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EN ISO 15189:2012

Medical laboratories - Requirements for quality and competence (ISO 15189:2012)

Status: Harmonized EN ISO 15189:2012 replaces   EN ISO 15189:2022 (Concurrent) EN ISO 15189:2007 (Canceled)
Poznámka:
Full text EAD:
Sector of EN ISO 15189:2012: NLF-EMAS | The new legislative framework and the eco-management audit scheme
Sphere of EN ISO 15189:2012: Horizontal regulations (NLF)
Publications in the Official Journal:

(EU)2024/581 (hEN 20. 2. 2024)
(EU)2020/1835 (hEN 4. 12. 2020)
(EU)2019/1729 (hEN 16. 10. 2019)
2018/C/209/2

Summary list hEN for information purposes only (27. 2. 2024)

Notified bodies (NANDO): Notified bodies for Regulation EP and Council (EC) 765/2008
ES/EU regulation ČR regulation SR regulation
Regulation EP and Council (EC) 765/2008 consolidated text
/ amendment by Regulation No (EU)2023/988 applicable from 13. December 2024
/ Commission Implementing Regulation No (EU)2021/2248 applicable from 16 December 2025
Regulation EP and Council (EC) 765/2008 consolidated text
/ amendment by Regulation No (EU)2023/988 applicable from 13. December 2024
/ Commission Implementing Regulation No (EU)2021/2248 applicable from 16 December 2025
Regulation EP and Council (EC) 765/2008 consolidated text
/ amendment by Regulation No (EU)2023/988 applicable from 13. December 2024
/ Commission Implementing Regulation No (EU)2021/2248 applicable from 16 December 2025
Decision EP and Council 768/2008/EC (aktuální znění)
Regulation EP and Council (EC) 1221/2009 consolidated text 12. 7. 2023
amendment (EU)2023/1199 does not concern en language
/ Decision Commission (EU)2023/1533
/ Decision Commission (EU)2021/2054
/ Decision Commission (EU)2021/2053
/ Decision Commission (EU)2020/519
/ Decision Commission (EU)2019/63
/ Decision Commission (EU)2019/62
/ Decision Commission (EU)2019/61
/ Decision Commission (EU)2016/1621
nařízení EP a Rady (ES) 1221/2009 consolidated text 12. 7. 2023
amendment (EU)2023/1199 does not concern en language
/ Decision Commission (EU)2023/1533
/ Decision Commission (EU)2021/2054
/ Decision Commission (EU)2021/2053
/ Decision Commission (EU)2020/519
/ Decision Commission (EU)2019/63
/ Decision Commission (EU)2019/62
/ Decision Commission (EU)2019/61
/ Decision Commission (EU)2016/1621
nariadenie EP a Rady (ES) 1221/2009 consolidated text 12. 7. 2023
amendment (EU)2023/1199 does not concern en language
/ Decision Commission (EU)2023/1533
/ Decision Commission (EU)2021/2054
/ Decision Commission (EU)2021/2053
/ Decision Commission (EU)2020/519
/ Decision Commission (EU)2019/63
/ Decision Commission (EU)2019/62
/ Decision Commission (EU)2019/61
/ Decision Commission (EU)2016/1621
Co-existence period end date: 30.11.2015 (NLF-EMAS)
Released: March, 2013

ČSN

ČSN EN ISO 15189 ed. 2:2013 replaces ČSN EN ISO 15189:2007 - Canceled ČSN EN ISO 15189 ed. 3:2023 Note to ČSN EN ISO 15189 ed. 2:2013: Nahrazena od 31.12.2025 ČSN EN ISO 15189 ed. 3 (855101) z července 2023
Změna Z1-7.23   Note to Změna Z1-7.23: Nahrazena od 31.12.2025 ČSN EN ISO 15189 ed. 3 (855101) z července 2023
Oprava 1-11.17  

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