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Inspection readiness, Brazil, worked through São Paulo and Rio de Janeiro

ANVISA and ONA readiness quiz for Brazilian clinics

This ANVISA, CFM and ONA readiness check is 12 questions drawn from ANVISA's RDC 63/2011 and RDC 36/2013, the CFM's resolutions, the LGPD and ONA's three accreditation levels. Answer each one and you get a score for each area, the three things to fix first, and the ANVISA, CFM and ONA guide and template for each. wai is clinic software built to help you achieve ONA Acreditado com Excelência.

Updated , and every standard links to gov.br.

The 12 questions

  1. The licença sanitária and boas práticasIs your licença sanitária current, and displayed where the public can see it?

    Drawn from RDC 63/2011 art. 10, licença atualizada, afixada em local visível ao público, ANVISA, CFM and ONA

  2. The licença sanitária and boas práticasDo you have a named responsável técnico and a substitute, with any change notified to the vigilância?

    Drawn from RDC 63/2011 art. 14, responsável técnico e substituto, com alteração notificada, ANVISA, CFM and ONA

  3. Patient safety and adverse eventsHas the direção constituted a Núcleo de Segurança do Paciente and written a Plano de Segurança do Paciente?

    Drawn from RDC 36/2013 artigos 4 e 8, Núcleo de Segurança do Paciente e Plano de Segurança do Paciente, ANVISA, CFM and ONA

  4. Patient safety and adverse eventsAre adverse events notified monthly by the 15th working day, and deaths within 72 hours?

    Drawn from RDC 36/2013 art. 10, notificação mensal até o 15º dia útil, óbito em até 72 horas, ANVISA, CFM and ONA

  5. CRM registration and the diretor técnicoIs the clinic, and every branch, registered with the CRM, with the certificate renewed this year?

    Drawn from Resolução CFM 1.980/2011, registro da pessoa jurídica no CRM e certificado anual, ANVISA, CFM and ONA

  6. CRM registration and the diretor técnicoDoes the diretor técnico keep each doctor's CRM registration and specialist title on file?

    Drawn from Resolução CFM 2.147/2016 art. 2, deveres do diretor técnico, ANVISA, CFM and ONA

  7. The prontuárioDoes every prontuário entry carry the date, time, signature and the doctor's CRM number?

    Drawn from Código de Ética Médica art. 87, data, hora, assinatura e número do CRM, ANVISA, CFM and ONA

  8. The prontuárioIs there a Comissão de Revisão de Prontuários, coordinated by a doctor, that meets on a set cycle?

    Drawn from Resolução CFM 1.638/2002, Comissão de Revisão de Prontuários, ANVISA, CFM and ONA

  9. The prontuárioAre records kept at least 20 years from the last entry before any is eliminated?

    Drawn from Lei 13.787/2018 art. 6, guarda mínima de 20 anos a partir do último registro, ANVISA, CFM and ONA

  10. Telemedicine, AI and health dataIs telemedicine consent kept in the electronic record, and is AI use noted in the prontuário?

    Drawn from Resolução CFM 2.314/2022 artigo 15 e Resolução CFM 2.454/2026 artigo 4, consentimento e uso de IA no prontuário, ANVISA, CFM and ONA

  11. Telemedicine, AI and health dataCould you report a data incident to the ANPD and to patients within three working days?

    Drawn from LGPD art. 48 e Resolução CD/ANPD 15/2024, comunicação em três dias úteis, ANVISA, CFM and ONA

  12. ONA accreditationHave you traced a real patient through the clinic and compared the record with what the patient perceived?

    Drawn from Triangulação, o que a organização diz que faz, o que faz e o que o paciente sente e percebe, ANVISA, CFM and ONA

Email me the full report

Answer every question above and we will email your score for each area, the three things to fix first and the guide for each.

The score for each area, the three things to fix first and the guide and template for each, in your inbox.

Your details are used to send the report, under our Privacy Policy.

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What the questions are drawn from

Each area below is ANVISA, CFM and ONA's own, with the page where ANVISA, CFM and ONA publishes it. The ANVISA, CFM and ONA hub explains the whole framework, and its guides carry the templates.

  1. 2 questionsThe licença sanitária and boas práticasgov.br
  2. 2 questionsPatient safety and adverse eventsgov.br
  3. 2 questionsCRM registration and the diretor técnicogov.br
  4. 3 questionsThe prontuáriogov.br
  5. 2 questionsTelemedicine, AI and health datagov.br
  6. 1 questionONA accreditationgov.br
  7. ANVISA, CFM and ONA hubANVISA, CFM and ONA software, the framework and every guide

Questions

Where do the ANVISA, CFM and ONA questions come from?

Each question is drawn from ANVISA's RDC 63/2011 and RDC 36/2013, the CFM's resolutions, the LGPD and ONA's three accreditation levels, and names the standard it comes from with a link to the regulator's own page. The facts were checked against gov.br on 15 October 2026.

