Quality Policy and Standards

“ALPCO is committed to producing in vitro diagnostic devices that exceed its customers’ expectations. This is accomplished by maintaining an effective quality management system and operating in compliance with its rigorous requirements. This commitment is evidenced by the company’s establishment and constant pursuit of total quality objectives.”

ALPCO’s quality management system (QMS) is certified to the ISO 13485:2016 standard, which is applicable to the design, development, manufacture, and distribution of in vitro diagnostic reagents and kits.

The International Organization for Standardization (ISO) is the prominent and independently led worldwide organization that utilizes experts to develop specifications for products, services and systems for many different industries. ISO 13485:2016 is the gold standard for medical device companies to ensure the quality, safety and efficacy of products in the clinical diagnostics field.

Below you will find our ISO 13485:2016 certificate.

Download Certificate

 

FDA Establishment and Device Registration

ALPCO is an FDA registered medical device manufacturer under 21 CFR 820.

ALPCO’s establishment registration can be found here.