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50+ Useful terms for ISO 17025

50 TERMS OF ISO 17025

ISO 17025 is an international standard that outlines the general requirements for the competence of testing and calibration laboratories.

Here are 50+ terms associated with ISO 17025 along with brief definitions:

  1. Accreditation: Formal recognition by an accrediting body that a laboratory is competent to perform specific tests or calibrations.
  2. Audit: Systematic examination to determine whether activities comply with planned arrangements and whether these arrangements are implemented effectively.
  3. Calibration: Comparison of a measurement device with a standard to determine its accuracy.
  4. Competence: The ability to apply knowledge and skills to achieve intended results.
  5. Conformity Assessment: The process of evaluating whether a product or service meets specified requirements.
  6. Control Chart: A statistical tool used to monitor and control a process over time.
  7. Corrective Action: Action taken to eliminate the cause of a detected nonconformity or other undesirable situation.
  8. Data Integrity: The accuracy and reliability of data throughout its lifecycle.
  9. Deviation: Departure from the documented test or calibration procedure.
  10. Documented Information: Information required to be controlled and maintained by an organization.
  11. Equipment Validation: The process of confirming that equipment is fit for its intended purpose.
  12. Incident: Any event that is not part of the standard operation of a laboratory and that influences the quality of its work.
  13. Interlaboratory Comparison: The comparison of test or calibration results among two or more laboratories.
  14. Measurement Uncertainty: The parameter, associated with the result of a measurement, that characterizes the dispersion of the values that could reasonably be attributed to the measurand.
  15. Nonconformity: Failure to meet one or more specified requirements.
  16. Observation: Statement of fact made during an audit and substantiated by objective evidence.
  17. Performance Evaluation: Process of assessing the competence of a laboratory.
  18. Proficiency Testing: Determination of laboratory performance by means of interlaboratory comparisons.
  19. Quality Manual: Documented statement of the laboratory’s quality policy and operating procedures.
  20. Range of Accreditation: The scope of activities for which accreditation is granted.
  21. Reference Material: Material, sufficiently homogeneous and stable with respect to one or more specified properties, used for calibration or testing.
  22. Sampling Plan: A plan that describes the methods and techniques used to obtain a sample.
  23. Traceability: The property of the result of a measurement whereby it can be related to a reference through a documented unbroken chain of calibrations.
  24. Validation: Confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled.
  25. Witnessing: The act of observing a test or calibration being carried out by the laboratory.
  26. Zero Calibration: Calibration using a reference with a known output of zero.
  27. Measurement Standard: A reference standard used for the calibration of measuring instruments.
  28. Uncertainty Budget: A detailed and itemized list of all uncertainty components.
  29. Scope of Work: The range of activities or services covered by a testing or calibration laboratory.
  30. Proficiency Testing Provider: An organization that provides proficiency testing services to laboratories.
  31. Proficiency Test Sample: A sample distributed to laboratories for proficiency testing.
  32. Repeatability: The precision obtained when a single operator measures the same sample multiple times.
  33. Reproducibility: The precision obtained when measurements are made under different conditions by different operators.
  34. Quality Policy: A statement of the laboratory’s commitment to quality.
  35. Evaluation of Measurement Uncertainty: The process of estimating the uncertainty of measurement results.
  36. Laboratory Information Management System (LIMS): Software used to manage and organize laboratory data and information.
  37. Out-of-Specification (OOS): A result that falls outside the specifications or acceptance criteria.
  38. Quality Control: Procedures and activities used to monitor and control the quality of laboratory processes and results.
  39. Risk Assessment: Systematic process of evaluating the likelihood and consequences of events that may adversely affect the laboratory’s objectives.
  40. Measurement Traceability: The ability to trace measurement results to a recognized standard.
  41. Sampling Error: The difference between a population value and the value obtained from a sample.
  42. Measurement Interval: The range of values within which a measurement is expected to lie.
  43. Verification: Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled.
  44. Master Calibration Schedule: A schedule outlining the planned calibrations of all measurement equipment.
  45. Recovery: The degree to which a measured value approaches the true value after a known error has been introduced.
  46. Measurement Procedure: Documented instructions for performing a measurement.
  47. Validation Protocol: A document that outlines the approach and criteria for the validation of a process.
  48. Sampling Bias: A systematic error introduced by the sampling process that results in a non-representative sample.
  49. Calibration Interval: The time between successive calibrations of a measuring instrument.
  50. Matrix Effect: The influence of the sample matrix on the accuracy and precision of a measurement.

