Norma Brasileira ABNT NBR ISO/IEC 17021-1:2016 - PDF
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Instituto Nacional de Metrologia, Qualidade e Tecnologia – Inmetro
2016
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This document is a Brazilian standard (ABNT NBR ISO/IEC 17021-1:2016) on conformity assessment. It details the requirements for bodies providing audits. This standard is focused on quality management standards.
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NORMA ABNT NBR BRASILEIRA ISO/IEC 17021-1 Primeira edição...
NORMA ABNT NBR BRASILEIRA ISO/IEC 17021-1 Primeira edição 16.05.2016 Versão corrigida 12.09.2016 Avaliação da conformidade — Requisitos para organismos que fornecem auditoria HFHUWL¿FDomRGHVLVWHPDVGHJHVWmR Parte 1: Requisitos Conformity assessment — Requirements for bodies providing audit DQGFHUWL¿FDWLRQRIPDQDJHPHQWV\VWHPV Part 1: Requirements ICS 03.120.20 ISBN 978-85-07-06232-5 Número de referência ABNT NBR ISO/IEC 17021-1:2016 54 páginas © ISO/IEC 2015 - © ABNT 2016 ABNT NBR ISO/IEC 17021-1:2016 © ISO/IEC 2015 7RGRVRVGLUHLWRVUHVHUYDGRV$PHQRVTXHHVSHFL¿FDGRGHRXWURPRGRQHQKXPDSDUWHGHVWDSXEOLFDomRSRGHVHU UHSURGX]LGDRXXWLOL]DGDSRUTXDOTXHUPHLRHOHWU{QLFRRXPHFkQLFRLQFOXLQGRIRWRFySLDHPLFUR¿OPHVHPSHUPLVVmRSRU HVFULWRGD$%17~QLFRUHSUHVHQWDQWHGD,62QRWHUULWyULREUDVLOHLUR © ABNT 2016 7RGRVRVGLUHLWRVUHVHUYDGRV$PHQRVTXHHVSHFL¿FDGRGHRXWURPRGRQHQKXPDSDUWHGHVWDSXEOLFDomRSRGHVHU UHSURGX]LGDRXXWLOL]DGDSRUTXDOTXHUPHLRHOHWU{QLFRRXPHFkQLFRLQFOXLQGRIRWRFySLDHPLFUR¿OPHVHPSHUPLVVmRSRU escrito da ABNT. ABNT $Y7UH]HGH0DLRDQGDU 20031-901 - Rio de Janeiro - RJ 7HO )D[ DEQW#DEQWRUJEU ZZZDEQWRUJEU ii © ISO/IEC 2015 - © ABNT 2016 - Todos os direitos reservados ABNT NBR ISO/IEC 17021-1:2016 Sumário Página Prefácio Nacional..............................................................................................................................vii Introdução...........................................................................................................................................ix 1 Escopo................................................................................................................................1 2 Referências normativas.....................................................................................................1 7HUPRVHGH¿QLo}HV...........................................................................................................1 4 Princípios............................................................................................................................4 4.1 Generalidades.....................................................................................................................4 4.2 Imparcialidade....................................................................................................................5 4.3 Competência.......................................................................................................................6 4.4 Responsabilidade...............................................................................................................6 4.5 Transparência.....................................................................................................................6 &RQ¿GHQFLDOLGDGH..............................................................................................................6 &DSDFLGDGHGHUHVSRVWDDUHFODPDo}HV..........................................................................6 4.8 Abordagem baseada em risco..........................................................................................7 5 Requisitos gerais...............................................................................................................7 5.1 Aspectos legais e contratuais...........................................................................................7 5.1.1 Responsabilidade legal.....................................................................................................7 &RQWUDWRGHFHUWL¿FDomR....................................................................................................7 5HVSRQVDELOLGDGHSHODVGHFLV}HVGHFHUWL¿FDomR..........................................................8 5.2 Gestão da imparcialidade..................................................................................................8 5HVSRQVDELOLGDGHFLYLOH¿QDQoDV..................................................................................10 6 Requisitos de estrutura...................................................................................................10 6.1 Estrutura organizacional e Alta Direção........................................................................10 6.2 Controle operacional....................................................................................................... 11 7 Requisitos de recursos.................................................................................................... 