ISO 9001:2000 - Embracing Process Management and Continual Improvement
The year 2000 saw a significant advancement in quality management with the release of ISO 9001:2000. This revision marked a pivotal shift towards process management and continual improvement, paving the way for the modern approach we see today. Let's delve into the key aspects of ISO9001:2000
Paradigm Shift
Structure
A significant step forward compared to 1987, reflecting changing business landscapes and best practices.
Introduced the "process approach," shifting emphasis from document control to understanding how processes interact and create value.
Cl
arified and strengthened requirements for design control, making it more relevant to various industries
Retained the 20 clauses from 1987, but with clearer organization and emphasis on process control.
Clauses
grouped into four sections: Management Responsibility, Resource Management, Product Realization, and Measurement, A
nalysis and Improvement
Main Requirements:
- Process Identification and Management: Identifying and managing key processes that impact product quality
- Control of Design and Development: Emphasizing the importance of planning and controlling the design process.
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Control of Purchased Products and Services: Ensuring suppliers meet quality requirements
- Product Identification and Traceability: Maintaining traceability of products throughout the production process.
- Final Inspection and Testing: Ensuring finished products meet requirements before delivery.
- Control of Nonconforming Product: Properly handling and correcting nonconforming products.
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Preventive Action: Taking proactive steps to prevent nonconformities from occurring.
- Continuous Improvement: Continuously seeking ways to improve the quality management system