Webinar: Microbiology Uncertainty of Measurement

according to ISO 19036:2019

Presented by Janine Musso
INTRODUCTION TO ISO 19036:2019
The international standard ISO/IEC 17025 for testing and calibration
laboratories requires the laboratories to estimate the Measurement
Uncertainty(MU).
A laboratory’s customers use the results for taking important
business decisions globally.
Laboratories therefore select and determine the measurement
methods to ensure the overall variability by evaluating
measurement uncertainty.
Too large or too small uncertainty may affect the reliability of the
decision and may make the situation complex and costly.
Thus, an appropriable estimate of measurement uncertainty is an
important task performed by laboratories.
INTRODUCTION TO ISO 19036:2019
ISO 19036:2019 specifies the requirements and gives guidance for
the estimation and expression of measurement uncertainty (MU)
associated with quantitative results in microbiology of the food
chain.
It is applicable to the quantitative analysis of:
✓ products intended for human consumption or the feeding of
animals;
✓ environmental samples in the area of food production and food
handling;
✓ samples at the stage of primary production.

ISO 29201:2012 describes measurement uncertainty in water.

INTRODUCTION TO ISO 19036:2019
The quantitative analysis is typically carried out by enumeration of
microorganisms using a colony-count technique.
ISO 19036 is also generally applicable to other quantitative analyses,
including:
✓ most probable number (MPN) techniques;
✓ instrumental methods, such as ATP and flow cytometry;
✓ molecular methods, such as quantitative PCR (qPCR).
The uncertainty estimated by ISO 19036 does not include systematic
effects (bias).
INTRODUCTION TO ISO 19036:2019
Measurement Uncertainty (MU):

✓ The term “measurement uncertainty”

(MU) is used to indicate the lack of
accuracy (trueness and precision) that
can be associated with test results.

✓ In the context of quantitative

microbiology, it provides an indication of
the degree of confidence that can be
placed on laboratory estimates of
microbial numbers in foods or other
materials.
INTRODUCTION TO ISO 19036:2019
ISO/IEC 17025:2017 Clause 7.6.1:
✓ Laboratories shall identify the contributions to measurement
uncertainty.

✓ When evaluating measurement uncertainty, all contributions

that are of significance, including those arising from sampling,
shall be taken into account using appropriate methods of analysis.

Furthermore, the contributions to MU, and how they are controlled,

in your laboratory should be documented, e.g. in a procedure,
method validation report, etc.
INTRODUCTION TO ISO 19036:2019
Note:
✓ MU includes all sources of uncertainty at the laboratory linked to
a given laboratory sample received by the laboratory.
✓ The laboratory sample may consist of a packaged food (food unit),
an aliquot of bulk food, an environmental sample in the area of
food production/food handling, or a sample at the stage of
primary production.
✓ Thus, MU defined in such a way includes in particular the effects
of sub-sampling (e.g. taking a test portion of 10 g or 25 g from the
laboratory sample) but excludes any uncertainty linked to
sampling (i.e. taking a sample from the production batch).
INTRODUCTION TO ISO 19036:2019
ISO/IEC 17025:2017 Clause 7.8.3.1 c):
Laboratories need to produce data on measurement uncertainty
(MU) for the tests that they perform and may be required to report
relevant information in certain circumstances such as:
✓ it is relevant to the validity or application of the test results;
✓ a customer's instruction so requires, or
✓ the measurement uncertainty affects conformity to a
specification limit;
INTRODUCTION TO ISO 19036:2019
Examples of sources of uncertainty in microbiology:

Technical competence, Original sample Homogenisation of the Dilution fluid accuracy,

bias and experience homogeneity, time, sample & no. dilution steps,
transport and storage microorganism mixing, pipette
conditions distribution accuracy

