ISO 22163:2023
Railway applications — Railway quality management system — ISO 9001:2015 and specific requirements for application in the railway sector
This document specifies requirements for a quality management system when an organization:
a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
All the requirements of this document are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.
NOTE 1 In this document, the terms “product” or “service” only apply to products and services intended for, or required by, a customer.
NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.
This document specifies the requirements for a railway quality management system (RQMS)
— applicable throughout the whole supply chain of the railway sector related to industrial products and services,
— providing continual improvement, emphasizing defect prevention and defect reduction in the supply chain, and
— enhancing and sustaining product quality, including its safety aspects.
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Foreword
Introduction
1 Scope
1.1 Scope — Supplemental
2 Normative references
3 Terms, definitions and abbreviated terms
3.1 Terms and definitions
3.1.1 System
3.1.2 Process
3.1.3 Requirement
3.1.4 Product and tools
3.2 Abbreviated terms
4 Context of the organization
4.1 Understanding the organization and its context
4.1.1 Understanding the organization and its context — Supplemental
4.1.2 Social responsibility
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the quality management system
4.3.1 Determining the scope of the quality management system — Supplemental
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
5.3 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 Business continuity
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
7 Support
7.1 Resources
7.1.1 General
7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment for the operation of processes
7.1.5 Monitoring and measuring resources
7.1.6 Organizational knowledge
7.2 Competence
7.2.1 Competence — Supplemental
7.3 Awareness
7.4 Communication
7.4.1 Communication — Supplemental
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 Operational planning and control — Supplemental
8.1.2 Tender management
8.1.3 Project management
8.1.4 Configuration management and change control
8.2 Requirements for products and services
8.2.1 Customer communication
8.2.2 Determining the requirements related to products and services
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
8.3.2 Design and development planning
8.3.3 Design and development inputs
8.3.4 Design and development controls
8.3.5 Design and development outputs
8.3.6 Design and development changes
8.4 Control of externally provided processes, products and services
8.4.1 General
8.4.2 Type and extent of control
8.4.3 Information for external providers
8.4.4 Supply chain management
8.5 Production and service provision
8.5.1 Control of production and service provision
8.5.2 Identification and traceability
8.5.3 Property belonging to customers or external providers
8.5.4 Preservation
8.5.5 Post-delivery activities
8.5.6 Control of changes
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 Reliability, availability, maintainability, safety and life cycle costing
8.8.1 General
8.8.2 Reliability, availability and maintainability
8.8.3 Safety
8.8.4 Life cycle costing
8.9 First article inspection
8.10 Obsolescence management
9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
9.1.2 Customer satisfaction
9.1.3 Analysis and evaluation
9.2 Internal audit
9.2.3 Internal audit — Supplemental
9.3 Management review
9.3.1 General
9.3.2 Management review inputs
9.3.3 Management review outputs
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
Annex A (informative) List of processes
Annex B (informative) Subordinate concept of requirements for products and services
Annex C (informative) Performance indicators
Bibliography
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Foreword
Introduction
1 Scope
1.1 Scope — Supplemental
2 Normative references
3 Terms, definitions and abbreviated terms
3.1 Terms and definitions
3.1.1 System
3.1.2 Process
3.1.3 Requirement
3.1.4 Product and tools
3.2 Abbreviated terms
4 Context of the organization
4.1 Understanding the organization and its context
4.1.1 Understanding the organization and its context — Supplemental
4.1.2 Social responsibility
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the quality management system
4.3.1 Determining the scope of the quality management system — Supplemental
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
5.3 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 Business continuity
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
7 Support
7.1 Resources
7.1.1 General
7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment for the operation of processes
7.1.5 Monitoring and measuring resources
7.1.6 Organizational knowledge
7.2 Competence
7.2.1 Competence — Supplemental
7.3 Awareness
7.4 Communication
7.4.1 Communication — Supplemental
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 Operational planning and control — Supplemental
8.1.2 Tender management
8.1.3 Project management
8.1.4 Configuration management and change control
8.2 Requirements for products and services
8.2.1 Customer communication
8.2.2 Determining the requirements related to products and services
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
8.3.2 Design and development planning
8.3.3 Design and development inputs
8.3.4 Design and development controls
8.3.5 Design and development outputs
8.3.6 Design and development changes
8.4 Control of externally provided processes, products and services
8.4.1 General
8.4.2 Type and extent of control
8.4.3 Information for external providers
8.4.4 Supply chain management
8.5 Production and service provision
8.5.1 Control of production and service provision
8.5.2 Identification and traceability
8.5.3 Property belonging to customers or external providers
8.5.4 Preservation
8.5.5 Post-delivery activities
8.5.6 Control of changes
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 Reliability, availability, maintainability, safety and life cycle costing
8.8.1 General
8.8.2 Reliability, availability and maintainability
8.8.3 Safety
8.8.4 Life cycle costing
8.9 First article inspection
8.10 Obsolescence management
9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
9.1.2 Customer satisfaction
9.1.3 Analysis and evaluation
9.2 Internal audit
9.2.3 Internal audit — Supplemental
9.3 Management review
9.3.1 General
9.3.2 Management review inputs
9.3.3 Management review outputs
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
Annex A (informative) List of processes
Annex B (informative) Subordinate concept of requirements for products and services
Annex C (informative) Performance indicators
Bibliography