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ISO Certification

Because of our commitment to provide the very highest quality products and service, ADC has worked successfully towards ISO 13485:2012 and ISO 9001:2008 certification by TUV Rheinland.  In fact, we are one of the few US companies in this product space to hold both certifications.

The ISO 13485:2012 standard is specifically written for medical device manufacturers while the broader ISO 9001:2008 quality management standard is sought after by any firm committed to quality. The designations were earned from TUV Rheinland, a leading international standards, testing, registration, and certification organization.

Our ISO certification ensures that we build quality into our products and services and avoid costly, after-the-fact inspections and rework. You know with an ADC product, you'll get:

  • Services designed to meet your needs and ensure your satisfaction,
  • Products manufactured with quality planned and documented in every step of the process,
  • A team of skilled employees consistently and continuously working to make your experience better, and
  • The peace of mind knowing that we work to fulfill our promise to you.

Everyone at ADC is part of the ISO experience: marketing, sales, accounting, customer service, manufacturing, shipping, and receiving. The ISO experience is a company-wide philosophy of business practices that puts the needs of our customers at the center of all that we do. ISO certification isn't one time, it's a continuous quality-improvement process.

ADC's certification, which was earned after a thorough, independent audit of our quality management system, facilitates our company's CE marking of products for sale in Europe. It is also recognized by Canadian regulatory authorities as being in compliance with that country's quality requirements. In order to be certified to ISO 13485:2012 and ISO 9001:2008, a company must implement and document strict quality management processes for product development and delivery, employee training, and materials purchasing, among others.

What Is ISO?

The International Organization for Standardization (ISO) is a worldwide federation of national standards bodies from more than 150 countries. The purpose of ISO is to promote the development of standardization and related world activities to facilitate the international exchange of goods and services, and to develop cooperation in intellectual, scientific, technological, and economic activity.

The American National Standards Institute (ANSI) represents the United States in ISO. It is a private, non-profit membership organization composed of public and private sector organizations and was a founding member of ISO. ANSI does not develop American national standards but facilitates their development by establishing consensus among qualified groups.

Why Be ISO Certified?

While no organization must be ISO 9001:2008 certified, it has become a standard for conducting business in the international arena. In fact, ISO 9001:2008 is the only quality system accepted internationally. Many companies in the European community have become ISO certified and many are requiring their suppliers to prove they have a quality system, such as ISO, in place as a condition of purchase. To keep this certification, a company must maintain this commitment and incorporate a process of continual improvement and satisfaction.

And that's our promise to you.

Click the badges below to view our certificates in PDF format.

View our ISO certificate