---
title: ISO 13485:2003 Certification
description: Helmer received ISO 13485:2003 certification for the design, development, manufacture, sales and service of biological material storage and processing equipment
image: https://blog.helmerinc.com/hubfs/Logos/Helmer/logo.png
---

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- ISO 13485:2003 Certification

# ISO 13485:2003 Certification

 Posted on Apr 16, 2009 by Donna Holpuch

![logo.png](https://blog.helmerinc.com/hs-fs/hubfs/Logos/Helmer/logo.png?width=350&height=108&name=logo.png)

---

Helmer, Inc. received ISO 13485:2003 certification for the design, development, manufacture, sales, and service of biological material storage and processing equipment. ISO 13485:2003 certifies:

- an organization consistently demonstrates its ability to provide medical devices and related services that meet both customer expectations and regulatory requirements
- there are controls in the work environment to ensure product safety
- risk management activities are implemented during product development
- specific requirements are set for the verification of corrective and preventive actions

This certification demonstrates Helmer's commitment to quality management and assurance, and bears witness to the care and responsibility put into the design and manufacture of Helmer products. ISO 13485:2003 is becoming widely accepted as the international standard to address medical device regulations around the world.

Certification Organization: BSI Management Systems  
Certificate Number: FM 536286  
Registration Date: 4/14/2009

#### About Helmer:

Helmer is a manufacturer and distributor of Storage and Processing Equipment for the Clinical Market. Our products include blood bank, laboratory, and pharmacy refrigerators; plasma and laboratory freezers; platelet storage equipment; plasma thawing system; and centrifuges. Our world headquarters is located in Noblesville, IN, with distribution throughout the world.

![Donna Holpuch](https://blog.helmerinc.com/hubfs/Blog/authors/DHolpuch.jpg)

### Written by [Donna Holpuch](https://blog.helmerinc.com/author/donna-holpuch)

Donna Holpuch is the sales enablement and programs leader for Life Science Solutions, a business unit of Trane Technologies. With more than 25 years experience, she has an extensive background in marketing to the clinical market.

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