Q: Can somebody tell me if I should only use third-party service providers that have an ISO certification? Is it a big deal?
A: Manufacturers will not certify a third-party servicer if they compete with the manufacturer’s service revenue.
A: ISO certification will become more important once the FDA and Congress figure out what they want to do to appease the lobbyists for the several OEM and third-party organizations who are pushing for this action against in-house and third-party medical device service organizations. Obviously, the ACA has had a negative impact on margins and these lobbying organizations are trying to get the government to preserve as much margin as possible for them through legislation. Rarely is there a discussion about patient safety as the primary goal. The organizations pushing for this legislation like to present anecdotal information about poor service from third-parties and in-house programs. I have similar data that supports poor service and results on devices that have been under full-service OEM contracts. The argument made by these organizations is false, in my opinion. In the end, it comes down to the personnel who directly service the medical devices in question. This is why I personally am so picky about who joins my team. Regardless of the service provider – OEM, third-party or in-house, is the person servicing the device invested into the work he and/or she is performing? That person and their commitment to excellence will tell me the quality of the service product delivered, not the name of the company on the ID badge.
So back to your original question, is ISO certification important? Sure it is. Is it the only criteria to make a decision about partnering with a service/parts organization? No, but it certainly helps. Much like ACI certification for the HTM professional. Does ACI certification ensure that any successful test-taker will deliver exceptional service for their employer? Certainly not, but it does make any HTM professional more knowledgeable about the career they have chosen and the service they deliver. The solution for exceptional service always come down to the individual delivering the service. Is ACI certification or ISO certification a “big deal?” “You betcha!” Does it guarantee anything about quality? No guarantees, but it should make it better. That is why the HTM professional and the employer should always choose wisely. Do your homework about the people you do business with, that includes OEMs, third-parties, in-house organizations, etc … I bet most of us research the car we will buy, the washer and dryer we buy, or even the haircut professional we use. Why not do that in your career? I suspect most organizations in health care who service or provide parts are either ISO certified or are looking into ISO certification. Are you as a healthcare technology management professional looking into your certification and professional development? I hope so. The patient is counting on it!
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