What is ISO and how does it work?
ISO, “International Organization for Standardization”, is a worldwide federation of national standards bodies, representing more than 130 countries. The object of ISO is to promote common standards between nations.
ISO 13485 is an International Quality Management Standard for medical devices. ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Total Scope, Inc. is “ISO 13485” certified. Our company is audited by an accredited certified body annually. These yearly assessments are to assure that Total Scope, Inc. continues to implement all the requirements of ISO 13485.
Is it true that the FDA is considering regulating scope and instrument repair?
Yes. In the past several months, there have been discussions of the FDA possibly regulating the independent service organization in the instrument and scope repair market.
TOTAL SCOPE is ready!
Total Scope, Inc. has been an ISO certified company for 17 years. We were the first registered company in our industry to be awarded the ISO 13485 certificate.
Total Scope’s earliest quality meetings were shaped by a thorough understanding of the FDA’s Quality System Regulations. It was a milestone event for our company when we harmonized the FDA Quality System Regulation and the ISO 13485 independent audit system together at Total Scope, Inc.
Total Scope, Inc. has been complying with the FDA’s Quality System Regulations for the past 17 years through our ISO 13485 certification. Our procedures, such as, training, calibration, internal audits, recalls, non-conformance review, process evaluation, warranties, complaint handling and data analysis, have been implemented and maintained.
Total Scope, Inc. made the choice 17 years ago to become an ISO certified company given that we repair products used on patients every day.
What type of pricing programs do you offer?
We offer a variety of financing options to meet the needs of our clients, including discounted list pricing, cost-per-procedure, fully capitated, and shared risk. An equipment leasing program is also available. Our sales specialists can provide more in-depth explanations of our pricing options at your request.
Do you offer repair services on Saturdays?
At a client’s request, Total Scope will perform minor repairs on Saturdays, making it possible to get the scope back on Monday in time for procedures.
Is my equipment being repaired in-house or being outsourced?
We perform all endoscope repairs in our state-of-the-art repair facility located outside of Philadelphia, Pennsylvania. As a result, Total Scope, Inc. can provide the quickest turnaround time possible and have the greatest degree of control over the workmanship of the repair.
Do you offer a warranty on repairs?
Total Scope offers a 120-day satisfaction guarantee on all repairs across the board.
When will I receive my repair requisition/estimate?
In most cases, we are able to provide clients with a cost estimate within 2 hours of receiving a device at our facility.
Do you offer loaners?
At your request, Total Scope will provide your facility with a free loaner for the full duration of your repair.
How long will it take to repair my equipment?
According to our turn-time statistics, 90% of our minor repairs are completed in the same day, with major repairs averaging 3-5 days.
Do you carry a repair certification?
Total Scope, Inc. is certified by the ISO 13485: 2016 quality standard. This ISO certification is specific to the medical device industry. No other scope repair company in the country has achieved this certification – Total Scope stands alone in this level of quality assurance.
What types of parts are used in the repair of my equipment?
Total Scope, Inc. only utilizes FDA Class VI replacement parts. In addition, any vendors supplying parts to our company must undergo a quality review as part of our ISO certification process. Our clients can rest assured that their equipment is repaired with the highest quality parts available.
How does your price compare to the competition?
While cost should not be the only consideration, we understand the reality of budgetary constraints. Total Scope, Inc. is proud to provide its clients with a Price Guarantee: we will meet or beat the pricing of our competitors for the same repair. Our clients also have the benefit of completely free shipping for packages sent to and from our facility. As always, we make sure to only repair what is necessary in an effort to keep your costs low.