Акредитација на 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 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

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://ilac.org/publications-and-resources/ilac-policy-series/
ILAC Policy for participation in national and international proficiency testing activities

https://ilac.org/publications-and-resources/ilac-policy-series/

ILAC-R7 M

Rules for the Use of the ILAC MRA Mark

https://ilac.org/publications-and-resources/ilac-rules-series/

ILAC G21 M

Cross frontier accreditation – principles for avoiding duplication

https://ilac.org/publications-and-resources/ilac-guidance-series/

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://ilac.org/publications-and-resources/ilac-policy-series/

ILAC-P9 M

ILAC policy for participation in national and international proficiency testing activities

https://ilac.org/publications-and-resources/ilac-policy-series/

ILAC P10 M

ILAC Policy on the Traceability of Measurement Results

https://ilac.org/publications-and-resources/ilac-policy-series/

  

ILAC P14 M

ILAC Policy for Uncertainty in Calibration

https://ilac.org/publications-and-resources/ilac-policy-series/

-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-4/18 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

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

ILAC-G7:04/2021

ILAC G7:04/2021Accreditation Requirements and Operating Criteria for Horseracing Laboratories 

ILAC-G8:09/2019

LAC G8:09/2019 Guidelines on Decision Rules and Statements of Conformity

ILAC-G17:01:2021

ILAC G17:01/2021 ILAC Gidelines for  Measurement Uncertainty in Testing

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

  
  
  

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

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

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