Quality Management System
Best Quality Practices
At BioLife Solutions, Inc., we are committed to class-defining Best Practices in Quality. Our focus on developing and understanding critical quality elements, maintaining ongoing process controls, and creating a culture of continuous improvement, ensures that customers can rely on us to consistently meet their specifications and requirements.
BioLife Quality
Quality Management System
The BioLife Solutions Quality Management System (QMS) is built upon the international standards for quality management. Designed with the customer in mind, we focus on developing and understanding Critical-to-Quality Elements (CQE), ensuring ongoing process controls, and creating a culture of continuous improvement.
Quality Management Certifications
Given the diversity of manufacturing at BioLife Solutions, our sites hold a variety of different certifications for international standards, including ISO 13485, and ISO 9001. Each facility is dedicated to the maintenance of these certifications to ensure the highest quality in our products.
Quality Policy
We are committed to manufacturing products and providing services and customer support in accordance with our Quality Standards, applicable regulations, and good manufacturing practices that support customer needs. Every team member in the organization is responsible for ensuring product quality and exceptional customer support; and championing continuous improvement during the performance of their duties.
Our promise
- Provide products and services that consistently meet our quality standards to satisfy customer expectations of quality, safety, reliability, performance, and on-time delivery
- Focus on getting things done “right the first time”
- Encourage a culture of quality improvement and collaborative interactions.
- Maintain an effective Quality Management System
- Invest in establishing subject matter expertise in all team members
- Establish partnerships with our suppliers
Class-defining solutions for biological and pharmaceutical storage
17+
COMMERCIAL
THERAPIES
700+
SCIENTIFIC
CITATIONS
700+
MASTER FILE
REFERENCES
70%
SHARE OF US-BASED
CLINICAL TRIALS
