АКРЕДИТАЦИЈА НА ЛАБОРАТОРИИ ЗА ТЕСТИРАЊЕ, КАЛИБРАЦИЈА И МЕДИЦИНСКИ ЛАБОРАТОРИИ 

Задолжителни документи за примена во лаборатории за тестирање, лаборатории за калибрација, медицински лаборатории од НИВО 3 се МКС EN ISO/IEC 17025:2018 и МКС EN ISO 15189:2013

 

Задолжителни документи од НИВО 4 се МКС EN ISO 15195:2019 (за лаборатории за калибрација во лабораториската медицина) и МКС EN ISO 22870:2016 (за медицински лаборатории кои бараат проширување на опсегот за испитување покрај или во близина на пациентот (POCT – point of care testing)

 

Задолжителни ИАРСМ документи:

 

ИАРСМ Р 04        Правилник за општите барања за компетентност на телата за оцена на сообразност

ИАРСМ Р 05        Правилник за барањата при повикување на акредитацијата и употреба на знакот за акредитација

ИАРСМ Р 06       Правилник за барањата за учество во тестирања на оспособеност и меѓулабораториски споредби

ИАРСМ Р 11       Правилник за начинот за обезбедување на мерната следливост во Република Македонија

ИАРСМ Р 15        Правилник за определување на подрачја за области на калибрација, тестирање, инспекција и

                               сертификација

ИАРСМ ПР 05 14 Подрачје и опсег на акредитација на телата за оцена на сообразност

 

Задолжителни документи за ЕА членките

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/

Задолжителни документи за ЕА членки, потписници на ILAC договорите

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 ДОКУМЕНТИ ЗА ПРИМЕНА ВО ЛАБОРАТОРИИ ЗА ТЕСТИРАЊЕ, ЛАБОРАТОРИИ ЗА КАЛИБРАЦИЈА, МЕДИЦИНСКИ ЛАБОРАТОРИИ

 

EA, ILAC Задолжителни документи за примена во лаборатории за тестирање, лаборатории за калибрација, медицински лаборатории

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 (uder revision)

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 Советодавни и информативни документи за примена во лаборатории за тестирање, лаборатории за калибрација и медицински лаборатории

 

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

Aide –Mémoire for environmental conditions and treatment of biological models

EURACHEM TA

 

 

 

BIPM, OIML I EURAMET

 

BIPM 

 

 

 

 

BIPM 

 

KCDB    

 

 

JCGM  

 

 

OIML

 

OIML 

 

 

 

 

OIML 

 

 

EURAMET 

Guidance on Accreditation of Microbiological Laboratories

 

 

 

ИНФОРМАЦИИ И ДОКУМЕНТИ ЗА ПРИМЕНА ВО ЛАБОРАТОРИИ ЗА КАЛИБРАЦИЈА

 

 

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/

 

 

  

Објаснување на некои кратенки:

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