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| Effective risk management requires an in-depth and sometimes painfully honest assessment of your processes and your areas of risk. |
by Lillian Erickson
Global Quality Manager, MasterControl Inc.
The publication of ISO 9001:2015 in September generated much anxiety among companies fearing a bumpy transition to the new and significantly changed international standard. Admittedly, we at MasterControl were not immune to those worries.
Despite having quality experts involved with the ISO changes since they were proposed some years ago, even we did not know how our ISO assessors would apply the new requirements, what evidence they would expect to see, and how to pre-emptively satisfy their expectations.
Additionally, MasterControl is not a typical manufacturer of materials, but rather of software and services. This means we needed to understand the intent of each requirement under the new standard in order to correctly apply them to our products and services.
After much research and preparation, we’re proud of the fact that when we completed the audit successfully on Nov. 12, 2015, no other company in the world had yet received a certificate for the new ISO 9001:2015 standard (1), though a few held audits the same week we did. In fact, it was only that very week that ISO assessors across the globe were authorized by their governing bodies to begin certifying companies to the revised standard.
Some people have asked me what I learned from the audit experience, as well as the preparation that preceded it. Below are five lessons I learned, but first, a quick background.
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