Media and reagents, Inoculation of media & Incubation conditions, Reading and
raw material quality, volume, agar time, temperature, interpretation, colonies
weighing accuracy, pH, temperature humidity counted, dilution
conductivity, heat chosen, proportion
processing, mixing colonies confirmed
INTRODUCTION TO ISO 19036:2019
The GUM approach:
✓ ISO/IEC Guide 98-3 (also known as the “GUM”) is a widely adopted
reference document.
✓ The principal approach of ISO/IEC Guide 98-3 is to construct a
mathematical model that quantitatively describes the relationship
between the quantity being measured (the measurand) and every
quantity on which it depends (input quantities).
✓ That measurement model is then used to deduce the uncertainty
in the measurand from the uncertainties in the input quantities.
INTRODUCTION TO ISO 19036:2019
Why do we not follow the GUM approach?
In the case of the microbiological analysis, it is not feasible to build a
comprehensive quantitative measurement model, since it is not
possible to quantify accurately the contribution of each input
quantity, where:
✓ the analyte is a living organism, whose physiological state can be
largely variable;
✓ the analytical target includes different strains, different species or
different genera;
✓ many input quantities are difficult, if not impossible, to quantify (e.g.
physiological state);
✓ for many input quantities (e.g. temperature, water activity), their
effect on the measurand cannot be described quantitatively with
adequate precision.
INTRODUCTION TO ISO 19036:2019
Why do we not follow the GUM approach?
✓ For these reasons given previously, ISO 19036 mostly uses a top-
down or global approach to MU.
✓ The contribution of most input quantities is estimated as a
standard deviation of reproducibility of the final result of the
measurement process.
✓ It is calculated from experimental results with replication of the
same analyses, as part of the measurement process. These
quantities reflect operational variability and result in technical
uncertainty.
INTRODUCTION TO ISO 19036:2019
Why do we not follow the GUM approach?
✓ The holistic “top-down” approach also considers the test method
performance as a whole, making use of the routine quality
control (QC) and method validation data, instead of the time-
consuming step-by-step ISO GUM “bottom-up” approach which
study the uncertainty contributions in each and every step of the
laboratory analysis before summing up for the expanded
uncertainty of the method.
INTRODUCTION TO ISO 19036:2019
Why do we not follow the GUM approach?
✓ The top-down MU approach as per ISO 19036 evaluates the overall
variability of the analytical process in question.
MEASUREMENT UNCERTAINTY COMPONENTS
There are three distinct types of uncertainty components:

Technical
uncertainty
(utech)

MU Matrix
uncertainty
components (umatrix)

Distributional
uncertainty
(u Poisson / u conf / u MPN )
MEASUREMENT UNCERTAINTY COMPONENTS
In general, the expanded measurement uncertainty is used when
MU is applied to test results.

Steps to calculating expanded MU:

1. Determine the individual MU components
a) technical uncertainty (u tech )
b) matrix uncertainty (u matrix )
c) distributional uncertainty (u Poisson / u conf / u MPN )

2. Calculate the combined MU

3. Calculate the expanded MU
TECHNICAL UNCERTAINTY Sample

✓ Technical uncertainty arises from

operational variability and is
estimated, using a global
approach, from a reproducibility
standard deviation of the final
result of the measurement Analyst A Analyst B

process.
✓ This global approach means that Equipment A Equipment B

the technical uncertainty estimate

comes from final test results Media A Media B
rather than by calculation using
estimates of uncertainty at every Different conditions a, b, c, etc.
individual stage of the test.
How different are results
between A and B?
TECHNICAL UNCERTAINTY
There are three approaches to calculate technical uncertainty.
They are based upon repeated measurements of nominally
identical material:
1) Intralaboratory reproducibility, i.e. reproducibility estimated
within a laboratory as per ISO 16140-3:2021 for method verification
2) Interlaboratory studies
a) Reproducibility derived from method validation interlaboratory studies
b) Reproducibility derived from interlaboratory proficiency tests

Option 1 is recommended since it enables a laboratory to attach the

MU value to the results that it reports, in line with the definition of
MU, and it provides a value of technical uncertainty linked to each
laboratory.
TECHNICAL UNCERTAINTY
Example using Option 1 - Intralaboratory reproducibility:
The estimation of intralaboratory reproducibility is designed to
exclude contributions from heterogeneity within the laboratory
sample, so it is not necessary to repeat this estimation for different
matrices, and this estimate may be based on a single matrix.

