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1.1 General
1.2 Application
2 Normative references
3 Terms and definitions
4.1 General requirements
4.2.1 General
4.2.2 Quality manual
4.2.3 Control of documents
4.2.4 Control of records
5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
5.4.1 Quality objectives
5.4.2 Quality management system planning
5.5.1 Responsibility and authority
5.5.2 Management representative
5.5.3 Internal communication
5.6.1 General
5.6.2 Review input
5.6.3 Review output
6.1 Provision of resources
6.2.2 Competence, training and awareness
6.3 Infrastructure
6.4 Work environment
7 Product realization
7.1 Planning of product realization
7.2 Customer-related processes
7.2.1 Determination of requirements related to the product
7.2.2 Review of requirements related to the product
7.2.3 Customer communication
7.3 Design and development
7.3.1 Design and development planning
7.3.2 Design and development inputs
7.3.3 Design and development outputs
7.3.4 Design and development review
7.3.5 Design and development verification
7.3.6 Design and development validation
7.3.7 Control of design and development changes
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 Validation of processes for production and service provision
7.5.3 identification and traceability
7.5.4 Customer property
7.5.5 Preservation of product
7.6 Control of monitoring and measuring equipment
8.1 General
8.2.1 Customer satisfaction
8.2.2 Internal audit