IQC - The ISO Pros

of Rutland, VT & ISO 9001 Experts

In case you continue to be intrigued about what the ISO 13485 standard is all about – you should never mind it unless your business or your organization is involved and engaged in the medical device and the pharmaceutical industry or supply chain. If otherwise, then this is not the standard that can help you improve, enhance, and further develop the quality of your products and your services.

Akin to how most, if not all ISO standards are, the ISO 13485 or the Medical Devices standard is not a mandatory standard that all businesses and companies need to have. However, it is worth noting that there are some countries and some states that consider it as a requirement – therefore, disabling and ceasing facilities’ operations if caught non-compliant or with no certification.

What is the ISO 13485 For?

For businesses and organizations in the Medical Devices industry, being Certified against the ISO 13485 is one of the fewest but the most effective ways in proving to your clients and the market that you are working to meet their expectations and their needs.

In the event that you find yourself in dire need of help, assistance, and guidance in the ISO 13485, you can bank and count on us here at IQC – the ISO Professionals to help you with it! Our company or our organization has been deemed and considered as the most trusted, the most reliable, and the most comprehensive in providing the training & implementation for the standard.

ISO 13485 and ISO 9001

The most common mistake that people think about, with regard to the ISO 13485 is that it’s exactly the same as the ISO 9001. Although the ISO 13485 is the set of guidelines, requirements, and policies of businesses, facilities, and organizations in the pharmaceutical and the medical device industry, it is actually the same as the ISO 9001 – but the latter is just in general.

To further clarify this claim, the requirements that the ISO 13485 standard has included:

Work Environment Requirements
Documentation Requirements for Medical Device Files
Production Requirements for Products’ Cleanliness
Contamination Control Requirements
Reporting to Regulatory Authorities
Production Requirements For Sterile Medical Devices

When you choose and decide to work with us here at IQC – the ISO Professionals, you will never have a stagnant and a stale moment. Everything that you need to know about ISO 13485 will be given to you holistically and comprehensively.

Why Choose Us?

There are plentiful of ways why you should choose and consider us as your main go-to or option when it comes to the Training and Implementation of the ISO 13485 – some of which include:

Lower costs and expenses
Higher quality of training programs and lessons
More effective and seamless program and standard integrations
And many more!

Give us a ring or a buzz and we will be more than happy to help you with your needs of integrating and implementing the ISO 13485 to your business or your organization!

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