Technical Requirements
5.2 Personnel
Basic ISO 17025 training provided by AOAC International. See course descriptions for detail.
ISO 17025 training in Canada can be obtained at Accademia Qualitas.
MS PowerPoint template for laboratory training.
Training certificate template for training providers to give participants/attendees.
ISO 17025:2005 Quality Manual Template for laboratory accreditation.
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Generic performance review templates for your employees:
This section deals with ensuring that environmental conditions do not invalidate the results or adversely affect the required quality of any measurement. It also outlines that incompatible areas must be separated. Biological Testing Laboratories should review the following resource for biosafety guidelines: Laboratory Biosafety Guidelines 5.4 Tests and Calibration Methods and Method Validation Search AOAC International's Official Methods of Analysis Effivalidation - Method Validation and Uncertainty software. This package is designed to support ISO 17025 accredited testing laboratories. Details and demo versions can be found at A useful book recently published in December 2006 is: 5.5 Equipment All equipment being used in the lab must be properly maintained, calibrated, and operated by authorized personnel. If the lab needs to borrow a piece of equipment from another area due to unforeseen circumstances, the lab still maintains the responsibility to verify that the borrowed equipment complies with the standard with respect to its use. Equipment inventory spreadsheet from Microsoft. Measuring and Test Equipment Master List Calibration tools, resources and white papers can be found at Blue Mountain Quality Resources The formal definition of "traceability is given in the International Vocabulary of Basic and General Terms in Metrology (VIM - 1993) as: "6.10 traceability: property of the result of a measurement or the value of a standard whereby it can be related to stated references, usually national or international standards, through an unbroken chain of comparisons all having stated uncertainties." Search Google for Codex Stan 234. This document is titled "Recommended Methods of Analysis and Sampling". 5.8 Handling of Test and Calibration Items ISO 22000 information 5.9 Assuring the Quality of Test and Calibration Results An Example Control Chart produced in MS Excel by Microsoft Corporation. Where proficiency testing programs are available, the laboratory must participate. An example of an accreditation program is as follows: http://www.aoac.org/proficiencytesting/proficiency.html 5.10 Reporting the Results General Test reports and calibration certificates Test reports Calibration certificates Opinions and interpretations Testing and calibration results obtained from subcontractors Electronic transmission of results Format of reports and certificates Amendments to test reports and calibration certificates The final section of the standard specifies a series of items to be included on a test report / calibration certificate. These include: - name and address of laboratory - date of test - method used - name and address of customer - date of sampling - location where sampling was carried out - reference to sampling plans and procedures - environmental conditions during sampling - conditions during calibration - uncertainty of measurement - traceability information - before and after results Information about Laboratory Information Management Systems (LIMS) can be found at Starlims. Information on security management systems can be reviewed at:
5.3 Accommodation and Environmental Conditions
Effichem - Method Validation Software
Download the measurement uncertainty calculator from Agilent: http://metrologyforum.tm.agilent.com/download3.shtml
5.6 Measurement Traceability
5.7 Sampling