ISO 16140-1:2016

Overview

ISO 16140-1:2016 - Microbiology of the food chain - Method validation - Part 1: Vocabulary defines the standardized terms and definitions used for microbiological method validation across the food chain. This part gives a consistent vocabulary for validating methods for the detection or quantification of microorganisms in foods (human and animal), environmental samples from food/feed production and handling, and primary production samples. ISO 16140-1:2016 (first edition, June 2016) harmonizes terminology used in method validation, supporting clear communication among laboratories, regulators and suppliers.

Key topics and technical terms

The standard focuses on precise definitions relevant to method validation rather than procedures. Key technical topics covered include:

• Method validation terminology: alternative method, reference method, result of alternative method, assigned value.
• Performance concepts: accuracy (exactitude), bias, limit of acceptability, precision (repeatability and reproducibility), uncertainty.
• Detection metrics for qualitative methods: level of detection (LOD), probability of detection, detection probability examples (e.g., LOD as the level giving 50% positive results).
• Study elements: interlaboratory study, blind replicates, inclusivity and exclusivity studies, confirmation and identification procedures.
• Reference materials: certified reference material (CRM), internal reference material (IRM), homogeneity.
• Statistical terms: tolerance interval, confidence interval, expanded uncertainty and coverage factor.

These definitions are cross-referenced to related measurement guides (e.g., ISO 17511, JCGM) as appropriate.

Applications and who uses it

ISO 16140-1:2016 is used to:

• Standardize terminology during method validation studies (intralaboratory, interlaboratory, validation of commercial/alternative methods).
• Support laboratory accreditation and quality management systems by ensuring consistent interpretation of validation results.
• Aid manufacturers of test kits and reagents, regulatory authorities, food safety auditors, and research organizations in reporting and assessing method performance.
• Facilitate comparability of microbiological data across laboratories and jurisdictions in food safety, surveillance and compliance testing.

Primary users: microbiology laboratories, QA/QC managers, method developers, test-kit manufacturers, accreditation bodies, and regulators.

Related standards

• ISO 16140 (series) - Part 2: protocol for validation of alternative (commercial) methods (and additional parts under preparation).
• ISO 17468 - validation of standardized methods.
• ISO 17511 and JCGM guides - referenced for metrology and uncertainty terminology.

By adopting ISO 16140-1:2016 vocabulary, stakeholders ensure clarity and consistency in microbiological method validation across the food chain, improving reliability of detection and quantification results and regulatory compliance.