Quality & Compliance

Sekbio maintains a rigorous quality management system in compliance with international standards. We deliver IVD antibody raw materials with batch-to-batch consistency and full traceability.

Our Certifications

ISO

ISO 13485

Certificate No: 13485-202X

Quality Management System for Medical Devices

CE

CE Marking

Directive: 98/79/EC

In Vitro Diagnostic Medical Devices

GMP

GMP Compliance

Good Manufacturing Practice

Consistent quality production

Quality Management System

Quality Control Process

  • Raw material incoming inspection and testing
  • In-process quality control at each production stage
  • Final product release testing with full specifications
  • Stability studies under accelerated and real-time conditions
  • Document review and batch record verification
  • Final release only after meeting all acceptance criteria

Quality Assurance Measures

  • Annual internal audits and management review
  • External audits by certification bodies
  • Supplier qualification and monitoring
  • Equipment calibration and preventive maintenance
  • Complaint handling and CAPA implementation
  • Continuous improvement and risk management

Testing Standards & Specifications

Purity Testing

  • SDS-PAGE analysis
  • SEC-HPLC aggregation test
  • Concentration verification
  • UV absorbance analysis

Activity Testing

  • Binding affinity (Kd)
  • Sensitivity evaluation
  • Specificity testing
  • Cross-reactivity assessment

Safety Testing

  • Endotoxin testing (LAL)
  • Sterility testing
  • Mycoplasma detection
  • Viral safety assessment

Quality Performance

99.9%
Product Compliance Rate
95%
Purity Standard
<0.1%
Endotoxin Level
<5%
Aggregation Level

Document Control & Traceability

Document Control

  • Standard Operating Procedures (SOPs)
  • Batch manufacturing records (BMR)
  • Test protocols and reports
  • Change control documentation
  • Validation and qualification documents
  • Training records for all personnel

Traceability System

  • Unique batch number for each product
  • Full traceability from raw materials to final product
  • Complete batch record documentation
  • Certificate of Analysis (CoA) for each batch
  • Retention samples for stability monitoring
  • Online batch tracking system

Regulatory Compliance

We Comply With

ISO Standards

  • ISO 13485:2016 - Medical Devices QMS
  • ISO 9001:2015 - Quality Management
  • ISO 14971 - Risk Management

IVD Directive

  • Directive 98/79/EC - IVD Medical Devices
  • IVDR compliance preparation
  • Performance evaluation

Best Practices

  • GMP guidelines for IVD raw materials
  • GLP for analytical testing
  • EHS compliance

Need Quality Documentation?

Contact our quality team to request certificates of analysis (CoA), validation reports, or other quality documentation for our products.

Request Documentation Download Quality Manual