医疗器械.质量管理体系.与医疗器械单一审核程序（MDSAP）集成的监管要求（ISO  13485-2016）

MDSAP成员：美国、日本、澳大利亚、加拿大和巴西

组织机构：制造商

Quality Management  System

质量管理体系

·        Medical Devices file

医疗器械文件

·        Control of documents

文件控制

·        Control of Records.

记录控制

Quality Policy

质量方针

·        Establishment of the Quality Policy

 制定质量政策

·        Quality Objectives & Realization plan质量目标和实现计划

·        Quality Policy Integration

质量政策集成

Quality Manual

质量手册

·        Preparation of the Quality Manual

编制质量手册

Human Resources

人力资源

·        Human Resource training program

人力资源培训计划

·        Training record

培训记录

·        Record of attendances

出席记录

·        human resources integration

人力资源整合

Infrastructure and Work  Environment

基础设施和工作环境

·        Documentation, process and procedures of Infrastructure and work  environment

基础设施和工作环境的文件、过程和程序

·        Record of Infrastructure Maintenance 基础设施维护记录

Risk Management

风险管理

·        Risk Management plan

风险管理计划

·        FMEA risk assessment integration FMEA风险评估集成

·        FMEA Risk assessment record

FMEA风险评估记录

·        Risk management review

风险管理审查

·        Risk management Integration

风险管理集成

Sales Procedure Integrated

集成销售程序

·        Sales procedures

销售程序

Customer Complaints and Feedback

客户投诉和反馈

·        Customer complaint & feedback

客户投诉和反馈

·        Registry of customer complaints

客户投诉登记

·        Registry of record to the authorities

向当局登记记录

·        Procedures of customer communication

客户沟通程序

Design and Development

设计和开发

·        Design and development,

设计和开发

·        Change review records

变更审查记录

·        Design review minutes

设计审查纪要

·        Design and development verification and validation

设计和开发验证和确认

·        Design and development transfer records and

设计和开发移交记录

·        Design and development integration

设计和开发集成

Purchasing and Evaluation of  Suppliers

供应商的采购和评估

·        Checklist for supplier evaluation

供应商评估检查表

·        Listing of the approved suppliers

               批准的供应商名单

• Registry of complaint suppliers

               投诉供应商登记处

• Request and order for purchasing integration

               采购集成的请求和订单

·        Purchasing validation record, quality assessment for critical  suppliers

采购验证记录，关键供应商的质量评估

·        Quality assessment for sub-contractor, Purchasing and evaluation for  the suppliers

分包商的质量评估、供应商的采购和评估

Production and Service Provision

生产和服务提供

·        Product specification, record of product and services, conformance

产品规范、产品和服务记录、合规性

·        Product and services quality plan

               产品和服务质量计划

·        notification to the customers on the property change

物业变更通知客户

·        Record of production process and validation

生产过程和验证记录

·        Record of medical devices installation, record of servicing activities

医疗器械安装记录、维修活动记录

·        Procedures for production and service provision

生产和服务提供程序   

Sterilization

灭菌

·        Sterilization procedures Eto, procedures for steam sterilization,  procedures for dry, heat sterilization

Eto灭菌程序、蒸汽灭菌程序、干燥、加热灭菌程序

·        Procedures for filtration Sterilization, Record for Sterilization, Lionizing  Radiation Procedures

过滤灭菌程序、灭菌记录、电离辐射程序

Software Validation if applicable

软件验证（如适用）

• Record for Software validation, procedures for the documentation and  validation on the software procedures. 软件验证记录、文件编制程序和软件程序验证

Warehousing

仓储

·        Procedures and record set up for the Temperature and Humidity control.

温度和湿度控制程序和记录

·        Warehousing Pest control procedures仓储害虫控制程序

·        Warehousing procedures

仓储程序

·        Non-conformity and Product record Integrated

不合格和产品记录集成

Nonconformities

不符合项

·        Registry of Non-conformities

不符合项登记

·        Procedures of Control of Non-conformities products

不合格品控制程序

Adverse Event Investigation

不良事件调查

·        Adverse event report structure

不良事件调查

·        Adverse event report, event, Investigation and reporting integration 不良事件报告、事件、调查和报告集成

Equipment Maintenance

设备维护

·        Control of equipment, Plan for preservative Maintenance

设备控制，防腐剂维护计划

·        Maintenance of Calibration record

校准记录的维护

·        procedures for Equipment Maintenance and Measuring Equipment  Integration

设备维护和测量设备集成程序

Post Market Surveillance

上市后监督

·        Post Market Surveillance plan

上市后监督计划

·        Periodic Safety update Report

定期安全更新报告

·        Post Market surveillance clinical follow up plan

上市后监督临床跟进计划

·        Post Market surveillance system

上市后监督系统

Clinical Performance evaluation

临床性能评估

·        Literature review protocol

文献综述方案

·        Development of the declaration of the conflict of Interest

利益冲突声明的制定

·        Procedure for the clinical performance evaluation

临床表现评估程序

Internal Audit

内部审计

·        Internal audit program

内部审计计划

·        Internal audit reporting procedures

内部审计报告程序

Corrective and Preventive Action

纠正和预防措施

·        Corrective and prevention action report and request procedures

纠正和预防措施报告和请求程序

·        Registry and status of Corrective and preventive action process

纠正和预防措施过程的登记和状态

·        Procedure on the corrective action plan 纠正措施计划程序

Data Analysis

数据分析

·        Data Analysis report and procedures

数据分析报告和程序

Management Review

管理评审

·        Management review, Matrix of key Performance indicators

管理评审，关键绩效指标矩阵

·        Management minutes review process管理会议记录审查流程

·        Procedures of management Review

管理评审程序