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BSI PD ISO/TS 22163:2017

$215.11

Railway applications. Quality management system. Business management system requirements for rail organizations: ISO 9001:2015 and particular requirements for application in the rail sector

Published By Publication Date Number of Pages
BSI 2017 86
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ISO 9001:2015, Quality management systems — Requirements

1   Scope

This International Standard specifies requirements for a quality management system when an organization:

  1. needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and

  2. 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 International Standard 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 International Standard, 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.

1.1 Scope — Supplemental

This document defines quality management system requirements in the rail sector (RQMS):

  • applicable throughout the whole supply chain of railway industrial related products for the design and development, manufacturing and maintenance activities (excluding operations and services of rail transports);

  • providing continual improvement, emphasizing defect prevention and defect reduction in the supply chain; and

  • enhancing and sustaining product quality, including its safety aspects.

NOTE This document allows organizations to have the same flexibility when determining the boundaries and applicability of the quality management system as described in ISO 9001:2015, 4.3.

PDF Catalog

PDF Pages PDF Title
2 National foreword
8 Foreword
9 0 Introduction
17 1 Scope
1.1 Scope — Supplemental
18 2 Normative references
3 Terms and definitions
3.1 Terms and definitions for the rail sector
23 3.2 Abbreviations
24 4 Context of the organization
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested parties
25 4.3 Determining the scope of the quality management system
26 4.4 Quality management system and its processes
4.4.3 Quality management system and its processes — Supplemental
27 5 Leadership
5.1 Leadership and commitment
5.1.1 General
5.1.2 Customer focus
28 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
29 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
30 6 Planning
6.1 Actions to address risks and opportunities
6.1.3 Actions to address risks and opportunities — Supplemental
31 6.1.4 Contingency planning
6.2 Quality objectives and planning to achieve them
32 6.3 Planning of changes
6.4 Business planning
33 7 Support
7.1 Resources
7.1.1 General
7.1.2 People
34 7.1.3 Infrastructure
7.1.4 Environment for the operation of processes
7.1.5 Monitoring and measuring resources
36 7.1.6 Organizational knowledge
37 7.2 Competence
7.2.1 Competence — Supplemental
38 7.3 Awareness
7.3.1 Awareness — Supplemental
7.4 Communication
39 7.5 Documented information
7.5.1 General
7.5.2 Creating and updating
40 7.5.3 Control of documented information
41 8 Operation
8.1 Operational planning and control
8.1.1 Planning for the outsourcing or transfer of processes
42 8.1.2 Tender management
8.1.3 Project management
46 8.1.4 Configuration management
47 8.1.5 Change management
49 8.2 Requirements for products and services
8.2.1 Customer communication
8.2.2 Determining the requirements related to products and services
50 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
51 8.3 Design and development of products and services
8.3.1 General
52 8.3.2 Design and development planning
53 8.3.3 Design and development inputs
54 8.3.4 Design and development controls
56 8.3.5 Design and development outputs
57 8.3.6 Design and development changes
8.4 Control of externally provided processes, products and services
8.4.1 General
60 8.4.2 Type and extent of control
62 8.4.3 Information for external providers
63 8.4.4 Supply chain management
64 8.5 Production and service provision
8.5.1 Control of production and service provision
67 8.5.2 Identification and traceability
68 8.5.3 Property belonging to customers or external providers
8.5.4 Preservation
69 8.5.5 Post-delivery activities
70 8.5.6 Control of changes
8.5.7 Production scheduling
71 8.6 Release of products and services
8.6.1 Release of products and services — Supplemental
72 8.7 Control of nonconforming outputs
8.7.3 Control of nonconforming outputs — Supplemental
73 8.8 RAMS / LCC
74 8.9 First article inspection
8.10 Obsolescence management
75 8.11 Innovation management
9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
77 9.1.2 Customer satisfaction
9.1.3 Analysis and evaluation
78 9.2 Internal audit
9.2.3 Internal audit — Supplemental
79 9.3 Management review
9.3.1 General
80 9.3.2 Management review inputs
81 9.3.3 Management review outputs
9.4 Process reviews
82 10 Improvement
10.1 General
83 10.2 Nonconformity and corrective action
10.2.3 Nonconformity and corrective action — Supplemental
84 10.3 Continual improvement
85 Bibliography
BSI PD ISO/TS 22163:2017
$215.11