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 |
ISO 9001:2015, Quality management systems — Requirements
1 Scope
This International Standard specifies requirements for a quality management system when an organization:
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needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and
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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):
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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);
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providing continual improvement, emphasizing defect prevention and defect reduction in the supply chain; and
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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 |