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ImmucorGamma is committed to complying with applicable regulatory requirements and standards, as well as maintaining the effectiveness and continual improvement of our Quality Management System.
The Quality Management System supporting the design and manufacturing activities for Immucor products is certified to the requirements of ISO 13485:1996. The certification is under the surveillance of a European Notified Body. Additionally, the quality system conforms to the United States Food and Drug Administration's Quality System Requirements.
Immucor products are manufactured in an environment conforming to current Good Manufacturing Processes (cGMP) and to current Good Laboratory Practices (cGLP) according to the Quality Plan and Quality Policies of the Immucor Quality Manual.
Immucor also participates in laboratory proficiency programs of the College of American Pathologists (CAP) and the National External Assessment Scheme (NEQAS) of the United Kingdom.
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