"Documentation of Quality Management" refers to the systematic recording and management of all quality-related information, processes, and actions within a company. It aims to ensure compliance with quality standards, enable traceability, and support continuous improvement.
Typical software functions in the area of "Documentation of Quality Management":
Document Management: Centralized management and versioning of quality documents such as manuals, procedures, and work instructions.
Audit Management: Planning, execution, and tracking of internal and external audits to review quality management systems.
Action Management: Capture, track, and monitor actions for correcting deviations, preventing errors, and continuous improvement.
Risk Management: Identification, assessment, and management of risks related to quality processes and products.
Training Management: Planning, management, and documentation of training and qualifications for quality assurance personnel.
Non-Conformance Management: Handling of deviations and non-conformities, and tracking and documenting corrective actions.
Change Management: Management of changes to quality-related documents, processes, or products with approval processes in place.
Reporting and Analysis: Generation of reports, dashboards, and analyses on the performance of the quality management system.
Integration and Interfaces: Integration with other enterprise systems such as ERP systems for seamless data transfer and utilization.
Compliance Management: Ensuring compliance with legal and regulatory requirements related to quality assurance.
Examples of "Documentation of Quality Management":
Quality Management Manual: Document outlining the quality policies, processes, and responsibilities within a company.
Audit Report: Documentation of the results of an audit conducted, including findings, assessments, and recommendations.
Corrective Action Report: Documentation of identified deviations, actions taken, and effectiveness verification.
Training Record: Document confirming successful completion of training or qualification by an employee.
Risk Assessment Document: Document assessing identified risks, describing their impacts, and proposing appropriate risk mitigation measures.