) what will be done;做什么； b) what resources will be required (see 7.1)所需的資源（見 7.1） ； c) who will be responsible;責(zé)任人； d) when i

52、t will be completed, and 完成的時(shí)間表； e) how the results will be evaluated.結(jié)果如何評(píng)價(jià)。 6.3planning of changes 變更的策劃變更的策劃 the organization shall determine the needs and opportunities for change to maintain and improve the performance of the quality management system.組織應(yīng)確定變更的需求和機(jī)會(huì)， 以保持和改進(jìn)質(zhì)量管理體系績效。 the organiza

53、tion shall undertake change in a planned and systematic manner, identifying risks and opportunities and reviewing the potential consequences of change.組織應(yīng)有計(jì)劃、 系統(tǒng)地進(jìn)行變更，識(shí)別風(fēng)險(xiǎn)和機(jī)遇，并評(píng)價(jià)變更的潛在后果。 注：specific requirements on control of changes are included in clause 8.變更控制的特定要求在第 8 條規(guī)定。 7 support 支持支持 7.1resou

54、rces 資源資源 7.1.1 general 總則總則 the organization shall determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system.組織應(yīng)確定、提供為建立、實(shí)施、保持和改進(jìn)質(zhì)量管理體系所需的資源。 the organization shall consider 組織應(yīng)考慮： a) what are existing in

55、ternal resources, capabilities and limitations, and 現(xiàn)有的資源、 能力、 局限 b) which goods and services are to be sourced externally.外包的產(chǎn)品和服務(wù) 7.1.2 infrastructure 基礎(chǔ)設(shè)施基礎(chǔ)設(shè)施 the organization shall determine, provide and maintain the infrastructure necessary for its 9operations and to assure conformity of goods

56、and services and customer satisfaction.組織應(yīng)確定、提供和維護(hù)其運(yùn)行和確保產(chǎn)品、服務(wù)符合性和顧客滿意所需的基礎(chǔ)設(shè)施。 注：note infrastructure can include:基礎(chǔ)設(shè)施可包括： a) buildings and associated utilities;建筑物和相關(guān)的設(shè)施 b) equipment including hardware and software, and設(shè)備（包括硬件和軟件） c) transportation, communication and information systems.運(yùn)輸、通訊和信息系統(tǒng) 7.

57、1.3 process environment 過程環(huán)境過程環(huán)境 the organization shall determine, provide and maintain the process environment necessary for its operations and to assure conformity of goods and services and customer satisfaction.組織應(yīng)確定、提供和維護(hù)其運(yùn)行和確保產(chǎn)品、服務(wù)符合性和顧客滿意所需的過程環(huán)境。 注：process environment can include physical, soc

58、ial, psychological and environmental factors (such as temperature, recognition schemes, ergonomics and atmospheric composition).過程環(huán)境可包括物理的、社會(huì)的、心理的和環(huán)境的因素（例如：溫度、承認(rèn)方式、人因工效、大氣成分） 。 7.1.4 monitoring and measuring devices 監(jiān)視和測(cè)量設(shè)備監(jiān)視和測(cè)量設(shè)備 the organization shall determine, provide and maintain the monitoring

59、 and measuring devices needed to verify conformity to product requirements and shall ensure that the devices are fit for purpose.組織應(yīng)確定、 提供和維護(hù)用于驗(yàn)證產(chǎn)品符合性所需的監(jiān)視和測(cè)量設(shè)備， 并確保監(jiān)視和測(cè)量設(shè)備滿足使用要求。 the organization shall retain appropriate documented information as evidence of fitness for purpose of monitoring and me

60、asuring devices.組織應(yīng)保持適當(dāng)?shù)奈募畔ⅲ?以提供監(jiān)視和測(cè)量設(shè)備滿足使用要求的證據(jù)。 注 1：monitoring and measurement devices can include measuring equipment and assessment methods such as surveys.監(jiān)視和測(cè)量設(shè)備可包括測(cè)量設(shè)備和評(píng)價(jià)方法（例如：調(diào)查問卷） 。 注 2：monitoring and measurement devices can be calibrated or verified, or both, at specified intervals, or pr