At CellBios, quality is at the core of everything we do. Our Quality Assurance (QA) team is dedicated to ensuring that every product we manufacture adheres to the highest standards of safety, reliability, and performance. We have implemented a robust Quality Management System (QMS) that aligns with national and international regulatory standards, ensuring compliance with ISO 13485, and other industry-specific certifications.

Comprehensive Quality Management System (QMS)

• Our QMS is designed to uphold the highest quality standards across all stages of the manufacturing process. The QA team works closely with all departments to monitor production activities, ensuring that final products consistently conform to established specifications.
• Regular internal and external audits are conducted to assess the effectiveness of the QMS, helping us identify potential areas for improvement and ensuring that we maintain compliance with regulatory requirements.

PDCA Methodology for Continuous Improvement

• We adopt the PDCA (Plan, Do, Check, Act) methodology to promote lean manufacturing and continuous improvement across our processes.
• This systematic approach helps us regularly monitor and assess each stage of production, ensuring that we reduce waste, optimize processes, and improve product quality over time.

Strong Process Controls

• Our manufacturing processes are equipped with advanced quality control tools that help detect any out-of-control situations early, allowing us to take corrective actions promptly and restore the process to compliance.
• We continuously monitor key performance indicators (KPIs) and implement preventive actions to address potential quality issues before they impact the final product.

Regular Training and Education

• Quality assurance is not just the responsibility of the QA team, but of every member of our production workforce. Our QA team provides ongoing education and training to the production team to ensure that standard operating procedures (SOPs) are followed rigorously throughout the manufacturing process.
• This commitment to continual learning ensures that the production team is always equipped with the knowledge and skills required to maintain product quality at every step.

Complaint Management and Corrective Actions

• We take customer feedback and complaints seriously. Any issues raised regarding marketed products are thoroughly investigated by our QA team.
• The root cause of quality defects is identified, and appropriate corrective and preventive actions are implemented to address the issue. We ensure that defective products are removed from the market and that preventive measures are applied to avoid similar issues in the future.

Ongoing Process Monitoring

• To maintain our commitment to quality, we continuously monitor production processes to identify trends or potential risks that could affect product quality. By detecting potential problems early, we are able to prevent defects from occurring and ensure that all products meet the highest standards before they reach the market.