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所在平台: Udemy |
课程主页: https://www.udemy.com/course/iso-13485-2016-for-medical-devices-quality-management-systems-updated/
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课程名称：ISO 13485:2016医疗器械质量管理体系（更新版2025） 课程概述：ISO 13485:2016标准是一个国际公认的文件，被多家监管机构使用，旨在明确医疗器械行业组织需满足的质量管理体系（QMS）要求。该标准规定了一个质量管理体系的要求，组织必须能够证明其提供的医疗器械及相关服务能够持续符合客户和适用的监管要求。这些组织可能涉及生命周期中的一个或多个阶段，包括设计和开发、生产、存储和分发、安装或医疗器械的服务，及相关活动的设计和开发（例如技术支持）。 ISO 13485:2016的要求适用于任何规模和类型的组织，除非明确说明。在涉及医疗器械的要求时，这些要求同样适用于组织提供的附属服务。适用的ISO 13485:2016要求中，虽然某些过程未由组织直接执行，但组织仍需对这些过程负责，并通过监控、维护和控制相应流程来纳入组织的质量管理体系。 如果适用的监管要求允许设计和开发控制的豁免，则可以作为不纳入质量管理体系的理由。这些监管要求可提供在质量管理体系中应对的替代方案。组织需确保其关于ISO 13485:2016合规性的声明准确反映任何设计和开发控制的豁免情形。 深入理解该标准对于在质量体系中正确实施所需的流程和操作程序至关重要，以满足医疗器械在产品设计、生产、分发和服务过程中的适用要求。本培训课程的目标是为学员提供ISO 13485:2016要求的扎实理解，使他们能够在各自的组织中顺利实施这些要求。
The standard ISO 13485:2016 is an internationally recognized document, used by several regulatory authorities, which outlines the requirements to be fulfilled by the Quality Management System (QMS) of organizations working in the medical devices industry. The standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system by monitoring, maintaining, and controlling the processes.If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity to ISO 13485:2016 reflect any exclusion of design and development controls.A detailed understanding of this standard is critical for the correct implementation of the required processes and operating procedures in the quality system, to meet the applicable requirements during product design, production, distribution and servicing of the medical devices.The aim of this training course is to provide the students with a solid understanding of the ISO 13485:2016 requirements, so they can be prepared to implement those requirements in their organization.
