ISO13485-2016中英文对照(三)-管理职责

5Management responsibility5 管理职责5.1Management commitment 管理承诺Top managementshall provide evidence of its commitm

5Management responsibility

5 管理职责

5.1Management 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。

5.2Customer 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。

5.4Planning 策划

5.4.1Quality 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。

5.4.2Quality 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。

5.5Responsibility, authority and communication 职责,权限和沟通

5.5.1Responsibility and authority 职责和权限

Top managementshall ensure that responsibilities and authorities are defined, documented and communicatedwithin the organization.

最高管理者应当保证组织内的职责和权限清晰的被界定、文件化和沟通。

Top managementshall document the interrelation of all personnel who manage, perform andverify work affecting quality and shall ensure the independence and authoritynecessary to perform these tasks.

最高管理者应当文件化所有从事影响质量的管理、执行和验证工作的人员的相互关系。最高管理者还应当保证其完成这些任务所必须的独立性和权限。

其中没有YY/T0287的备注项目。(删减)

5.5.2Management representative 管理者代表

Top managementshall appoint a member of management who, irrespective of otherresponsibilities, has responsibility and authority that includes:

最高管理者应当制定一名管理者,不管他是否有其他责任,他都应具有以下的职权:

a) ensuring thatprocesses needed for the quality management system are documented;

保证质量管理体系所需的过程都被文件化;

b) reporting totop management on the effectiveness of the quality management system and anyneed for improvement;

向最高管理者报告质量管理体系的业绩和任何改进的需要;

c) ensuring thepromotion of awareness of applicable regulatory requirements and quality managementsystem requirements throughout the organization.

确保贯穿于组织内部的质量管理体系需求和适应的法规需求意识的提升。

其中没有YY/T0287的备注项目。(删减)

5.5.3Internal communication 内部沟通

Top managementshall ensure that appropriate communication processes are established within theorganization and that communication takes place regarding the effectiveness ofthe quality management system.

最高管理者应保证在组织内部建立适宜的沟通程序,并保证对质管理体系的有效性进行沟通。

5.6Management review 管理评审

5.6.1General 总则

The organizationshall document procedures for management review. Top management shall review theorganization’s quality management system at documented planned intervals toensure its continuing suitability, adequacy and effectiveness. The review shallinclude assessing opportunities for improvement and the need for changes to thequality management system, including the quality policy and quality objectives.Records from management reviews shall be maintained (see 4.2.5).

最高管理者应建立管理评审的程序。最高管理者应当在规定策划时间间隔内审核该组织的质量管理体系,从而保证质量管理体系持续的适宜性、充分性和有效性。评审应包括评估质量管理体系改进的机会和变更的需要,包括质量方针和质量目标。应保持管理评审的记录(4.2.5)

5.6.2Review input 审核输入

The input tomanagement review shall include, but is not limited to, information arisingfrom: 管理评审的输入应当包括但不限于以下信息:

a) feedback; 反馈

b) complaint handling; 抱怨的处理

c) reporting to regulatoryauthorities; 向药监部门报告

d) audits; 审计

e) monitoring and measurement ofprocesses;过程的控制和测量;

f) monitoring and measurement ofproduct; 产品的控制和测量;

(新增部分)

g) correctiveaction; 纠正措施;

h) preventive action;预防措施;

i) follow-upactions from previous management reviews; 以往管理评审的跟踪措施;

j) changes thatcould affect the quality management system;可能影响质量管理体系的变更;

k) recommendationsfor improvement;改进的建议;

l) applicablenew or revised regulatory requirements. 新的或修订的法规要求。

5.6.3Review output 评审输出

The output frommanagement review shall be recorded (see 4.2.5) and includethe input reviewed and any decisions and actions related to:

管理评审的输出应当被记录(见4.2.5),并且应当包括经审核输出和任何与下述有关的决定和措施:

  1. a)     improvement needed to maintain thesuitability, adequacy, and effectiveness of the quality management system andits processes;

维持质量管理系和其过程适宜性、有效性和充分性所需的改进;

b) improvementof product related to customer requirements;

与顾客要求有关的产品的改进;

c) changesneeded to respond to applicable new or revised regulatory requirements;

适应新的和修订的法规所需的变更;(新增)

d) resourceneeds. 资源需求。

   总结:管理职责变化不大,只是略微调整。其中5.5.15.5.2去掉了注意项;5.6.2管理评审输入增加了几个输入内容;5.6.3管理评审输出增加了一项输出内容。

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