Note:
Technical uncertainty is the characteristics of the method. It is
estimated for one method cannot be applied to other methods.
TECHNICAL UNCERTAINTY
7.1. Determination of Intralaboratory Reproducibility (S IR)
Example using Option 1 - Intralaboratory reproducibility:
Laboratory sample
A minimum of 10 laboratory samples
belonging to the same (food) item are
required. Mix or homogenise the sample
to uniformly distribute the
microorganisms.
Homogenise • Liquid products: Mix by shaking the
sample by hand approximately 25
times.
• Solid products: Transfer the product
to a sterile stomacher bag and
homogenise by mechanical means, i.e.
stomacher or blender.
TECHNICAL UNCERTAINTY
7.1. Determination of Intralaboratory Reproducibility (S IR)
Example using Option 1 - Intralaboratory reproducibility:
Laboratory sample
Prepare the test portions:
• Prepare two 1:10 dilutions from
the homogenised product and
label the test portions as A and B.
• Repeat for all 10 products to end
Homogenise up with 10 duplicate test portions
of A and B.

1:10 dilution 1:10 dilution 1:10 dilution

Test Test Test Test Test Test

portion portion portion portion portion portion
1A 1B 2A 2B 3A 3B

1A 1B 2A 2B 3A 3B → Continue 10×
TECHNICAL UNCERTAINTY
7.1. Determination of Intralaboratory Reproducibility (S IR)
Example using Option 1 - Intralaboratory reproducibility:
Laboratory sample
Inoculate the initial suspensions:
• For each duplicate, inoculate the test
portions with the 1ml of the prepared
culture. All 10 samples are inoculated
at different levels to cover a range for
Homogenise low, medium and high contamination
levels.

• If naturally contaminated products

are used, they can be analysed directly
after the sample is homogenised.

1:10 dilution 1:10 dilution 1:10 dilution

Test Test Test Test Test Test

portion portion portion portion portion portion
1A 1B 2A 2B 3A 3B
+ Inoculate
with culture
Low,
1A 1B 2A 2B 3A 3B → Continue 10× Medium or
High
TECHNICAL UNCERTAINTY
7.1. Determination of Intralaboratory Reproducibility (S IR)
Example using Option 1 - Intralaboratory reproducibility:
Laboratory sample

Homogenise

→ End with at least 10

duplicate samples of
A and B
1:10 dilution

1A 2A 3A 4A 5A 6A 7A 8A 9A 10A
1:10 1:10 1:10 1:10 1:10 + Inoculate
1:10 1:10 1:10 1:10 1:10
with culture
Low,
Medium or
1B 2B 3B 4B 5B 6B 7B 8B 9B 10B
High
1:10 1:10 1:10 1:10 1:10 1:10 1:10 1:10 1:10 1:10
Low Low Low Low Med Med Med High High High
TECHNICAL UNCERTAINTY
7.1. Determination of Intralaboratory Reproducibility (S IR)
Example using Option 1 - Intralaboratory reproducibility:
Analyse the samples: Test portion 1A to 10A Test portion 1B to 10B
Analyse test portions A and B using
the test method’s protocol but
under changed conditions. A B

Test conditions between test

portions A and B shall be different in
as many ways as possible. Examples:
• Technicians - biggest influence Analyst A Analyst B
• Batches of culture media,
consumables and reagents -
biggest influence Media batch A Media batch B
• Optional: different strains may + +
also be used to inoculate different Other consumables Other consumables

samples)
• Apparatus (e.g. incubators, vortex Incubator A Incubator B
mixer, pipettes) - based on (if possible) (if possible)
availability

Repeat for all 10 samples in duplicate Different conditions a, b, c, etc.

