ISO & Accreditation Cumulative Practice Quiz (90 questions)

These flashcards cover essential vocabulary and concepts of ISO/IEC 17025:2017, including proficiency testing, reference materials, and quality management in laboratories.

ISO/IEC 17025:2017

A standard that establishes the competence of testing and calibration laboratories.

Proficiency Testing (PT)

Interlaboratory comparisons for performance evaluation.

Certified Reference Materials (CRM)

Materials with an assigned value and uncertainty for calibration and validation purposes.

ISO Guide 34

A standard that defines requirements for reference material producers.

Reference Materials (RM)

Substances or materials used to validate test methods and ensure accuracy in measurements.

Metrological Traceability

The property of a measurement result to be related to national or international measurement standards.

Quality Management System (QMS)

A systematic approach to managing organizational processes to achieve quality objectives.

ISO/IEC 17043

Standard for proficiency testing providers.

Homogeneity testing

A process to ensure consistency across material units.

Instruments Qualification

The process of verifying that instruments work properly and reliably.

Traceability

An unbroken chain of comparisons to reference standards.

Method Validation

The process of demonstrating that a method is suitable for its intended purpose.

Certificate of Analysis (CoA)

A document reporting the value, traceability, and uncertainty of a CRM.

Standard Operating Procedure (SOP)

Detailed written instructions to achieve uniformity in a process.

Robustness

The method's reliability under small changes in conditions.

Accuracy

The closeness of a measured value to the true value.

Precision

The degree to which repeated measurements under unchanged conditions show the same results.

Limit of Detection (LOD)

The lowest concentration of an analyte that can be reliably detected.

Risk-based scoring

A method used to assess and manage risks in quality management.

Corrective and Preventive Actions (CAPAs)

Processes for identifying and investigating problems and implementing actions to prevent their recurrence.

Quality Manual

A document outlining an organization's quality management system.

Internal Audit

An objective examination of a company's financial and operational business activities.

Design Qualification (DQ)

Confirmation that the proposed design and intended use of a facility or system is appropriate.

Operational Qualification (OQ)

Verification of that an instrument performs according to its operational specifications.

Performance Qualification (PQ)

Verification that a system or equipment performs its intended function consistently.

Accreditation Bodies

Organizations that are recognized to assess and accredit laboratories for compliance with standards.

ISO Guide 30

Provides definitions and terminology related to reference materials.

ISO Guide 35

Sets out requirements for the production and certification of reference materials.

ISO Guide 31

Provides specifications for the provision of reference material certificates.

ISO Guide 80

A guide for proficiency testing providers.

Test Methods

Procedures developed to analyze a sample or process.

Analytical Instrument Qualification (AIQ)

A systematic process to assess the capability of laboratory equipment.

Continuous Quality Improvement (CQI)

An ongoing effort to enhance products, services, or processes.

FDA Audit

An inspection conducted by the Food and Drug Administration to ensure compliance with regulations.

ALCOA

A principle that stands for Attributable, Legible, Contemporaneous, Original, and Accurate.

Audit Trail

A record of the sequence of events related to a specific operation or process.

User Requirement Specification (URS)

Document specifying the functional requirements of a software or system.

Calibration Chain

A series of calibrations that demonstrates traceability of measurement.

Interval for PT participation

Frequency at which laboratories are required to participate in proficiency testing.

Traceability Assurance

Oversight of the processes that ensure consistent metrics tied to valid references.

SOP for PT Participation

Standard Operating Procedure ensuring systematic involvement in proficiency testing.

Regulatory Compliance

Adhering to laws, regulations, guidelines, and specifications relevant to its business processes.

Experience Record

Documentation of skills or achievements of personnel in a laboratory.

Continuous Training

Ongoing educational programs designed to enhance knowledge and skill.

FDA Form 483

A form issued by the FDA to document observations made during an inspection.

Unbroken calibration chain

Seamless connection between measurements and national or international standards.

Sample Spectra Saving

The practice of digitally preserving analytical results for future reference.

Laboratory Management System

A software solution designed to manage laboratory operations.

Quality Objectives

Goals aimed at ensuring the highest quality in processes and results.

Accreditation Scope

The range of activities that an organization is certified to perform.

Root Cause Analysis

A method of problem-solving that focuses on identifying and addressing the root causes of issues.

Testing or Calibration Laboratory

A facility that conducts tests or calibrations.

Risk Assessment

The identification and analysis of potential issues that could negatively affect key business initiatives.

Guideline on GxP

Best practices for good laboratory, clinical, and manufacturing practices.

Data Integrity

The accuracy and consistency of data over its entire lifecycle.

Certified Analyst

An individual recognized as having met predefined criteria related to laboratory analysis.

Training Validation

The process of ensuring training quality and effectiveness.

Audit Preparedness

The state of being ready for an audit through proper organization and documentation.

Environmental Compliance

Conformance to laws and regulations that protect the environment.

Standard Practices

Established protocols for conducting laboratory work.

Quality Control (QC)

The part of quality management focused on fulfilling quality requirements.

Accreditation Timeline

A schedule outlining the steps and duration of the accreditation process.

Sample Handling Protocols

Procedures established for the management of samples in a laboratory.

Inter-laboratory Comparisons

The practice of analyzing the same sample or set of samples across different laboratories.