ISO 9004:2018 Available

ISO 9004:2018, “Quality management – Quality of an organization – Guidance to achieve sustained success”, has been published.  It replaces ISO 9004:2009, “Managing for the sustained success of an organization – A quality management approach”.

The 4th edition of ISO 9004 provides guidance for organizations to achieve sustained success in a complex, demanding, and ever-changing environment, with reference to the seven quality management principles described in ISO 9001:2015. Where they are applied collectively, quality management principles can provide a unifying basis for an organization’s values and strategies.

Top management’s focus on the organization’s ability to meet the needs and expectations of customers and other relevant interested parties provides confidence in achieving sustained success. ISO 9004:2018 addresses the systematic improvement of the organization’s overall performance. It includes the planning, implementation, analysis, evaluation, and improvement of an effective and efficient management system.

Factors affecting an organization’s success continually emerge, evolve, increase, or diminish over the years, and adapting to these changes is important for sustained success. Examples include social responsibility, environmental and cultural factors, in addition to those that might have been previously considered, such as efficiency, quality, and agility; taken together, these factors are part of the organization’s context.

The ability to achieve sustained success is enhanced by managers at all levels learning about and understanding the organization’s evolving context. Improvement and innovation also support sustained success. ISO 9004:2018 promotes self-assessment and provides a self-assessment tool for reviewing the extent to which the organization has adopted the concepts in the document.

The 59-page standard can be purchased at this ISO web page for about $186. ANSI members can order it for $167.20 at this ANSI web page.

Table of Contents
1. Scope
2. Normative references
3. Terms and definitions

4. Quality of an organization and sustained success
4.1 Quality of an organization
4.2 Managing for the sustained success of an organization

5. Context of an organization
5.1 General
5.2 Relevant interested parties
5.3 External and internal issues

6. Identity of an organization
6.1 General
6.2 Mission, vision, values, and culture

7. Leadership
7.1 General
7.2 Policy and strategy
7.3 Objectives
7.4 Communication

8. Process management
8.1 General
8.2 Determination of processes
8.3 Responsibility and authority for processes
8.4 Managing processes

9. Resource management
9.1 General
9.2 People
9.2.1 General
9.2.2 Engagement of people
9.2.3 Empowerment and motivation of people
9.2.4 Competence of people
9.3 Organizational knowledge
9.4 Technology
9.5 Infrastructure
9.5.1 General
9.5.2 Infrastructure
9.5.3 Work environment
9.6 Externally provided resources
9.7 Natural resources

10. Analysis and evaluation of an organization’s performance
10.1 General
10.2 Performance indicators
10.3 Performance analysis
10.4 Performance evaluation
10.5 Internal audit
10.6 Self-assessment
10.7 Reviews

11. Improvement, learning, and innovation
11.1 General
11.2 Improvement
11.3 Learning
11.4 Innovation
11.4.1 General
11.4.2 Application
11.4.3 Timing and risk

Annex A: Self-assessment tool
A.1 General
A.2 Maturity model
A.3 Self-assessment of detailed elements
A.4 Using the self-assessment tools