ISO Certification

Because of our commitment to provide the very highest quality products and service, ADC has worked successfully towards certification to the ISO 13485:2016 quality management system standard under the Medical Device Single Audit Program or MDSAP.

 

The ISO 13485:2016 standard is specifically designed to be applicable to medical device manufacturers, and includes requirements for quality, management responsibility, and commitment to continually improving our products and services. The MDSAP program is a global system, involving regulations from multiple countries rolled into a single audit to ensure that ADC’s systems meet the requirements of key global markets. The designation was earned from UL LLC, 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:

 

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, Australian, Japanese, and US regulatory authorities as showing compliance with regulations in each of these countries.

 

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.

 

While no organization must be ISO 13485:2016 certified, it has become a standard for conducting business in the international arena. In fact, ISO 13485:2016 is the primary quality system standard accepted internationally for medical device manufacturers. 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. In some markets, such as Canada, ISO 13485:2016 certification under MDSAP has become a mandatory requirement for companies seeking to keep their medical devices on the market.

 

A quality management system under ISO 13485:2016 also ensures that our products and services are monitored for safety, effectiveness, and for opportunities for improvement. To keep this certification, a company must maintain this commitment and incorporate a process of continual improvement and satisfaction into all aspects of our business activities.

 

And that's our promise to you.