Swipe to the right

Why buy from an ISO certified FDA registered facility?

By Hygenic 12 years ago 7652 Views No comments


This article is written by Ralph Buster, Jr. Ralph is in his eleventh year with The Hygenic Corporation. During his time with the Company, he has served in several roles: Compliance Manager, Compliance Director, Director of Corporate Compliance and currently in the role of Vice President Corporate Compliance. Prior to coming to Hygenic, Ralph worked for several medical device manufacturers. Ralph holds a BS in both Biology and Chemistry and a MEd. in Education.

The Hygenic Corporation manufactures a host of products used in both medical and non-medical applications. For the medical customer each Hygenic manufacturing site is registered with the US Food and Drug Administration (FDA). Periodic audits of our facilities by the Agency ensure adherence to the FDA’s stringent requirements as defined in 21 CFR Part 820 Quality System Regulation. From product ideation through realization and even into distribution our customers can count on our products being manufactured and controlled in a manner that ensures sound regulatory compliance. For the non-medical customer each site is also ISO 9001:2008 certified. Bi-annual quality system audits are performed at each location by a third party ISO registrar and every three years our facilities are re-certified to the most recent standard.

No matter the end use of a product, (medical or non-medical) Hygenic maintains one single company-wide quality system ensuring the highest level of quality standards are being maintained for all customers.

For the “new” customer seeking to understand “why FDA registration” or “why ISO certification” is important a brief description might prove useful.


The rising “awareness” of customers both domestically and worldwide has established FDA as symbol of reliance and trust. Even though the FDA has authority only within the United States, the FDA’s Quality System requirements have been internationally recognized as a means to assure product safety and efficacy and customer satisfaction for almost three decades. Medical device manufacturers have the responsibility to use sound judgment when developing their quality system and applying those sections of the FDA’s regulations pertinent to their products and operations. But, the obligation does not end here. It is also the responsibility of each manufacturer to establish requirements for each type or family of devices that will result in products that are safe and effective for their intended use.

Within the Quality System Regulation, the FDA has identified essential elements that must be embodied within a quality system. Following is a list of these elements:

  • Personnel training and qualification
  • Control of product design
  • Control of documentation
  • Purchasing controls
  • Product identification and traceability at all stages of production
  • Definition and control of production and processes
  • Definition and control of inspection, measuring and test equipment
  • Validation of processes
  • Product acceptance criteria
  • Control of non-conforming product
  • Institution of corrective and preventive action when errors occur
  • Labeling and packaging controls
  • Handling, storage, distribution and installation controls
  • Record keeping
  • Servicing
  • Statistical techniques


ISO is an international voluntary organization that began in 1926 as the International Federation of the National Standardizing Associations (ISA). Some believe “ISO” is an acronym however, the name ISO is derived from the Greek word “isos” meaning “equal” – the idea behind the organization being that if two objects meet the same standard they should be equal.

Being ISO certified means that companies operate using ISO guidelines for quality control. When customers know their product has been manufactured in an ISO certified facility, they can feel assured their product will be exactly what they expect – a quality product.

The Hygenic Corporation takes great pride in maintaining our quality system in a manner worthy of scrutiny not only by regulatory authorities but also by customers. Attention to detail and dedication to quality is what sets Hygenic apart from our competition.