DS/EN ISO 15189:2013

Medical laboratories - Requirements for quality and competence


Status:
Current
Type:
Standard
Language:
DA;EN
Subject:
Price from:
€ 123.59
Legislation:

Legislation

Harmonized under:
  • Regulation (EC) No 765/2008 of the European Parliament and of the Council, Decision No 768/2008/EC of the European Parliament and of the Council, Regulation (EC) No 1221/2009 of the European Parliament and of the Council )

Harmonized standards:
Links

Scope

1.1 This International Standard specifies the requirements for quality and competence in medical laboratories.
1.2 This International Standard is for use by medical laboratories in developing their quality management systems and assessing their own competence. Laboratory customers, regulating authorities, and accreditation bodies may also use it for confirming or recognizing the competence of medical laboratories.
This International Standard is not intended to be used as the basis for certification of laboratories.
1.3 International, national, or regional regulations or requirements may apply to specific topics covered in this International Standard and shall be followed when applicable.


Number of pages: 120

Published: 2013-09-19

Date of approval: 2013-08-15

International relationships : EN ISO 15189:2012 IDT ISO 15189:2012 IDT

ICS: 03.120.20 - Product and company certification. Conformity assessment 11.100.01 - Laboratory medicine in general 03.120.10 - Quality management and quality assurance

Item number: M275017


Committees

Committee

  • CEN/TC 140/WG 3
  • ISO/TC 212/WG 1

Danish committee

DS/S-260