PECB ISO/IEC 17025 Lead Assessor key terms

A structured framework of processes, responsibilities, and resources established by a laboratory to consistently meet customer, regulatory, and ISO/IEC 17025 requirements, and to continually improve its quality and technical performance.

The presence of objectivity, meaning that conflicts of interest are identified and managed so that laboratory activities are not influenced by financial, commercial, or other pressures that could compromise results.

The obligation to protect proprietary information and results obtained during laboratory activities, ensuring they are not disclosed to unauthorized parties without proper authorization, except as required by law.

An approach that requires the laboratory to consider risks and opportunities that could affect the validity of results or the effectiveness of the management system, and to plan actions to address them.

The demonstrated ability to apply knowledge and skills to achieve intended results, including appropriate education, training, experience, and proficiency in the laboratory's specific testing or calibration activities.

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

A non-negative parameter characterizing the dispersion of quantity values being attributed to a measurand, based on the measurement model and the information available at the time of evaluation.

Evaluation of participant performance against pre-established criteria by means of interlaboratory comparisons, used to monitor and demonstrate the reliability of the laboratory's testing or calibration results.

A systematic, independent, and documented process for obtaining objective evidence and evaluating it objectively to determine the extent to which the laboratory's management system conforms to planned arrangements and ISO/IEC 17025 requirements.

A formal, periodic evaluation by top management of the laboratory's management system to ensure its continuing suitability, adequacy, and effectiveness, including consideration of improvement opportunities and need for changes.

Action taken to eliminate the cause of a nonconformity and to prevent recurrence, including investigation of root causes, implementation of actions, and verification of their effectiveness.

The failure to meet a specified requirement, such as a requirement of ISO/IEC 17025, the laboratory's own procedures, or agreed customer requirements, which must be addressed through correction and corrective action.

A set of policies, procedures, or requirements used as a reference against which objective audit evidence is compared to determine conformity.

Records, statements of fact, or other information that are relevant to the audit criteria and verifiable, forming the basis for audit findings and conclusions.

Results of the evaluation of collected audit evidence against audit criteria, indicating conformity or nonconformity and forming the basis for the audit report.

The outcome of an audit, after consideration of the audit objectives and all audit findings, that provides the audit client with an overall determination of conformity and effectiveness.

The extent and boundaries of an audit, including the organizational units, physical locations, activities, and processes covered, as well as the audit criteria and duration.

A description of the activities and arrangements for an audit, including objectives, criteria, scope, schedule, roles, and resources, used to guide the conduct of the audit.

A formal meeting at the start of an audit to confirm the audit plan, introduce the audit team, explain the audit methods, and ensure that all necessary arrangements are in place.

A formal meeting at the end of an audit where the audit team presents the audit findings and conclusions to the auditee and relevant parties, and agrees on follow-up actions.

A documented summary of the audit that includes the audit objectives, scope, criteria, findings, conclusions, and any agreed actions, serving as a formal record of the audit.

The process of selecting a representative subset of items or records from a larger population for examination, used to gather audit evidence when full examination is impractical.

Information required to be controlled and maintained by the laboratory, including documented procedures, records, and other media that provide evidence of conformity and effective operation.

The set of activities to ensure that records are legible, identifiable, retrievable, protected, and retained for specified periods, providing evidence of conformity and traceability.

The operation that, under specified conditions, establishes a relation between the quantity values with measurement uncertainties provided by measurement standards and corresponding indications, and uses this information to establish a relation for obtaining a measurement result.

The process of verifying that a method is fit for its intended purpose by demonstrating that its performance characteristics meet the requirements for the specific intended use.

A systematic process for identifying the fundamental reason for a nonconformity or problem, so that effective corrective actions can be taken to prevent recurrence.

One or more auditors conducting an audit, supported if needed by technical experts, with a designated team leader responsible for the overall conduct of the audit.

An auditor who is responsible for managing the audit, including planning, conducting, reporting, and following up, and who has demonstrated competence in leading audit teams.

A person who provides specific knowledge or expertise to the audit team regarding the technology, process, or activity being audited, but who does not act as an auditor.

A set of one or more audits planned for a specific time frame and directed towards a specific purpose, including arrangements for managing and scheduling the audits.

An audit conducted to verify that corrective actions taken in response to previous audit findings have been implemented and are effective, often part of the audit programme.

The organization or person that requested the audit, which may be the auditee or another party, and that determines the audit objectives and receives the audit report.

The specific goals or purposes of an audit, such as evaluating conformity, effectiveness, or improvement opportunities, which guide the planning and conduct of the audit.

The combination of the likelihood of an audit failing to detect a significant nonconformity and the consequences of such failure, considered when planning the audit.

The freedom from bias and conflict of interest that allows auditors to make objective judgments, ensuring that they are not auditing their own work or activities for which they have responsibility.

The quality of being unbiased and impartial in judgment, based on evidence rather than personal opinions or external influences, essential for auditors and laboratory personnel.

The specific activities, methods, and locations for which a laboratory has been accredited, as defined by the accreditation body and referenced in the accreditation certificate.

Third-party attestation related to products, processes, systems, or persons, distinct from accreditation which is specific to conformity assessment bodies such as laboratories.