IQC - The ISO Pros

of Essex Junction, VT & ISO 9001 Experts

The Medical Devices Standard is one of the few standards that are often misunderstood and isn’t given too much value because of all the other standards and certifications around it. However, as difficult as it may seem, the ISO 13485 is actually one of the most important – and in fact, the most efficient and the most effective products there are in the ISO world.

Being the main Quality Management System (QMS) standard for the industry and the sector of Medical Devices, the ISO 13485 is the standard that is recommended to be gotten and to be learned by all institutions, organizations, and facilities in the medical devices industry.

Medical Devices ISO 13485-IQC ISO9001

What You Need to Know About ISO 13485

Part of the most important and the most relevant facts about the ISO 13485 that continues to be a hindrance for most people in terms of further understanding the standard include:

  • The size of your company or your organization doesn’t matter;
  • ISO 13485 IS NOT a PRODUCTS STANDARD. Therefore, the quality of the products wouldn’t be defined in this standard.
  • What the ISO 13485 is, is a standard that is based on the overall effectiveness and efficiency of the processes – if it meets the outcome and the results that clients and customers are expecting

Those are only a few of the things that clearly define what the ISO 13485 standard is all about – and if you find yourself in need of help and assistance with it, you can bank and count on us here at IQC – the ISO Professionals, the most talented and the most recognized organization or institution in the industry.

ISO 9001 vs. ISO 13485

It is also imperative and essential to understanding that the Quality Standard ISO 9001 is not the same as the ISO 13485. Although the ISO 13485 is the standard that sets out the qualifications, goals, and practices that organizations and facilities should have, it has additional and extra requirements that only pertain to businesses, institutions, and facilities in the medical devices industry.

ISO 9001 is the general standard for implementing a QMS; and ISO 13485 is based on the requirements of ISO 9001. So, if you pass the ISO 13485 Certification and your company gets certified against the ISO 13485, they would be certified in the ISO 9001 standard, too.


Why Choose Us?

There are a lot of companies, businesses, organizations, and institutions in the industry that offers the same level of expertise and mastery like we do here at IQC – the ISO Professionals but why should you choose us?

Other than the fact that we’re the best and the most experienced in the industry, when you ask us for your ISO 13485 Training & Implementation, we will never leave you with questions and confusions – we will work hard and we will assist you in terms of implementing the standard into your business processes and operations.

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