'ISO Certified' vs. 'ISO Compliant' for Imaging Equipment Vendors

With Block Imaging Parts & Service’s yearly ISO audit right around the corner, I am reminded of the value it brings to our company and our customers.  It is an investment of hard work and capital to maintain and to be continually improving in all areas, but definitely the kind of investment we are eager to make.

Because of ISO Certification we run more efficiently and are more effective at what we do.

I am also reminded of some companies who advertise with misleading phrases or taglines and want you to believe that they are an ISO certified/registered company when, in fact, they may not be!  A lot of organizations know and understand some of the ISO standards and sincerely try to follow them, but aren’t certified. They adhere to some of the standards, but haven’t made the significant dollar investment or done the really hard work of implementing the entire standard or have gone through an audit with an accredited certification company to actually become ISO certified.

How to know if a vendor is ISO Certified

Watch Out For These Red Flags!

You may find yourself talking to a company that might say:

  • We are an ISO compliant company
  • We recognize the ISO 9001:2015 standards
  • We follow the ISO 9001:2015 standards
  • We have a quality management program in place

Well that is all fine and dandy, but are they actually certified? Chances are if they never pointedly say “We are a ISO 9001:2015 registered/certified company” then they may not be.

Be on the alert and make sure you ask questions specifically about their ISO registration/certification. They could have been ISO at one time and lost certification. This actually happens quite often. Some companies spend the money and do all the hard work to get certified and then lose it because maintaining the certification wasn’t a priority. So advertising the phrases above could be somewhat true, because they could still be following some parts of the standards.

I know lots of Medical Imaging Equipment Vendors that are not ISO certified, but have quality management programs in place. Some companies want to continue to have the benefits that come from being recognized as an ISO registered company without actually pursuing the certification and maintaining it.

Ask These Clarifying Questions

To make absolutely sure that you are working with an ISO registered company it wouldn’t hurt to ask a few questions:

  • When was your company ISO registered/certified?
  • How long have you been ISO registered/certified?
  • May I have your ISO registration number and the name of the company that did your certification?
  • May I see a copy of your ISO certificate?

If they send you a copy of their certificate pay close attention to the expiration date. If they will not supply you with a copy of the certificate, you can call the company they were certified with and supply their registration number to verify that they are still ISO registered/certified.  

Knowing Exactly Who You are Working with is SO Important

If you are concerned about a company you are currently working with, send me a message and we will make sure you are working with a company that has your best interest in mind.  

Working with ISO Certified companies gives you added confidence you deserve in selecting top tier vendors.

(If you liked this post you should also check out ISO Certified Medical Imaging Equipment Company?... It IS a Big Deal)

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Trish Payne

Trish Payne is Block Imaging’s OEM and FDA Liaison. Trish is passionate about understanding the causes of challenges and working collaboratively to overcome them for the good of the imaging industry and the healthcare providers it serves. In addition to keeping Block Imaging’s work in step with industry standards, Trish is a wife, mother of two, tennis player, and world traveler.