Quality Management System (QMS) is a formalized framework that outlines the structure, responsibilities, and processes for achieving quality objectives in an organization. The QMS ensures that products or services meet customer and regulatory requirements.
Content of a QMS
A typical QMS consists of the following elements:
- Quality Policy: A statement outlining the organization’s commitment to quality.
- Quality Objectives: Specific, measurable targets for achieving quality excellence.
- Scope: A description of the processes, products, and services covered by the QMS.
- Responsibilities and Authorities: Definitions of roles, responsibilities, and authorities for quality-related activities.
- Processes and Procedures: Documented processes and procedures for managing quality, including:
- Management review
- Internal audits
- Corrective and preventive actions (CAPA)
- Continual improvement
- Training and awareness
- Documentation and Records: A system for managing documents and records, including:
- Quality manual
- Procedures
- Records of quality activities
- Risk Management: A process for identifying, assessing, and mitigating risks that could impact quality.
- Continuous Improvement: A process for identifying and implementing opportunities for improvement.
- Customer Feedback and Complaint Handling: Processes for collecting and addressing customer feedback and complaints.
- Regulatory Compliance: Processes for ensuring compliance with relevant regulatory requirements.
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