Quality Management System
Rigorous Quality Management for Reliable Products and Trusted Services
Since its establishment, Cnpair has regarded quality management as a cornerstone of sustainable growth. We go beyond simply “meeting standards” to build a rigorous, transparent, and continuously evolving quality ecosystem—driven by traceable processes, verifiable data, and responsive support. Through this approach, we deliver reliable products and professional services that go beyond customer expectations. Empowering customers to accelerate assay development and regulatory registration.
Our Quality Policy is: “Integrity and Compliance, Customer First, Scientific Rigor, Quality and Efficiency, Pursuit of Excellence.”
Our Quality Objectives are:
Continuously Evolving Quality Management System
Cnpair continuously aligns its quality management practices with international quality standards and industry requirements, strengthening its quality capabilities through ongoing improvement:
2019
First obtained TÜV ISO 13485 Quality Management System Certification.
2019
Established a GMP-compliant manufacturing facility, continuously standardizing the production environment and manufacturing processes.
2023
Obtained BSI ISO 9001 Quality Management System Certification.
We recognize that an excellent quality management system is never static. It must continuously evolve in response to changing customer needs, regulatory requirements, industry trends, and market dynamics.
Cnpair has established a systematic mechanism for continuous self-assessment and improvement, consistently refining every aspect of R&D, manufacturing, quality control, and supply chain management. Our goal is to stay one step ahead of potential issues and consistently exceed customer expectations.
From product development to final delivery, and from quality control to after-sales support, Cnpair has established a comprehensive, end-to-end and closed-loop quality management system.
Cnpair Quality Management System
R&D
- End-to-end design and development
- Multi-dimensional performance verification
- Standardized product development
- Full traceability throughout the R&D process
Manufacturing
- Standardized production processes
- Monitoring of critical process parameters
- Comprehensive process control
- Batch-to-batch consistency and stability assurance
Quality Control
- Multi-level quality inspection
- Stringent quality standards
- Multiple verification and cross-check mechanisms
- Comprehensive product quality control
Warehousing
- Standardized warehouse management
- Strict control of storage conditions
- Real-time inventory status management
- Full traceability of product information
Logistics
- Professional packaging and product protection
- Cold-chain temperature control management
- Real-time monitoring of transportation conditions
- End-to-end shipment status tracking
After-Sales Service
- Rapid response to customer needs
- Professional technical support
- Continuous product quality monitoring
- Root-cause analysis and corrective improvement
Production Qualification of Suppliers
ISO 13485 Certified (TÜV)
ISO 9001 Certified (BSI)
Certified BSL-2 Laboratory
GMP Standard Facilities
Document Management System of Cnpair: Four-level "Pyramid" Structure
Quality Manual
The overarching document of the Quality Management System, defining the quality policy, quality objectives, organizational responsibilities, and principles for system operation. It provides overall guidance for the establishment, implementation, and continual improvement of the Quality Management System.
Procedures
The overarching document of the Quality Management System, defining the quality policy, quality objectives, organizational responsibilities, and principles for system operation. It provides overall guidance for the establishment, implementation, and continual improvement of the Quality Management System.
Work Instructions
The overarching document of the Quality Management System, defining the quality policy, quality objectives, organizational responsibilities, and principles for system operation. It provides overall guidance for the establishment, implementation, and continual improvement of the Quality Management System.
Quality Records
The overarching document of the Quality Management System, defining the quality policy, quality objectives, organizational responsibilities, and principles for system operation. It provides overall guidance for the establishment, implementation, and continual improvement of the Quality Management System.