ISO13485：2022质量手册英文版模板.docx
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1、ISO13485：2022质量手册英文版模板 Table of Contents Approvals Revision and Approval Record 1.0 Scope 1.1 General 1.2 Application 1.3 Quality policy statement 2.0 Company information 3.0 Terms and definitions 4.0 Quality management system 4.1 General requirements 4.2 Documentation requirements 5.0 Management re
2、sponsibility 5.1 Management commitment 5.2 Customer focus 5.3 Quality policy 5.4 Planning 5.5 Responsibility, authority, and communication 5.6 Management review 6.0 Resources 6.1 Provision of resources 6.2 Human resources 6.3 Infrastructure 6.4 Work environment and contamination control 7.0 Product
3、realization 7.1 Planning of product realization 7.2 Customer-related processes 7.3 Design and development 7.4 Purchasing 7.5 Production and service provision 7.6 Control of monitoring and measuring equipment 8.0 Measurement, analysis and improvement 8.1 General 8.2 Monitoring and measurement 8.3 Control of nonconforming product 8.4 Analysis of data 8.5 Improvement
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- ISO13485 2022 质量 手册 英文 模板
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