ISO13485认证前需要准备哪些文件？

What documents need to be prepared before ISO13485 certification?

1、法律地位证明文件；

1. Proof of legal status;

2、有效的资质证明；

2. Valid qualification certificate;

3、组织简介、人员情况、管理体系范围涉及的产品的生产/加工/服务流程图（标明关键过程、特殊过程和外包过程）；

3. Organization profile, personnel, production / processing / service flow chart of products involved in the scope of management system (indicating key processes, special processes and outsourcing processes);

4、管理体系文件：方针、目标、范围、任命书、程序文件、作业指导书以及车间布局图（洁净车间）、工艺流程图、灭菌过程等及其有关的过程文件；

4. Management system documents: policies, objectives, scope, letter of appointment, procedure documents, operation instructions, workshop layout (clean workshop), process flow diagram, sterilization process, etc. and relevant process documents;

5、质量管理体系覆盖的产品和服务的接收准则清单或说明（产品检验规范）；

5. List or description of acceptance criteria for products and services covered by the quality management system (product inspection specifications);

6、涉及安装、维修等服务项目的，还需要提供在实施项目清单。

6. If installation, maintenance and other service items are involved, a list of items under implementation shall also be provided.