ISO 9001 is an international standard for Quality Management Systems (QMS). Many organizations have pursued ISO 9001 certification to gain customer trust and enhance their competitive position in the marketplace.
However, even organizations that have obtained ISO 9001 certification often fail to achieve the expected quality improvements.
The fundamental reason for this lies in the fact that obtaining ISO 9001 certification has become an end in itself, rather than a means to achieve genuine quality improvement.
The true purpose of ISO 9001 is not certification itself, but to establish effective processes based on the standard’s requirements and achieve continuous quality improvement throughout the organization by reliably executing the Plan-Do-Check-Act (PDCA) cycle.
Unfortunately, many organizations have repeatedly engaged in activities solely aimed at obtaining ISO 9001 certification: creating quality manuals and other documents, compiling a complete set of required documents, and producing records that formally comply with these documents. In essence, they have focused on formalized documentation and record-keeping that has become disconnected from actual process improvement and quality enhancement.
With such a formalistic approach, genuine quality improvement cannot possibly be achieved.
Organizations have invested substantial budgets and human resources in obtaining ISO 9001 certification while continuing to produce formalized documentation that yields no practical benefits. It is only natural that many executives have come to question the effectiveness and return on investment of ISO 9001.
Relaxation of Documentation Requirements in ISO 9001:2015
The ISO 9001 standard itself recognized these problems and significantly relaxed documentation requirements in the 2015 revision.
In ISO 9001:2015, even the creation of a quality manual, previously mandatory, was removed from the requirements. This represents a major change since the standard’s inception.
The previous expression “documented procedures” was changed to “maintain documented information,” and the former term “records” was unified under the expression “retain documented information.” This terminological change is not merely a substitution of words but an attempt to redefine the essential purpose of documentation.
By adopting such flexible expressions, ISO 9001:2015 clearly indicates that documentation and record-keeping are not final objectives (goals) but means to effectively operate the quality management system. Organizations can now determine the necessary level of documentation according to their size, types of activities, process complexity, and personnel competence.
However, this relaxation does not mean that documentation has become unnecessary. Creating a quality manual remains extremely important, and appropriate documentation and retention of records are indispensable for effective operation of the quality management system. What matters is not formalistic document creation but documentation that is practical and aligned with the organization’s actual circumstances.
Results-Oriented Approach and the Role of Leadership
ISO 9001:2015 emphasizes a results-oriented (outcome-based) approach. In other words, merely documenting and establishing processes is insufficient; these processes must actually function and produce results such as improved product and service quality, enhanced customer satisfaction, and realized continuous improvement.
To implement this results-oriented approach, ISO 9001:2015 significantly strengthened requirements related to “Leadership.” The previous clause “Management Commitment” was replaced with “Leadership and Commitment,” defining top management’s role more clearly and proactively.
Executive leaders must not only establish quality policies and conduct management reviews but also demonstrate true leadership, permeate quality culture throughout the organization, show clear commitment to quality (a responsible promise), and be accountable for the effectiveness of the quality management system.
Specifically, top management must demonstrate the following:
- Take accountability for the effectiveness of the quality management system
- Ensure that the quality policy and quality objectives are compatible with the organization’s strategic direction
- Integrate quality management system requirements into the organization’s business processes
- Promote the application of the process approach and risk-based thinking
- Ensure that the resources needed for the quality management system are available
- Ensure that the quality management system achieves its intended results
- Promote continual improvement
In essence, what is being questioned is the effectiveness of the quality management system. The evaluation focuses not on the mere existence of formal documents and records but on whether the quality management system actually functions and contributes to improving organizational performance.
Outlook for ISO 9001:2026 Revision
The next revision of ISO 9001, ISO 9001:2026, is scheduled to be published in September 2026. This revision is positioned as an evolutionary update rather than a revolutionary change, with particular emphasis on:
- Addition of leadership requirements regarding the promotion of quality culture and ethical behavior
- Clearer separation and more detailed guidance on risk and opportunity management
- Consideration of climate change (integrating the 2024 amendment)
- Further clarification of leadership’s role in continual improvement
Current ISO 9001:2015 certifications will remain valid until late 2029, with a standard three-year transition period expected.
Conclusion
Obtaining ISO 9001 certification is not an end in itself but a means to achieve the true objective of organizational quality improvement. Rather than being satisfied with merely obtaining certification, organizations are required to make their quality management system truly functional and realize continuous improvement.
This requires strong leadership from executives, active participation of all employees, continuous monitoring and improvement of processes, and accountability for results. The key to creating true value lies in utilizing ISO 9001 not merely as a certification tool but as a strategic framework to enhance organizational competitiveness and improve customer satisfaction.
Comment