20 Feb Certification Matters
An expert’s guide on making the best partnership choice for your next development partnership.
“Does certification to an ISO standard matter when it comes to choosing a design and development partner?” Here at the Realtime Group, we absolutely believe it does.
From an experts’ perspective, it’s obviously a good idea (as well as being a requirement in the regulated space) to fully vet a company before selecting them as a design and development partner. Choosing an engineering partner based solely on an ISO certification, though, is not foolproof. We’ve seen the following less-than-scrupulous approaches…
First, I’ve seen companies advertise themselves as “compliant” with particular standards. While that may be true, it is no indication that they are actually compliant or may be “selectively” compliant. This is a rather passive-aggressive approach but really carries no weight. They may be a perfectly fine company, but it is somewhat deceptive to advertise as being compliant while not having the backing of full industry compliance.
Next, ISO certifications could be forged (personally, I’ve only seen this outside the United States). This is downright falsification so it’s important to check those certs with a trusted source! Certs are always issued by a Certification Body (CB) and the CB will always provide a way to verify the cert. Prior to selecting a supplier based on an ISO cert, be sure to always check if it is valid.
We have also seen cases of what I’ll call “pay-for-certification”. The certification is issued based on payment, not performance. This is particularly challenging because it’s likely you can confirm the cert is valid. However, to be totally legitimate, the cert should be issued through an accredited body. There are numerous accreditation bodies, and they are typically shown on the cert. So, after you confirm the cert is legitimate, you need to confirm that the cert was issued through an accredited registrar. This means that the CB is scrutinized to ensure it is following the correct procedures to assess an organization for compliance to the particular standard(s).
So now you’ve found a supplier with a legitimate cert issued from an accredited organization – does that mean they’re the best for you? Unfortunately, not necessarily. The company could be treating compliance as a “check the box” exercise – doing just enough that they can demonstrate to the CB that they are compliant. However, that doesn’t truly embrace the spirit of the standards. The standards, for the most part, drive good business practices, but at the heart of the standards is the spirit of continuous improvement. This is difficult to assess, but you can ask what they do to ensure they are current and always improving.
Certification to ISO 13485 is challenging for a design and development company as the standard is written to be more closely aligned to physical product development and manufacturing. To adapt, we have to consider “service” as our product. This challenge is demonstrated by the “postmarket” aspects of the standard.
As the design and development engagement ends when the product goes into production, we have to still consider what to do for these postmarket requirements. This is where the Realtime Group embodies the spirit of the standard. If we identify issues with parts on one design that could impact previously-designed projects, we communicate these concerns with the product owners irrespective of whether or not we are under contract. We conduct post-delivery discussions with clients and collect (unsolicited) post-delivery feedback from clients to see if there are any issues arising following our deliveries and use this information to improve our processes.
An example of our continuous improvement can be shown in how we manage our suppliers. The standard requires that suppliers are qualified and approved prior to use. For years, we have exempted ourselves from this since we were not making finished products (only providing design services). We realized, however, that many of the suppliers we chose would either directly impact quality or need to be qualified and approved by our customers.
We decided to improve how we select suppliers by establishing qualification criteria that our customers could also use, if needed, and approving suppliers internally. While this may appear to be “administrivia,” it is a value to our customers, ensuring that they can rely on our selections.
Attaining certification and (properly) maintaining the supporting quality management system is a commitment – both financial (audit fees, certification fees, etc.) and time (internal audits, management reviews, etc.) and this dissuades many design and development companies from pursuing certification.
One of our measurements is based on customers returning for additional work and, based on the quality of our efforts, we do maintain a high rate of customers returning for additional work. Realtime believes our certification both demonstrates commitment to quality and to improvement and this is borne out through our high level of customer satisfaction.
The Realtime Group is your ISO 13485 / ISO 9001 certified development partner. We have a shared passion for time-to-market and product compliance. Visit us at www.TheRealtimeGroup.com or call us at 972-985-9100 to see how we can help you with your product development and testing!