11 7.1 Competência do pessoal................................................................................................. 11 &RQVLGHUDo}HVJHUDLV...................................................................................................... 11 7.1.2 Determinação de critérios de competência................................................................... 11 7.1.3 Processos de avaliação...................................................................................................12 2XWUDVFRQVLGHUDo}HV......................................................................................................12 3HVVRDOHQYROYLGRQDVDWLYLGDGHVGHFHUWL¿FDomR........................................................12 7.3 Uso de auditores e especialistas técnicos externos....................................................13 7.4 Registros do pessoal.......................................................................................................13 7.5 Terceirização.....................................................................................................................14 5HTXLVLWRVVREUHLQIRUPDo}HV........................................................................................14 ,QIRUPDo}HVS~EOLFDV......................................................................................................14 'RFXPHQWRVGHFHUWL¿FDomR...........................................................................................15 5HIHUrQFLDjFHUWL¿FDomRHDRXVRGHPDUFDV...............................................................16 &RQ¿GHQFLDOLGDGH............................................................................................................17 7URFDGHLQIRUPDo}HVHQWUHXPRUJDQLVPRGHFHUWL¿FDomRHVHXVFOLHQWHV..............18 ,QIRUPDo}HVVREUHDDWLYLGDGHHRVUHTXLVLWRVGHFHUWL¿FDomR...................................18 © ISO/IEC 2015 - © ABNT 2016 - Todos os direitos reservados iii ABNT NBR ISO/IEC 17021-1:2016 1RWL¿FDomRGHDOWHUDo}HVSHORRUJDQLVPRGHFHUWL¿FDomR..........................................18 1RWL¿FDomRGHDOWHUDo}HVSHORFOLHQWHFHUWL¿FDGR........................................................18 9 Requisitos dos processos...............................................................................................19 $WLYLGDGHVGHSUpFHUWL¿FDomR........................................................................................19 9.1.1 Solicitação........................................................................................................................19 9.1.2 Análise crítica da solicitação..........................................................................................19 9.1.3 Programa de auditoria.....................................................................................................20 9.1.4 Determinação do tempo de auditoria.............................................................................21 9.1.5 Amostragem de multi-site...............................................................................................21 0~OWLSODVQRUPDVGHVLVWHPDVGHJHVWmR......................................................................22 9.2 Planejando auditorias......................................................................................................22 9.2.1 Determinação dos objetivos, escopo e critérios de auditoria.....................................22 9.2.2 Seleção da equipe auditora e designação de tarefas...................................................22 9.2.3 Plano de auditoria............................................................................................................24 &HUWL¿FDomRLQLFLDO............................................................................................................25 $XGLWRULDLQLFLDOGHFHUWL¿FDomR.....................................................................................25 9.4 Conduzindo auditorias....................................................................................................27 9.4.1 Generalidades...................................................................................................................27 9.4.2 Condução da reunião de abertura..................................................................................27 9.4.3 Comunicação durante a auditoria..................................................................................28 2EWHQomRHYHUL¿FDomRGHLQIRUPDo}HV........................................................................28 ,GHQWL¿FDomRHUHJLVWURGDVFRQVWDWDo}HVGHDXGLWRULD...............................................28 3UHSDUDomRGDVFRQFOXV}HVGDDXGLWRULD......................................................................29 9.4.7 Condução da reunião de encerramento.........................................................................29 9.4.8 Relatório de auditoria......................................................................................................30 9.4.9 Análise das causas das não