PECB ISO/IEC 17025 Lead Implementer key terms

The structured set of policies, processes, documented procedures and records a laboratory uses to consistently deliver valid results and to meet the requirements of ISO/IEC 17025.

Managing laboratory work as a network of interrelated processes whose inputs, outputs, controls and interactions are identified, so that results depend on planned control rather than individual effort.

Deciding how much rigour, documentation and control each laboratory activity needs, based on the likelihood and impact of invalid results or other harm.

The actual presence of objectivity in laboratory activities, meaning that commercial, financial or other pressures do not influence decisions, results or reported opinions.

The obligation to keep information obtained or created during laboratory work legally protected and disclosed only to authorised parties, typically through a documented commitment from all personnel.

The demonstrated ability to apply knowledge and skills to perform a defined laboratory task correctly, verified through education, training, experience and observed performance.

The hierarchy of policies, manuals, procedures, work instructions and forms that records how the laboratory operates and provides evidence that requirements are met.

The set of controls ensuring documents are approved, uniquely identified, available where needed, reviewed when changes are planned and withdrawn when obsolete.

The controls that protect the integrity, legibility, retention and retrievability of technical and quality records, including any changes that can be traced to the original.

The specific tests, calibrations, sampling activities or measurement parameters, methods and locations for which a laboratory has been formally recognised as competent.

A planned top-management evaluation of the laboratory management system, using defined inputs and producing decisions and actions on improvement, resources and system changes.

An independent, planned examination of laboratory activities against its own arrangements and the standard, performed by trained personnel who do not audit their own work.

Action taken to eliminate the underlying cause of a detected nonconformity so that it does not recur, following an investigation of root cause and an assessment of similar risks elsewhere.

A structured investigation method used to move beyond the immediate symptom of a problem and identify the systemic conditions that allowed a nonconformity to occur.

A failure to meet a requirement, whether from the standard, the laboratory's own procedures, a customer specification or a regulatory obligation, requiring containment and follow-up.

The ongoing, planned activity of enhancing the laboratory management system's suitability, adequacy and effectiveness, driven by data, audits, feedback and identified opportunities.

A maintained record listing identified risks to valid laboratory results, their assessed likelihood and impact, assigned owners, planned actions and the effectiveness of those actions.

A person or organisation that can affect, be affected by, or perceive itself affected by laboratory activities, such as customers, regulators, personnel, suppliers or the public.

A structured comparison of the laboratory's current practices and documentation against each requirement of ISO/IEC 17025, producing a prioritised list of what must change.

A schedule of tasks, responsibilities, resources and milestones that converts gap analysis findings into a working management system within an agreed timeframe.

The documented process of defining required skills for each role, training and qualifying staff, authorising them for specific activities and monitoring their continuing performance.

Formal permission given to a named individual to perform a specific laboratory activity, such as a method, instrument or report sign-off, based on demonstrated competence.

The process of confirming through objective evidence that a non-standard or modified method is fit for its intended use, covering performance characteristics such as accuracy, precision and range.

Confirmation that the laboratory can properly perform a standard method as published, by demonstrating that its performance in-house meets stated requirements.

A quantified expression of the range of values within which the true result is expected to lie, accounting for contributions from sampling, equipment, operators, environment and method.

An unbroken chain of calibrations, each contributing stated uncertainty, linking a measurement result to national or international reference standards.

Comparing an instrument's indication against a reference standard of known value and recording the relationship, so that corrections or uncertainty statements can be applied.

The planned arrangements for selecting, installing, calibrating, checking, maintaining and retiring laboratory equipment, including records of status and any interim checks.

A documented approach describing how samples are selected, taken, transported and stored, so that the portion tested validly represents the material under investigation.

The ability to link a sample, record or result back through documented steps to its origin, including who handled it, when, and under what conditions.

An external comparison in which the laboratory tests identical material alongside other laboratories and its reported result is evaluated against an assigned value.

Routine internal checks such as blanks, duplicates, control materials and trend charts used to confirm that measurement results remain within defined acceptance limits.

Structured information collected from clients about their experience of laboratory services, used as an input to performance evaluation and improvement decisions.

An authoritative organisation that independently assesses a laboratory against ISO/IEC 17025 and, if satisfied, formally attests its competence for a defined scope.

An on-site or remote evaluation by accreditation assessors that examines documents, records, witness activities and interviews staff to verify conformity with the standard.

Observations raised by assessors during an assessment, classified as nonconformities or improvement notes, each requiring a response and, where applicable, corrective action.

A situation in which financial, personal or organisational interests could improperly influence laboratory judgements, requiring identification, disclosure and management.