ECA ILAC G26 : 2012
Current
The latest, up-to-date edition.
GUIDANCE FOR THE IMPLEMENTATION OF A MEDICAL LABORATORY ACCREDITATION SYSTEM
12-01-2013
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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