TECHNICAL UNCERTAINTY
7.1. Determination of Intralaboratory Reproducibility (S IR)
Example using Option 1 - Intralaboratory reproducibility:

Results are tabulated for

Result A Result B Absolute Squared
Sample Spike level Log Result A Log Result B
Food item Date Analyst A Analyst B (xiA) (xiB) difference difference
no. (cfu/g) yiA = log10(xiA) yiB = log10(xiB)
test portions A and B, as
2
(cfu/g) (cfu/g) y -y (y - y )
iA iB iA iB
Cereal 08/04/2021 1 JM 1 VM 1 300 110 182 2.041393 2.260071 -0.218679 0.047820
2 JM 2 VM 2 300 410 620 well
2.612784as the
2.792392inoculum
-0.179608 0.032259

level used for reference

3 JM 3 VM 3 600 640 330 2.806180 2.518514 0.287666 0.082752
4 JM 4 VM 4 600 690 570 2.838849 2.755875 0.082974 0.006885
5
6
JM 5
JM 6
VM 5
VM 6
600
600
780
620
640
1 300
purposes.
2.892095
2.792392
2.806180
3.113943
0.085915
-0.321552
0.007381
0.103395
7 JM 7 VM 7 600 870 1 500 2.939519 3.176091 -0.236572 0.055966
8 JM 8 VM 8 6 000 8 600 6 400 3.934498 3.806180 0.128318 0.016466
9 JM 9 VM 9 6 000 16 000 5 000 4.204120 3.698970 0.505150 0.255177
10 JM 10 VM 10 30 000 20 000 32 000 4.301030 4.505150 -0.204120 0.041665
Sum 0.649766
p = 10 10
Sum / 2p 0.032488
Intralaboratory Reproducibility: SIR (√Sum/2p) 0.18
(Insert validation S IR ) Validation SIR 0.18
2x Validation SIR 0.36
(Must be TRUE to pass) SIR < 2xV.SIR? TRUE
TECHNICAL UNCERTAINTY
7.1. Determination of Intralaboratory Reproducibility (S IR)
Example using Option 1 - Intralaboratory reproducibility:

Result A Result B Absolute Squared

Sample Spike level Log Result A Log Result B
Food item Date Analyst A Analyst B (xiA) (xiB) difference difference
no. (cfu/g) yiA = log10(xiA) yiB = log10(xiB) 2
(cfu/g) (cfu/g) yiA - yiB (yiA - yiB)
Cereal 08/04/2021 1 JM 1 VM 1 300 110 182 2.041393 2.260071 -0.218679 0.047820
2 JM 2 VM 2 300 410 620 2.612784 2.792392 -0.179608 0.032259
3 JM 3 VM 3 600 640 330 2.806180 2.518514 0.287666 0.082752
4 JM 4 VM 4 600 690 570 2.838849 2.755875 0.082974 0.006885
5 JM 5 VM 5 600 780 640 2.892095 2.806180 0.085915 0.007381
6 JM 6 VM 6 600 620 1 300 2.792392 3.113943 -0.321552 0.103395
7 JM 7 VM 7 600 870 1 500 2.939519 3.176091 -0.236572 0.055966
8 JM 8 VM 8 6 000 8 600 6 400 3.934498 3.806180 0.128318 0.016466
9 JM 9 VM 9 6 000 16 000 5 000 4.204120 3.698970 0.505150 0.255177
10 JM 10 VM 10 30 000 20 000 32 000 4.301030 4.505150 -0.204120 0.041665
Sum 0.649766
p = 10 10
Sum / 2p 0.032488
Intralaboratory Reproducibility: SIR (√Sum/2p) 0.18
(Insert validation S IR ) Validation SIR 0.18
S =u
IR = 0.18 log10 cfu
tech2x Validation SIR0.36
(Must be TRUE to pass) SIR < 2xV.SIR? TRUE
TECHNICAL UNCERTAINTY
7.1. Determination of Intralaboratory Reproducibility (S IR)
Example using Option 1 - Intralaboratory reproducibility using
Campden BRI calculator:

SIR = utech = 0.18 log10 cfu

TECHNICAL UNCERTAINTY
Technical uncertainty – Reproducibility standard deviation:
Note:
✓ Reproducibility standard deviation will include any of the matrix
and distributional components relevant to the reproducibility
data, thus the combined uncertainty measurement of the test
result will be an overestimate of uncertainty.
✓ As an option, the lab can avoid this by subtracting any of the
relevant matrix and distributional components from the
experimental reproducibility.
MATRIX UNCERTAINTY
✓ Matrix uncertainty arises from imperfect mixing of the laboratory
sample, resulting in poor reproducibility of microbial levels
between test portions, which can be large for solid matrices, and
especially for composite food products.
✓ Matrix uncertainty is estimated for each kind of matrix.
✓ It is independent of the analytical method used.
✓ Applies to all measurands on the same matrix/food item
✓ Can be estimated if/when required (e.g., by customer)
MATRIX UNCERTAINTY
Can be estimated based on three approaches:

a) Use of a fixed value - for well-mixed/homogeneous

laboratory (or test) samples, the matrix uncertainty is umatrix =
0.1 log cfu/g
expected to be small and a fixed (minimum) value can be or cfu/ml
used.

b) Use of within-laboratory-sample repeatability standard Conduct lab

deviation (S r ). experiment
for each
matrix

c) Use of known value; relevant characteristics of the matrix Refer to

well known and matrix uncertainty estimated from prior values
published in
knowledge. studies
MATRIX UNCERTAINTY
✓ Repeat design for each laboratory sample:
• do not homogenise
• do not artificially contaminate

✓ Matrix uncertainty is regarded as independent of target microorganism

and test method used.

✓ Choose target microorganisms for which naturally contaminated

samples are likely to be found (e.g. TVC).
MATRIX UNCERTAINTY
Take at least two test portions from each laboratory sample:
Total number of test portions = at least 10 or more than the number of
laboratory samples, i.e.:

✓ 1 laboratory sample - at least 11 results (all in same batch)

OR
✓ 10 or more laboratory samples (from same matrix) - at least 2 results
each (replicates in same batch)
MATRIX UNCERTAINTY Laboratory sample 1:10 dilutions

Example of Option b) Within-

laboratory-sample repeatability
1 2 3
✓ Repeated measurements on a single
laboratory sample are made under
same conditions (i.e., same time, 4 5 6
same operator, same equipment, 1 analyst

same media batches, same

equipment, etc). Same 7 8 9
equipment
✓ Repeated measurements from
multiple laboratory samples, may be
analysed over a period of time to Same media 10 11
give a more generally applicable
estimate of matrix uncertainty. Repeatable conditions
MATRIX UNCERTAINTY
Example of Option b) Within-laboratory-sample repeatability
Calculate the repeatability standard deviation

Sr = umatrix = 0.27 log10 cfu

Result 1 to 11
DISTRIBUTIONAL UNCERTAINTY
Even for homogeneous materials, the random distribution of
microorganisms leads to distributional uncertainty. The relevance
of each depends on the method used. There are 3 types:

✓ for colony-count techniques:

o Poisson uncertainty (u Poisson )
o confirmation uncertainty (u conf )
✓ for MPN techniques: MPN uncertainty (u MPN )

The uncertainty for each distributional uncertainty source is

estimated mathematically.
DISTRIBUTIONAL UNCERTAINTY
Poisson uncertainty (u Poisson ):
✓ The contribution of distributional
uncertainty depends on the total
number of counted colonies used
in the calculation of results, ∑𝐶.