Does the score predict my ANVISA, CFM and ONA accreditation?

No. The score shows where your evidence is strong and where it is thin, area by area, so you know what to work on first. ANVISA, CFM and ONA decides the accreditation after its own assessment.

Does ANVISA, CFM and ONA endorse this quiz or wai?

ANVISA and the vigilância sanitária, the Conselho Federal de Medicina and the CRMs, and the Organização Nacional de Acreditação registers and rates providers. It does not approve, certify or endorse software, wai included, and software cannot earn an accreditation on a provider's behalf. wai keeps the records your team uses to show ANVISA, CFM and ONA how care is delivered, and ANVISA, CFM and ONA decides the accreditation.

What happens to my answers?

Your answers are scored in your browser and stay there. They are sent to us only if you ask for the full report by email, and then only to write and send it.

See your ANVISA, CFM and ONA evidence kept as the work is done.

We show wai on your own diary, notes and inbox in a 15 minute video call. wai is built to help you achieve ONA Acreditado com Excelência, and ANVISA, CFM and ONA decides the accreditation.

Request a demoEmail us

Other regulators

Every readiness quiz
  1. EnglandCQC readiness quiz
  2. Dubai, United Arab EmiratesDHA readiness quiz
  3. SingaporeHCSA readiness quiz
  4. Abu Dhabi, United Arab EmiratesDOH readiness quiz
  5. Hong KongORPHF readiness quiz
  6. International, with the Gulf and Asia firstJCI readiness quiz
  7. United StatesJoint Commission readiness quiz
  8. United StatesAAAHC readiness quiz
  9. AustraliaNSQHS and RACGP readiness quiz
  10. ScotlandHIS readiness quiz
  11. WalesHIW readiness quiz
  12. Northern IrelandRQIA readiness quiz
  13. QatarMOPH readiness quiz
  14. KuwaitKuwait MOH readiness quiz
  15. Kingdom of BahrainNHRA readiness quiz
  16. Sultanate of OmanOman MOH readiness quiz
  17. FranceHAS readiness quiz
  18. IrelandHIQA readiness quiz
  19. Ontario, British Columbia and Quebec, CanadaCanada readiness quiz
  20. Aotearoa New ZealandNgā Paerewa readiness quiz
  21. Zurich and Geneva, SwitzerlandSwiss cantonal licensing readiness quiz
  22. IndiaNABH readiness quiz
  23. MalaysiaMOH and MSQH readiness quiz
  24. GermanyQM-RL readiness quiz
  25. Madrid and Cataluña, SpainSpanish autorización sanitaria readiness quiz
  26. the NetherlandsIGJ readiness quiz
  27. South AfricaHPCSA and OHSC readiness quiz
  28. EgyptGAHAR readiness quiz
  29. JapanMHLW readiness quiz
  30. South KoreaKOIHA readiness quiz

Sources

  1. 1ANVISA, AnvisaLegis, 2011Resolução RDC nº 63, de 25 de novembro de 2011, Requisitos de Boas Práticas de Funcionamento para os Serviços de SaúdeRead source
  2. 2ANVISA, AnvisaLegis, 2013Resolução RDC nº 36, de 25 de julho de 2013, ações para a segurança do paciente em serviços de saúdeRead source
  3. 3Conselho Federal de Medicina, 2011Resolução CFM nº 1.980/2011, cadastro, registro e responsabilidade técnica das pessoas jurídicasRead source
  4. 4Conselho Federal de Medicina, 2002Resolução CFM nº 1.638/2002, define prontuário médico e a Comissão de Revisão de ProntuáriosRead source
  5. 5Conselho Federal de Medicina, 2026Resolução CFM nº 2.454, de 11 de fevereiro de 2026, normatiza o uso da inteligência artificial na medicinaRead source
  6. 6Organização Nacional de Acreditação (ONA), 2026Jornada de Acreditação, Níveis 1, 2 e 3Read source
  7. 7Conselho Federal de Medicina, 2016Resolução CFM nº 2.147/2016, diretores técnicos, diretores clínicos e chefias de serviçoRead source
  8. 8Conselho Federal de Medicina, 2018Resolução CFM nº 2.217/2018, Código de Ética MédicaRead source
  9. 9Presidência da República, Planalto, 2018Lei nº 13.787, de 27 de dezembro de 2018, digitalização e guarda do prontuário de pacienteRead source
  10. 10Conselho Federal de Medicina, 2022Resolução CFM nº 2.314/2022, define e regulamenta a telemedicinaRead source
  11. 11Diário Oficial da União, 2024Resolução CD/ANPD nº 15, de 24 de abril de 2024, Regulamento de Comunicação de Incidente de SegurançaRead source
  12. 12Organização Nacional de Acreditação (ONA), 2026Método de Avaliação, Manual de Diretrizes para o Avaliador (2026)Read source