ONA accreditation is voluntary and runs in three levels, Nível 1 Acreditado, Nível 2 Acreditado Pleno and Nível 3 Acreditado com Excelência, assessed by an Instituição Acreditadora Credenciada against ONA's own standards. Level 3 recognises an organisation led by results, with integrated processes, continuous improvement, innovation and an established culture.
The three levels
ONA describes accreditation as a path that starts at the Nível Fundamento, where an organisation builds the foundations for quality. Nível 1 recognises that care and organisational processes meet safety and compliance requirements. Nível 2, Acreditado Pleno, shows integrated processes and more mature management, and Nível 3, Acreditado com Excelência, shows an organisation oriented by results, with integrated processes, continuous improvement, innovation and a consolidated culture.1 Organisations assessed from 2026 are assessed on the Manual OPSS 2026.1
ONA does not visit the clinic itself. It selects and credentials Instituições Acreditadoras Credenciadas, which assess health organisations against ONA's standards and manuals and train their own assessors.2 ONA's map lists 1,803 accredited organisations in 25 states, from hospitals to ambulatory services, imaging, ophthalmology, oncology and telehealth.3
What the 2026 method looks for
ONA's 2026 manual for assessors builds every assessment on three perspectives, what the organisation says it does, what it really does, and what the patient feels and perceives, and triangulates them.4 It assesses organisational strategy and direction, the Jornada do Paciente and cross-cutting requirements. A non-hospital organisation receives at least one tracer in each certification and maintenance assessment, with at least one interview with a patient or family member where it fits the service and one with a front-line professional.4
| Level | Name | What ONA says it recognises |
|---|---|---|
| Start | Nível Fundamento | The foundations for quality, safety and patient-centred care |
| 1 | Acreditado | Safety and compliance of care and organisational processes |
| 2 | Acreditado Pleno | Integrated processes and more mature management |
| 3 | Acreditado com Excelência | Results, continuous improvement, innovation and a consolidated culture |
- Read the manual for your service. Use the Manual OPSS 2026 and the Normas Orientadoras in ONA's library for your type of service.
- Choose an IAC. Pick one of ONA's credentialed accrediting institutions to run the assessment.
- Write down what you do. Strategy, protocols and procedures, as the first perspective asks.
- Check that you do it. Trace real patients through the clinic and compare the record with the protocol.
- Ask patients what they noticed. Interview patients and families, as the assessor will, and act on what they say.
- Measure and improve. Indicators and improvement cycles, reviewed against results, are what Level 3 rewards.
- Patient pathway traced ______ Date ______
- What the protocol says ______
- What the record shows ______
- What the patient said ______
- What the professional said ______
- Gap found ______ Action, owner and date ______
Why the level shows to patients and plans
ONA takes part in the ANS's QUALISS programme for health plan providers. Level 3 appears under the accreditation attribute in the QUALISS search, and Levels 1 and 2 under other certifications, so beneficiaries and plans can see them.5 ONA has homologated more than 2,500 certifications since it was founded in 1999 and is a member of ISQua.6
Questions
Is ONA accreditation required by law?
No, it is voluntary. The licença sanitária and the CRM registration are the legal requirements. ONA accreditation sits on top of them.
Who carries out the ONA assessment?
An Instituição Acreditadora Credenciada, an organisation ONA has selected and credentialed to assess against its standards.
Can an outpatient clinic be accredited?
Yes. ONA's map lists ambulatory services, imaging, ophthalmology and telehealth among the types of service it accredits.
Does accreditation show anywhere public?
In the ANS's QUALISS search. Level 3 under accreditation, Levels 1 and 2 under other certifications.
Sources
- 1Organização Nacional de Acreditação (ONA), 2026Jornada de Acreditação, Níveis 1, 2 e 3Read source
- 2Organização Nacional de Acreditação (ONA), 2026Acreditadoras, Instituições Acreditadoras CredenciadasRead source
- 3Organização Nacional de Acreditação (ONA), 2026Organizações acreditadas, Mapa da AcreditaçãoRead source
- 4Organização Nacional de Acreditação (ONA), 2026Método de Avaliação, Manual de Diretrizes para o Avaliador (2026)Read source
- 5Organização Nacional de Acreditação (ONA), 2026Níveis 1 e 2 da metodologia ONA poderão ser identificados no buscador do QUALISS da ANSRead source
- 6Organização Nacional de Acreditação (ONA), 2026Sobre a ONARead source
Written by the wai team from ANVISA and the vigilância sanitária, the Conselho Federal de Medicina and the CRMs, and the Organização Nacional de Acreditação guidance, checked on 16 October 2026. This is guidance, not legal advice. Neither ANVISA, the CFM nor ONA endorses wai or any software.