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BS EN ISO 9001:2015

BS EN ISO 9001:2015

$115.09

Quality management systems. Requirements

Published By Publication Date Number of Pages
BSI 2015 44
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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.

PDF Catalog

PDF Pages PDF Title
7 Foreword
8 Introduction
13 1 Scope
2 Normative references
3 Terms and definitions
4 Context of the organization
4.1 Understanding the organization and its context
14 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
15 5 Leadership
5.1 Leadership and commitment
5.1.1 General
5.1.2 Customer focus
16 5.2 Policy
5.2.1 Establishing the quality policy
5.2.2 Communicating the quality policy
5.3 Organizational roles, responsibilities and authorities
6 Planning
6.1 Actions to address risks and opportunities
17 6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
18 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
19 7.1.5 Monitoring and measuring resources
7.1.6 Organizational knowledge
20 7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
7.5.1 General
21 7.5.2 Creating and updating
7.5.3 Control of documented information
8 Operation
8.1 Operational planning and control
22 8.2 Requirements for products and services
8.2.1 Customer communication
8.2.2 Determining the requirements for products and services
8.2.3 Review of the requirements for products and services
23 8.2.4 Changes to requirements for products and services
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
24 8.3.4 Design and development controls
8.3.5 Design and development outputs
8.3.6 Design and development changes
25 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
26 8.5 Production and service provision
8.5.1 Control of production and service provision
8.5.2 Identification and traceability
27 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
28 8.7 Control of nonconforming outputs
9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
29 9.1.2 Customer satisfaction
9.1.3 Analysis and evaluation
9.2 Internal audit
30 9.3 Management review
9.3.1 General
9.3.2 Management review inputs
9.3.3 Management review outputs
31 10 Improvement
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement
33 Annex A (informative) Clarification of new structure, terminology and concepts
37 Annex B (informative) Other International Standards on quality management and quality management systems developed by ISO/TC 176
40 Bibliography

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BS EN ISO 9001:2015
$115.09