ISO13485-2016中英文對照 管理職責（5.1~5.4）

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:

最高管理者應通過以下活動，對其開發、實施質量管理體系并維持其有效性的承諾提供證據:

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

向組織傳達滿足顧客和法律法規要求的重要性;

b) establishingthe quality policy;

確定質量方針;

c) ensuring thatquality objectives are established;

確保質量目標的確定;

d) conductingmanagement reviews;

進行管理評審;

e) ensuring theavailability of resources.

確保資源的獲得。

5.2 Customer focus 客戶關注

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

最高管理者應確保顧客和相應的法律法規要求得到確定并予以滿足。

5.3 Qualitypolicy 質量方針

Top managementshall ensure that the quality policy:

最高管理者應確保質量方針：

a) is applicableto the purpose of the organization;

與組織的宗旨相適應；

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

包括一個符合要求和維持質量管理體系有效性的承諾;

c) provides aframework for establishing and reviewing quality objectives;

提供制定和評審質量目標的框架;

d) iscommunicated and understood within the organization;

在組織內得到溝通和理解;

e) is reviewedfor continuing suitability.

為了保證持續適宜性應當進行評審。

5.4 Planning 策劃

5.4.1 Quality objectives 質量目標

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.

最高管理者應確保在組織的相關職能和層次上建立質量目標，質量目標包括滿足適應的法律法規和產品要求所需的內容。質量目標應是可測量的，并與質量方針保持一致。

5.4.2 Quality management system planning 質量管理體系策劃

Top managementshall ensure that: 高層管理者應當保證：

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

質量管理體系的策劃應當得到貫徹以符合4.1項下和質量目標的要求;

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

經策劃和實施質量管理體系發生變更時，應當保持質量管理體系的完整性。