ISO 17025:2005(E) & Laboratory Accreditation

Flashcards summarizing key vocabulary and concepts related to ISO 17025:2005(E) and laboratory accreditation.

ISO 17025

An international standard that specifies the general requirements for the competence of testing and calibration laboratories.

Accreditation

A formal recognition by an authoritative body that a laboratory is competent to perform specific tasks.

Laboratory Accreditation

Formal recognition that a testing or calibration laboratory is competent to carry out specific tests or calibrations.

Competence

The ability of a laboratory to perform specific tasks accurately and reliably.

Proficiency Testing (PT)

A program that laboratories participate in to compare their testing results against a standardized benchmark to ensure quality.

Deficiency

Any nonconformity to accreditation requirements affecting a laboratory's performance.

Management System

An organized system used by a laboratory to manage its policies, procedures, and responsibilities.

Periodic Re-assessment

A regular review process to ensure ongoing conformity to accreditation standards.

Surveillance Assessment

An annual review to confirm that a laboratory is still in compliance with its accreditation requirements.

Technical Requirements

Requirements addressing the technical aspects of testing and calibration, including methods and personnel qualifications.

Management Requirements

Requirements that relate to the management systems, documentation, and operational controls of the laboratory.

ISO 9001

An international standard that specifies requirements for a quality management system.

Document Control

The process of managing documentation to ensure that it is current, available, and properly handled.

Corrective Actions

Actions taken to eliminate the causes of detected nonconformities to prevent recurrence.

Internal Audits

Systematic examinations of a quality management system performed by internal auditors to verify compliance and effectiveness.

Regulatory Authorities

Government or statutory bodies responsible for ensuring compliance with laws and standards.

Accrediting Body

An organization that provides accreditation to laboratories based on specific criteria.