ISO 9004:2018 Quality management — Quality of an organization — Guidance to achieve sustained success provides guidelines for enhancing an organization’s ability to achieve sustained success in a complex, demanding, and ever-changing environment. While ISO 9001 focuses on providing confidence in an organization’s products and services, this document focuses on providing confidence in the organization’s ability to achieve sustained success. Where they are applied collectively, quality management principles can provide a unifying basis for an organization’s values and strategies.
Who should use the standard?
ISO 9004 is applicable to any organization, regardless of its size, type and activity. The standard was last reviewed and confirmed in 2023; therefore, this version remains current.
The standard includes a self-assessment tool to review the extent to which the organization has adopted the concepts. This is, in effect, an audit of the effectiveness of the quality management system. You can download a free copy from here (.pdf).
What does it cover?
| Introduction |
| 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 |
| 9.3 Organizational knowledge |
| 9.4 Technology |
| 9.5 Infrastructure and 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 |
| 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 |
What are the steps in applying ISO 9004?
The main steps in applying the guidance for organizations on the quality of the organization to achieve sustained success in conformity with ISO 9004 are as follows.
1. Understand ISO 9004 Guidelines
- Familiarize yourself with the guidance provided in ISO 9004.
- Understand the principles, concepts, and best practices outlined in the standard.
2. Define Organizational Objectives
- Clearly define the organization’s objectives, vision, mission, and values.
- Ensure that these objectives are aligned with stakeholder needs and expectations and support the organization’s long-term sustainability and success.
3. Assess Organizational Context
Evaluate the internal and external factors that impact the organization’s ability to achieve its objectives. This includes analyzing market trends, regulatory requirements, technological advancements, competitive landscape, and internal capabilities and resources.
4. Engage Leadership Commitment
- Obtain commitment and involvement from top management in driving a culture of quality and continuous improvement throughout the organization.
- Leadership commitment is essential for establishing priorities, allocating resources, and fostering a quality-focused mindset.
5. Implement a Quality Management System (QMS)
Develop, implement, and maintain a robust Quality Management System (QMS) that aligns with the principles of ISO 9001 and ISO 9004. The QMS should encompass processes, procedures, policies, and resources to ensure consistent delivery of products or services that meet customer requirements.
6. Focus on Stakeholder Needs
- Identify and understand the needs, expectations, and requirements of all relevant stakeholders, including customers, employees, suppliers, shareholders, and society at large.
- Ensure that organizational activities are aligned with stakeholder needs to enhance satisfaction and loyalty.
7. Empower and Develop People
- Invest in the development and empowerment of employees at all levels of the organization.
- Provide training, education, and opportunities for professional growth to enhance competence, motivation, and engagement.
- Encourage collaboration, innovation, and knowledge sharing among employees.
8. Implement Process Approach
- Adopt a process approach to managing organizational activities. Identify key processes, their interdependencies, and critical success factors.
- Establish performance metrics, monitor process performance, and implement continual improvement initiatives to enhance efficiency and effectiveness.
9. Manage Relationships and Partnerships
- Build strong and mutually beneficial relationships with customers, suppliers, partners, and other stakeholders.
- Foster open communication, trust, and collaboration to create value and drive innovation across the value chain.
10. Monitor and Measure Performance
- Establish performance indicators and metrics to monitor organizational performance against objectives, targets, and benchmarks.
- Conduct regular assessments, audits, and reviews to identify areas for improvement and take corrective actions as necessary.
11. Pursue Continual Improvement
- Foster a culture of continual improvement and innovation within the organization.
- Encourage experimentation, risk-taking, and learning from failures.
- Implement systematic approaches such as Plan-Do-Check-Act (PDCA) cycle to drive ongoing improvement in processes, products, and services.
12. Benchmark and Best Practices
- Benchmark organizational performance against industry standards and best practices.
- Learn from successful organizations and adopt proven strategies and techniques to enhance competitiveness and achieve sustained success.
Some further words of advice…
By following these steps, organizations can effectively apply the guidance provided in ISO 9004 to achieve sustained success by improving overall quality, performance, and customer satisfaction.
ISO 9004 can be purchased through the ISO.org website.
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