Introduction
0.1 General
0.2 Clarification of concepts
0.3 Process approach
0.4 Relationship with ISO 9001
0.5 Compatibility with other management systems
1 Scope
2 Normative references
3 Terms and definitions
3.1
3.2
3.3
3.4
3.5
distributor
3.6
implantable medical device
3.7
importer
3.8
labelling
3.9
life-cycle
3.10
manufacturer
3.11
medical device
3.12
medical device family
3.13
performance evaluation
3.14
post-market surveillance
3.15
product
3.16
purchased product
3.17
risk
3.18
risk management
3.19
sterile barrier system
3.20
sterile medical device
4 Quality management system
4.1 General requirements
4.1.1
4.1.2
4.1.3
4.1.4
4.1.5
4.1.6
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
7.5.9.1 General
7.5.9.2 Particular requirements for implantable medical devices
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