Quality & Regulatory Systems
Our Quality Management System is certified to ISO 13485:2003, Quality Management Systems – Requirements for Regulatory Purposes. Regularly scheduled surveillance audits by our certifying authority ensure continued adherence to this standard. Under the standard, we must demonstrate not only the dedication of senior management to cGMP standards, but also our commitment to provide quality product using the best available materials and methods.
Since the commencement of operations of our manufacturing facility in the second quarter of 2009, we have successfully passed over 100 audits by current and prospective customers.
Customer feedback is a vital part of our continuous quality improvement process. Our Case Management System is designed to quickly respond to customer requests and track trends to improve processes and provide input to corrective and preventive actions. We combine this valuable input with our own internal audit findings to continually improve our quality environment.
To assist customers with their clinical regulatory marketing applications, Type II Master Files for BioLife products are on maintained with the United States FDA. To request a cross reference to our Master Files, please complete our convenient request form.