Bonus terms

  1. Audit Trail: A chronological record that reconstructs and examines the sequence of activities in a system or process.
  2. Batch Testing: Testing or calibration performed on a group of samples processed together.
  3. Client: The entity or person that requests laboratory services.
  4. Confidentiality: Ensuring that information about the client and their work is protected from unauthorized disclosure.
  5. Determination Limit: The lowest quantity of the measurand that can be reliably detected but not necessarily quantified.
  6. Equipment Maintenance: Activities performed to keep measuring equipment in a state of compliance with requirements.
  7. Fitness for Purpose: The capability of a laboratory’s activities to achieve the intended result.
  8. Handling of Test Items: Procedures for the receipt, storage, and transportation of test or calibration items.
  9. Impartiality: The quality of being objective, unbiased, and free from conflicts of interest.
  10. Instrumentation: All devices used for measurements, including measuring instruments and supporting equipment.
  11. Key Comparison: An international comparison of primary measurement standards.
  12. Measurement Standardization: Ensuring measurements are consistent and comparable across different laboratories.
  13. Notification of Changes: Informing the accrediting body of any changes in the laboratory’s organization or activities.
  14. On-site Assessment: Evaluation of a laboratory’s competence by visiting and inspecting its facilities.
  15. Personnel Competence: The collective knowledge, skills, and abilities of laboratory personnel.
  16. Quality Control Sample: A sample used to verify the accuracy and precision of test or calibration results.
  17. Risk Management: The systematic application of policies, procedures, and practices to manage laboratory risks.
  18. Statistical Analysis: Application of statistical methods to analyze data and draw meaningful conclusions.
  19. Technical Record: Documentation that provides evidence of the execution of a test or calibration.
  20. Unaccredited Calibration: Calibration performed by a laboratory that is not formally recognized by an accrediting body.
  21. Validation Master Plan: A document that outlines the overall strategy for the validation of a process or system.
  22. Weighing Balance Verification: Confirming the accuracy and precision of a weighing balance.
  23. Zero Error: The difference between the instrument reading and the true value when the input is zero.
  24. Measurement Range: The span of values over which a measuring instrument is intended to operate.
  25. Proficiency Testing Scheme: A program that provides samples for laboratories to analyze and compare their results.
  26. Reagent Blank: A sample that contains all the components of the test except the analyte.
  27. Sampling Point: The location or stage in a process where a sample is collected.
  28. Standard Operating Procedure (SOP): A detailed step-by-step guide to perform a specific task or operation.
  29. Test Item Identification: Ensuring that test or calibration items are uniquely identified throughout the process.
  30. Traceability Chain: The documented series of comparisons that links a measurement result to a reference standard.
  31. Quality System: The organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.
  32. Customer Satisfaction: The perception of the customer regarding the fulfillment of their needs and expectations.
  33. Interference: The influence of one substance on the measurement of another.
  34. Measurement Facility: The physical location where measurement activities are conducted.
  35. Proficiency Testing Material: A substance with known properties distributed to laboratories for proficiency testing.
  36. Report of Test or Calibration Results: Document presenting the results of tests or calibrations performed by the laboratory.
  37. Sampling Plan: A plan that describes the methods and techniques used to obtain a sample.
  38. Verification of Methods: Confirming that the selected method is suitable for the intended use.
  39. Audit Finding: A result of the evaluation of audit evidence against audit criteria.
  40. Batch Number: A unique identifier assigned to a group of test or calibration items processed together.

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