TR MINISTRY OF FOREIGN AFFAIRS
TURKISH ACCREDITATION AGENCY

Announcements

30.07.2024  Announcements
TS EN ISO 15189:2023 TÜRKAK Transition Policy Revised

The transition period for the revised TS EN ISO 15189:2023 standard, published on 06.12.2022, was initially set by ISO and ILAC to conclude in December 2025. TÜRKAK, in its policy published on 21.02.2023, had announced the final transition date as December 5, 2025.

However, following the European Commission's decision published in the Official Journal of the European Union on 16.02.2024, ISO 15189:2022 has been recognized as a harmonized standard. Consequently, the validity of the TS EN ISO 15189:2013 standard has been shortened by four months, with its withdrawal date set as August 20, 2025 (Commission Implementing Decision (EU) 2024/581 Art.02).

As a result, accredited medical laboratories that fail to complete their transition by August 20, 2025, will lose their accreditation after this date. TÜRKAK has updated its transition policy for TS EN ISO 15189:2023 accordingly:

As of January 1, 2024, all surveillance, scope expansion, or accreditation renewal assessments for TÜRKAK-accredited medical laboratories are conducted according to the TS EN ISO 15189:2023 standard, ensuring a smooth transition process.
Medical laboratories that have not transitioned their accreditation to TS EN ISO 15189:2023 by August 20, 2025, will have their accreditation under TS EN ISO 15189:2013 suspended for up to six months.
If the laboratory fails to complete the necessary steps for the transition within this suspension period, its accreditation under TS EN ISO 15189:2013 will be withdrawn, and the laboratory will need to reapply for accreditation.
This policy ensures that all accredited medical laboratories align with the updated standard in a timely manner, maintaining compliance with international and European accreditation requirements

TARİH

AKTİVİTE

Süreç

6 Aralık 2022

ISO 15189 standardı yayımlandı.

Tamamlandı

Aralık 2022-Nisan 2023

TÜRKAK tarafından geçişe yönelik hazırlıkların tamamlanması

Tamamlandı

1 Mayıs 2023

TÜRKAK tarafından TS EN ISO 15189:2023 standardına yönelik eğitim ve bilgilendirme faaliyetlerinin başlaması

Tamamlandı

1 Temmuz 2023 ve sonrası

İlk akreditasyon başvurularının sadece TS EN ISO 15189:2023 standardına göre kabul edilmesi

Tamamlandı

1 Ocak 2024 ve sonrası

Tüm ilk akreditasyon denetimlerinin TS EN ISO 15189:2023 standardına göre yapılmaya başlanması

Tamamlandı

1 Ocak 2024 ve sonrası

Tüm rutin gözetim/kapsam genişletme/akreditasyon yenileme denetimlerinin TS EN ISO 15189:2023 standardına göre yapılmaya başlanması

Tamamlandı

5 Aralık 2025

20 Ağustos 2025

TS EN ISO 15189:2023 standardına geçişin tamamlanması. Bu tarihten sonra TS EN ISO 15189:2013 versiyonuna göre verilmiş olan akreditasyon geçerli olmayacaktır.

GÜNCELLENDİ

 

Yararlı Bağlantılar:

Avrupa Komisyonu Karar Metni: https://eur-lex.europa.eu/eli/dec_impl/2024/581/oj

TÜRKAK Geçiş Politikası Duyurusu: https://www.turkak.org.tr/duyurular/iso-151892022-turkak-gecis-politikasi-yayimlandi.html