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ECA ILAC G26 : 2012

Current
Current

The latest, up-to-date edition.

GUIDANCE FOR THE IMPLEMENTATION OF A MEDICAL LABORATORY ACCREDITATION SYSTEM
Published date

01-12-2013

Publisher

European Co-operation for Accreditation

PREAMBLE
PURPOSE
AUTHORSHIP
1 ISO 15189 and Medical Laboratories
2 Unique Elements of ISO 15189
3 Development and Maintenance of Accreditation
  Programs
4 Factors for Accreditation Bodies to Consider
  When Implementing an ILAC Accreditation System
  for Medical Laboratories using ISO 15189
5 Companion Documents
6 Assessment Teams
7 Scope of Accreditation
ANNEX A - Key Differences Between ISO 15189:2007
          and ISO/IEC 17025:2005
REFERENCES

Describes key aspects of the standard, points out its unique elements and gives advice for the development and maintenance of an accreditation program that is based on ISO 15189.

DocumentType
Standard
PublisherName
European Co-operation for Accreditation
Status
Current

ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
ISO 22870:2016 Point-of-care testing (POCT) — Requirements for quality and competence
ECA ILAC P9 : 2014 ILAC POLICY FOR PARTICIPATION IN PROFICIENCY TESTING ACTIVITIES
ISO 15189:2012 Medical laboratories — Requirements for quality and competence
ECA 4-17 : 2008 EA POSITION PAPER ON THE DESCRIPTION OF SCOPES OF ACCREDITATION OF MEDICAL LABORATORIES
ECA ILAC G22 : 2004 USE OF PROFICIENCY TESTING AS A TOOL FOR ACCREDITATION IN TESTING
ECA ILAC G11 : 2006 GUIDELINES ON QUALIFICATIONS AND COMPETENCE OF ASSESSORS AND TECHNICAL EXPERTS
ECA ILAC G18 : 2010 GUIDELINE FOR THE FORMULATION OF SCOPES OF ACCREDITATION FOR LABORATORIES
ISO 15190:2003 Medical laboratories Requirements for safety
ISO/IEC 17043:2010 Conformity assessment — General requirements for proficiency testing
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
ECA ILAC P10 : 2013 ILAC POLICY ON TRACEABILITY OF MEASUREMENT RESULTS

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