ISO 13485:2003 Certification

Our Quality Management System (QMS) is now ISO 13485:2003 certified by DEKRA. ISO 13485:2003 is an internationally recognized quality management standard for businesses in the medical device industry. This certification means that Alpha Source meets international standards in the distribution of lamps, batteries, battery packs, related items, and medical devices. Access Battery, a division of Alpha Source, Inc., is approved for the design, development, assembly, and sale of battery packs for use in medical and non-medical devices.

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Certification Process

DEKRA is a recognized certification company that performs audits on manufacturers for a variety of standards including ISO9000, AS9100, CE Marketing, TL9000 and others. The certification process is divided into phases. DEKRA begins the process by defining an audit program that will expand with the company to keep them in line with industry standards as they change. From there time is given for the company to implement the new standards before an audit is completed.

After an initial audit is passed, DEKRA awards a certificate to the companies who conform to the standards. Additional audits are done each year to ensure that the companies maintain their ISO certification status.

What Does This Mean for You?

Our QMS ISO certification assures you that all of our products are manufactured with quality in mind. Every process from design to development to sale conforms to international standards in the medical device industry. So you know the product you are receiving is reliable and will perform its best.

If you have any questions on our ISO certification or would like more information about Alpha Source, please contact one of our Customer Service or Sales Representatives at customer.service@alphasource.com

Health Canada License

Alpha Source, Inc. and Access Battery, LLC Class 2 Battery Packs including batteries for syringe pumps, ventilators, defibrillators, and infusion pumps have been licensed to be sold in Canada by Health Canada.

Health Canada is Canada's federal department responsible for helping the people of Canada maintain and improve their health, while respecting individual choices and circumstances.

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