第2部分:处理全球法规遵从性的复杂性;从EMC开始

D. Staggs
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引用次数: 0

摘要

有许多与产品法规遵从性相关的过程要么没有记录,要么没有被公司遵守。缺乏明确的流程和责任意味着从产品开发到产品制造的整个过程都增加了复杂性。电磁兼容性(EMC)领域是所有要求的监管批准中最困难的领域之一,因为标准的数量,涉及的测试方法的数量以及最初获得和维持合规性所需的过程的数量。本文提供了在处理和执行产品合规性方面建立权威的见解,检查了产品不合规性对公司的风险,给出了如何评估使产品符合法规的方法的示例,讨论了对信号完整性和EMC工程师进行法规遵从性培训的必要性,并提供了管理原始设备制造商产品法规遵从性的不同方法。本文就如何实施质量管理体系提出了建议,该体系将大大降低这些复杂性,并为记录EMC过程提供清晰的结构。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Part 2: Dealing with complexities of worldwide regulatory compliance; beginning with EMC
There are many processes associated with product regulatory compliance that either are not documented or not adhered to by companies. This lack of clear process and responsibility represents added complexity from product development all the way through product manufacturing. The field of electromagnetic compatibility (EMC) is one of the most difficult of all required regulatory approvals due to the number of standards, number of test methods involved and number of processes needed to initially obtain and sustain compliance. This paper provides insight to establishing authority in handling and enforcing product compliance, examines the risk to companies of product non-compliance, gives an example on how to evaluate methods of bringing a product into compliance, discusses the need for regulatory compliance training for signal integrity and EMC engineers, and offers different approaches to managing the regulatory compliance of original equipment manufacturer products. Recommendations are made on how to implement a quality management system that will greatly reduce these complexities and provide for a clear structure for documenting EMC processes.
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