Medical laboratories - Requirements for quality and competence (ISO 15189:2022); German version EN ISO 15189:2022+A11:2023
Abstract
This International Standard specifies requirements for the quality and competence of medical laboratories on the basis of ISO/IEC 17025 and ISO 9001. This is the consolidated version with the purely European amendment that adds Annex Z as part of the M/580 Standardization Request as regards accreditation and conformity assessment in support of Regulation (EC) No 765/2008.
Begin
2023-12-04
WI
00140165
Planned document number
DIN EN ISO 15189+A11
Project number
17600060
Responsible national committee
NA 176-08-08 AA - Quality management in medical laboratories
Responsible european committee
CEN/TC 140 - In vitro diagnostic medical devices
