ISO stands for International Organization for Standardization. It is a worldwide federation of national standards bodies that 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.

Is the ISO Certification Required?


Third-party medical device repair companies are not required to be regulated by any outside agency or held to any sort of industry standard. While third-party repair companies are eligible to apply for an ISO 13485 certification, a standard specific to the medical device repair industry, many choose not to due to the rigorous application and adherence process.

However, this certification is important for any third-party repair facility in delivering high-quality service to the end user.

Benefits of ISO Certification

There are several benefits to having the ISO Certification. ISO 1348 certified repair facilities:

  • Can better meet customer requirements, increase customer satisfaction and enhance production quality.
  • Meet stringent quality requirements in a range of vital areas, including handling, preservation and delivery, internal quality audits, employee training, and more. This quality management system typically results in a superior product.
  • Are always looking for ways to operate more efficiently and eliminate waste, which saves money.
  • Have a quality management system in place, ensuring that there are fewer failures and that processes are in place to correct the ones that happen.
  • Adhere to the principal of ensuring the quality of products and services being offered consistently improve and meet the needs of the customer.

Learn more about how using an ISO certified company can help.

Total Scope is ISO 13485 Certified

In March 2018, Total Scope was certified to the new standard of ISO 13485:2016. This new standard strengthens the controller supply process, increases focus regarding the feedback mechanism and has the inclusion of risk management and risk-based decision making throughout the quality management system.

To this day, we remain one of only a few third-party repair facilities to hold this certification. Learn more about our ISO certification.

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