ISO 9001:2000 includes many requirements for control of monitoring and measuring devices, and two relate directly to the use of calibration stickers. Neither requires stickers, and our investigations indicate a global conspiracy is unlikely.

As with many ISO 9001:2000 requirements, folk tales have emerged in the 20-odd years since the standard was released. The need for calibration stickers on all devices is one of those folk tales.

To develop a system that makes the best sense for a given organization, it is important to first understand the requirements, then think creatively about how to address the requirements.

Calibration Requirements ISO 9001:2000 section 7.6 states:

1. "The organization shall determine...the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements."
2. "...measuring equipment shall...c) be identified to enable the calibration status to be determined."

Therefore, ISO 9001:2000 requires devices that check product conformity be identified, and that identification must include a way to determine if the device has been calibrated.

Not all devices must be, "calibrated or verified." Only those used to check product conformity must be addressed (the rest are optional). A decision must be made to determine what devices those will be, and how everyone will know which devices those are.

After the devices that will be calibrated have been determined, the methods for identifying the calibration status must be decided.

Slapping calibration stickers on devices is easy and simple enough, but some devices and environments are not conducive to the use of stickers. For example, if the device is used in an environment where the sticker may become unreadable (or fall off), a calibration sticker may not be a good solution. If the use of sticker will change the performance of the device (such as a calibrated weight), a sticker would also not be appropriate.

It is important to keep the precise requirement in mind, which is, "...measuring equipment shall...c) be identified to enable the calibration status to be determined." It is up to the organization to decide what method is best for them, and then demonstrate the method selected provides adequate control to satisfy the requirement.

Many Valid Methods

A good registrar auditor understands that many different methods may be used. Some examples from our experience are listed below. These examples are intended to generate creative thought on methods other than calibration stickers, and are not presented as approaches approved by Platinum Registration. All methods must be tested during registration audits to determine if the controls implemented and objective evidence presented satisfy the requirements.

Device Availability - The simple availability of the device may be a method for indicating the device is calibrated. For example, if the device is not locked and tagged out, it has been calibrated. Alternately, an organization may make the calibrated version of smaller devices available, and all uncalibrated versions of the device are placed beyond use (stored under lock and key, etc.).

Records - Documents stored nearby or easily accessible may provide the required identification

Calibrate Before Use - This one is easy to say, and harder to actually prove. Expect a deep investigation and long interviews with everyone who uses the device. Remember, a record of calibration results is also a requirement of ISO 9001.

Creative Thinking Foils Conspiracy

While addressing the ISO 9001 requirements, avoid the conventional wisdom of tradition and folk tales. Have a well worn version of ISO 9001 handy, and refer to it often with a critical eye for what the standard specifies. And if you have any questions, please contact us.

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