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Dr. Muayad Koji President of KSQCA Talal Khalid Hassan QC & QM Expert
INTRODUCTION
These questions are designed to assist testing and calibration laboratories set up a quality management
system that conforms to (ISO 17025:2005), the international standard for laboratory quality management systems. Compliance with this standard provides a globally accepted base for laboratory accreditation. The standard specifies the management and technical requirements to be met by testing and calibration laboratories in both their organization and their management of quality. Answering these questions will enable laboratories to identify where their current operations meet the requirements of ISO 17025 as well as the areas where they do not. It will also guide them in develop systems capable of achieving compliance. These questions are put in the a way to cover most requirements of ISO 17025 and classified them to categories that makes compliance easier to achieve:
Where this is found not to be the case, do you have a mechanism for taking corrective action to ensure that the situation is remedied and not likely to recur? Do you use the information from any quality problem to enable you to identify where the quality system can be improved and do you act on this? Do you have mechanisms to monitor trends in quality performance so that failures can be anticipated and dealt with before they become critical? Do you have mechanisms in place to scrutinize the quality system for areas where improvements might be possible? Do you review the performance of your quality system to determine whether it is delivering the objectives which you have identified for it?
3. Personnel
Do you have a record of the qualifications and experience of your staff, with objective evidence of their qualifications, for example copies of certificates? Do you have a clear record with regard to your proposed scope of accreditation of which members of staff are authorized to conduct each test or calibration? Do you have a documented procedure for training staff in quality issues and technical procedures, including tests?
Do you have a documented procedure for conducting evaluation of the competence of staff after training and before authorizing them for the procedure in which they were trained? Do you have a system for recording training, including objective evidence of competence? Do you have a mechanism for identifying which staff conducted each procedure, test or calibration?
Have you determined the accuracy, precision and, where relevant, the limit of detection of the methods which you use, including standard published methods? Do you run routine quality control samples and evaluate the results before releasing data? Do you monitor trends in quality control results in order to anticipate possible problems? Have you tested your methods and laboratory by use of certified reference methods and/or inter laboratory comparison?
6. Equipment:
Do you have a system for commissioning equipment and verifying its performance and calibration before it is used for test or calibration work? Do you have a plan for periodic calibration and verification of the performance of all equipment which affects the validity of measurements? Do you have records showing that this plan is followed and which enable the status of any equipment to be verified at any point in its history of use? Is equipment subject to regular checks or calibrations labeled so that its status can be seen immediately by users?
7. Traceability of measurement:
Have you identified all the measuring equipment which is involved, directly or indirectly, in measurement or calibration and which, if not properly calibrated, would affect the validity of measurements? Is this equipment calibrated in a manner which provides traceability to the international measurement system? Do you have a management procedure to ensure that the calibration is maintained at all times, i.e. recalibration is conducted as necessary and, where possible, equipment is monitored so that any drift away from calibration will be detected? Do you have records which could be audited to confirm the calibration status of the equipment at any point in the past?
Do you have control of what software may be loaded onto any of your computers? Are all computer systems, including software, checked to ensure that they record and process data correctly? Is all software secured against unauthorized changes? Do you have records showing when software was updated and that checks were made on its correct functioning after update? Do you have a procedure for regular backup of data held on computers?
13. Sub-contracting:
Do you evaluate the suitability of any sub-contractors used against a defined set of criteria? Do you have a list of these approved sub-contractors? Do you have a mechanism which ensures that the use of any sub-contractors found unsatisfactory is discontinued? Do you obtain clearance from clients before sub-contracting work?