**Quality management system **
- General requirements
- Documentation requirements
- Quality manual
- Control of documents
- Control of records
**Management responsibility **
- Management commitment
- Customer focus
- Quality policy
- Quality Planning
- Responsibility and authority
- Management representative
- Management review
Resource management
- Provision of resources
- Human resources
- Competence, awareness, and training ………………………………………………………………….7
- Infrastructure………………………………………………………………………………………………………………….7
- Work environment…………………………………………………………………………………………………………..7
- 7 Product realization ……………………………………………………………………………………………………………………8
- 7.1 Planning of product realization………………………………………………………………………………………….8
- 7.2 Customer-related processes…………………………………………………………………………………………….8
- Copyright Association for the Advancement of Medical Instrumentation
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- 7.2.1 Determination of requirements related to the product ……………………………………………..8
- 7.2.2 Review of requirements related to the product ……………………………………………………….8
- 7.2.3 Customer communication……………………………………………………………………………………9
- 7.3 Design and development …………………………………………………………………………………………………9
- 7.3.1 Design and development planning ……………………………………………………………………….9
- 7.3.2 Design and development inputs …………………………………………………………………………..9
- 7.3.3 Design and development outputs …………………………………………………………………………9
- 7.3.4 Design and development review…………………………………………………………………………10
- 7.3.5 Design and development verification…………………………………………………………………..10
- 7.3.6 Design and development validation…………………………………………………………………….10
- 7.3.7 Control of design and development changes ……………………………………………………….10
- 7.4 Purchasing…………………………………………………………………………………………………………………..10
- 7.4.1 Purchasing process ………………………………………………………………………………………….10
- 7.4.2 Purchasing information……………………………………………………………………………………..10
- 7.4.3 Verification of purchased product ……………………………………………………………………….11
- 7.5 Production and service provision …………………………………………………………………………………….11
- 7.5.1 Control of production and service provision………………………………………………………….11
- 7.5.2 Validation of processes for production and service provision………………………………….12
- 7.5.3 Identification and traceability ……………………………………………………………………………..12
- 7.5.4 Customer property……………………………………………………………………………………………13
- 7.5.5 Preservation of product……………………………………………………………………………………..13
- 7.6 Control of monitoring and measuring devices……………………………………………………………………13
- 8 Measurement, analysis, and improvement …………………………………………………………………………………14
- 8.1 General ……………………………………………………………………………………………………………………….14
- 8.2 Monitoring and measurement …………………………………………………………………………………………14
- 8.2.1 Feedback………………………………………………………………………………………………………..14
- 8.2.2 Internal audit……………………………………………………………………………………………………14
- 8.2.3 Monitoring and measurement of processes………………………………………………………….14
- 8.2.4 Monitoring and measurement of product ……………………………………………………………..15
- 8.3 Control of nonconforming product……………………………………………………………………………………15
- 8.4 Analysis of data…………………………………………………………………………………………………………….15
- 8.5 Improvement………………………………………………………………………………………………………………..16
- 8.5.1 General…………………………………………………………………………………………………………..16
- 8.5.2 Corrective action………………………………………………………………………………………………16
- 8.5.3 Preventive action ……………………………………………………………………………………………..16