What is QMS?
Quality Management System, which serves as the foundation for quality management, including quality information generated in the product manufacturing process, prototype development management information, and standard management required for internal quality control tasks.
QMS Range
1. Design and development: Product planning, design verification, and feasibility checks
2. Manufacture: Raw material receiving, production process, process management
3. Inspection: Incoming inspection, in-process inspection, outgoing inspection
4. Custody: Warehouse management, inventory management, First-In, First-Out (FIFO)
5. Selling: Order management, distribution management, customer management
6. Installation and Service: Installation verification, user training, after-sales service management
Post-marketing management
A series of procedures and record management systems established to ensure continuous product improvement, including post-market complaint reception, corrective actions, communication with regulatory authorities, and recalls.
QMS Key Elements
1. Document System: All documents required for quality control, such as standards, procedures, guidelines, and forms.
2. Process: A procedure and flow that defines how each task is performed.
3. Records: Records and data proving that actual work was performed
QMS Purpose
1. Safe and effective supply
2. Production of products of uniform quality
3, Reduction in customer complaints and improvement in satisfaction
4. Compliance with regulatory requirements
5. Continuous quality improvement
6. Minimize risk
Composition
Master Data Management
Registration of inspection standards by item
Registration of inspection standards by client
Registration of validity periods by item
Registration of inspection sample standards
Acceptance Level (AQL) Registration
Inspection after receipt
Inspection registration after receipt
Current status of quality analysis results
Current status of product analysis results
Shipment, Return, Inspection, Registration
Registration of test results
Inspection of goods
Import inspection registration
Import Inspection Status
Incoming Inspection PPM Status
Non-conformity management
Non-conforming registration
Non-conformity status
Registration of improvement measures
Validity evaluation registration
Standard Management
Standard registration (work, inspection, test)
Certification Audit and Evaluation
Certification Review Registration