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:
- Accreditation: Formal recognition by an accrediting body that a laboratory is competent to perform specific tests or calibrations.
- Audit: Systematic examination to determine whether activities comply with planned arrangements and whether these arrangements are implemented effectively.
- Calibration: Comparison of a measurement device with a standard to determine its accuracy.
- Competence: The ability to apply knowledge and skills to achieve intended results.
- Conformity Assessment: The process of evaluating whether a product or service meets specified requirements.
- Control Chart: A statistical tool used to monitor and control a process over time.
- Corrective Action: Action taken to eliminate the cause of a detected nonconformity or other undesirable situation.
- Data Integrity: The accuracy and reliability of data throughout its lifecycle.
- Deviation: Departure from the documented test or calibration procedure.
- Documented Information: Information required to be controlled and maintained by an organization.
- Equipment Validation: The process of confirming that equipment is fit for its intended purpose.
- Incident: Any event that is not part of the standard operation of a laboratory and that influences the quality of its work.
- Interlaboratory Comparison: The comparison of test or calibration results among two or more laboratories.
- 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.
- Nonconformity: Failure to meet one or more specified requirements.
- Observation: Statement of fact made during an audit and substantiated by objective evidence.
- Performance Evaluation: Process of assessing the competence of a laboratory.
- Proficiency Testing: Determination of laboratory performance by means of interlaboratory comparisons.
- Quality Manual: Documented statement of the laboratory’s quality policy and operating procedures.
- Range of Accreditation: The scope of activities for which accreditation is granted.
- Reference Material: Material, sufficiently homogeneous and stable with respect to one or more specified properties, used for calibration or testing.
- Sampling Plan: A plan that describes the methods and techniques used to obtain a sample.
- Traceability: The property of the result of a measurement whereby it can be related to a reference through a documented unbroken chain of calibrations.
- Validation: Confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled.
- Witnessing: The act of observing a test or calibration being carried out by the laboratory.
- Zero Calibration: Calibration using a reference with a known output of zero.
- Measurement Standard: A reference standard used for the calibration of measuring instruments.
- Uncertainty Budget: A detailed and itemized list of all uncertainty components.
- Scope of Work: The range of activities or services covered by a testing or calibration laboratory.
- Proficiency Testing Provider: An organization that provides proficiency testing services to laboratories.
- Proficiency Test Sample: A sample distributed to laboratories for proficiency testing.
- Repeatability: The precision obtained when a single operator measures the same sample multiple times.
- Reproducibility: The precision obtained when measurements are made under different conditions by different operators.
- Quality Policy: A statement of the laboratory’s commitment to quality.
- Evaluation of Measurement Uncertainty: The process of estimating the uncertainty of measurement results.
- Laboratory Information Management System (LIMS): Software used to manage and organize laboratory data and information.
- Out-of-Specification (OOS): A result that falls outside the specifications or acceptance criteria.
- Quality Control: Procedures and activities used to monitor and control the quality of laboratory processes and results.
- Risk Assessment: Systematic process of evaluating the likelihood and consequences of events that may adversely affect the laboratory’s objectives.
- Measurement Traceability: The ability to trace measurement results to a recognized standard.
- Sampling Error: The difference between a population value and the value obtained from a sample.
- Measurement Interval: The range of values within which a measurement is expected to lie.
- Verification: Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled.
- Master Calibration Schedule: A schedule outlining the planned calibrations of all measurement equipment.
- Recovery: The degree to which a measured value approaches the true value after a known error has been introduced.
- Measurement Procedure: Documented instructions for performing a measurement.
- Validation Protocol: A document that outlines the approach and criteria for the validation of a process.
- Sampling Bias: A systematic error introduced by the sampling process that results in a non-representative sample.
- Calibration Interval: The time between successive calibrations of a measuring instrument.
- Matrix Effect: The influence of the sample matrix on the accuracy and precision of a measurement.
Bonus terms
- Audit Trail: A chronological record that reconstructs and examines the sequence of activities in a system or process.
- Batch Testing: Testing or calibration performed on a group of samples processed together.
- Client: The entity or person that requests laboratory services.
- Confidentiality: Ensuring that information about the client and their work is protected from unauthorized disclosure.
- Determination Limit: The lowest quantity of the measurand that can be reliably detected but not necessarily quantified.
- Equipment Maintenance: Activities performed to keep measuring equipment in a state of compliance with requirements.
- Fitness for Purpose: The capability of a laboratory’s activities to achieve the intended result.
- Handling of Test Items: Procedures for the receipt, storage, and transportation of test or calibration items.
- Impartiality: The quality of being objective, unbiased, and free from conflicts of interest.
- Instrumentation: All devices used for measurements, including measuring instruments and supporting equipment.
- Key Comparison: An international comparison of primary measurement standards.
- Measurement Standardization: Ensuring measurements are consistent and comparable across different laboratories.
- Notification of Changes: Informing the accrediting body of any changes in the laboratory’s organization or activities.
- On-site Assessment: Evaluation of a laboratory’s competence by visiting and inspecting its facilities.
- Personnel Competence: The collective knowledge, skills, and abilities of laboratory personnel.
- Quality Control Sample: A sample used to verify the accuracy and precision of test or calibration results.
- Risk Management: The systematic application of policies, procedures, and practices to manage laboratory risks.
- Statistical Analysis: Application of statistical methods to analyze data and draw meaningful conclusions.
- Technical Record: Documentation that provides evidence of the execution of a test or calibration.
- Unaccredited Calibration: Calibration performed by a laboratory that is not formally recognized by an accrediting body.
- Validation Master Plan: A document that outlines the overall strategy for the validation of a process or system.
- Weighing Balance Verification: Confirming the accuracy and precision of a weighing balance.
- Zero Error: The difference between the instrument reading and the true value when the input is zero.
- Measurement Range: The span of values over which a measuring instrument is intended to operate.
- Proficiency Testing Scheme: A program that provides samples for laboratories to analyze and compare their results.
- Reagent Blank: A sample that contains all the components of the test except the analyte.
- Sampling Point: The location or stage in a process where a sample is collected.
- Standard Operating Procedure (SOP): A detailed step-by-step guide to perform a specific task or operation.
- Test Item Identification: Ensuring that test or calibration items are uniquely identified throughout the process.
- Traceability Chain: The documented series of comparisons that links a measurement result to a reference standard.
- Quality System: The organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.
- Customer Satisfaction: The perception of the customer regarding the fulfillment of their needs and expectations.
- Interference: The influence of one substance on the measurement of another.
- Measurement Facility: The physical location where measurement activities are conducted.
- Proficiency Testing Material: A substance with known properties distributed to laboratories for proficiency testing.
- Report of Test or Calibration Results: Document presenting the results of tests or calibrations performed by the laboratory.
- Sampling Plan: A plan that describes the methods and techniques used to obtain a sample.
- Verification of Methods: Confirming that the selected method is suitable for the intended use.
- Audit Finding: A result of the evaluation of audit evidence against audit criteria.
- Batch Number: A unique identifier assigned to a group of test or calibration items processed together.








