Quality - ISO Certification

We are committed to quality. Omega Bio-tek is ISO 9001:2015 and ISO 13485:2016 certified by NSF-ISR. We ensure that all products are properly assembled, tested, recorded, stored, and shipped. We perform rigorous quality checks of our products and thoroughly train our employees to ensure compliance. We also have several quality control steps within our processes to deliver the best consistent product.

We firmly believe that quality in equals quality out.

Lot Traceability: Our quality system allows for complete traceability from the incoming chemicals from our vendors all the way to Omega Bio-tek’s customers orders. This allows us to know every buffer, component, and even every chemical that is used within our products.

Quality Control: All Omega Bio-tek products have rigorous standards that must be met prior to leaving our door. Each product is checked multiple times in the production process to ensure proper function and packaging. Most of our products are quality controlled using similar methods to which you would be using in the lab. 

Process Controls: All equipment used in our manufacturing process must be in calibration prior to use and there is full traceability between the finished product and all the equipment used during its manufacture. Employees are trained, and competency tested to ensure that their work is consistently completed in accordance with standard operating procedures. Our quality system ensures that changes made to the system are thoroughly validated prior to being implemented.