MID Module H1 认证

What is Annex H1? 什么是H1 模式的认证？

Annex H1 looks a lot like the combination of annexes B and D of MID: it includes a system certification (serving a similar purpose as Annex D) and a design examination that is comparable to the type examination of Annex B. If a manufacturer is certified to work according Annex H1, he is allowed to do the testing himself, thus saving external costs.

Module H1认证类似于MID Module B 和D的组合，它包括质量体系认证（Module D）和Module B 设计检查，如果制造商通过了Module H1的认证，那么以后他将允许自己去测试，这样可以节省许多外部的测试成本.

A manufacturer must guarantee that all measuring instruments that he puts on the market meet the legal re Annex H1 of MID is the conformity assessment procedure that allows the manufacturer to prove that his measuring instruments comply with the MID. The procedure consists of two parts:

制造商必须保证所有投放市场的计量产品符合计量的要求，MID Module H1的符合性评估程序可以允许制造商证明他所生产的计量产品符合MID的要求，认证程序包括两部分：

1、  system certification  质量体系认证
The manufacturer’s system must be certified. The system includes the design process, the manufacture and final product inspection, and the testing of the measuring instrument.

制造商首先必须通过质量体系认证的要求，质量体系需包括产品的设计过程、生产过程和成品的检验、以及计量相关的测试，原则上要求ISO9001质量体系认证的机构需是通过国际IQNET成员的发证机构；

During the audit the following four elements will be taken into account: 审核时主要考虑以下四部分因素：
• implementation of the ISO 9001 certified system: depending on the ‘aliveness’ of the system； 现有ISO9001质量体系的审核；
• design process: planning, in- and outputs, review, verification/validation and control of changes 设计过程：产品计划、输入与输出，评审，验证和变更控制等；
• manufacture and final product inspection: incoming goods, production model versus technical design, packaging, integration of test in manufacture 生产过程和成品检验: 来料、生产模型和技术设计对比，包装，生产过程测试整合等；
• testing: facilities, traceability, measurement uncertainty, test engineers 测试： 设备、追溯、测试不确定性、测试人员等；
When the system is certified, the manufacturer is allowed to verify for himself  只有质量体系符合了，制造商才被允许自我验证；

2 、Design examination  设计检查
The manufacturer uses the certified system to develop new measuring instruments. For each measuring instrument that the manufacturer develops, the notified body that certified the system examines the design. This is effectuated on the basis of technical documentation and supporting evidence (for instance: test results) that the manufacturer makes up for each design. When the design meets the re, the notified body issues an EC design examination certificate to the manufacturer.

制造商采用被认可的质量体系来开发新的计量产品，对于每开发一个新的计量产品，公告机构都将验证其体系和检查设计，基于提交的技术文档和相关的支持性证据（例如测试报告），当设计符合要求后，公告机构将颁发EC设计检查证书给制造商.

关于衡硕检测 about HISONIC

Hisonic Testing is devoting different kinds of Metrology instrutments Regulations and standards for all over the world, we have sucessfully applied MID and other certificates for more than 5,00 manufactures and 1,000 products.

衡硕检测致力于全球各种计量仪器的法规和标准的研究，已成功为超过500家制造商的1000种产品申请认证。:02