ISO 9004

ISO 9004 is a standard containing guidelines for the improvement of the quality management system, as well as to improve the whole organization. It is an extension of ISO 9001 and part of ISO 9000 family. The guidelines in ISO 9004 are for:

• implementation of activities aimed at improving effectiveness of the organization and its quality management system
• achieve satisfaction of all stakeholders (customers, employees, owners, suppliers and society) to which the organization or its products have an impact.

ISO 9004 standard is not intended for certification. This standard is recommended for those organizations that are improving and want to go beyond the requirements of ISO 9001 It is therefore not mandatory but usable, for organizations that want to improve the quality management system

ISO 9004 standard extends the ISO 9001 standard requirements of the following aspects:

• Focus not only on customer satisfaction but also the satisfaction of other stakeholders,
• Application of the eight quality management principles,
• Additional resources included: information, suppliers and partners, natural resources, finance,
• Economic evaluation,
• Self-assessment,
• Process of continuous improvement

History of ISO 9004

It is important to state, that ISO 9004 standards had always Quality management in the title, while ISO 9001 had only Quality assurance until 2000 revision.

• 1987 - first edition. "Quality management and quality system elements -- Guidelines"
• 1994 revision - ISO 9004-1 with the title "Quality management and quality system elements -- Part 1: Guidelines". The other parts were never published.
• 2000 revision - substantial change (whole ISO 9000 family was changed in 2000), new title "Managing for the sustained success of an organization - A quality management approach".
• 2009 revision - small changes due to ISO 9001 change in 2008

ISO 9004 vs. ISO 9001

ISO 9001 and ISO 9004 were developed as a consistent pair of standards for quality management system.

• ISO 9001 contains the requirements for the quality management system that can be applied to organization and certified. The standard focuses on the effectiveness of the quality management system in meeting customer requirements.
• ISO 9004 standard is not intended for certification purposes or for purposes connected with contracts. It contains guidelines for continuous improvement of the quality management system and guidelines to assess its efficiency and effectiveness.

ISO 9001 and ISO 9004 standards operate though as completely independent of each other, but there were designed so as to complement each other. These standards have an identical arrangement of chapters. ISO 9001 provides requirements and ISO 9004 standard extends them.

ISO 9004 structure

The structure of ISO 9004:2009 standard:

1. Scope
2. Normative references
3. Terms and definitions
4. Managing for the sustained success of an organization
   1. General
   2. Sustained success
   3. The organization's environment
   4. Interested parties, needs and expectations
5. Strategy and policy
   1. General
   2. Strategy and policy formulation
   3. Strategy and policy deployment
   4. Strategy and policy communication
6. Resource management
   1. General
   2. Financial resources
   3. People in the organization
   4. Suppliers and partners
   5. Infrastructure
   6. Work environment
   7. Knowledge, information and technology
   8. Natural resources
7. Process management
   1. General
   2. Process planning and control
   3. Process responsibility and authority
8. Monitoring, measurement, analysis and review
   1. General
   2. Monitoring
   3. Measurement
   4. Analysis
   5. Review of information from monitoring, measurement and analysts
9. Improvement, innovation and learning
   1. General
   2. Improvement
   3. Innovation
   4. Learning

Annex A. Self-assessment tool

Annex B. Quality management principles

Self-assessment tool (Annex A)

Self-assessment tool is a tool of organization's maturity assessment. By the mature organization is understood the one that performs effectively and efficiently and achieves success through implementation of quality management principles.

The self-assessment tool defines 5 levels of maturity. They have no names, only numbers (former revision contained names). The maturity levels are evaluated for each chapter from 4 to 9, and then overall maturity is calculated.

For each chapter there is a table containing key elements (criteria of evaluation) and description of each of 5 levels. Using the tables managers evaluate the maturity level. In order to achieve higher level, all requirements from that and lower levels have to be fulfilled. Therefore, it is important to improve the organization in balance.

