High Level Structure

0. Introduction

ISO 9001:2015
1. Scope

2. Normative
references

3. Terms and
definitions
PLAN DO CHECK ACT
4 Context of the 9 Performance
5 Leadership 6 Planning 7 Support 8 Operation 10 Improvement
organization evaluation

4.1 5.1 6.1 7.1 8.1 9.1 10.1

Understanding the Leadership and Actions to Resources Operational planning Monitoring, measure- General
organization and commitment address risks and 7.1.1 and control ment, analysis and
its context opportunities General evaluation 10.2
5.1.1
8.2 Nonconformity and
General 7.1.2 9.1.1
6.2 Requirements for products corrective action
4.2 5.1.2 People General
Quality objectives and services
Understanding Customer focus 7.1.3 9.1.2 10.3
and planning to 8.2.1
the needs and Infrastructure Customer satisfaction Continual improvement
5.2 achieve them Customer communication
expectations of 7.1.4 9.1.3
interested parties Policy 8.2.2
6.3 Environment for Analysis and evaluation
5.2.1 Determining the requirements
Planning of the operation of
Establishing the processes 8.2.3 9.2
4.3 changes
quality policy Review of the requirements Internal audit
Determining the 7.1.5
5.2.2 8.2.4
scope of the Monitoring 9.3
Communicating Changes to requirements
quality manage- and measuring Management review
the quality policy
ment system resources 8.3 9.3.1
5.3 7.1.6 Design and development of General
4.4 Organizational Organizational products and services 9.3.2
Quality manage- roles, knowledge 8.3.1 Management review
ment system and responsibilities General inputs
its processes and authorities 7.2
8.3.2 9.3.3
Competence
Design and development Management review
7.3 planning outputs
Awareness 8.3.3
Design and development inputs
7.4
Annex A (informative): Clarification of new structure, 8.3.4
Communication
terminology and concepts Design and development controls 8.5
7.5 8.3.5 Production and service provision
A.1 Structure and terminology Design and development outputs
Documented 8.5.1
A.2 Products and services information 8.3.6 Control of production and service provision
A.3 Understanding the needs and expectations 7.5.1 Design and development changes 8.5.2
of interested parties General Identification and traceability
8.4
A.4 Risk-based thinking 7.5.2 8.5.3
Control of externally provided
Creating and Property belonging to customers or
A.5 Applicability processes, products and
updating external providers
A.6 Documented information
services
7.5.3 8.5.4
8.4.1
A.7 Organizational knowledge Control of Preservation
General
A.8 Control of externally provided processes, documented 8.5.5
information 8.4.2
products and services Type and extent of control Post-delivery activities
8.4.3 8.5.6
Information for external Control of changes
Annex B (informative): Other International Standards on
quality management and quality management systems providers 8.6
developed by ISO/TC 176 Release of products and services
8.7
Control of nonconforming outputs