ISO 9001 Training

Understanding ISO 9001:2008
Requirements for Quality Management Systems

7.6 Control of Monitoring and Measuring Equipment - Con'td  

ISO 9001 Training - Key Explanation Points and Tips:

There are MME’s that are capable of being both calibrated and verified (e.g. a CMM- coordinate measuring machine) and may require both to be done in specific situations based on frequency of use and criticality of measurement. This requirement also applies to the use of computer software whose capability and calibration status must be established prior to initial use and reconfirmed (verified) at defined intervals.

You must define the frequency and method of calibration for each type and level (shop floor; laboratory or standard) of MME. Your calibration records must identify what standard you used for calibration and show traceability of the standards you use at your facility to national or international standards.

In rare circumstances, national or international standards may not exist for calibrating a specific MME. In such situations consider using industry, manufacturer or even your own organizational standard to validate the accuracy and reliability of your MME. Consult with your customer if the contractual circumstances require it. 

Your quality plan must define the measurement and monitoring required and the type of MMD needed for it, including the frequency of measurement and acceptance criteria. Depending on the risk and precision and reliability of measurements needed, you might consider doing statistical studies on MME referenced in your quality plans. Ensure that personnel performing such statistical studies are trained and competent to do so.

A multitude of software tools are available to manage and control MME. There are many acceptable methods to identify MME and their calibration status. The methods you select must consider the manufacturers recommendations; frequency of use; environment the MMD is used in; risk in misuse or incorrect tool being used; etc.

Where an MME is found to be out of calibration, you must take appropriate correction action to contain and re-verify the product affected, to the extent practical. This is in addition to containing, repair and recalibration of the defective MME.

Customer or internal engineering changes may result in a change in product measurement, requirements and/or the MME to be used.  These changes would normally be reflected in your quality plan.

If you use external calibration services, you are still expected to impose the specific control requirements of this clause to the external organization. One way to achieve this is by requiring them to be ISO 9001 certified or sector specific standard such as ISO/IEC 17025.

If the nature of your business does not require the use of MME (e.g. a financial service such as a credit counseling service), then you must clearly state this exclusion to your QMS scope, in your Quality manual.

Clause 4.1f requires you to continually improve your processes. Consider using appropriate performance indicators such as the monthly trends in - the number of out of calibration MME; or the number of MME past their calibration due date; number of MME being used and not controlled; etc. Use these indicators to tighten and improve the effectiveness of your MME process.

Clause 7.6 does not require a ‘documented’ procedure. However, you must identify and document all processes addressing this clause as part of your QMS (see clause 4.1). For these processes, you must also identify what specific documents, controls and resources are needed (see clause 4.2.1d. and 7.1b.).

You could use a product quality plan; documented procedure or other combination of specific practices, procedures, documents and methods. Look at the risks related to your product, processes and resources in determining the extent of documented controls you need to have (also see clause 4.2.1 notes).

Performance indicators (to measure the effectiveness of processes that control MME) may include reduction - in MME found past due for calibration and being used; reduction in damaged, uncontrolled and uncalibrated MME being used; reduction in untrained personnel found using MME; reduction in lost MME; reduction in MME found out of calibration; etc.