A Quality Management System Requires Procedures to Ensure Its Long-Term Maintenance
Maintaining an effective quality management system over time within an organization is a specific requirement of the ISO 9001:2015 standard. Let's explore what this means in practice.
Since a quality system is essentially a systemic view of an organization from the perspective of how it creates and retains customers, maintaining this system over time could be interpreted as a mere reflection of reality. For many, this might imply that if system processes do not achieve the expected results, this should be reflected in the model, rendering it useful only as a simple “repository” of historical system records.
Even though it is easy to understand that quality system documents should not be confused with the model itself, the same mistake is often made by equating these records with the quality system itself. This results in merely updating documented information to comply with the requirement of system maintenance. However, it is evident that real change must occur in what people do, as this is the only way to alter the system's outputs. What we call a “quality management system” consists of a series of interdependent elements that acquire and retain customers over time. Therefore, maintaining a quality system means preserving this series of interacting elements, which requires sustaining the structure and processes that hold the system together.
In simple terms, it is necessary to maintain relationships, interactions, and connections and to restore anything that has deteriorated or become disrupted over time. Why is it so crucial to comply with this requirement, outlined in section 4.4.1 of ISO 9001:2015? The answer is straightforward: any system, without maintenance, will inevitably degrade. This principle aligns with the second law of thermodynamics, the law of entropy, which applies to all open systems—including quality systems that rely on an external environment subject to change. To prevent external modifications from negatively impacting the structure and its processes, timely corrective actions must be taken to adjust system outputs based on structural changes. Neglecting these elements and the relationships between them would quickly lead to a decline in the system's ability to achieve expected results, resulting in performance deterioration and, ultimately, negative effects on customer satisfaction.
Now that we have clarified the dynamics of maintaining an effective quality system over time, how can it be practically achieved? The answer is simple—by:
- ensuring long-term retention of competent personnel who can operate individual processes and promptly identify any anomalies;
- correcting, whenever necessary, special causes of variance—remembering that “special causes” refer to occasional anomalies that can be detected through continuous process monitoring. These may include operator errors, equipment failures, material defects, and similar issues;
- providing all necessary resources for optimal system and process management;
- keeping documented information updated to ensure the system and its elements function correctly;
- maintaining clean and organized workspaces where processes take place—applying the principles of the “5S” methodology may be useful in this regard;
- benchmarking processes against industry best practices to drive continuous improvement;
- replacing departing employees by training new personnel to properly follow processes;
- upgrading management technologies to keep the system up to date;
- allocating resources to address unforeseen extraordinary events and using acquired knowledge to prevent their recurrence in the future;
- staying updated on the latest techniques relevant to the industry to maintain system and process efficiency;
- periodically reviewing the organization's vision and mission to ensure alignment with corporate values.
Finally, what evidence demonstrates compliance with this requirement? The answer is simple: proving that system performance has remained stable over time and that any variations have been promptly analyzed and corrected.