Community Forum – ISO Certification

Do You Recommend ISO Certification?

Sandia’s Science, Technology, and Engineering Management Unit is beginning a three-year journey to become ISO-9000 certified.  Because work in this SMU constitutes much of the basic and applied R&D within the Labs, our greatest concern is that ISO certification will negatively impact free thinking, creativity, and innovation in the research staff. Similarly, we are concerned that certification would create additional complexity and administrative burden without producing commensurate benefits.

We would like to hear from other research organizations who have implemented ISO certification. What are the positive and negative impacts of ISO certification on your research organization and culture, and what would you do differently? What were the key motivations driving the decision to pursue certification? In this early stage of the decision process, feedback from our peers could prove to be crucial input. – Peter Oelschlaeger and Randy Watkins, ST&E Strategy and University Research, Sandia National Labs

Community Responses

Pat Moore, Development Director, Milliken Research Corporation
We have been ISO certified for many years. My view is from 20 years of experience with ISO and operational control of Chemical Division R&D and Regulatory Management.   Early benefits in the R&D Labs were confined to equipment standardization and to enforcement of standard operating procedures and training.  Our residual benefit is “club membership” that promotes our quality control reputation. This is a minor part of a creative R&D organization’s activity.  The major cost is in the internal audits and preparing for the external audits.  These audits are an exceptionally difficult exercise in detailed documentation and process confirmation.  We have developed internal experts that think in ISO logic and can tolerate/enjoy detailed exploration of exceptionally trivial paper work minutia.  The cost is hundreds of man-hours of effort and tens of thousands of dollars in expense per year.  I would strongly advise any lab thinking of ISO certification to confine their controlled processes to the minimum necessary to produce reliable experimental information.

Timo Rauth, Physicist, D. SWAROVSKI & Co.
I am not working in a certified company but started to “live” some of the ISO recommendations during my everyday work as a (senior) researcher in basic and applied R&D some ten years ago. Actually, I had some QM- and IA-refreshing very recently to keep on track.  If some member of the board gives your activities in implementing the QM-System high to highest priority, it’s perfect. Otherwise you will run into troubles anyhow.

The big advantage of being ISO certified is: You start to re-think your procedures from a helicopter view. This helps you and your enterprise to improve any step of innovation. Gaining efficiency gives more time for free thinking and creativity to your (research) staff. The ISO includes helpful guidelines on topics like setting up new projects, project management, and reporting. – Acting according to these recommendations was one of the backbones in managing any successful project in my personal career.

Having in mind that ISO intends to lead you to business excellence: If you are already working on some higher quality level, the workload towards getting the ISO certificate will be minor, the administrative burden might be vanishing, not creating any additional tasks for your staff. Otherwise, some change in culture cannot be excluded: But would that not be acceptable growing in business excellence? You will face an exciting period and gain new insights. (I enjoyed it, really, although we did not ask for certification these days!)

In to my experience the limiting factors are individuals. They need to be convinced or persuaded to collaborate. So, it might be helpful to have some additional training on communication techniques in advance – for those acting as guides through your journey.

The negative impact might be seen in costs: Once you reach the ISO certificate you intend to keep it. That is a full-time job for at least one person (depending on various factors, like the size of the enterprise and the complexity of your products) and should not be out-sourced. The re-certification process has to be passed in a three year period, so the system needs to be kept up-to-date permanently.  The benefit is sustainability, and well defined procedures according to aspects of safety, harm and security – not always the laboratory’s best friends!

David Kashdan, IRI Member Emeritus
I believe the majority of companies that earn ISO certification are driven by the need to satisfy customer demands.  Some companies require that suppliers provide proof of ISO certification in order to give confidence that the product supplied this month will be the same as the product next month.
Indeed, ISO certification can help your manufacturing division achieve this goal;  for example, there will be a paper trail showing how balances are all calibrated at regular intervals, your staff will be educated to better understand how their calibration can be traced back to national standard weights, and so on.  However, there is a pretty complex set of paper work, inspections and assorted hurdles that must be tolerated to obtain certification, and in my experience, most companies choose to forgo this effort unless there is an immediate driver, either severe quality control issues or customer demands.  The extent to which ISO certification impacts the research environment at your company depends on the the type of certification being sought and the choices made by the organization;  I have seen little if any benefit to research organizations as a result of ISO certification.

Walter Decleyre, Manager Innovation and New Product Development, Bekaert Engineering
Our engineering R&D department, part of technology R&D, has had our ISO certification since 1993. The advantage is that it lets you think in a process way; starting from the input coming from the customer through the process and giving output to the customer in a continuous improvement cycle.  It does not affect creativity but helps in better understanding our customer needs and better performance through a stage gate process.  What we would do less is writing lots of procedures and instead focus more on process definition and implementation.

Al Aanonson, Business Improvement Manager, DuPont
Please answer these questions and then you can decide. 

Mark Pietz (via Brian Joseph, Touchstone Research Lab)
Touchstone Research Laboratory had similar concerns in the past – that ISO certification could change the culture of the company from one of creativity to one of conformance. In fact, there were prior occasions where certification was nearly launched and did not proceed out of this concern. A different approach was incorporated in the final planning and certification process.

One motivation to achieve certification was a desire to capture those elements that could be defined in the business process as somewhat repetitive, for opportunities for improvement. A second reason was to demonstrate to our customers that a quality system was in fact in place. Elements were there, but not always tied together.

What Touchstone did differently in the actual launch was different than most ISO certification approaches, but here are a few key, but very important points – ISO Leader selection, Certification Body selection, and avoiding “ISO-speak”.

ISO Leader Selection. Earlier discussions about certification included personnel that were more experienced in quality systems than in running a business. Consequently, their approach was biased towards implementing a quality system for its own sake, and certification was not pursued at that time. The actual certification process was led by someone with both managerial experience, along with both ISO and Baldrige model experience, where the approach was that processes would only be implemented when and where the requirement was understood and there was a business justification.

Certification Body Selection. The certification body was selected through a series of surveys, which included questions that were important to an R&D facility. The management of the certification body was interviewed as part of the process to ensure alignment with the company’s plans.

Avoiding “ISO-speak”. The phrase “we are doing this because of ISO” was not permitted in any employee vocabulary. Part of the process was to ensure employees understood why a particular step or process was needed or required, or even documented. The focus was on understanding the process benefit, without needing to understand the ISO standard. ISO-jargon was avoided whenever possible, and the focus was on ensuring employees knew what to do in particular situations, as opposed to reading and understanding endless procedures and work instructions.

The end result was a system whereby most employees did not see a significant change to their work environment. The benefits were an efficient and effective system for those elements where innovation was not desired, without changing the culture of innovation and creativity. Additionally, as the system gained maturity over the years, employees themselves identified areas for additional documentation that, although not required, was value-added.

For any clarification on this approach, please contact Mark Pietz at markpietz@yahoo.com. Mark has implemented standards such as ISO, AS, Nadcap and ATEX.

Kurt Olson, PPG Industries
Maintaining calibration of equipment and communication of goals and progress are the biggest advantages of the ISO system – Data output quality is thus improved. The downside is the administrative burden. A lesson learned for me is that any technical community tends to “overcomply” and do more than is required or than even makes sense.

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