ISO 9000 Quality Management: Principles, PDCA, and Implementation
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ISO 9000 Quality Management System: Core Principles
The ISO 9000 Quality Management System (QMS) is built upon eight fundamental principles derived from Total Quality Management (TQM):
- Customer Focus: Understand customer needs, meet their requirements, and strive to exceed their expectations.
- Leadership: Establish unity of purpose and organizational direction, fostering an environment that promotes employee involvement and objective achievement.
- Involvement of People: Leverage the full abilities of involved employees for the benefit of the organization.
- Process Approach: Recognize that desired results are achieved more efficiently when activities and related resources are managed as processes.
- System Approach to Management: Identify, understand, and manage interrelated processes as a system to contribute to the organization's effectiveness.
- Continual Improvement: Make continual improvement a permanent objective for the organization, its people, processes, systems, and products.
- Factual Approach to Decision Making: Base decisions on the analysis of accurate, relevant, and reliable data and information.
- Mutually Beneficial Supplier Relationships: Cultivate relationships where both the organization and its suppliers benefit from shared resources and knowledge, creating value for all.
ISO 9000's Operating Principle: The PDCA Cycle
The Plan-Do-Check-Act (PDCA) cycle is the operating principle for ISO's management system standards. It functions in a never-ending loop, driving continual improvement for products, services, processes, and systems. The steps are:
- Plan: Establish objectives and develop the necessary plans to achieve them.
- Do: Implement the plans.
- Check: Measure the results of the action to determine if the planned action is working and if objectives were met.
- Act (or Adjust): Learn from the results of the "Check" step, make any necessary changes to the plans, and repeat the cycle.
Applying ISO 9000 in Organizations
Once an organization is registered, it must adhere to specific requirements to maintain its ISO 9000 certification:
- Apply its QMS to its operations strictly according to the standard and exactly as the QMS documentation states.
- Continually assess the effectiveness of the QMS and implement changes to improve it.
- Conduct periodic internal QMS audits.
- Submit to external (third-party) surveillance audits at least annually by its registrar.
- Submit to a new registration audit every third year by a registrar.