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ISO/IEC 17025:1999
Description of 5.0 Technical Requirements
Description
The lab should recognize that many factors affect tests and calibrations; equipment, environment and human factors contribute, among others. Personnel need to be qualified to perform their functions, following appropriate training and competency guidelines. Labs also need to ensure that the particular lab environment
doesn't throw off testing and calibration. These labs need to provide guidelines for the use of equipment, handling, methods and preparation of tests. Methods need to be properly validated, and uncertainty must be accurately estimated. If software is used in the testing and/or calibration process, then it must be reliable and control confidentiality. Lab equipment obviously needs to be accurate, but it should also be operated by the appropriate individual and be given a unique identifier. There must be a regular and systematic calibration of the equipment used in calibrations. Likewise, there should be regular and systematic testing of the equipment used in tests. Reference standards and materials must done by a body that can provide effective traceability. Labs need to maintain and circulate an appropriate sampling plan. Also, these organizations must have plans for shipping and handling test or calibration items. As long as these items are kept in the lab, they must have accurately maintained identification. Additionally, the lab must monitor test/calibration validity through quality control procedures. The results of the lab work completed must be reported in an accurate and objective manner. The standard sets down specific requirements for test reports and calibration certificates, and any opinions or interpretations must be accompanied by documentation covering the basis of the opinions. Communications of results must be clear, and they can be sent electronically.
Subclauses
5.1 General
5.2 Personnel
5.3 Accommodation and environmental conditions
5.4 Test and calibration methods and method validation
5.5 Equipment
5.6 Measurement traceability
5.7 Sampling
5.8 Handling of test and calibration items
5.9 Assuring the quality of test and calibration results
5.10 Reporting the results
EwQMS® Modules
Below are the Enterprise-wide Quality Management System® modules which address this clause of the standard:
AQuA Pro - APQP, PPAP processes. 5.0
HR Pro - Human performance management functions, competency, training management and satisfaction
surveys. 5.2
MSA Pro - Calibration and measurement systems analyses. 5.0
Process Pro - Tracking business processes, charting organizational structure, support product realization. 5.0
TPM Pro - Preventive and reactive maintenance. 5.5
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FMEA 4th Edition is Coming! Are You Ready? Omnex Is! AIAG will be rolling out the 4th Edition FMEA Reference Manual on July 22, 2008. To help you get up-to-date with the changes made in the latest revision, Omnex has scheduled a webinar on August 5, 2008 1pm-4pm EDT. Click here for more information. A recording of this webinar and/or a hardcopy of the presentation material will be available for purchase if you cannot attend this online session.
All our FMEA-related courses such as Manufacturing Process Development using PFMEA, APQP & DFMEA including Robust Design Linkages, FMEA/Control Plan including Robust Design Linkages and Advanced Product Quality Planning also incorporate the FMEA 4th Edition. See our Training Offerings and Training Schedule for more information.
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