Accreditation of laboratories

LABORATORIES ACCREDITATION FOR TESTING, CALIBRATION AND MEDICAL LABORATORIES

Mandatory documents for application in testing, calibration laboratories and medical laboratories, [МКС EN ISO/IEC 17025: 2006], [МКС EN ISO 15189:2013 (МКС ISO 15189:2010) ]
 
IARM R04 Regulation on the General Requirements for the Competence of the Conformity Assessment Bodies
IARM R05 Regulation on Requirements for Reference to Accreditation and the Use of the Accreditation mark
IARM R06 Regulation on Requirements for Participation on Proficiency Testing and Interlaboratory Comparisons
IARM R11 Regulation on Ensuring Manner of Measurement Traceability in the Republic of Macedonia

Members’ procedural document – Mandatory

EA1/22
(rev.01)
EA policy for Conformity Assessment Schemes (Sector schemes) http://www.european-accreditation.org/publication/ea-1-22-a-ab
EA 2/13 M
(rev.01)
EA Cross Border Accreditation Policy and Procedure for Cross Border Cooperation between EA Members http://www.european-accreditation.org/publication/ea-2-13-m
EA2/13 Transitory M
(rev.00)
EA Cross Border Accreditation Policy and Procedure for Cross Border Cooperation between EA Members
EA 2/13 M S1
(rev.00)
Interpretation of Terminology in clause 5.1 of EA-2.13
EA-2/14 M
(rev.00)
Procedure for Regional Calibration ILCs in Support of the EA MLA
EA-2/15 M
(rev.00)
EA Requirements for the Accreditation of Flexible Scopes
EA-2/17 M
(rev.01)
EA Guidance on the horizontal requirements for the accreditation of conformity assessment bodies for notification purposes
EA-3/01 M
(rev.03)
EA conditions for the use of accreditation symbols, text reference to accreditation and MLA signatory status

Applicable to EA members signatories to ILAC Arrangement

ILAC-P8
ILAC Mutual Recognition Arrangement (Arrangement): Supplementary Requirements and Guidelines for the Use of Accreditation Symbols and for Claims of Accreditation Status by Accredited Laboratories
ILAC-R7:09/2009
Rules for the Use of the ILAC MRA Mark
ILAC G21:09/2012
Cross Frontier Accreditation – Principles for Cooperation

EA and ILAC's documents for application in testing laboratories, calibration laboratories and medical laboratories

EA-2/09 INF
(rev.00)
EA Policy on the Accreditation of the Providers of Proficiency Testing Schemes
EA-3/04 G
(rev.01)
Use of Proficiency Testing as a Tool for Accreditation in Testing (with EUROLAB and EURACHEM). Reinstated according to EA Resolution 2012(29)24
EA-4/02 M
(rev.00)
Expressions of the Uncertainty of Measurements in Calibration (including supplement 1 to EA-4/02) (previously EAL- R2)
EA-4/09 G
(rev.01)
Accreditation for Sensory Testing Laboratories (previously EAL-G16)
EA-4/10 G
(rev.02)
Accreditation for Laboratories Performing Microbiological Testing (previously EAL G18)
EA-4/14 INF
(rev.00)
Selection and Use of Reference Materials
EA-4/15 G
(rev.00)
Accreditation for Bodies Performing non-Destructive Testing
EA-4/16 G
(rev.00)
EA Guidelines on the Expression of Uncertainty in Quantitative testing
EA-4/17 M
(rev.00)
Position Paper on the description of scopes of accreditation of medical laboratories
EA-4/18 TA
(rev.00)
Guidance on the level and frequency of proficiency testing participation
EA-4/18: 2010
Советодавен документ EA-4/18: 2010, превод на македонски јазик
ILAC-G7:06/2009
Accreditation Requirements and Operating Criteria for Horseracing Laboratories
ILAC-G8:03/2009
Guidelines on the Reporting of Compliance with Specification
ILAC-G9:2005
Guidelines for the Selection and Use of Reference Materials
ILAC-G12:2000
Guidelines for the Requirements for the Competence of Reference Materials Producers
ILAC-G17:2002
Introducing the Concept of Uncertainty of Measurement in Testing in Association with the Application of the Standard ISO/IEC 17025
ILAC-G18:04/2010
Guideline for the Formulation of Scopes of Accreditation for Laboratories
ILAC-G19:2002
Guidelines for Forensic Science Laboratories
ILAC-G24:2007
Guidelines for the determination of calibration intervals of measuring instruments
ILAC-G26:07/2012
Guidance for the Implementation of a Medical Laboratory Accreditation System
ILAC-P8:12/2012
ILAC Mutual Recognition Arrangement (Arrangement): Supplementary Requirements and Guidelines for the Use of Accreditation Symbols and for Claims of Accreditation Status by Accredited Laboratories
ILAC-P9:11/2010
ILAC Policy for Participation in National and International Proficiency Testing Activities
ILAC P10:01/2013
ILAC Policy on the Traceability of Measurement Results
ILAC-P13:10/2010
Application of ISO/IEC 17011 for the Accreditation of Proficiency Testing Providers
ILAC P14:01/2013
ILAC Policy for Uncertainty in Calibration
   
