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Review of 2022 version ISO 15189 draft

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 Dispositifs médicaux de diagnostic in AFNOR/S94C
vitro et laboratoires de biologie
médicale
Date : Numéro du document:
24/11/2021 PR NF EN ISO 15189

Mes commentaires
sur le document suivant :

PR NF EN ISO 15189 Laboratoires de biologie médicale -

Exigences concernant la qualité et la compétence
Début Clôture de la
consultation:
28/10/2021 consultation :
10/12/2021

Ma position : opposition

It is basically very important to be more accurate on all statistical process control issues (IQC and
EQA results management ). It is also very important to have a realistic approach with uncertainty of
measurement estimation issues

page 1 / 3
Commentaires sur la version anglaise classés par paragraphe Date : 24/11/2021
Paragraphe
Type
Répondant Ligne Clause figure/alinéa Commentaire
(te/ed/ge)
tableau/note
415980 6.4.3 About equipment acceptance
testing : equipment used for
measurement shall be capable of
achieving the measurement
accuracy AND/OR measurement
uncertainty (UM) to provide a valid
result : it means that UM is not a
mandatory to respect for equipment
acceptance testing which is not on
line with 7.2.4 chapter content about
UM of measured quantity values
Projet : PR NF EN ISO 15189
Décisions et
Proposition
commentaires
these chapters are interesting insofar as there
is a return to the concepts of the 2007 version
of the ISO 15189 standard: no need to define
specifications in measurement uncertainty
(UM) even if it is necessary to define them! It
is a realistic use of UM for which there is no
estimation method which unanimously
agrees!
Long live the return to the 2007 version: UM
yes ! but without getting stuck on notions of
specifications in the matter to be respected

415980 3 No definition of the term "trend" Define the term "ternd" especially for
which appears later in the text quantitative methods (see comment for the
(7.2.7.1) definition)
It is fundamental to define the term
"trend"
In quality engineering (Bibliography
: "Introduction to statistical quality
control" Douglas C Montgomery
Wiley books), the term trend
corresponds to a PERSISTENT
increase of the variance (increase
of random error) of the methods
AND/OR to a PERSISTENT off-
center (increase of systematic error)
of the methods

Type de commentaire : te = technique ed = éditorial (rédactionnel) ge = général page 2 / 3

View publication stats
Paragraphe
Type
Répondant Ligne Clause figure/alinéa Commentaire
(te/ed/ge)
tableau/note
415980 3.11 About IQC definition : the sentence
".. to check that the system is
working correctly and which gives
confidence ..." is a lot TOO
SIBYLLINE mainly for quantitative
methods
By remaining also generic in this
IQC definition, it leaves people with
a deep miss understanding of
statistical process control goals of
IQC plans
415980 7.2.7.4 It is fundamental to specify that one
of the criteria for choosing an EQA
organization is its ability to provide
REAL patient samples taken from
patients with documented
pathologies / hemophilia, von
Willebrand's disease ... with
therefore respect of the concept of
commutability refuted (legitimately)
on the IQC
Type de commentaire : te = technique ed = éditorial (rédactionnel) ge = général
Décisions et
Proposition
commentaires
For quantitative methods, a IQC plan aims to
identify 2 issues :
1: a sudden TRANSIENT loss of methods
control with an immediate impact on patient
care
2: trends (both types): PERSISTENT increase
in random error (drift on the inter assay SD)
and/or systematic error (drift on the target
value of control charts)
To add another NOTE :
It is FUNDAMENTAL to point out that it is
possible to make a comparison on EQA
returns with regard to the conditions on the
EQA organization mentioned in the comment
section (I add it is not obvious to find real
patients samples with all the upstream pre
analytical issues to manage)
page 3 / 3