ISO Certification for Product Design Firms: Blessing or Curse?

 In Medical Product Design

MPE (Formerly Mindflow Design) has not renewed ISO 9001 certification and continues to be certified through ISO 13485.


As  we at MPE (Formerly Mindflow Design) were investigating whether to pursue ISO certification, we were surprised at the antagonism toward ISO that was on display in some quarters of the product design industry.

Critics were saying that the ISO certification process is wasteful and not useful for organizations such as design firms.  They said that following ISO procedures is no guarantee of success.  They claimed that the process is cumbersome and will slow projects down, that it is nothing more than an excuse for failure to achieve deadlines. They insist that clients have unique design control systems requiring flexibility that ISO 9000 contractors cannot provide.

Our search for a better way stemmed from a realization that as we were taking on increasingly complex and larger projects with sophisticated clients, we were outgrowing our old ways of doing things.  Today, more than one million organizations worldwide are certified through ISO 9001, so adopting  one of the most widely used management tools in the world today had strong appeal.

Disregarding the criticism we encountered, we decided upon a two-step approach – first creating a robust quality management system earning ISO 9001 certification, then immediately following up with ISO 13485 certification to align processes with our medical device clients. Step one is complete and step two is in process.

We believe that we have made a good investment. Here’s why:

  • Certification presents us with a flexible process has opened our eyes to how we, as a learning organization, can grow and adapt to achieve more consistent outcomes from project to project.
  • Certification enables us to more easily identify and address client decision points at which risky corner-cutting may jeopardize project success.
  • Our new ISO quality management system serves as a framework for running our business. We no longer have to reinvent the wheel when it comes to policies and procedures, enabling us to focus 100% on creative and technical challenges.
  • While certification giving us a framework for how we run our business, our trademarked Guideway™ Design and Development Process is our framework for designing and developing products. Neither is a hindrance for clients with unique design control systems and both are vitally important in identifying gaps if clients have incomplete design control systems, or, in the case of start-ups, no design control systems at all.
  • Certification provides guideposts for new hires to come up to speed quickly on our business standards and how we serve clients, and how to do it most effectively.
  • We are finding that a well-grounded approach introduces efficiencies that expedite the search for the best solutions.
  • Certification demonstrates to clients that we care about going the extra mile to be the best we can be. Other design firms claim to “follow ISO principles” or otherwise imply a kinship with the process without having actually having earned the certification. We find these claims to be disingenuous.

Thus far, relatively few product design firms have elected to take the ISO 9000 challenge. We have found that doing so ourselves did not introduce an additional level of bureaucracy, become a distraction, cause conflict with client quality systems or produce other dire effects. The international business community has great respect for ISO 9000 certification. Consistent  program growth portends a day when becoming certified may become essential for design firms like ours, particularly if they aspire to attract clients with an international focus.

It appears to us that the root cause of concerns about ISO is fear of the unknown.

For more details about MPE’s (Formerly Mindflow Design) ISO 9001:2015 certification announcement please see our press release.


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