EN ISO 15195:2019/prA1
(Amendment)Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures - Amendment 1 (ISO 15195:2018/DAM 1:2026)
- Status
- Not Published
- Publication Date
- 27-Apr-2028
- Technical Committee
- CEN/TC 140 - In vitro diagnostic systems
- Drafting Committee
- CEN/TC 140 - In vitro diagnostic systems
- Current Stage
- 3099 - Dispatch of ENQ draft to CMC - Consensus building
- Start Date
- 15-Jun-2026
- Completion Date
- 15-Jun-2026
EN ISO 15195:2019/prA1 is a CEN draft amendment to ISO 15195:2018 in laboratory medicine. It updates the requirements for the competence of calibration laboratories using reference measurement procedures. In practice, it is for calibration laboratories, assessors, and quality staff who apply or review ISO 15195 requirements.
What does EN ISO 15195:2019/prA1 specify?
EN ISO 15195:2019/prA1 specifies one change to the base standard ISO 15195:2018 for laboratory medicine. It amends the competence requirements for calibration laboratories that use reference measurement procedures.
The amendment is organized as a single instruction tied to subclause 6.4 of the base document. It tells the reader exactly what to change in that clause, so the updated requirement can be applied consistently alongside ISO 15195:2018.
What are the key requirements of EN ISO 15195:2019/prA1?
The amendment’s only substantive action is a deletion in subclause 6.4. EN ISO 15195:2019/prA1 removes the sentence that linked all equipment relevant to the measurements to the required measurement accuracy.
What this means in practice
For laboratories, this means the updated version of clause 6.4 should be read without that sentence. When applying or auditing ISO 15195, the focus stays on the remaining competence requirements in the base standard, while this specific equipment-accuracy statement is no longer part of subclause 6.4.
Why the change matters
This kind of amendment matters because even a single deleted sentence can change how laboratory competence is interpreted during implementation, assessment, or internal review. Anyone maintaining procedures, checklists, or conformity assessments against ISO 15195:2018 needs to apply the amendment text to avoid using superseded wording.
Who uses EN ISO 15195:2019/prA1?
EN ISO 15195:2019/prA1 is used by calibration laboratories working in laboratory medicine. It is also relevant to medical laboratory quality managers, conformity assessors, and buyers or technical reviewers who need to check whether a laboratory’s competence framework follows the amended ISO 15195 text.
The standard is relevant wherever reference measurement procedures are used to support measurement quality in laboratory medicine and related in vitro diagnostic work. In practice, users apply it when writing procedures, reviewing equipment competence statements, or auditing against the ISO 15195 base requirements.
What changed in EN ISO 15195:2019/prA1 from the previous edition?
EN ISO 15195:2019/prA1 is an amendment to ISO 15195:2018. The stated change is in subclause 6.4, third sentence, where the sentence about all relevant equipment being capable of achieving the required measurement accuracy is deleted.
Which standards are used with EN ISO 15195:2019/prA1?
EN ISO 15195:2019/prA1 is intended to be used with ISO 15195:2018, because the amendment modifies that standard rather than replacing it. The amendment applies only to the specified clause in the base document, so readers need ISO 15195:2018 to use the change in context.
What does the EN ISO 15195:2019/prA1 document contain?
EN ISO 15195:2019/prA1 contains the amendment notice, the document identification, and the specific clause instruction for the change. Its technical content is a targeted deletion in subclause 6.4 of ISO 15195:2018.
The front matter identifies the draft status and the ISO/TC 212 committee responsible for the work. It also shows that the document is part of the ISO/CEN parallel process and gives the voting period for the draft.
Relations
- Effective Date
- 03-Dec-2025
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Frequently Asked Questions
EN ISO 15195:2019/prA1 is a draft published by the European Committee for Standardization (CEN). Its full title is "Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures - Amendment 1 (ISO 15195:2018/DAM 1:2026)". This standard covers: Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures - Amendment 1 (ISO 15195:2018/DAM 1:2026)
Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures - Amendment 1 (ISO 15195:2018/DAM 1:2026)
EN ISO 15195:2019/prA1 is classified under the following ICS (International Classification for Standards) categories: 11.100.99 - Other standards related to laboratory medicine. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 15195:2019/prA1 has the following relationships with other standards: It is inter standard links to EN ISO 15195:2019. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 15195:2019/prA1 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2026
Laboratorijska medicina - Zahteve za usposobljenost kalibracijskih laboratorijev z
uporabo referenčnih merilnih postopkov - Dopolnilo 1 (ISO 15195:2018/DAM
1:2026)
Laboratory medicine - Requirements for the competence of calibration laboratories using
reference measurement procedures - Amendment 1 (ISO 15195:2018/DAM 1:2026)
Laboratoriumsmedizin - Anforderungen an die Kompetenz von Kalibrierlaboratorien mit
Referenzmessverfahren - Änderung 1 (ISO 15195:2018/DAM 1:2026)
Biologie médicale - Exigences relatives à la compétence des laboratoires d'étalonnage
utilisant des procédures de mesure de référence - Amendement 1 (ISO
15195:2018/DAM 1:2026)
Ta slovenski standard je istoveten z: EN ISO 15195:2019/prA1
ICS:
11.100.01 Laboratorijska medicina na Laboratory medicine in
splošno general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT
Amendment
ISO 15195:2018/
DAM 1
ISO/TC 212
Laboratory medicine —
Secretariat: ANSI
Requirements for the competence
of calibration laboratories using
Voting begins on:
2026-07-21
reference measurement procedures
Voting terminates on:
AMENDMENT 1 2026-10-13
Biologie médicale — Exigences relatives à la compétence des
laboratoires d'étalonnage utilisant des procédures de mesure de
référence
AMENDEMENT 1
ICS: 11.100.99
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document has not been edited by the ISO Central Secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO 15195:2018/DAM 1:2026(en)
DRAFT
ISO 15195:2018/DAM 1:2026(en)
Amendment
ISO 15195:2018/
DAM 1
ISO/TC 212
Laboratory medicine —
Secretariat: ANSI
Requirements for the competence
of calibration laboratories using
Voting begins on:
reference measurement procedures
Voting terminates on:
AMENDMENT 1
Biologie médicale — Exigences relatives à la compétence des
laboratoires d'étalonnage utilisant des procédures de mesure de
référence
AMENDEMENT 1
ICS: 11.100.99
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document has not been edited by the ISO Central Secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2026
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior writt
...