1Τln(10) 0,4343
𝑢𝑃𝑜𝑖𝑠𝑠𝑜𝑛 = =
σ𝐶 σ𝐶

✓ If ∑𝐶 = 0 (no colonies counted),

u Poisson = 0,434 (Poisson constant)
✓ For large values of ∑𝐶 , this
uncertainty component may be
negligible
DISTRIBUTIONAL UNCERTAINTY
Confirmation uncertainty (u conf ):
✓ In some colony counting methods,
confirmation tests are used to correct the
presumptive count by estimating the
proportion of a selected number of colonies
that is confirmed as the target organism.
✓ Assuming 𝑛 𝑝 is the number of colonies
tested and 𝑛 𝑐 is the number of colonies
confirmed, calculate the confirmation
uncertainty.

1 (𝑛𝑐 + 0,5)(𝑛𝑝 − 𝑛𝑐 + 0,5)𝑛𝑝2

𝑢𝑐𝑜𝑛𝑓 = 2
2,303 𝑛 + 1 (𝑛 + 2)𝑛2
𝑝 𝑝 𝑐

if 𝑛 𝑐 = 0, calculate u conf as if 𝑛 𝑐 = 1.
DISTRIBUTIONAL UNCERTAINTY
MPN uncertainty (u MPN):
✓ The Most Probable Number technique derives most probable
numbers from multiple detection or non-detection results.
✓ Statistical procedure used to determine the uncertainty of MPN
technique is detailed in Annex C of ISO 19036.
✓ Some MPN tests require confirmation of the presence of the
target organism in every presumptive positive. In that situation,
calculate the MPN and its uncertainty from the number of
confirmed positive results.
DISTRIBUTIONAL UNCERTAINTY
MPN uncertainty (u MPN):
✓ The u MPN can be calculated according to Annex C or by using the
ISO 7218 MPN calculation tool in Table C.7 or the Excel sheet.
✓ Use the standard deviation value as the u MPN .
COMBINED UNCERTAINTY
ISO 19036 presents two options for estimating the combined
uncertainty [u c (y)] for a reported measurement.
Option 1:
✓ Technical, matrix and distributional uncertainty components for
a reported value may be estimated separately from each other,
after which the three components are combined.
2 2 2 2
𝑢𝑐 𝑦 = 𝑢 𝑡𝑒𝑐ℎ + 𝑢 𝑚𝑎𝑡𝑟𝑖𝑥 + 𝑢 𝑐𝑜𝑛𝑓 + 𝑢 𝑃𝑜𝑖𝑠𝑠𝑜𝑛 𝑜𝑟 𝑀𝑃𝑁

Where u tech = s R OR u tech = s R:corr

u matrix = s r OR u matrix = sr r:corr

Technical uncertainty is indeed often the largest of the three

uncertainty components.
COMBINED UNCERTAINTY
Option 2:
✓ A general value of uncertainty may be reported as based only on
a reproducibility standard deviation, if consistent with laboratory
protocols and client requirements.

𝑢 𝑐 𝑦 = 𝑆𝐼𝑅 = 𝑢 𝑡𝑒𝑐ℎ

Note:
This option may lead to an underestimation of MU, in particular
when analysing solid or multi-component food, and/or at low levels.
EXPANDED UNCERTAINTY
✓ Calculate the expanded uncertainty, U, from the combined standard
uncertainty 𝑢𝑐 (𝑦), with a coverage factor k:

U = k × 𝑢𝑐 (𝑦)

✓ in ISO 19036 , k is chosen as a value of 2 (to correspond approximately

to a confidence level of 95%), therefore:

U = 2𝑢𝑐 (𝑦)
REPORTING MEASURMENT UNCERTAINTY
✓ MU should be reported in the same unit as the test result, e.g.
cfu/g or cfu/ml.
✓ The number of figures in reported MU to reflect practical
measurement capability.
✓ It is recommended that expanded uncertainty be rounded to 2
significant figures.

