5月2017

ISO/TS 22163:2017規格の発行

ISO/TS 22163:2017「Railway applications — Quality management system — Business management system requirements for rail organizations: ISO 9001:2015 and particular requirements for application in the rail sector」規格が2017年5月24日に発行されました。その箇条を下記に記載しておきます。

Foreword
0 Introduction
1 Scope
1.1 Scope — Supplemental
2 Normative references
3 Terms and definitions
3.1 Terms and definitions for the rail sector
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
6.3 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

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
8.4.1.1.1 Classification of external providers and external provided products, process or service
8.4.1.1.2 Evaluation of external providers
8.4.1.1.3 Approval of external providers
8.4.1.1.4 External provider offer selection
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
8.5.1.1.1 Controlled conditions
8.5.1.1.2 Verification of the process for production and service provision
8.5.1.1.3 Validation of the process for production and service provision
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
Bibliography