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 |
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 |
-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/ 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 |
EA-4/17 M | Position Paper on the description of scopes of accreditation of medical laboratories (uder revision) |
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 |
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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 INF | 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/ | |||
ЕА-4/21 INF ЕА-4/22 ЕА-4/23 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-G7:04/2021 | 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 G18:12/2021 | ILAC G18:12/2021 Guideline for describing Scopes of Accreditation | ||
| ILAC-G19:06/2022 | ILAC G19:06/2022 Modules in a Forensic Science Process | ||
| 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 | ||
| 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 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 |
-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
