IQC - The ISO Pros

of South Burlington, VT & ISO 9001 Experts

The Medical Devices Industry has curbed a lot of influence and appeal over the years and it has, in fact, been the reason why the ISO 13485 Standard has been developed and published. The ISO 13485 or the standard that clarifies the goals, objectives, and the guidelines in implementing a Quality Management System (QMS) for businesses, organizations, and facilities in the medical devices industry.

Medical Devices ISO 13485-IQC ISO9001

Is ISO 13845 Mandatory?

To answer the question, it should not be – akin to how other ISO standards are developed and published. However, there are some countries where it’s considered a mandatory standard to be able to pursue and to proceed to operations.

Here in the U.S., though, as per the guidelines and the directives of the Food and Drug Administration (FDA), the ISO 13485 standard has been made mandatory for businesses and organizations involved and engaged in the medical devices industry.

What ISO 13485 Certified Means

So what does being ISO 13485 mean? Does it have a favorable effect on businesses, companies, organizations, and facilities that are involved in the medical devices industry – whether they are assembly, manufacturing, distribution, etc.?

Being ISO 13485 Certified basically means that a specific organization was successful in implementing the ISO 13485 standard to their business – meaning that they were able to meet all of the requirements of the standard.


Where to Go For Certification

There are numerous institutions and organizations that provide ISO 13485 Training & Certification but if you are in the city of South Burlington, and you want to experience the best and the highest quality of ISO 13485 Training, there’s no doubt that it’s us at IQC – the ISO Professionals you need to work with.

We have been the most reliable and the most trusted business in the industry, having serviced more than 3,500 businesses and organizations, we’ve been the only company to give and provide the training and the integration that they needed.


Is ISO 13485 For You?

Unless your facilities are involved in the medical devices industry, or if you are looking for a way on how you can become more trusted and more relevant in the medical field, the ISO 13485 standard is perfect for you and for what you need.

The main and primary purpose of ISO 13485 is to harmonize and standardize the requirements for the business of handling, managing, and creating medical devices – and it’s a standard that is closely related to ISO 9001. It would not be necessary for you or for your organization if you are not operating in the medical devices industry or the pharmaceutical supply chain.

For all your queries, questions, and concerns about the ISO 13485 and its training processes and procedures – as well as its implementation, you can bank and count on us here at IQC – the ISO Professionals.  You will never regret your decision of choosing us for the ISO 13485 training & implementation service that you’ve been aspiring to have. Talk to us today and be given the best and the highest quality of ISO 13485 Training & Implementation!

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