   
CEC TA
ISO/IEC 17025 interpretation document for CEC test methods
Contact Person: Ian Bown
EDQM/OMCL TA
Validation of analytical procedures
EDQM/OMCL TA
Scope of accreditation of official medicines laboratories
EDQM/OMCL TA
Uncertainty of measurement
EWDTS TA
European Laboratory Guidelines for Legally Defensible Workplace Drug Testing
Contact Person: R. Jonsson
EWDTS TA
Drug and Alcohol Testing in Hair, Collection and Analysis
EWDTS TA
Guidelines for oral fluid
CITAC / EURACHEM TA
Guide to Quality in analytical Chemistry
EDQM/OMCL TA
Standard – Aide –Mémoire for the Mutual Joint Audit of OMCLs
EDQM/OMCL TA
Qualification of Equipment (core document)
EDQM/OMCL TA
Annex 1: Qualification of HPLC equipment
EDQM/OMCL TA
Annex 2: Qualification of GC equipment
EDQM/OMCL TA
Annex 3: Qualification of UV – visible spectrophotometers
EDQM/OMCL TA
Annex 4: Qualification of IR spectrophotometers
EDQM/OMCL TA
Aide –Mémoire for environmental conditions and treatment of biological models

BIPM, OIMIL I EURAMET' s documents for Calibration Laboratories

BIPM
GUM: Guide to the Expression of Uncertainty in Measurement (JCGM 100:2008, GUM 1995 with minor corrections)

BIPMʼs specifically documents (for Meter Convention, International system of measurement units-SI, data bases for CIPM MRA signatories, key and supplementary comparisons, calibration measurements capabilities -CMC) are available at

http://www.bipm.org/

OIMIL

V 2-200         International Vocabulary of Metrology ? Basic and General Concepts and Associated Terms (VIM). 3rd Edition 2012

V 1-               International vocabulary of terms in legal metrology (VIML) Edition 2013

G 1-100-en    Evaluation of measurement data - Guide to the expression of uncertainty in measurement (Edition 2008 Uploaded 2009-01-07)

OIMIL' s Specifically documents (recommendation and guides) for calibration are available at: http://www.oiml.org


EURAMET

EURAMETʼ s specifically documents (recommendation and guides) for calibration are available http://www.euramet.org/


Explanation of some abbreviations:

EDQM - European Directorate for the Quality of Medicine and Health Care

OMCL Official Medicines Control Laboratories - Official Medicines Control Laboratories OMCL - Official Medicines Control Laboratories

EURACHEM - Network of organisations in Europe having the objective of establishing a system for the international traceability of chemical measurements and the promotion of good quality practices

EWDTS - European Workplace Drug Testing Society

CEC - Crown Estate Commissioners

CITAC - Cooperation on International Traceability in Analytical Chemistry

CITAC - Cooperation on International Traceability in Analytical Chemistry