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Uso das Normas NBR ISO/IEC 17025 e NBR NM ISO 15189 Quais so as diferenas e aplicaes?
IN n34, JULHO/2011
Pargrafo nico. Os laboratrios que no atenderem ao prazo estabelecido no caput deste artigo tero o credenciamento de suas determinaes analticas ou ensaios suspenso. Art. 34. As determinaes analticas ou ensaios somente continuaro credenciados junto ao MAPA enquanto sua acreditao na Norma ABNT NBR ISO IEC 17.025 se mantiver vlida e ativa junto ao Inmetro.
Requisitos Tcnicos
Equipamentos, padres, controle ambiental, mtodos, garantia da qualidade, relatrios, rastreabilidade, amostragem, manuseio itens de ensaios, pessoal.
Dificuldades
14
Paper: ANALYSIS OF NON CONFORMITIES OF TESTING AND CALIBRATION LABORATORIES, HIGHLIGHTED IN ASSESSMENTS FOR RECOGNITION BY REDE METROLGICA RS.
In: Metrologia2011. Metrology as Factor of Quality, Innovation and Competitiveness. Natal/RN Set/2011
Dmaris Felzke da Rosa (UFSM) Morgana Pizzolato (UFSM) Filipe Albano (RMRS) Tatiane Sartori (UFSM)
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Coletados dados referentes s avaliaes de laboratrios realizadas em 2008 e 2009; Avaliaes conduzidas pelos avaliadores da RMRS
Avaliaes realizadas com base nos requisitos da ABNT NBR ISO/IEC 17025: 2005
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Laboratrios de ensaio
5 reas
ensaios qumicos e fsico-qumicos; ensaios microbiolgicos; ensaios biolgicos e toxicolgicos; ensaios mecnicos e ensaios bioqumicos;
93 laboratrios de ensaio; Ensaios qumicos e fsico-qumicos e microbiolgicos apresentam maior percentual de laboratrios de ensaios avaliados; 190 no conformidades gerenciais; 332 no conformidades tcnicos.
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Percentual de no conformidades
Registros
14 12 10 8 6 4 2 0 % NC 4.13.2 15,3 4.13 6,8 4.2 4,2 4.3 4,2 4.12 3,7 4.3.1 3,7 4.6 3,7 4.6.2 3,7
AP
Aquisio
18
Rastreabilidade
Percentual de no conformidades
Cond. Ambiental
5.9.1 6,6
5.3 6,0
5.9.2 5,7
5.4 5,1
5.5.2 4,8
5.8 4,8
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Percentage of nonconformities
4.13.2 5,6
5.6 5,4
5.4.1 4,4
5.9.1 4,2
5.3 3,8
5.9.2 3,6
5.4 3,3
20
... Depois de um determinado perodo ... 2reao Incio da motivao ( realmente possvel)
Resultado ...
Lab de nvel internacional !
No se iludam ...
No se iludam ... durante a busca pela qualidade ... problemas difceis vo aparecer, ... ... mas isso um desafio e vocs so suficientemente competentes para superar os obstculos !
fundamental:
Apoio da Alta Direo; Comprometimento; Treinamento; Aprimoramento; Aceitar a cultura da qualidade, a 17025/BPL e fazer as coisas acontecerem!
Laboratrios Reconhecidos
Dados CGCRE-INMETRO
Laboratrios
Fonte: Coutinho. Processo de Acreditao e Requisitos gerais para a competncia de Laboratrios de Ensaio e Calibrao. Maio, 2012.
A2LA - USA
Zima, Tom . Accreditation in clinical laboratories Special issue: Quality in laboratory diagnostics: from theory to practice Accreditation in clinical laboratories. Biochemia Medica 2010. 20(2):215-20.
United Kingdom: CPA/UKAS partnership developed in 1996 and CPA standards were incorporating ISO 15189 requirements and the future development of accreditation consider the use of ISO 15189. Netherlands: The first Guidance document about quality was published in 1991 and the experts set the specific Accreditation Body for Medical Laboratories CCKL in 1994. This body became as a division (of health) of national accreditation body in the Netherlands in 2008. The process of accreditation is voluntary, but more then 90% of clinical chemistry labs are accredited. Germany: Quality assessment of quantitative measurements in medical laboratories has been regulated by the directive of German Federal Medical Board since 1971. In the most recent edition of RiLiBAK a new chapter has been added that prescribes quality requirements on the basis ISO 15189. Three accreditation bodies will be joint together based on EU rules that one country has only one national accreditation body. Accreditation is still performed voluntarily and around 20% of labs are accredited (4).
Sweden: Quality system management was implemented from 1989 (ISO Guide 25, EN 45001, ISO 17025 and 15189). Accreditation is on voluntary basis but it is the key part for health care insurance companies for the contract and reimbursement of expenses for health care. Belgium: Clinical laboratories must be licensed by Ministry of Health and quality manual was adopted in the royal decree in 1999. There is close cooperation between professional society and BELAC (National Accreditation Body). A mandatory quality system based on the requirements of ISO 15189 but no formal accreditation is required. Formal accreditation becomes more and more conditional for reimbursement of laboratory tests. France: According the decision of Ministry of Health all clinical labs must be accredited (ISO 15189) by COFRAC (National Accreditation Body) to the end of 2010.