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 19^th 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.