ISO 9001 Clause 10.3, which addresses continual improvement, emphasizes the ongoing enhancement of the suitability, adequacy, and effectiveness of the quality management system (QMS).
Clause 10.3 Explained
Ongoing Improvement: The organization is mandated to continually enhance its QMS. This involves a systematic and proactive approach to refining processes and systems over time.
Consideration of Results: The organization should take into account the outcomes of analysis, evaluation, and outputs from management reviews. This comprehensive assessment aids in identifying areas that need improvement.
Identification of Needs or Opportunities: Through the analysis of data and management review, the organization must determine whether there are specific needs or opportunities for improvement.
Incorporation of Improvement into Processes: Once needs or opportunities are identified, the organization should incorporate them into its continual improvement processes. This could involve adjusting procedures, training programs, or other elements of the QMS.
Clause 10.3 Example Manufacturing Company
Imagine a manufacturing company that identifies a recurring issue in the production process through regular quality checks. ISO 9001 Clause 10.3 means that the organization not only corrects the immediate problem but also examines the larger picture.
It considers:
What led to this issue?
Are there similar issues elsewhere?
How can processes be adjusted to prevent such issues in the future?
For example, it might involve updating employee training, recalibrating machinery, or reevaluating suppliers. The idea is to foster a culture of ongoing improvement, where each identified issue becomes an opportunity to refine and optimize the QMS.
ISO 9001:2015 Clause 10.3 Continual improvement
ISO 9001 Clause 10.3 emphasizes a dynamic, learning-oriented approach to quality management. It’s not just about fixing problems but about systematically evolving and becoming better over time. It emphasizes a proactive and systematic approach to continually enhance the QMS, reflecting a commitment to meeting customer needs, improving efficiency, and responding to changing circumstances.