Accreditation of laboratories

ACCREDITATION OF LABORATORIES FOR TESTING, CALIBRATION AND MEDICAL LABORATORIES

 

Mandatory documents for use in testing laboratories, calibration laboratories, medical laboratories of LEVEL 3 are МКС EN ISO/IEC 17025: 2018 and МКС EN ISO 15189: 2013

 

 

Mandatory documents of LEVEL 4 are МКС EN ISO 15195:2019 (for calibration laboratories in laboratory medicine) and МКС EN ISO 22870:2016 (for medicine laboratories applying for extension of scope for point of care testing (POCT)

 

Mandatory IARNM documents:

 

IARNM R04             Regulation on the General Requirements for the Competence of the Conformity Assessment Bodies

IARNM R05             Regulation on Requirements for Reference to Accreditation and the Use of the Accreditation mark

IARNM R06             Regulation on Requirements for Participation on Proficiency Testing and Interlaboratory Comparisons

IARNM R11             Regulation on Ensuring Manner of Measurement Traceability in the Republic of Macedonia

IARNM R15             Regulation for determining the scope of calibration, testing, certification and inspection

 

IARNM PR05 14     Field and Scope of Accreditation of Conformity Assessment Bodies

Members’ procedural document – Mandatory

EA-1/06 AB

Multilateral Agreement. Criteria for signing. Policy and procedures for development.

https://european-accreditation.org/publications/ea-1-06-a-ab/

EA1/22 А

EA procedure and criteria for the evaluation of conformity assessment schemes by EA accreditation Body Members

https://european-accreditation.org/publications/ea-1-22-a/

EA 2/13 M

EA Cross Border Accreditation Policy and Procedure for Cross Border Cooperation between EA Members 

https://european-accreditation.org/publications/ea-2-13-m/

EA-2/15 M

EA Requirements for the Accreditation of Flexible Scopes

https://european-accreditation.org/publications/ea-2-15-m/

EA-2/17 M

EA Document on Accreditation for Notification purposes

https://european-accreditation.org/publications/ea-2-17-m/

EA-3/01 M

EA conditions for the use of accreditation symbols, text reference to accreditation and MLA signatory status

https://european-accreditation.org/publications/ea-3-01-m/

 

Mandatory documents for EA members, signatories of ILAC agreements

ILAC-P8 M

 

 

ILAC P9 M

 

                                  

ILAC Mutual Recognition Arrangement (Arrangement): Supplementary Requirements and Guidelines for the Use of Accreditation Symbols and for Claims of Accreditation Status by Accredited Laboratories

https://european-accreditation.org/publications/ilac-p8-m/
ILAC Policy for participation in national and international proficiency testing activities

https://european-accreditation.org/publications/ilac-p9-m/

ILAC-R7 M

 

Rules for the Use of the ILAC MRA Mark

https://european-accreditation.org/publications/ilac-r7-m/

ILAC G21 M

Cross frontier accreditation - principles for avoiding duplication

https://european-accreditation.org/publications/ilac-g21-m/

 

EA, ILAC DOCUMENTS FOR APPLICATION TO TESTING, CALIBRATION AND MEDICAL LABORATORIES

EA, ILAC Required Documents for Testing, Calibration and Medical Laboratories (Mandatory)

EA-4/02 M

Evaluation of the Uncertainty of Measurement in Calibration

https://european-accreditation.org/publications/ea-4-02-m/

EA-4/17 M

Position Paper on the description of scopes of accreditation of medical laboratories

https://european-accreditation.org/publications/ea-4-17-m/

ILAC-P8 M

ILAC Mutual Recognition Arrangement (Arrangement): Supplementary Requirements and Guidelines for the Use of Accreditation Symbols and for Claims of Accreditation Status by Accredited Laboratories

https://european-accreditation.org/publications/ilac-p8-m/

ILAC-P9 M

ILAC policy for participation in national and international proficiency testing activities

https://european-accreditation.org/publications/ilac-p9-m/

ILAC P10 M

ILAC Policy on the Traceability of Measurement Results

https://european-accreditation.org/publications/ilac-p10-m/

ILAC-P13 M

Application of ISO/IEC 17011 for the Accreditation of Proficiency Testing Providers

https://european-accreditation.org/publications/ilac-p13-m/

ILAC P14 M

ILAC Policy for Uncertainty in Calibration

https://european-accreditation.org/publications/ilac-p14-m/

 