conformidades.................................................................31 (¿FiFLDGHFRUUHo}HVHDo}HVFRUUHWLYDV......................................................................31 'HFLVmRGHFHUWL¿FDomR...................................................................................................31 9.5.1 Generalidades...................................................................................................................31 $o}HVDQWHVGDWRPDGDGHGHFLVmR................................................................................32 ,QIRUPDo}HVSDUDFRQFHVVmRGDFHUWL¿FDomRLQLFLDO....................................................32 ,QIRUPDo}HVSDUDFRQFHVVmRGDUHFHUWL¿FDomR............................................................33 0DQXWHQomRGDFHUWL¿FDomR............................................................................................33 9.6.1 Generalidades...................................................................................................................33 9.6.2 Atividades de supervisão................................................................................................33 5HFHUWL¿FDomR...................................................................................................................34 9.6.4 Auditorias especiais........................................................................................................35 6XVSHQVmRFDQFHODPHQWRRXUHGXomRGRHVFRSRGHFHUWL¿FDomR.............................36 $SHODo}HV.........................................................................................................................36 5HFODPDo}HV....................................................................................................................37 9.9 Registros de clientes.......................................................................................................38 5HTXLVLWRVGHVLVWHPDGHJHVWmRSDUDRUJDQLVPRVGHFHUWL¿FDomR...........................39 2So}HV..............................................................................................................................39 iv © ISO/IEC 2015 - © ABNT 2016 - Todos os direitos reservados ABNT NBR ISO/IEC 17021-1:2016 10.2 Opção A: Requisitos gerais de sistema de gestão.......................................................39 10.2.1 Generalidades...................................................................................................................39 10.2.2 Manual do sistema de gestão.........................................................................................39 10.2.3 Controle de documentos.................................................................................................39 10.2.4 Controle de registros.......................................................................................................40 10.2.5 Análise crítica pela direção.............................................................................................40 10.2.6 Auditorias internas...........................................................................................................41 $o}HVFRUUHWLYDV..............................................................................................................41 10.3 Opção B: Requisitos de sistema de gestão de acordo com a ABNT NBR ISO 9001.42 10.3.1 Generalidades...................................................................................................................42 10.3.2 Escopo..............................................................................................................................42 10.3.3 Foco no cliente.................................................................................................................42 10.3.4 Análise crítica pela direção.............................................................................................42 Anexo A (normativo) Conhecimentos e habilidades exigidos........................................................43 A.1 Generalidades...................................................................................................................43 A.2 Requisitos de competência para auditores de sistemas de gestão............................44 A.2.1 Conhecimento de práticas de gestão de negócios.......................................................44 A.2.2 Conhecimento de princípios de auditoria, práticas e técnicas...................................44 $ &RQKHFLPHQWRGHQRUPDVGRFXPHQWRVQRUPDWLYRVHVSHFt¿FRVGHVLVWHPDV de gestão..........................................................................................................................44 $ &RQKHFLPHQWRGRVSURFHVVRVGRRUJDQLVPRGHFHUWL¿FDomR.....................................44 A.2.5 Conhecimento do setor de negócios do cliente...........................................................44 A.2.6 Conhecimento dos produtos, processos e organização do cliente............................44 A.2.7 Habilidades no idioma apropriadas para todos os níveis dentro da organização do