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- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Quality management system
- 4.1 General requirements
- 4.2 Documentation requirements
- 4.2.1 General
- 4.2.2 Quality manual
- 4.2.3 Medical device file
- 4.2.4 Control of documents
- 4.2.5 Control of records
- 5 Management responsibility
- 5.1 Management commitment
- 5.2 Customer focus
- 5.3 Quality policy
- 5.4 Planning
- 5.4.1 Quality objectives
- 5.4.2 Quality management system planning
- 5.5 Responsibility, authority and communication
- 5.5.1 Responsibility and authority
- 5.5.2 Management representative
- 5.5.3 Internal communication
- 5.6 Management review
- 5.6.1 General
- 5.6.2 Review input
- 5.6.3 Review output
- 6 Resource management
- 6.1 Provision of resources
- 6.2 Human resources
- 6.3 Infrastructure
- 6.4 Work environment and contamination control
- 6.4.1 Work environment
- 6.4.2 Contamination control
- 7 Product realization
- 7.1 Planning of product realization
- 7.2 Customer-related processes
- 7.2.1 Determination of requirements related to product
- 7.2.2 Review of requirements related to product
- 7.2.3 Communication
- 7.3 Design and development
- 7.3.1 General
- 7.3.2 Design and development planning
- 7.3.3 Design and development inputs
- 7.3.4 Design and development outputs
- 7.3.5 Design and development review
- 7.3.6 Design and development verification
- 7.3.7 Design and development validation
- 7.3.8 Design and development transfer
- 7.3.9 Control of design and development changes
- 7.3.10 Design and development files
- 7.4 Purchasing
- 7.4.1 Purchasing process
- 7.4.2 Purchasing information
- 7.4.3 Verification of purchased product
- 7.5 Production and service provision
- 7.5.1 Control of production and service provision
- 7.5.2 Cleanliness of product
- 7.5.3 Installation activities
- 7.5.4 Servicing activities
- 7.5.5 Particular requirements for sterile medical devices
- 7.5.6 Validation of processes for production and service provision
- 7.5.7 Particular requirements for validation of processes for sterilization and sterile barrier systems
- 7.5.8 Identification
- 7.5.9 Traceability
- 7.5.10 Customer property
- 7.5.11 Preservation of product
- 7.6 Control of monitoring and measuring equipment
- 8 Measurement, analysis and improvement
- 8.1 General
- 8.2 Monitoring and measurement
- 8.2.1 Feedback
- 8.2.2 Complaint handling
- 8.2.3 Reporting to regulatory authorities
- 8.2.4 Internal audit
- 8.2.5 Monitoring and measurement of processes
- 8.2.6 Monitoring and measurement of product
- 8.3 Control of nonconforming product
- 8.3.1 General
- 8.3.2 Actions in response to nonconforming product detected before delivery
- 8.3.3 Actions in response to nonconforming product detected after delivery
- 8.3.4 Rework
- 8.4 Analysis of data
- 8.5 Improvement
- 8.5.1 General
- 8.5.2 Corrective action
- 8.5.3 Preventive action
- Annex A (informative) Comparison of content between ISO 13485:2003 and ISO 13485:2016
- Annex B (informative) Correspondence between ISO 13485:2016 and ISO 9001:2015
- Bibliography
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ISO13485 医疗行业质量管理体系-英文原档
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