Последни новости

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 15189:2022

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) – Requirements for quality and competence.

ISO 22870:2006 (POCT – point of care testing) – Requirements for quality and competence е повлечен во 12.2022, а важи до 12.2025. Со публикувањето на новото издание на МКС EN ISO 15189:2022, вклучени се и барањата за POCT.

-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-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-4/20

Guidance for the Assessment of Laboratories against EN ISO 15189 and 22870

ЕА-4/21 INFGuidelines 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/

ЕА-4/21 INF

ЕА-4/22

ЕА-4/23 INF

Превод на македонски

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-G7:04/2021ILAC G7:04/2021Accreditation Requirements and Operating Criteria for Horseracing Laboratories 
ILAC-G8:09/2019LAC G8:09/2019 Guidelines on Decision Rules and Statements of Conformity
ILAC-G17:01:2021ILAC G17:01/2021 ILAC Gidelines for  Measurement Uncertainty in Testing
ILAC G18:12/2021ILAC G18:12/2021 Guideline for describing Scopes of Accreditation
ILAC-G19:06/2022ILAC G19:06/2022 Modules in a Forensic Science Process
ILAC-G24:2022ILAC G24:2022 Guidelines for the determination of calibration intervals of measuring equipment
ILAC-G26:07/2012ILAC G26:11/2018 Guidance for the Implementation of a Medical Accreditation Scheme
  
  
  
EDQM/OMCL TAValidation of analytical procedures
EDQM/OMCL TAScope of accreditation of official medicines laboratories
EDQM/OMCL TAUncertainty of measurement
EWDTS TAEuropean Laboratory Guidelines for Legally Defensible Workplace Drug Testing
EWDTS TADrug and Alcohol Testing in Hair, Collection and Analysis
EWDTS TAGuidelines for oral fluid
CITAC / EURACHEM TAGuide to Quality in analytical Chemistry
  
EDQM/OMCL TAQualification of Equipment (core document)
EDQM/OMCL TAAnnex 1: Qualification of HPLC equipment
EDQM/OMCL TAAnnex 2: Qualification of GC equipment
EDQM/OMCL TAAnnex 3: Qualification of UV – visible spectrophotometers
EDQM/OMCL TAAnnex 4: Qualification of IR spectrophotometers
EDQM/OMCL TAAide –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