7.

6 Control of monitoring and measuring devices

The organization shall determine the monitoring and measurements to be undertaken and the monitoring
and measuring devices needed to provide evidence of conformity of product to determined requirements
(see 7.2.1).

The organization shall establish processes to ensure that monitoring and measurement can be carried out
and are carried out in a manner that is consistent with the monitoring and measurement requirements.

Where necessary to ensure valid results, measuring equipment shall

a) be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable
to international or national measurement standards; where no such standards exist, the basis used for
calibration or verification shall be recorded;

b) be adjusted or re-adjusted as necessary;

c) be identified to enable the calibration status to be determined;

d) be safeguarded from adjustments that would invalidate the measurement results;

e) be protected from damage and deterioration during handling, maintenance and storage.

In addition, the organization shall assess and record the validity of the previous measuring results when the
equipment is found not to conform to requirements. The organization shall take appropriate action on the
equipment and any product affected. Records of the results of calibration and verification shall be maintained
(see 4.2.4).

When used in the monitoring and measurement of specified requirements, the ability of computer software
to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and
reconfirmed as necessary.

NOTE See ISO 10012-1 and ISO 10012-2 for guidance.

(From BS EN ISO 9001:2000)

In short, measurements must be made with product realization processes to ensure the product or service
meets the specified requirements. To do that, monitoring and measuring equipment should be compatible
with the measurements being performed and should be carried out in a manner that is consistent with
monitoring and measuring requirements (i.e., make sure the process is performed in the same manner each
time). Additionally, where necessary to ensure valid results, measurement equipment must be calibrated or
verified at specified intervals, or prior to use, against measurement standards traceable to international or
national standards. Where no standard exists, the basis for calibration or verification shall be recorded.

This type of precise measurement is critical in the modern marketplace as international standards and
measurements become more and more critical for product and business success. Indeed, making sure that
all units of measure, such as pounds, feet, inches, volts, amps, etc., are equivalent anywhere in the world is
absolutely crucial. Imagine if your product was using measurements for feet and inches when the
requirement was for meters and centimeters! Not only would your customer be displeased, there also could
be a significant danger to users of the product.

We’ve all heard those horror stories: The Mars landing mission that didn’t convert metric and standard
measurements, believed to be the cause of the mission’s failure; or the bungee-jumper who didn’t consider
the stretch of the cord and plummeted to disaster.

Accurate measurements and calibrations are key, and so is the equipment that performs these tasks.
When trying to understand this very important clause, let’s examine a standard measurement that still
causes trouble for everyone—time.

In the early 19th century, towns and villages in Great Britain had a local time that varied significantly from
place to place, which often caused confusion between the communities when holding events. Then, in 1825,
the Stockton-Darlington Railway was established, connecting most of these towns and villages with just a
few whistle-stops in between. This forced everyone to standardize time in the region, so the townspeople
built station clocks that were synchronized with stationmasters to keep the train on schedule—and everyone
else as well. This eventually became the basis for Greenwich Mean Time, which of course has become the
time standard for the world.

Clause 7.6 can be explained by using this example of time, the clock towers and the Stockton-Darlington
Railway. Examine the clauses and the examples together—7.6.a already has been explained above.

7.6.b—This requires that equipment be adjusted or re-adjusted as necessary. In the case of the clock tower
on the railway, this would involve regular time checks between different towns on a daily basis to ensure
accuracy. Adjustments would be carried out as appropriate.

7.6.c—This requires that monitoring and measuring devices be identified to enable calibration status to be
determined. This is easy—the clock towers are our devices—no need to identify them. In business today,
this would be done typically by the use of a serial number that can be referenced on its associated calibration
certificate.

7.6.d—The measuring equipment must be safeguarded. In the day of the railway, this would involved clocks
being kept under secure condition to stop people from altering the time.

7.6.e—This clause outlines the need to protect equipment from damage and deterioration during handling,
maintenance and storage. For instance, the clock on the railway would be enclosed in a robust case that was
watertight and resistant to the elements. Maintenance of such clocks and the storage during maintenance
and use also ensured that these valuable pieces of equipment remained accurate and reliable.

In addition, the organization “shall assess and record the validity of the previous measuring results when the
equipment is found not to conform to requirements….” Again, in the case of the clock, a log would be
maintained if adjustments were made to synchronize the clock to GMT. If a clock was found to be varying
from GMT excessively, plus or minus one minute, then train officials would have to alert other stations down
the line on the possible impact to the schedule, or if necessary, the clock would be decommissioned and a
new clock purchased. In any event, records of the results of these calibrations and verifications would be
maintained so the history of the timepieces could be used for reference in the event of problems being
encountered.

The next section of Clause 7.6 deals with modern-day issues, specifically computer software and its need for
all applications to be confirmed. Of course in 1825, the townspeople relied on mechanical or clockwork
clocks—they had to be wound each and every day. Today, technology takes society way beyond mechanical
clocks for many applications including railways and trucking. Global Positioning Systems, radar, sonar and
satellites are used with navigation.

Still, for all their wonders, these systems must be reconfirmed periodically to ensure that the computer
software continues to be a reliable source of information. The information also should be recorded.

Accurate records are essential with this clause, and documented procedures and work instructions for the
control and calibration of monitoring and measurement devices are encouraged.