PECB ISO/IEC 17025 Foundation key terms

The structured set of policies, processes, and resources a laboratory uses to consistently deliver valid results and meet the requirements of ISO/IEC 17025, covering both quality and technical operations.

The presence of objectivity, meaning laboratory activities are carried out without bias, conflict of interest, or undue influence from commercial, financial, or other pressures that could compromise results.

The obligation to keep information obtained or created during laboratory work secure and undisclosed to unauthorized parties, with legal or contractual exceptions handled transparently.

The demonstrated ability of a person to apply knowledge and skills to perform specified laboratory tasks correctly, typically evidenced through education, training, experience, and observed performance.

Formal third-party recognition, issued by an authoritative body, that a laboratory is competent to perform specific conformity assessment activities according to defined standards and scope.

An organization that performs activities such as testing, calibration, inspection, or certification to determine whether products, processes, or services meet specified requirements.

A technical operation that determines one or more characteristics of an object or material according to a defined procedure, producing a result used for conformity or characterization purposes.

An operation that establishes, under specified conditions, the relationship between values indicated by a measuring instrument and corresponding values realized by measurement standards, documented in a calibration certificate.

The property of a measurement result whereby it can be related to a national or international reference through an unbroken documented chain of calibrations, each contributing to the stated uncertainty.

A non-negative parameter characterizing the dispersion of quantity values attributed to a measurand, based on the information used and expressed as a range around the measured value.

Confirmation by examination and provision of objective evidence that a measurement or test method is fit for its intended use, showing it meets specified performance requirements before routine application.

The activity of demonstrating that a laboratory can properly operate a standard method under local conditions, achieving the performance characteristics claimed by the method's developer.

A published, consensus-based procedure issued by a recognized body for performing a test or measurement, intended for repeated use without further modification by the user.

A measurement standard of the highest metrological quality available in a given location, used as the basis for assigning values to other standards or materials and for calibrating instruments.

A material sufficiently homogeneous and stable with respect to specified properties that it is suitable for use in measurement, calibration, or quality control, sometimes certified with assigned values and uncertainties.

An external evaluation of laboratory performance against other participating laboratories on the same or similar samples, used to monitor and demonstrate competence in specific test areas.

The organization, performance, and evaluation of measurements or tests on the same or similar items by two or more laboratories according to predetermined conditions, often used to assess performance.

Ongoing, in-house checks using control samples, replicate analyses, or statistical techniques to confirm that measurement results remain within acceptable limits during routine testing.

A statistical graph plotting quality control results over time against defined limits, used to detect trends, shifts, or out-of-control conditions in a measurement process.

A documented rule describing how measurement uncertainty is accounted for when deciding whether a result conforms to a specification, including the treatment of values near the limit.

A declaration in a report that a result meets or does not meet a specified requirement, made only when the requirement and the decision rule are clearly identified.

A boundary value set by a customer, regulation, or standard that defines acceptable results; it is distinct from the laboratory's own measurement performance limits.

A defined procedure for selecting a portion of a substance, material, or population for testing, including plans and methods intended to yield representative results.

The controlled sequence of activities applied to samples from receipt to disposal, including identification, transport, storage, preparation, and protection from deterioration or contamination.

A formal document presenting test results and all information required by the standard, the method, or the customer, including identification, methods used, and any relevant uncertainty or conformity statements.

Documented evidence of activities and results that affect the validity of laboratory work, retained in sufficient detail to allow repetition of the activity under similar conditions.

Information the laboratory is required to control and maintain, including documented procedures, policies, and records, in whatever medium and format they are held.

The property of data being complete, consistent, accurate, and unaltered throughout its lifecycle, protected by controls over recording, transfer, storage, and amendment.

An approach that identifies, assesses, and addresses risks and opportunities affecting the validity of laboratory results and the effectiveness of the management system, proportionate to their potential impact.

Action taken to eliminate the cause of a detected nonconformity or undesirable situation so that it does not recur, following investigation of root causes and assessment of similar occurrences.

A failure to meet a requirement, whether a standard requirement, a customer requirement, or the laboratory's own documented procedure, which must be recorded and addressed.

A structured investigation to determine the underlying reason a nonconformity occurred, distinguishing the immediate symptom from the systemic cause that corrective action must address.

A periodic, top-management evaluation of the laboratory management system's suitability, adequacy, and effectiveness, using defined inputs and producing decisions on improvement and resources.

Individuals formally granted permission by the laboratory to perform specific activities such as sampling, testing, reporting, or approving results, based on verified competence and defined responsibilities.

The specific tests, calibrations, methods, or activities for which a laboratory has been accredited, stated precisely so that customers can identify what is covered.

The coordinated set of processes and responsibilities used to direct and control an organization with regard to quality, forming the quality-related part of a laboratory's overall management system.

A situation where financial, personal, or other interests could improperly influence laboratory judgments or results, requiring identification and mitigation to preserve impartiality.