EA, ILAC Advisory and guidance documents for application in testing, calibration and medical laboratories

 

EA-2/18 INF

 

Guidelines for Accreditation Bodies on the content of the scopes of accreditation for proficiency testing providers

https://european-accreditation.org/publications/ea-2-18-inf/

EA-4/09 G

Accreditation For Sensory Testing Laboratories

https://european-accreditation.org/publications/ea-4-09-g/

EA-4/14 INF

Selection and Use of Reference Materials

https://european-accreditation.org/publications/ea-4-14-inf/

EA-4/16 G

EA guidelines on the expression of uncertainty in quantitative testing

https://european-accreditation.org/publications/ea-4-16-g/

EA-4/18 INF

Guidance on the level and frequency of proficiency testing participation

https://european-accreditation.org/publications/ea-4-18-inf/

EA-4/18: 2010

 

 

EA-4/20

 

 

ЕА-4/21 INF            

 

 

 

EA-4/22 G

 

 

 

EA-4/23 INF

 

 

 

ILAC-R4                        

Советодавен документ EA-4/18: 2010, превод на македонски јазик

Водич за нивото и честотата на учеството во тестирање на оспособеноста

 

Guidance for the Assessment of Laboratories against EN ISO 15189 and 22870 (under revision)

https://european-accreditation.org/publications/ea-4-20-g/

 

Guidelines for the assessment of the appropriateness of small interlaboratory comparisons within the process of laboratory accreditation

https://european-accreditation.org/publications/ea-4_21-inf/

 

EA Guidance on Accreditation of Pesticide Residues Analysis in Food and Feed

https://european-accreditation.org/publications/ea-4-22-g/

 

 

The Assessment and Accreditation of Opinions and Interpretations using ISO/IEC 17025:2017

https://european-accreditation.org/publications/ea-4-23-inf/

 

 

Use of the ILAC logo and tagline

https://european-accreditation.org/publications/ilac-r4/

 

ILAC-G7:02/2016

 

ILAC G7:02/2016Accreditation Requirements and Operating Criteria for Horseracing Laboratories 

ILAC-G8:03/2009

LAC G8:03/2009 Guidelines on the Reporting of Compliance with Specification

ILAC-G17:2002

ILAC G17:2002 Introducing the Concept of Uncertainty of Measurement in Testing in Association with the Application of the Standard ISO/IEC 17025 – under revision

ILAC G18 G

ILAC G18:04/2010 Guideline for the Formulation of Scopes of Accreditation for Laboratories – under revision

ILAC-G19:08/2014

ILAC G19:08/2014 Modules in a Forensic Science Process

ILAC-G24:2007

ILAC G24:2007 Guidelines for the determination of calibration intervals of measuring instruments – under revision

ILAC-G26:07/2012

ILAC G26:11/2018 Guidance for the Implementation of a Medical Accreditation Scheme  

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

EURACHEM   TA

Aide –Mémoire for environmental conditions and treatment of biological models

Gudance on Accreditation of Microbiological Laboratories

BIPM, OIMIL I EURAMET' s documents for Calibration Laboratories

 

BIPM 

 

 

 

 

BIPM 

 

KCDB    

 

JCGM  

 

 

OIML

 

OIML 

 

 

 

 

OIML 

 

 

EURAMET 

 

 

 

 

International Bureau of Weights and Measures

https://www.bipm.org/en/about-us/

The International System of Units (SI)

https://www.bipm.org/en/measurement-units/

 

Publications

https://www.bipm.org/en/publications/

The BIPM key comparison database

https://kcdb.bipm.org/

Joint Committee for Guides in Metrology

https://www.bipm.org/en/committees/jc/jcgm/

 

International Organization of Legal Metrology 

https://www.oiml.org/en

Recommendations

https://www.oiml.org/en/publications/recommendations/publication_view?p_type=1&;p_status=1

Documents

https://www.oiml.org/en/publications/documents/publication_view?p_type=2&;p_status=1

 

Guides

https://www.oiml.org/en/publications/guides/publication_view?p_type=3&;p_status=1

 

https://www.euramet.org/

 

Guides & Publications  

https://www.euramet.org/publications-media-centre/

 

Explanations of 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