ISO13485认证审核

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一、初始认证

1、企业填写ISO13485认证分申请表，认证中心收到认证申请材料后，对文件进行初审，符合要求后出具《受理通知书》。

2、现场检查——提前几周将检查组的组成和检查计划正式上报企业确认。

3、现场检查应按照的要求和相应的环境标志产品认证技术要求进行。

4、检查组应根据企业申请材料、现场检查和产品环境行为检查报告，编制环境标识产品综合评价报告，并提交技术委员会审查。

5、认证中心收到技术委员会的评审意见后，应汇总评审意见。

6、认证中心向认证企业颁发环境标签证书，并组织公告和宣传。

7、如果认证企业需要认证，可以向认证中心订购;如有特殊打印要求，应将申请提交认证中心存档。

8、每年进行一次年度监督和审计。

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一、 Initial certification

1. The enterprise fills in the ISO13485 certification sub-application form. After receiving the certification application materials, the certification center conducts a preliminary review of the documents, and issues the Acceptance Notice after meeting the requirements.

2. On-site inspection - formally report the composition and inspection plan of the inspection team to the enterprise for confirmation several weeks in advance.

3. The on-site inspection shall be carried out in accordance with the requirements of the Guide for Safeguard Measures of Environmental Labeling Products and the corresponding technical requirements for certification of environmental labeling products.

4. The inspection team shall prepare a comprehensive evaluation report of environmental labeling products according to the enterprise application materials, on-site inspection and product environmental behavior inspection report, and submit it to the technical committee for review.

5. After receiving the review comments from the Technical Committee, the Certification Center shall summarize the review comments.

6. The certification center issues environmental label certificates to certification enterprises, and organizes announcements and publicity.

7. If the certification enterprise needs certification, it can order from the certification center; If there are special printing requirements, the application shall be submitted to the certification center for filing.

8. Conduct annual supervision and audit once a year.

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二、年度监督检查

1、认证中心应根据企业认证证书颁发时间制定年度检验计划，并提前向企业发出年度检验通知。企业按合同要求缴纳年度监督管理费，认证中心组织检查

企业进行现场检查。

2、现场检验时，检验组负责对被检验产品进行抽样、封存，并送指定检验机构检验。

3、检验组应根据企业材料、检验报告和产品检验报告编制综合评价报告，并提交认证中心总经理审批。

4、每年进行一次年度监督检查。

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2、 Annual supervision and inspection

1. The certification center shall formulate the annual inspection plan according to the issuing time of the enterprise certification certificate and send the annual inspection notice to the enterprise in advance. The enterprise pays the annual supervision and management fee according to the contract requirements, and the certification center organizes the inspection

The enterprise conducts on-site inspection.

2. During on-site inspection, the inspection team is responsible for sampling and sealing the inspected products and sending them to the designated inspection agency for inspection.

3. The inspection team shall prepare a comprehensive evaluation report based on the enterprise's material, inspection report and product inspection report and submit it to the General Manager of the Certification Center for approval.

4. Conduct annual supervision and inspection once a year.

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三、重新评估和认证

3年内到期的企业应重新填写ISO13485认证分申请表，并将其与相关材料一起提交认证中心。阶段认证程序与初始认证相同

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3、 Reassessment and certification

Enterprises expiring within 3 years shall re-fill the ISO13485 certification sub-application form and submit it to the certification center together with relevant materials. The stage certification procedure is the same as the initial certification

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引入13485是一个企业的战略决策

我们要用好这个过程

并不断引领企业走向成功

Q168

13485体系还明确设置管代，要有医疗相关资质才可担当

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Q168 发表于 2023-1-17 11:37
13485体系还明确设置管代，要有医疗相关资质才可担当

说的很对  管代对于13485的体系推行和管理有着至关重要的作用