ISO13485-2016中英文对照(四)-资源管理

6 Resourcemanagement6 资源管理6.1Provision of resources 资源供给The organizationshall determine and provide the resource

6 Resourcemanagement

6 资源管理

6.1Provision of resources 资源供给

The organizationshall determine and provide the resources needed to:

组织应当确定并提供以下所需资源:

a) implement thequality management system and to maintain its effectiveness;

实施质量管理体系和维护其有效的资源;

b) meetapplicable regulatory and customer requirements.

符合相应法规和客户要求的资源。

6.2 Humanresources 人力资源

Personnelperforming work affecting product quality shall be competent on the basis ofappropriate education, training, skills and experience.

对于从事影响产品质量的工作人员应当具有与其工作相适应的教育、培训、技能和经验,并且胜任。

The organizationshall document the process(es) for establishing competence, providing needed training,and ensuring awareness of personnel.

组织应当建立程序来促使这些能力的形成、并提供必要的培训和确保人员的认知。(新增)

The organizationshall: 组织应当

a) determine thenecessary competence for personnel performing work affecting product quality;

确定从事影响产品质量工作的人员所必要的能力;

b) provide trainingor take other actions to achieve or maintain the necessary competence;

提供培训或采取其他措施来达到或维持必要的能力;

c) evaluate theeffectiveness of the actions taken;

评估采取措施的有效性;

d) ensure thatits personnel are aware of the relevance and importance of their activities andhow they contribute to the achievement of the quality objectives;

确保员工认识到所从事活动的相关性和重要性,以及如何为实现质量目标作出贡献;

e) maintainappropriate records of education, training, skills and experience (see 4.2.5).

持教育、培训、技能和经验的适当记录( 4.2.5).

NOTE  The methodology used to check effectiveness isproportionate to the risk associated with the work for which the training orother action is being provided.

注意:评估用于检查有效性的方法学应当风险相适应,这些风险与从事培训或提供其他措施有关。(新增)

6.3Infrastructure 基础设施

The organizationshall document the requirements for the infrastructure needed to achieveconformity to product requirements, prevent product mix-up and ensure orderlyhandling of product. Infrastructure includes, as appropriate:

组织应当建立形成文件化的基础设施需求,来符合产品需求、防止产品混淆以及确保产品的正确处理。(新增)

a) buildings,workspace and associated utilities;

建筑物,工作场所和相关的设施;

b) processequipment (both hardware and software);

工艺设备(包括软硬件);

c) supportingservices (such as transport, communication, or information systems).

支持性服务(比如运输、通讯或信息系统(新增)

The organizationshall document requirements for the maintenance activities, including theinterval of performing the maintenance activities, when such maintenanceactivities, or lack thereof, can affect product quality. As appropriate, therequirements shall apply to equipment used in production, the control of thework environment and monitoring and measurement. Records of such maintenanceshall be maintained (see 4.2.5).

组织应建立和和形成文件化的维护措施需求,包括内部维护措施实施,当这样的维护措施实施时,或缺乏时,都会影响产品质量。如果可以,这些要求应当应用到生产、控制工作环境、检测和测量的设备上。(新增)应保持此类维护记录( 4.2 .5)

6.4 Workenvironment and contamination control

6.4.1 Workenvironment 工作环境

The organizationshall document the requirements for the work environment needed to achieve conformityto product requirements.

组织应建立文件化的工作环境需求,来达到产品符合要求。

If theconditions for the work environment can have an adverse effect on productquality, the organization shall document the requirements for the workenvironment and the procedures to monitor and control the work environment.

如果用于工作环境的条件对产品质量有不良影响,组织应当建立工作环境的文件化需求和程序来监控和控制工作环境。( YY/T6.4 b))

The organizationshall: 组织应当

a) documentrequirements for health, cleanliness and clothing of personnel if contactbetween such personnel and the product or work environment could affect medicaldevice safety or performance;

若人员与产品或工作环境的接触可能影响医疗器械的安全和性能;(新增),则组织应建立人员的健康、人员卫生和人员着装的文件化要求;

b) ensure thatall personnel who are required to work temporarily under special environmental conditionswithin the work environment are competent or supervised by a competent person.

确保在特殊技环境条件下工作的所有的临时人员都能胜任相应的工作或在一个胜任人员的监督下。

NOTE Furtherinformation can be found in ISO 14644 and ISO 14698.

注意:更多信息请见ISO14644ISO 14698。(新增)

6.4.2Contamination control

As appropriate,the organization shall plan and document arrangements for the control ofcontaminated or potentially contaminated product in order to preventcontamination of the work environment, personnel, or product.

如果可以,组织应当策划和形成文件化的安排来进行污染和潜在污染产品的控制,从而预防工作环境、人员或产品的污染。(YY/T6.4d))

For sterilemedical devices, the organization shall document requirements for control ofcontamination with microorganisms or particulate

对于无菌医疗器械而言,组织应当建立与微生物和颗粒有关的污染控制的文件化要求。(新增)

 

    总结:资源管理这部分,增添的内容还是相对较多的。然后是内容章节的略微的调整。6.2 Human resources 人力资源总则多了一段内容。并且最后部分多了一个注意项,再次提到风险管理(评估用于检查有效性的方法学应当风险相适应);6.3基础设施部分增加的内容要格外关注了,一个是增加混淆的概念(mix-up)、一个增加了信息系统(information systems)、再就是最后部分的维护措施,应用到生产、检测、厂房控制的所有设备;6.4是章节性的内容变化,另外增加了备注信息,关于环境标准和环境监测的,最后增加了无菌医疗器械环境控制的内容。

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