ISO 9001:2008 Calibration and Maintenance Requirements
This is one of the simplest requirements in the ISO standard. All equipment used in the measurement and monitoring of the companies processes must be in maintained and calibrated.
Calibration and maintenance is covered in section 7.6 of the ISO 9001 standard (control of measuring and monitoring devices). All equipment used for the production, development and test of product must be maintained and calibrated. The standard requires that measuring equipment be:
- Calibrated at routing intervals. The interval can be determined by engineering requirements.
- Labeled with the calibration status. Each piece of equipment should have a unique control number and "good until" calibration date on the device.
- Protected for accidental adjustment
- Re-adjusted as necessary
- Protected from damage
The heart of the requirement is covered in items one and two. Calibrate your measurement devices and then label them.
Protecting the devices for misuse is especially important for software setup of testing. Software used for setup and test should require a password to keep unqualified personnel from changing setup variables. Procedures for use of measurement equipment should include enough detail to avoid accidentally reconfiguring the measurement device.
Item four, re-adjustments are always done as part of the routine calibration so this requirement is really covered under item one.
Item five, protecting the device from damage, is easy in a production environment but it can be much more difficult in a service environment. In production, just store the equipment in a proper way so that they are not exposed to an environment that could decrease their ability to operate. In service, a tool kit or set of travel tools must be protected from moisture, excessive heat and cold, or any other environments that could damage the equipment. You may need to establish a procedure or standard for service personnel use of tools outside the building.
Un-calibrated equipment should be pulled from product or engineering and kept in a controlled area until it can be calibrated. If you calibrate your equipment before the end of the calibration period, then this will not be problem. If you want to keep un-calibrated equipment in your facility (for reference purposes only), keep it in a contained area with a label that states un-calibrated. Many companies don't calibrate rarely used engineering/service equipment because of the cost. As long as the equipment is not used for validation and the equipment is controlled, it is OK.
Maintaining calibration records can be implemented using a simple excel spreadsheet listing all the equipments (with an asset number) in the facility and their calibration and maintenance dates.
Make sure you get calibration certificate and most auditors like to see an ISO certified calibration service.
It is best to have equipment calibrated by a company that is ISO 9001 certified or is NIST traceable but this in not required by the standard. You can perform all calibration in house to save money. I recommend a combination of both. Use an out of house company for calibration of all off-the-shelf electronic device (multi-meters, power supplies, etc). In most area, you can contract with a company do pickup, calibration and return so you do not have any down time during calibration. Plan on $30-$300 per piece of electronic equipment for a calibration
Use in-house calibration for all custom build and rarely used equipment. Since the standard does not specify how calibration is performed, this can save the company a lot of money.
When ever possible, log which equipment is used for product validation on the product tracking documentation (traveler). Then if a piece of equipment is found out-of-calibration after the product has shipped (and this really happens) you can correct the effected product with a no impact to unaffected product.
Here is a link to the Sample Calibration and Maintenance Procedure that can be used as the staring point for your new procedure.