Iso 17025 Guide.docx

ISO 17025 Terminology Guide ISO 17025: An international standard that spells out general requirements for the competence of testing and calibration laboratories. Accreditation: Third-party attestation related to laboratory conveying formal demonstration of its competence to carry out specific testing / calibration activities. Note: Accreditation is an honor held by an Accreditation Body which is normally one in a country (like PNAC) Records: Records are materials created or received by an organization and that are preserved as evidence of the activities of the organization or for its information value. Technical Records: Technical records are accumulations of data and information which result from carrying out tests or calibrations and which indicate whether specified quality or process parameters are achieved. Non-conformance: Anything that is not conforming to the requirements / specifications of ISO 17025 standard or the procedures and policies laid by Laboratory. Root Cause Analysis: If an unwanted situation which consumes resources and tends to happen in a repeated fashion exists, it is beneficial for the laboratory to figure out what is really causing this situation to occur and remove it so the situation does not occur again. This is generally referred to as Root Cause Analysis, finding the real cause of the problem and dealing with it rather than simply continuing to deal with the symptoms. Complaints: Complaints are objections, errors, or non-conformities involving work quality, or failures to provide service or other requests of the customer including timeliness. Complaints can provide valuable feedback on the effectiveness of the organization and can be used to improve the organization with the customer in mind. Accommodation: This refers to space in the laboratory area and how it is suited for the work performed. Calibration: Calibration is the set of operations, under specified conditions, establishing the relationship between values of quantities by a measuring instrument or measuring system, or values represented by a material measure or reference material, and the corresponding values realized by standards. Measuring instruments: This includes balance, pH meter, spectrophotometer, thermometer etc. Physical standards: Physical standards include reference weights and reference thermometers. Reference Standard: A reference standard usually has the highest metrological quality found at a given location in a given organization, from which measurements made there are derived. Generally, this refers to recognized national or international traceable standards. Accuracy: It is the nearness of a measurement to the accepted or true value Precision: It is a measure of how close together the measurements are, not how close they are to the correct or true value Measurement uncertainty: The measurement of uncertainty is the parameter associated with the result of a measurement that characterized the dispersion of the values that could be reasonably attributed to the measurand. Measurand: The quantity being measured.

ISO 17025 Terminology Guide

Confidence Level: The confidence level is the number that is multiplied by the uncertainty to produce an uncertainty estimate that will contain a large fraction of all values that might be obtained on a test. The confidence interval is commonly noted as k, k=1 is used for 66.7 % confidence (not suitable for laboratory environmental) and k=2 is used for 95% confidence, and k=3 for 99% confidence. Expanded uncertainty (UE): The expanded uncertainty is the combined uncertainty (or standard uncertainty, if there is only one component), multiplied by the confidence level. Repeatability conditions: Identical samples prepared at the same time, by the same analyst, under identical conditions, run on the same instruments are repeatability conditions. Reproducibility conditions: Reproducibility conditions are identical samples analyzed under different conditions, including any of these: different times, different equipment, different analysts, or different Laboratory. Interlaboratory comparison: Organization, performance and evaluation of measurements or tests on the same or similar items by two or more laboratories in accordance with predetermined conditions Proficiency testing: Evaluation of participant performance against pre-established criteria by means of interlaboratory comparisons. The term “proficiency testing” is taken in its widest sense and includes, but is not limited to: a) Quantitative scheme — where the objective is to quantify one or more measurands of the proficiency test item b) Qualitative scheme — where the objective is to identify or describe one or more characteristics of the proficiency test item c) Sequential scheme — where one or more proficiency test items are distributed sequentially for testing or measurement and returned to the proficiency testing provider at intervals d) Simultaneous scheme — where proficiency test items are distributed for concurrent testing or measurement within a defined time period Proficiency test item: Sample, product, artefact, reference material, piece of equipment, measurement standard used for proficiency testing Proficiency testing provider: Organization which takes responsibility for all tasks in the development and operation of a proficiency testing scheme Proficiency testing round: Single complete sequence of distribution of proficiency test items, and the evaluation and reporting of results to the participants Proficiency testing scheme: Proficiency testing designed and operated in one or more rounds for a specified area of testing, measurement, calibration or inspection. NOTE A proficiency testing scheme might cover a particular type of test, calibration, inspection or a number of tests, calibrations or inspections on proficiency test items. Blind sample: a randomly coded sample that cannot be identified except for its random code.