Akreditimi
Dokumentet e detyrueshme për përdorim në laboratorët e testimit, laboratorët e kalibrimit, laboratorët mjekësorë nga NIVELI 3 janë MKS EN ISO / IEC 17025: 2018 dhe MKS EN ISO 15189: 2022
Dokumentet e detyrueshme nga NIVELI 4 janë MKS EN ISO 15195: 2019 (për laboratorët për kalibrimin në mjekësinë laboratorike) dhe MKS EN ISO 22870: 2016 (për laboratorët mjekësorë që kërkojnë zgjerimin e fushës së ekzaminimit pranë ose në afërsi të pacientit (POCT – point of care testing) – Requirements for quality and competence.
ISO 22870:2006 (POCT – testimi i pikës së kujdesit) – Kërkesat për cilësi dhe kompetencë u tërhoqën në 12.2022 dhe janë të vlefshme deri më 12.2025.
Dokumentet e detyrueshme të IARMV
IARMV Р 04 Rregullore për kërkesat për kompetencë të organeve të vlerësimit të konformitetit
IARMV Р 05 Rregullore për përdorimin e shenjës për akreditim, thirrje për akreditimin dhe thirrje për statusin e IARM si nënshkrues
IARMV Р 06 Rregullore për kërkesat për pjesëmarrje në testimin e aftësimit dhe në krahasimet ndërlaboratorike
IARМV Р 11 Rregullore për mënyrën e sigurimit të gjurmueshmërisë matëse në RM
IARMV Р 15 Rregullore për përcaktimin e fushave të kalibrimit, testimit, certifikimit dhe inspektimit (P15)
Dokumentet e detyrueshmepër anëtarët të EA
IARMV (FO 05-14) Zona dhe diapazoni i akreditimit të organeve oër vlerësimin e konformitetit
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 |
Dokumentet e detyrueshme për anëtarët e EA, nënshkruesit e marrëveshjeve ILAC
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 DOKUMENTET PËR PËRDORIM NË LABORATORËT PËR TESTIM, LABORATORËT E KALIBRIMIT, LABORATORËT MJEKËSORË
–EA, ILAC Dokumentet e detyrueshme për aplikim në laboratorët e testimit, laboratorët e kalibrimit, laboratorët mjekësorë
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 Dokumentet këshillimore dhe informative për aplikim në laboratorët e testimit, laboratorët e kalibrimit dhe laboratorët mjekësorë
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-4/18 INF | Guidance on the level and frequency of proficiency testing participation https://european-accreditation.org/publications/ea-4-18-inf/ | ||
EA-4/20 | Водич за нивото и честотата на учеството во тестирање на оспособеноста | ||
ЕА-4/21 INF
EA -4/23 INF
ILAC-R4 |
Guidance for the Assessment of Laboratories against EN ISO 15189 and 22870
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-G7:04/2021 | 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-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 INFORMACIONE DHE DOKUMENTE PËR APLIKIM NË LABORATORËT E KALIBRIMIT 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 Rekomandimhttps://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 |
Shpjegimi i disa shkurtesave:
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