ISO 19036-2019 PDF

Full title and description

ISO 19036:2019 — Microbiology of the food chain — Estimation of measurement uncertainty for quantitative determinations. This International Standard specifies requirements and gives guidance for estimating and expressing measurement uncertainty (MU) associated with quantitative microbiological results across the food chain.

Abstract

This document provides requirements and guidance for estimating and expressing the measurement uncertainty associated with quantitative determinations in food‑chain microbiology. It is primarily applicable to enumeration by colony‑count techniques but is also generally applicable to most probable number (MPN) techniques, instrumental methods (e.g., impediometry, ATP, flow cytometry) and molecular methods (e.g., qPCR). The uncertainty framework in the standard excludes systematic effects (bias) from the uncertainty estimate.

General information

• Status: Published (International Standard).
• Publication date: 2019 (published 2019‑11‑05; Edition 1, 2019‑10).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 07.100.30 — Food microbiology.
• Edition / version: Edition 1 (2019).
• Number of pages: 38.

Scope

ISO 19036:2019 applies to the quantitative analysis of samples related to the food chain, including products intended for human consumption or animal feed, environmental samples from food production/handling, and samples from primary production. The standard is designed for enumeration results (typically colony counts) but is broadly applicable to other quantitative microbiological techniques (MPN, instrument-based counts and molecular quantification). It provides a structured approach to estimate the uncertainty components associated with routine quantitative determinations; it does not incorporate systematic bias into the uncertainty estimate.

Key topics and requirements

• Framework and requirements for estimation and expression of measurement uncertainty (MU) for quantitative microbiological results.
• Applicability to colony‑count methods and general applicability to MPN, instrumental and molecular methods.
• Decomposition of uncertainty into components such as technical uncertainty (intralaboratory variability), matrix uncertainty and distributional uncertainty.
• Methods to combine components into a combined standard uncertainty and calculate an expanded uncertainty for reporting.
• Guidance on presentation of MU in test reports and examples/calculation support (including annexed calculation methods for standard deviations with two or more test portions).
• Explicit statement that the procedure does not include bias (systematic effects) in the uncertainty estimate.

Typical use and users

Primary users are microbiology testing laboratories (food, feed, environmental), method developers and validation specialists, accreditation assessors, regulators and proficiency‑testing providers who need to quantify and report uncertainty for quantitative microbiological measurements. The standard supports routine laboratory reporting, method validation/verification and conformity assessment activities.

Related standards

Related documents commonly used alongside ISO 19036:2019 include the withdrawn ISO/TS 19036:2006 (replaced by this standard), ISO/IEC 17025 (laboratory competence and reporting), the ISO 5725 series (accuracy — trueness and precision of measurement methods), ISO 16140 (method validation in microbiology) and guidance documents on uncertainty evaluation (e.g., ISO 21748 for Monte Carlo approaches where applicable).

Keywords

measurement uncertainty, microbiology, quantitative determinations, colony count, MPN, qPCR, food chain, matrix uncertainty, reproducibility, expanded uncertainty, test reports

FAQ

Q: What is this standard?

A: ISO 19036:2019 is an international standard that specifies how to estimate and express measurement uncertainty for quantitative microbiological analyses related to the food chain.

Q: What does it cover?

A: It covers the estimation and expression of uncertainty for quantitative results (primarily colony counts) and gives guidance applicable to MPN, instrument‑based and molecular quantification methods. It provides procedures to quantify technical, matrix and distributional uncertainty components and to combine them into a reported expanded uncertainty.

Q: Who typically uses it?

A: Food and feed microbiology laboratories, accreditation bodies, regulators, method developers and proficiency‑testing organisations that report quantitative microbiological results and need to include uncertainty statements with their results.

Q: Is it current or superseded?

A: ISO 19036:2019 is the current edition (Edition 1, published 2019) and replaced ISO/TS 19036:2006 and its 2009 amendment; the publication has been subject to periodic review and the ISO catalog entry indicates the standard remains current following review.

Q: Is it part of a series?

A: It is a standalone ISO International Standard focused on MU for quantitative microbiology but is typically applied in conjunction with related standards and guidance (e.g., ISO/IEC 17025, ISO 5725 series, ISO 16140) when performing method validation, laboratory accreditation and reporting.

Q: What are the key keywords?

A: Measurement uncertainty, microbiology, quantitative determination, colony count, MPN, qPCR, matrix uncertainty, reproducibility, expanded uncertainty.