Publication of ISO 15189:2022

Publication of ISO 15189:2022

The new version of ISO 15189, the international standard for Medical laboratories — Requirements for quality and competence, was published on 06 December 2022. A copy of this standard is available for purchase at Toppan Leefung Pte Ltd.
Accredited medical laboratories and medical imaging facilities are encouraged to purchase a copy to understand the changes and opt for an early transition to this revised standard.

SAC’s Transition Policy

The Singapore Accreditation Council (SAC) has adopted ILAC’s recommendation to give accredited laboratories and medical imaging facilities a 3-year transition period. Laboratories who are not accredited to ISO 15189: 2022 standard after 31 December 2025 will not be allowed to issue SAC-accredited reports.

• With effect from 01 January 2024, assessment for applicant laboratories and medical imagining facilities will be based on ISO 15189: 2022.

• With effect from 01 January 2024, all assessments for existing accredited medical laboratories and medical imaging facilities shall be based on ISO 15189: 2022.

• SAC will issue a new Certificate of Accreditation to the laboratory upon successful transition.

• Medical laboratories and medical imaging facilities who are not accredited to ISO 15189: 2022 by 31 December 2025 will not be allowed to issue accredited reports and will be suspended by SAC.

Please contact your SAC Account Manager for further information on the transition arrangements.