Change: Relaxed Requirements
Procedure Required: NO
Record(s) Required: Calibration records (e.g., Calibration Certificates/Reports")
This section requires the organiaztion to:
(1) define and establish the monitoring and measuring necessary to ensure product (or service) compliance with requirements, and
(2) define the equipment / instrumentation (i.e., monitoring and measuring devices) necessary to determine compliance with requirements.
This section of the standard further requires that "where necessary to ensure valid results, measuring equipment" (it is assumed that measuring equioment includes monitoring equipment, however it is arguable as to whether this is intended to include jigs and templates used for inspection) must also:
a) be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national (e.g., NIST in the USA) 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 (this is essentially a redundancy of the "intervals" requirement above);
c) be identified to enable the calibration status to be determined;
d) be safeguarded from adjustments that would invalidate the measurement result;
e) be protected from damage and deterioration during handling, maintenance and storage.
The organization must also "assess and record the validity of the previous measuring results" when the (monitoring and measuring) equipment is found out-of-tolerance and take appropriate action on the equipment (typically adjust the instrument back to within its specified tolerances) and any product affected (e.g., product recall). Records of out-of-tolerance conditions are typically referred to as an "Out-of-Tolerance Impact Analysis". The "Out-of-Tolerance Impact Analysis" consists of an evaluation of the effect that the incorrect readings may have had on the product measured.
Section 7.6 goes on to further require any software "used in the monitoring and measurement of specified requirements" must be confirmed (validated) "prior to initial use and reconfirmed as necessary". However, no record of this confirmation is required.
I suggest paraphrasing the wording of the standard in your Quality Manual AND utilizing the services of a commercial calibration laboratory that offers a full-service program providing calibration services to a recognized international or national standard (e.g., ISO 10012, NCSL Z540-1, ISO 17025) as well as a calibration recall program.
If you intend to manage ANY portion of your calibration program internally, then although not specifically required by the standard, I strongly recommend developing a procedure describing your system for controlling monitoring and measuring devices. Reference NCSL Z540-1, part 2 for guideance in developing such a program.
Calibration is an important concept directly related to ensuring consistency and standardization. ISO 9001:2000, section 7.6 has severely over-simplified the concepts of calibration and control of monitoring and measuring devices. If you are at all serious about ensuring the intergirty of your monitoring and measuring devices, then I recommend reading and applying the more advanced concepts contained in NCSL Z540-1 or ISO/IEC 17025.
Copyright © 2003 by Richard C. Randall
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