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PHILIPS验厂辅导---PHILIPS质量介绍(二)


M05.03  Documentation requirements QMS

The quality management system documentation shall include质量管理体系文件应包括

a) Documented statements of a quality policy and quality objectives, a)形成文件的质量方针和质量目标

b) A quality manual,质量手册

c) Documented procedures required by this International Standard,形成的程序文件要符合国际标准

d) Documents needed by the organization to ensure the effective planning, operation and control of its processes, d)本组织为确保有效的规划、运作和控制其过程所需的文件

e) Records required by the International Standard (see 4.2.4), and e)国际标准所要求的记录 (见4.2.4),和

f) Any other documentation specified by national or regional regulations. f)任何其他国家或区域的规例所指定的文档。


M05.12  QMS is adequate

The Quality Management System that the organization has implemented must support the strategy. Suppliers in the industry of medical devices are expected to have ISO 13485 or equivalent. 组织实施质量管理体系必须支持的战略。在医疗器械行业供应商预计将有ISO13485或等效。


M05.13  Solving findings previous audits

Auditors will ask for objective evidence to show that findings from previous audits are solved timely and effectively. 审计将要求提供客观证据显示及时有效地解决以往审核的结果。


M06.01  Management Commitment

Top management shall provide evidence of its commitment to the development and implementation of the quality management system and maintaining its effectiveness by最高管理应致力于发展与实施提供证据的质量管理体系和保持其效力

a) Communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements, a)向组织传达满足客户以及法律、法规要求的重要性

b) Establishing the quality policy,建立质量方针

c) Ensuring that quality objectives are established, c)确保质量目标的制定

d) Conducting management reviews, and d)进行管理审查,和

e) Ensuring the availability of resources. 确保资源的可用性。

NOTE For the purposes of this International Standard, statutory requirements are limited to the safety and performance of the medical device only注意为此国际标准、法定要求的目的仅限于安全和性能的唯一的医疗器械。


M06.03  Quality policy

Top management shall ensure that the quality policy最高管理层应确保质量方针

a) Is appropriate to the purpose of the organization a)适合于组织的宗旨

b) Includes a commitment to comply with requirements and to maintain the effectiveness of the quality management system b)包括致力于符合要求,维护的有效性质量管理体系,

c) Provides a framework for establishing and reviewing quality objectives, c)为建立和评审质量目标提供了框架

d) Is communicated and understood within the organization, and d)得到沟通和理解本组织内和

e) Is reviewed for continuing suitability. e)审查其持续适用性。


M06.04  Planning: Quality Objectives.

Realizing a strategy requires that objectives have been set for quality. These objectives are made measurable via performance indicators. A well deployed strategy will show positive trends and meeting targets for a time frame of 3 years. 实现战略需要定为质量目标。这些目标是可衡量的业绩指标通过。好已部署的战略将显示积极的趋势和3年时间内的达到目标。


M06.07  Responsibility and authority

The organizational charts of a company should show how many people are working in the various functional areas (development, quality, etc). The interrelation of the functions must be clear. Authorities and responsibilities should support the deployment of the strategy. 公司的组织结构图应显示究竟有多少人正在在各个功能领域 (开发、质量等)。必须明确职能之间的相互关系。当局和责任应该支持战略的部署。

Top management shall establish the interrelation of all personnel who manage, perform and verify work affecting quality  and shall ensure the independence and authority necessary to perform these tasks最高管理层应建立管理、执行和验证工作影响质量和应保证的独立性和权威性执行这些任务所需的所有人员的相互的关系。

NOTE National or regional regulations might require the nomination of specific persons as responsible for activities related to monitoring experience from the post-production stage and reporting adverse events注意国家或地区法规可能要求特定的人,作为负责监测经验从后期制作阶段和报告不良事件相关的活动提名。



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