cliente................................................................................................................................44 A.2.8 Habilidades para tomar notas e redigir relatórios........................................................44 A.2.9 Habilidades para apresentação......................................................................................45 A.2.10 Habilidades de realizar entrevistas................................................................................45 A.2.11 Habilidades para gestão da auditoria.............................................................................45 A.3 Requisitos de competência para o pessoal que analisa criticamente relatórios de DXGLWRULDHTXHWRPDGHFLV}HVGHFHUWL¿FDomR..............................................................45 A.3.1 Conhecimento dos princípios, práticas e técnicas de auditoria.................................45 $ &RQKHFLPHQWRGHQRUPDVGRFXPHQWRVQRUPDWLYRVHVSHFt¿FRVGHVLVWHPD de gestão...........................................................................................................................45 $ &RQKHFLPHQWRGRVSURFHVVRVGRRUJDQLVPRGHFHUWL¿FDomR.....................................45 A.3.4 Conhecimento do setor de negócios do cliente...........................................................45 A.4 Requisitos de competência para pessoal que conduz análise crítica da solicitação para determinar a competência necessária da equipe de auditoria, para selecionar os membros da equipe de auditoria e para determinar o tempo de auditoria...........46 $ &RQKHFLPHQWRGHQRUPDVGRFXPHQWRVQRUPDWLYRVHVSHFt¿FRVGHVLVWHPD de gestão...........................................................................................................................46 $ &RQKHFLPHQWRGRVSURFHVVRVGRRUJDQLVPRGHFHUWL¿FDomR.....................................46 A.4.3 Conhecimento do setor de negócios do cliente...........................................................46 © ISO/IEC 2015 - © ABNT 2016 - Todos os direitos reservados v ABNT NBR ISO/IEC 17021-1:2016 A.4.4 Conhecimento dos produtos, processos e organização do cliente............................46 Anexo B LQIRUPDWLYR Possíveis métodos de avaliação.................................................................47 B.1 Generalidades...................................................................................................................47 B.2 Análise crítica de registros.............................................................................................47 B.3 Realimentação..................................................................................................................47 B.4 Entrevistas........................................................................................................................48 % 2EVHUYDo}HV.....................................................................................................................48 B.6 Exames..............................................................................................................................48 Anexo C LQIRUPDWLYR ([HPSORGHXPÀX[RGHSURFHVVRSDUDGHWHUPLQDomRHPDQXWHQomR da competência................................................................................................................49 Anexo D LQIRUPDWLYR Comportamento pessoal desejado.............................................................50 Anexo E LQIRUPDWLYR $XGLWRULDHSURFHVVRGHFHUWL¿FDomR..........................................................51 %LEOLRJUD¿D.........................................................................................................................................53 Figuras )LJXUD&±([HPSORGHXPÀX[RGHSURFHVVRSDUDGHWHUPLQDomRHPDQXWHQomR da competência................................................................................................................49 Figura E.1 – Fluxo de processo típico para auditoria de terceira parte e processo GHFHUWL¿FDomR..................................................................................................................52 Tabela Tabela A.1 – Tabela de conhecimentos e habilidades...................................................................43 vi © ISO/IEC 2015 - © ABNT 2016 - Todos os direitos reservados ABNT NBR ISO/IEC 17021-1:2016 Prefácio Nacional $ $VVRFLDomR %UDVLOHLUD GH 1RUPDV 7pFQLFDV $%17 p R )RUR 1DFLRQDO GH 1RUPDOL]DomR $V 1RUPDV %UDVLOHLUDV FXMR FRQWH~GR p GH UHVSRQVDELOLGDGH GRV &RPLWrV %UDVLOHLURV $%17&% GRV 2UJDQLVPRV GH 1RUPDOL]DomR 6HWRULDO $%17216 H GDV &RPLVV}HV GH (VWXGR (VSHFLDLV $%17&(( VmR HODERUDGDV SRU &RPLVV}HV GH (VWXGR &( IRUPDGDV SHODV SDUWHV LQWHUHVVDGDV QRWHPDREMHWRGDQRUPDOL]DomR 2V'RFXPHQWRV7pFQLFRV$%17VmRHODERUDGRVFRQIRUPHDVUHJUDVGD'LUHWLYD$%173DUWH $ $%17 FKDPD D DWHQomR SDUD TXH DSHVDU GH WHU VLGR VROLFLWDGD PDQLIHVWDomR VREUH HYHQWXDLV GLUHLWRV GH SDWHQWHV GXUDQWH D &RQVXOWD 1DFLRQDO HVWHV SRGHP RFRUUHU H GHYHP VHU FRPXQLFDGRV 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