What is ISO?


ISO stands for International Organization for Standardization. It is a worldwide federation of national standards bodies which ensure that quality control standards are met in a variety of industries. The object of ISO is to promote the development of standards for quality control around the world.

Total Scope, Inc. is an ISO 13485 certified company. ISO 13485 is a quality standard specific to medical device repair. We were the first company in our industry to obtain an ISO certification. And to this day we remain one of only a handful of medical device repair companies to hold this level of certification.

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Why does an ISO certification matter?

In order to become ISO 13485 certified, a company has to meet stated quality requirements in a range of vital areas, including handling and delivery, internal quality audits, employee training, and more.

With an ISO certification, standardization and quality rule the day. This means that we hold ourselves to the highest standards when handling and repairing your scopes and devices.

When you partner with us, you don’t have to worry about receiving a scope that has been handled or repaired improperly.

An ISO certification speaks to the dedication of the company to quality control. ISO certifications are currently a choice––not a requirement––in the medical device repair industry (although this may change.) The fact that we are ISO certified demonstrates our serious commitment to quality.

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How we adhere to our ISO 13485 certification

We have a quality system in place which includes every aspect of the ISO 13485 requirements.

Our inspection process is rigorous. No part or product is allowed to continue on to the next stage unless it passes prescribed tests. This ensures that every aspect of your scope or device adheres to the highest standards.

The course of action taken with every scope is well documented and repairs are easily traced, in line with ISO requirements.

We are also required to ensure that we can handle any request before accepting any order, within the specified period of time. We will not accept your order unless we can handle all aspects of your project and return your device to you with the proper repairs completed in a timely fashion.

Higher quality repairs do not have to mean higher costs

You might worry that our commitment to quality repairs means that our prices are more expensive than average, but that is actually not the case. We help you limit your repair costs while maintaining a strong commitment to quality repairs.

When you choose Total Scope, Inc., you are choosing high-quality repairs that come at an affordable price.

We use FDA Class 6-approved parts, meaning that our parts are just as acceptable as the replacement parts offered by OEMs. No more relying on companies that only care about their bottom line.

Total Scope, Inc. offers its clients the best of all worlds: repairs done right the first time, quick turnaround, affordability, free shipping, and free loaners.

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