Continual Improvement

The practice of embedding improvement into the QMS as a permanent objective, often driven by models like the Plan-Do-Check-Act (PDCA) cycle. It involves tracking customer satisfaction and is required by ISO 9001.

In simple terms, continual improvement is the ongoing, structured effort to enhance processes, products, and overall organizational performance to better meet customer needs, mitigate risks, and achieve sustained success.

Core Principles and Methods

Continual Improvement is not merely suggested but is a fundamental management principle, explicitly detailed in international standards:

Quality Management Principle

Improvement (Continual Improvement) is one of the seven quality management principles underlying the ISO 9000 series of standards. The ISO 9001:2015 standard includes a dedicated section (Section 10.3) titled "Continual Improvement".

Systematic Approach

For improvement to occur consistently, it must be promoted and facilitated by the organization's management system. Effective QMS implementation fosters a culture of continuous improvement that permeates every level of the organization.

The PDCA Cycle

The foundational tool for driving continual improvement is the Plan-Do-Check-Act (PDCA) cycle. This iterative approach ensures process enhancement is systematic:

Plan: Identify opportunities for improvement and develop action plans.

Do: Implement these plans, often on a small scale.

Check: Analyze the results to determine if the desired improvements were achieved.

Act: Either standardize successful changes or modify the plan and restart the cycle.

Risk-Based Thinking

ISO 9001:2015 encourages improvement by requiring organizations to plan and implement actions to address risks and opportunities. Addressing both risks and opportunities establishes a basis for increasing the effectiveness of the QMS, achieving improved results, and preventing negative effects. Improvement actions include correcting, preventing, or reducing undesired effects, as well as improving the performance and effectiveness of the QMS.

Role in Regulatory Compliance and Quality Systems

Continual improvement is tightly linked to mandated quality processes:

CAPA System Integration

The Corrective and Preventive Action (CAPA) system is fundamental to QMS, as it addresses existing issues (Corrective Action) and prevents potential future issues (Preventive Action). Analysis of quality data, such as audit findings, deviations, nonconformities, and complaints, feeds into the CAPA process, which in turn documents measures to ensure continuous improvement.

Management Review

Relevant information on identified quality problems, as well as corrective and preventive actions, must be submitted for management review. Management reviews assess the suitability and effectiveness of the QMS at defined intervals to ensure the system satisfies requirements and is a basis for improvement of the quality system.

Performance Metrics (KPIs)

Converting subjective "quality" into quantitative data helps organizations spot strengths and weaknesses, which is crucial for continual improvement practices. Tracking trends helps identify ongoing patterns and opportunities for improvement.

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