The reported MU may be based on one of the two following options:

a) reproducibility standard deviation plus separate estimations of
matrix and any relevant distributional uncertainties; or
b) reproducibility standard deviation alone (S IR only)
REPORTING MEASURMENT UNCERTAINTY
Reporting Option a) Expanded MU:
When an estimate of MU is required in the test report, include in the
report an explicit statement that the indicated MU is an expanded
uncertainty, together with a statement of the confidence level and
an indication that the MU has been estimated in accordance with
ISO 19036. For example:

“The reported expanded measurement uncertainty has been

estimated in accordance with ISO 19036 and is based on a standard
uncertainty multiplied by a coverage factor of k = 2, providing a
level of confidence of approximately 95 %.”
REPORTING MEASURMENT UNCERTAINTY
Reporting Option b) Reproducibility SD alone:
If the MU is based on reproducibility standard deviation alone, this
shall be made clear in the test report. For example:

“The reported expanded measurement uncertainty has been

estimated in accordance with ISO 19036 and is based on a standard
uncertainty multiplied by a coverage factor of k = 2, providing a
level of confidence of approximately 95 %. Combined standard
uncertainty has been taken as equal to the intralaboratory
reproducibility standard deviation.”
REPORTING MEASURMENT UNCERTAINTY
Three options to express MU in test report:
Using log 10 scale:
• Option 1: log 10 result ± U:
y ± U log 10 cfu/g, e.g. 2.00 ± 0.1 log 10 cfu/g
• Option 2: log 10 result with limits:
y log 10 cfu/g [y - U; y + U], e.g. 2.00 log 10 cfu/g [1.9 ; 2.1]

Using natural values (anti-log):

• Option 3: Natural result value with limits:
x cfu/g [10 y – U; 10 y + U], e.g. 100 cfu/g [79 ; 126]
RESOURCES
✓ ISO 7218 MPN calculator to determine u MPN :
https://standards.iso.org/iso/7218/
MPN calculation Excel programm_ver5.xls (live.com)

✓ ISO 19036 Excel spreadsheet calculator:

ISO 19036 Estimation of measurement uncertainty for quantitative
determinations
ISO-19036_calculation tool_V_24-01-2020.xlsx (live.com)

✓ Matrix uncertainty values:

Matrix Uncertainty (MaU) values | EURL (anses.fr)
Matrix uncertainty EURL database (anses.fr)
CALCULATIONS EXCEL TOOL
Excel tool implementing the calculations of ISO 19036 (2019):
✓ Developed by Campden BRI (UK)
✓ Verified by WG 2 of ISO/TC 34/SC 9
✓ Freely available (See resources)
✓ Refer to the 1st worksheet “Read me” for the instructions
CALCULATIONS EXCEL TOOL
2nd worksheet “Reproducibility”:
✓ Calculates the intralaboratory reproducibility standard deviation
(s IR ).
= 1 st option to estimate the technical uncertainty
✓ Enter in column A laboratory sample identifiers and in column B
the results of the experimental study on technical uncertainty
(5.2.2 in ISO 19036).
3rd worksheet “Repeatability”:
✓ Calculates the repeatability standard deviation
= to estimate the matrix uncertainty
✓ Enter in column A laboratory sample identifiers and in column B
the results of the experimental study on matrix uncertainty (6.3).
CALCULATIONS EXCEL TOOL
4th worksheet “Combined”:
✓ Calculates the expanded uncertainty (MU).
✓ To associate MU to results obtained by the laboratory, enter in column A
laboratory sample identifiers and in column B the results of samples
analysed by the laboratory.
✓ Enter in column E technical uncertainty: s IR from worksheet
“Reproducibility”
or interlaboratory standard deviation from method validation (5.2.3.1)
or from PT (5.2.3.2)
Optional:
✓ Enter in column F matrix uncertainty from worksheet “Repeatability”.
✓ Enter in columns G-Q data for distributional uncertainties, depending
on the technique: CCT with/without partial confirmation, MPN.
THANK YOU