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5.1 Management commitment 管理承諾

Top managementshall provide evidence of its commitment to the development and implementationof the quality management system and maintenance of its effectiveness by:

最高管理者應(yīng)通過(guò)以下活動(dòng)，對(duì)其開(kāi)發(fā)、實(shí)施質(zhì)量管理體系并維持其有效性的承諾提供證據(jù):

a) communicatingto the organization the importance of meeting customer as well as applicable regulatoryrequirements;

向組織傳達(dá)滿(mǎn)足顧客和法律法規(guī)要求的重要性;

b) establishingthe quality policy;

確定質(zhì)量方針;

c) ensuring thatquality objectives are established;

確保質(zhì)量目標(biāo)的確定;

d) conductingmanagement reviews;

進(jìn)行管理評(píng)審;

e) ensuring theavailability of resources.

確保資源的獲得。

5.2 Customer focus 客戶(hù)關(guān)注

Top managementshall ensure that customer requirements and applicable regulatory requirementsare determined and met.

最高管理者應(yīng)確保顧客和相應(yīng)的法律法規(guī)要求得到確定并予以滿(mǎn)足。

5.3 Qualitypolicy 質(zhì)量方針

Top managementshall ensure that the quality policy:

最高管理者應(yīng)確保質(zhì)量方針：

a) is applicableto the purpose of the organization;

與組織的宗旨相適應(yīng)；

b) includes acommitment to comply with requirements and to maintain the effectiveness of thequality management system;

包括一個(gè)符合要求和維持質(zhì)量管理體系有效性的承諾;

c) provides aframework for establishing and reviewing quality objectives;

提供制定和評(píng)審質(zhì)量目標(biāo)的框架;

d) iscommunicated and understood within the organization;

在組織內(nèi)得到溝通和理解;

e) is reviewedfor continuing suitability.

為了保證持續(xù)適宜性應(yīng)當(dāng)進(jìn)行評(píng)審。

5.4 Planning 策劃

5.4.1 Quality objectives 質(zhì)量目標(biāo)

Top managementshall ensure that quality objectives, including those needed to meet applicableregulatory requirements and requirements for product, are established atrelevant functions and levels within the organization. The quality objectivesshall be measurable and consistent with the quality policy.

最高管理者應(yīng)確保在組織的相關(guān)職能和層次上建立質(zhì)量目標(biāo)，質(zhì)量目標(biāo)包括滿(mǎn)足適應(yīng)的法律法規(guī)和產(chǎn)品要求所需的內(nèi)容。質(zhì)量目標(biāo)應(yīng)是可測(cè)量的，并與質(zhì)量方針保持一致。

5.4.2 Quality management system planning 質(zhì)量管理體系策劃

Top managementshall ensure that: 高層管理者應(yīng)當(dāng)保證：

a) the planningof the quality management system is carried out in order to meet therequirements given in 4.1, as well as thequality objectives;

質(zhì)量管理體系的策劃應(yīng)當(dāng)?shù)玫截瀼匾苑?.1項(xiàng)下和質(zhì)量目標(biāo)的要求;

b) the integrityof the quality management system is maintained when changes to the quality managementsystem are planned and implemented.

經(jīng)策劃和實(shí)施質(zhì)量管理體系發(fā)生變更時(shí)，應(yīng)當(dāng)保持質(zhì)量管理體系的完整性。