The implementation of ISO 9001 relies on all aspects of an organization, and that especially includes the people within it. From top level leadership to general employees to clients, humans are involved and impacted by quality management.
People are central to the success of any management system, and ISO 9001 is no exception. Built on seven quality management principles, many focus specifically on leading, engaging, managing, and enhancing the workforce performance of people. This article will explore the importance of human factors in the success of ISO 9001 and how organizations can further understand it for business growth.
Quality Management Principles & People
All seven Quality Management Principles (QMPs) are inherently connected to people and are essential for understanding ISO 9001 and its effectiveness within an organization. Evaluating the role of human factors offers valuable insights into these principles, enhancing the standard’s impact on overall quality management.
The seven QMPs are defined in ISO 9000:2015 Clause 2.3 as:
“Customer Focus: The primary focus of quality management is to meet customer requirements and to strive to exceed customer expectations.
Leadership: Leaders at all levels establish unity of purpose and direction and create conditions in which people are engaged in achieving the organization’s quality objectives.
Engagement of People: Competent, empowered, and engaged people at all levels throughout the organization are essential to enhance the organization’s capability to create and deliver value.
Process Approach: Consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interrelated processes that function as a coherent system.
Improvement: Successful organizations have an ongoing focus on improvement.
Evidence-based Decision Making: Decisions based on the analysis and evaluation of data and information are more likely to produce desired results.
Relationship Management: For sustained success, organizations manage their relationships with interested parties, such as providers.”
Customer focus, leadership, and people engagement are essential components of effective organizational management. However, the key to achieving long-term success lies in the continuous cycle of planning and updating the management system. Ongoing improvement of the QMS requires change, as well as thorough planning. Sustained success demands strong leadership, adaptable strategies, and alignment.
Being mindful of human factors when implementing ISO 9001:2015 can be an effective way to reach these objectives.
Human Error
A challenge that organizations will always face is human error. There is always going to be a chance for nonconformities, workplace incidents, and other risks throughout a company’s operations. While human error cannot always be prevented, there are many ISO 9001 elements that can assist with risk mitigation and corrective/preventive actions.
Some methods that organizations can use in relation to human error include:
- Risk-Based Thinking: Risk-Based Thinking involves assessing risks at the process and procedural levels, not just focusing on loss prevention. This approach helps prevent issues before they arise, shifting the focus from reactive problem-solving to proactive risk management.
- Corrective and Preventive Actions (CAPA): CAPA addresses both current issues and potential risks. Corrective Actions resolve existing problems by identifying and eliminating root causes, with issues uncovered through customer surveys, audits, incident reports, and more. Preventive Actions aim to identify and eliminate risks before they arise by assessing potential nonconformities and addressing operational vulnerabilities.
- Incident Reporting and Documentation: Properly managing a workplace incident can drastically reduce future risks or hazards. Ensure that all factors, processes, materials, or people involved are documented for future reference. This documentation will assist any actions that are taken in response to incidents and can provide important statistics for workplace safety measurements.
Conclusion
In conclusion, the successful implementation of ISO 9001 hinges on the active involvement of people at every level of an organization. By recognizing the critical role of human factors and integrating them with the seven Quality Management Principles, organizations can foster a culture of continuous improvement and resilience.
Addressing challenges such as human error through proactive measures like Risk-Based Thinking, CAPA, and effective incident reporting will not only mitigate risks but also enhance overall operational effectiveness. Ultimately, by prioritizing the engagement and empowerment of their workforce, organizations can leverage ISO 9001:2015 as a powerful tool for driving business growth and achieving sustained success in today’s competitive landscape.
Contact us at ISO Certifications Group to start your journey in becoming ISO 9001 Certified, or transfer your existing certification today.
Sources:
https://asq.org/quality-resources/articles/the-influence-of-human-factors-on-iso-90012015-compliance?id=b97f8ee1fbea40fb982a3ff912b21fb3
