4月2017

ISO/TS 22163規格の概要

ISO/TS 22163規格の概要が徐々に分かってきました。

0 Introduction
0.1 General
0.2 Quality management principles
0.3 Process approach
0.3.1 General
0.3.2 Plan-Do-Check-Act cycle
0.3.3 Risk-based thinking
0.4 Relationship with other management system standards

1 Scope
1.1 Scope – Supplemental
2 Normative references

3 Terms and definitions
3.1 Terms and definitions for the rail sector
3.1.1 application software
3.1.2 availability (of an item)
3.1.3 commissioning
3.1.4 component
3.1.5 configuration audit
3.1.6 configuration baseline
3.1.7 configuration status accounting
3.1.8 consignment stock
3.1.9 critical / criticality
3.1.10 deferred work
3.1.11 deliverables
3.1.12 first article inspection
3.1.13 FRACAS
3.1.14 functional requirement
3.1.15 gate criteria
3.1.16 handover
3.1.17 installation
3.1.18 integration maturity
3.1.19 integration requirements
3.1.20 key performance indicator (KPI)
3.1.21 life cycle costing (LCC)
3.1.22 maintainability (of an item)
3.1.23 maintenance
3.1.24 manufacturing
3.1.25 multidisciplinary approach
3.1.26 non-functional requirements
3.1.27 operational maturity
3.1.28 product configuration information
3.1.29 product life cycle
3.1.30 production equipment
3.1.31 project core team
3.1.32 project management
3.1.33 quality assurance methods
3.1.34 quality deficiency cost (QDC)
3.1.35 reliability
3.1.36 safety (product safety)
3.1.37 safety case
3.1.38 safety integrity level (SIL)
3.1.39 safety-related
3.1.40 site
3.1.41 supply chain
3.1.42 transfer
3.2 Abbreviations

4 Context of the organization
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the quality management system
4.4 Quality management system and its processes
4.4.3 Quality management system and its processes – Supplemental

5 Leadership
5.1 Leadership and commitment
5.1.1 General
5.1.2 Customer focus
5.2 Policy
5.2.1 Establishing the quality policy
5.2.2 Communicating the quality policy
5.2.3 Quality policy – Supplemental
5.2.4 Safety policy
5.3 Organizational roles, responsibilities and authorities
5.3.1 Organizational roles, responsibilities and authorities – Supplemental
5.3.2 Responsibilities and authorities of process owners

6 Planning
6.1 Actions to address risks and opportunities
6.1.3 Actions to address risks and opportunities – Supplemental
6.1.4 Contingency planning
6.2 Quality objectives and planning to achieve them
6.2.3 Safety objectives
6.3 Planning of changes 6.4 Business planning

7 Support
7.1 Resources
7.1.1 General
7.1.1.1 General – Supplemental
7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment for the operation of processes
7.1.5 Monitoring and measuring resources
7.1.5.1 General
7.1.5.2 Measurement traceability
7.1.5.3 Monitoring and measuring resources – Supplemental
7.1.6 Organizational knowledge
7.1.6.1 Organizational knowledge – Supplemental
7.2 Competence
7.2.1 Competence – Supplemental
7.3 Awareness
7.3.1 Awareness – Supplemental
7.4 Communication
7.5 Documented information
7.5.1 General
7.5.2 Creating and updating
7.5.3 Control of documented information
7.5.4 Control of documented information – Supplemental

8 Operation
8.1 Operational planning and control
8.1.1 Planning for the outsourcing or transfer of processes
8.1.2 Tender management
8.1.3 Project management
8.1.3.1 Project integration management
8.1.3.2 Project scope management
8.1.3.3 Project time management
8.1.3.4 Project cost management
8.1.3.5 Project quality management
8.1.3.6 Project human resource management
8.1.3.7 Project communications management
8.1.3.8 Project risk and opportunity management
8.1.3.9 Project procurement management
8.1.4 Configuration management
8.1.5 Change management
8.2 Requirements for products and services
8.2.1 Customer communication
8.2.1.1 Customer communication – Supplemental
8.2.2 Determining the requirements related to products and services
8.2.2.1 Determining the requirements related to products and services – Supplemental
8.2.3 Review of requirements related to products and services
8.2.4 Changes to requirements for products and services
8.2.5 Requirements for products and services – Supplemental
8.3 Design and development of products and services
8.3.1 General
8.3.1.1 General – Supplemental
8.3.2 Design and development planning
8.3.2.1 Design and development planning – Supplemental
8.3.3 Design and development inputs
8.3.3.1 Design and development inputs – Supplemental
8.3.4 Design and development controls
8.3.4.1 Design and development controls – Supplemental
8.3.4.2 Design reviews
8.3.4.3 Design verification
8.3.4.4 Design validation
8.3.5 Design and development outputs
8.3.5.1 Design and development outputs – Supplemental
8.3.6 Design and development changes
8.4 Control of externally provided processes, products and services
8.4.1 General
8.4.1.1 General – Supplemental
8.4.2 Type and extent of control
8.4.2.1 External provided products, process or service approval of release
8.4.2.2 External provided products, process or service verification after release.
8.4.2.3 Monitoring of external provider performance, re-evaluation and ranking
8.4.3 Information for external providers
8.4.3.1 Information for external providers – Supplemental
8.4.4 Supply chain management
8.5 Production and service provision
8.5.1 Control of production and service provision
8.5.1.1 Control of production and service provision – Supplemental
8.5.1.2 Special processes
8.5.1.3 Production equipment
8.5.2 Identification and traceability
8.5.2.1 Identification and traceability – Supplemental
8.5.3 Property belonging to customers or external providers
8.5.3.1 Property belonging to customers or external providers – Supplemental
8.5.4 Preservation
8.5.4.1 Preservation – Supplemental
8.5.5 Post-delivery activities
8.5.5.1 Post-delivery activities – Supplemental
8.5.6 Control of changes
8.5.7 Production scheduling
8.6 Release of products and services
8.6.1 Release of products and services – Supplemental
8.7 Control of nonconforming outputs
8.7.3 Control of nonconforming outputs – Supplemental
8.8 RAMS / LCC
8.9 First article inspection
8.10 Obsolescence management
8.11 Innovation management

9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
9.1.1.1 General – Supplemental
9.1.2 Customer satisfaction
9.1.2.1 Customer satisfaction – Supplemental
9.1.3 Analysis and evaluation
9.1.3.1 Analysis and evaluation – Supplemental
9.2 Internal audit
9.2.3 Internal audit – Supplemental
9.2.3.1 Audit programme
9.2.3.2 Auditors management
9.3 Management review
9.3.1 General
9.3.1.1 General – Supplemental
9.3.2 Management review inputs
9.3.2.1 Management review inputs – Supplemental
9.3.3 Management review outputs
9.3.3.1 Management review outputs – Supplemental
9.4 Process reviews

10 Improvement
10.1 General
10.2 Nonconformity and corrective action
10.2.3 Nonconformity and corrective action – Supplemental
10.3 Continual improvement