Do ISO Certified Repairs Matter

Seriously, anyone can repair just about anything, as long as you have basic skills, a few tools, hand-eye coordination, and a garage with electricity.  But just because you can, doesn’t mean that you should.

Probe Repair processes matter. More than ever, in the imaging device industry, there is so much at risk. Patients can be failed by institutions that they trust to provide them access to timely, accurate information that could change or even save their lives.

The highest standard of quality assurance for imaging device repairs can only come from companies that take the time to earn ISO certification to apply to their repair services, specifically ISO 13845:2016, the latest certification in quality management systems.  ISO 13845:2016 certification identifies companies that demonstrate a consistent ability to provide medical devices and repair services which meet customer and applicable regulatory requirements.

Why does this matter?

Companies that earn ISO Certification for medical device manufacturing, maintenance and servicing are, simply, those which are most dedicated to quality in the medical device repair industry. Currently, earning ISO certification is not a legal requirement but is totally voluntary.  It takes hundreds of man hours and thousands of dollars and does not result in increased profitability.  Yet it does result in what matters most including:

  • Confidence that the probe repair or MRI coil repair is being performed by highly competent technicians following industry best practices based upon established standards to assure repairs maintain standards that enable it to perform to its original intention
  • Assurance that all aspects of the repair are being addressed to enable a probe or MRI coil to perform safely and effectively.
  • Knowledge that corners are not being cut during a repair process that can set a device up to perform inaccurately, or require an additional repair in the short term

For more information about ISO 13485:2016 certification processes, requirements and details, and compliance for sustainable probe repair services for 3D probes, TEE probes and standard probes, and MRI coil repairs, please email us at Innovatus Imaging is one of very few probe and coil service companies currently employing the 2016 certification.