Table 1. Example self-assessment criterion

Subclause	Level 1	Level 2	Level 3	Level 4	Level 5
6.2. Financial resources	Resources are defined and assigned in ad hoc way. Short-term financial planning is used.	A process for predicting, monitoring and controlling financial resources is implemented. Financial governance is structured systematically.	There are periodic reviews of the effectiveness of the use of financial resources. Financial risks are identified.	Financial risks are mitigated. Future financial needs are forecast and planned.	Financial allocation of resources contributes to the achievement of the organization's objectives. There is an ongoing process to continually reassess the allocation.

Source: ISO 9004:2009, p. 29.

In above criterion, if the company predicts, monitors and controls the financial resources (level 2) and mitigates the financial risks (level 4), but doesn't perform periodic reviews (level 3) it can announce only achievement of level 2. In order to achieve level 4, all the requirements from level 1-4 have to be fulfilled.

Quality management principles (Annex B)

The separate article describes Quality management principles in detail.

Advantages of ISO 9004

ISO 9004 provides many advantages for organizations that implement it, including:

• Increased customer satisfaction and loyalty by providing consistent, high-quality products and services.
• Improved efficiency and effectiveness of processes and systems, leading to improved productivity and cost savings.
• Improved morale and motivation among staff members through recognition of their efforts and improved communication.
• Improved ability to identify, analyze and address potential risks and opportunities.
• Improved ability to manage and review performance to ensure continual improvement.
• Improved ability to measure, monitor and control quality, leading to improved customer satisfaction.
• Improved ability to identify and address customer needs and market trends.
• Improved ability to meet legal and regulatory requirements.

Limitations of ISO 9004

ISO 9004 provides guidelines for improving the quality management system, as well as the overall organization. However, there are certain limitations to the advantages of ISO 9004:

• ISO 9004 does not guarantee quality performance, as it does not include specific requirements.
• ISO 9004 does not provide a framework for implementing the guidelines, so organizations must create their own implementation strategies.
• ISO 9004 does not provide a way to measure performance, so organizations must develop their own performance metrics.
• ISO 9004 does not provide a clear structure or process for making organizational changes, so organizations must develop their own plans for change.
• ISO 9004 does not provide detailed guidance on how to resolve quality issues, so organizations must develop their own solutions.
• ISO 9004 does not provide a way to ensure that the guidelines are followed, so organizations must create their own systems for compliance.

Other approaches related to ISO 9004

ISO 9004 provides guidance on how to effectively manage and improve the quality of an organization. It is an extension of ISO 9001 and part of the ISO 9000 family. Other approaches related to ISO 9004 include:

• ISO 19011: Guidelines for Auditing Management Systems - This standard provides guidance on internal and external audits of management systems, including quality management systems.
• ISO 31000: Risk Management - This standard provides guidance on how to identify, assess, and manage risks within an organization.
• ISO 15504: Process Assessment - This standard provides guidance on how to assess and improve the performance of processes within an organization.
• ISO 10005: Quality Management - This standard provides guidance on how to develop, implement, and maintain a quality management system.

In summary, ISO 9004 provides guidance on how to improve the quality management system and the organization as a whole. It is supported by other standards such as ISO 19011, ISO 31000, ISO 15504, and ISO 10005, which provide guidance on auditing, risk management, process assessment, and quality management respectively.

ISO 9004 — recommended articles

ISO 9001 — Quality policy — Quality management system — Managerial controlling — Process owner — Balanced scorecard perspectives — Validation master plan — Quality plan — Quality management principles

References

• ISO 9004:2009, Managing for the sustained success of an organization - A quality management approach, ISO, Geneva 2009
• ISO 9004:2009 (ISO)
• Is ISO 9004 a path to business excellence? (PDF)
• The process approach to QMS in ISO 9001 and 9004

Author: Kinga Gut, Slawomir Wawak