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7.1.5 Monitoring and Measuring Resources for ISO 9001

What is Monitoring & Measuring Resources for ISO 9001?

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Measurement Traceability Requirements

When it comes to monitoring and measuring resources under ISO 9001 guidelines, there are certain guidelines that must be strictly adhered to for the most accurate results possible.

Measurement traceability is the process of validating the equipment that will be used to measure products and resources. This is an ISO requirement, and will give the organization confidence that all measurements are completely correct.

The specific standards for measurement traceability are outlined briefly in the list below, and explained more in detail throughout the rest of this section.

Instruments Used for Measurement

To begin, the instruments that are used for measuring resources must always be calibrated in intervals before being used, while following the specified standards in doing so.

They must also be adjusted according to the instructions as provided by the manufacturer prior to being used to make accurate measurements. In a visible area on the outside of the machine, the operators must be able to clearly identify the status of calibration during these adjustments.

In addition, the machines and measurement equipment in question must be constantly protected from unnecessary adjustments that could affect the results of the measurement. While the equipment must be flexible for adjustments as needed before beginning the measurements, they should not be movable during the actual process.

In the event that the equipment must be moved to another location, repaired, or stored away for future use, it must always be protected from any exterior damages that could occur without careful handling.

If a measurement device is being used that is not compliant with ISO certifications, it must first be checked against another conforming device for accuracy. Otherwise, this device will not be considered accurate or efficient and will not be used for this purpose.

When the calibration of these devices take place before the actual measurement, the action must be performed by a provider that is certified by the ISO. Any other personnel that does not match these specifications will not be qualified to adjust or calibrate the machine in any way.

  1. Calibrated in intervals before being used (following standards)
  2. Adjusted according to manufacturer’s instructions
  3. Able to identify calibration status
  4. Protected from adjustment that could affect results of measurement
  5. Protected from damages during moving, repairs, or storage
  6. Non-conforming devices are checked against a conforming device
  7. Calibrated by ISO certified providers
  8. Calibration and verification records kept and maintained
  9. Computer software confirmed and validated before use
  10. Computer software re-validated if needed

If computer software is needed to take accurate measurements, it must be confirmed and validated before it can be used correctly. In addition to the initial validation of this technology, it must be maintained and re-validated as needed.

While most standard measurement equipment can adhere to the guidelines explained in this section, some do not indicate specified measurement standards.

In this case, the method of calibration and verification will have to be documented and kept as a record for accuracy and future reference.

Along with the measurement traceability requirements for the machines that are used for measuring resources, there are some specific points to hit when dealing with the equipment that requires calibration.

Equipment That Requires Calibration Should Be

  1. Calibrated in specific intervals
  2. Adjusted as needed
  3. Showing status of calibration
  4. Safe from adjustment
  5. Protected from damage

As you can see, there is a documented process that goes into accurately and efficiently monitoring and measuring resources. However, those who choose to adhere to the guidelines will reap the benefits in their business, knowing they have full control of all operations.

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What Does the Term “verification” Mean Within the Monitoring and Measuring Resources Clause of ISO 9001:2015?

The term verification refers to the confirmation that the equipment that is in question meets the standards as defined by ISO 9001. Whether this is completed by adjusting, calibrating, or testing the equipment against a confirmed device, all measurement devices must be verified before they can be used to provide reliable data.

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Calibrated Test Equipment ProcedureCalibrated Test Equipment Procedure

This procedure defines your organization’s responsibilities and activities to ensure that all inspection and test equipment used for product, service, and process monitoring and verification is controlled and calibrated against nationally traceable standards at specified intervals and that such devices are available to ensure continuity of measurement capability.

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Don’t Try to Manage It All Alone!

Our ISO Auditors and Quality Manager Trainers have been in this industry for years, and since 2002 we’ve been providing thousands of small businesses and large corporations with the tools they need to get certified.

Instead of trying to create everything you need to follow this process from scratch, use ours. We have procedures, templates, checklists, process maps, forms and gap analysis tools to help you control your documented information without missing a single input or output.

Before you invest all the hours reinventing the wheel, before you spend countless dollars outsourcing the task — try our templates.

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