ISO13485-2016中英文对照 管理职责（5.1~5.4）

5.1 Management commitment 管理承诺

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

最高管理者应通过以下活动，对其开发、实施质量管理体系并维持其有效性的承诺提供证据:

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

向组织传达满足顾客和法律法规要求的重要性;

b) establishingthe quality policy;

确定质量方针;

c) ensuring thatquality objectives are established;

确保质量目标的确定;

d) conductingmanagement reviews;

进行管理评审;

e) ensuring theavailability of resources.

确保资源的获得。

5.2 Customer focus 客户关注

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

最高管理者应确保顾客和相应的法律法规要求得到确定并予以满足。

5.3 Qualitypolicy 质量方针

Top managementshall ensure that the quality policy:

最高管理者应确保质量方针：

a) is applicableto the purpose of the organization;

与组织的宗旨相适应；

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

包括一个符合要求和维持质量管理体系有效性的承诺;

c) provides aframework for establishing and reviewing quality objectives;

提供制定和评审质量目标的框架;

d) iscommunicated and understood within the organization;

在组织内得到沟通和理解;

e) is reviewedfor continuing suitability.

为了保证持续适宜性应当进行评审。

5.4 Planning 策划

5.4.1 Quality objectives 质量目标

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.

最高管理者应确保在组织的相关职能和层次上建立质量目标，质量目标包括满足适应的法律法规和产品要求所需的内容。质量目标应是可测量的，并与质量方针保持一致。

5.4.2 Quality management system planning 质量管理体系策划

Top managementshall ensure that: 高层管理者应当保证：

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

质量管理体系的策划应当得到贯彻以符合4.1项下和质量目标的要求;

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

经策划和实施质量管理体系发生变更时，应当保持质量管理体系的完整性。