A recent article in the Calgary Herald described how prosecutors had to stay charges against Alberta motorists accused of driving over the legal blood-alcohol limit of .08 due to missing maintenance records for breathalyzers. Apparently, the company contracted to do maintenance on the breathayzers, Davtech, did not keep records of their service history. A quick look through the Davtech website revealed that they do not claim to be ISO 9001 certified. However, they did have this bit of marketing material posted: "Davtech has developed Annual Inspection Programs that meets or exceeds the requirements of the various manufacturers. DAVTECH maintains Canadian guidelines which are reinforced through our field expertise to provide a program which is second to none." It seems to me that a first-in-class company would keep records of equipment maintenance.
ISO 9001 requires companies to maintain testing devices in order to ensure their continuing fitness for their purpose, and to retain records of the maintenance. It requires testing devices to be calibrated or verified at specified intervals to international or national standards. Testing devices must also be identified as to their status, so that users know whether the device is in calibration. They must also be protected from adjustments or damage that would invalidate their measurement results. For a breathalyzer, this could mean being stored in a pelican case when not in use. It is also important to audit your preventive maintenance and calibration practices, to ensure that it is operated as intended and appropriate records are being kept.
Some might roll their eyes at the thought of keeping maintenance records and a calibration schedule, and dismiss it as "bureaucracy". It's rarely a case of life and death. But in this situation, retaining maintenance records could have kept drunk drivers off the road - a goal to which we can all agree.