What is ISO 9001?
ISO 9001 is an internationally recognized standard for Quality Management Systems (QMS). It focuses on establishing, implementing, maintaining, and continually improving an organization's quality management system. The standard is widely adopted by OEM manufacturers to help ensure that products and services consistently meet customer and regulatory requirements.
What are their requirements?
ISO 9001 requires organizations to establish and maintain a systematic approach to quality management across all operational processes. For manufacturers, this includes process control, document management, internal audits, corrective actions, and ongoing performance evaluation to ensure products consistently meet customer and regulatory requirements.
Core ISO 9001 requirements include:
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- Defined operating procedures and controlled documentation
- Leadership involvement and clear quality objectives
- Risk-based process control and preventive actions
- Regular internal audits and management reviews
- Continuous improvement through corrective and preventive actions
