Accreditation of
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 A-АB | 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 |
EA 2/13 M | EA Cross Border Accreditation Policy and Procedure for Cross Border Cooperation between EA Members |
EA-2/15 M | EA Requirements for the Accreditation of Flexible Scopes |
EA-2/17 M | EA Document on Accreditation for Notification purposes |
EA-3/01 M | EA conditions for the use of accreditation symbols, text reference to accreditation and MLA signatory status |
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-R7 M | Rules for the Use of the ILAC MRA Mark |
ILAC G21 M | Cross frontier accreditation – principles for avoiding duplication |
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 |
EA-4/17 M | Position Paper on the description of scopes of accreditation of medical laboratories |
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 |
ILAC-P9 M | ILAC policy for participation in national and international proficiency testing activities |
ILAC P10 M | ILAC Policy on the Traceability of Measurement Results |
ILAC-P13 M | Application of ISO/IEC 17011 for the Accreditation of Proficiency Testing Providers |
ILAC P14 M | ILAC Policy for Uncertainty in Calibration |
EA, ILAC Advisory and guidance documents for application in testing, calibration and medical laboratories
EA-2/18 INF |
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EA-4/09 G | Accreditation For Sensory Testing Laboratories | ||
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 | ||
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 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 | ||
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 G18:12/2021 | ILAC G18:12/2021 Guideline for describing Scopes of Accreditation | ||
ILAC-G19:06/2022 | |||
ILAC-G24:2022 | ILAC G24:2022 Guidelines for the determination of calibration intervals of measuring equipment | ||
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 Joint Committee for Guides in Metrology https://www.bipm.org/en/committees/jc/jcgm/ International Organization of Legal Metrology Recommendationshttps://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 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 |
