PUBLIC HEALTH INSTITUTE OF GEORGIAEN · ქართული  |  Verify a certificate →

Methodology

SheniEkimi Accreditation is an evidence-informed standard for non-hospital health and wellness facilities, organised around the path a patient or client takes through a facility. It comprises seven core Standards, each containing detailed sub-standards — the specific, measurable criteria a facility is assessed against.

How the standard was developed

The standard was built by synthesising four bodies of source material: international guidance from the World Health Organization, ISO and ISQua[1,6,9]; internationally recognised accreditation practice, with technical support from the Accreditation Canada (AC) Georgia office[10]; the relevant Laws of Georgia[20,21]; and the peer-reviewed scientific literature.

In structuring this work we followed recognised principles for how health and social care standards should be written and maintained. ISQua commits to revising the principles that underpin standards development at regular intervals, informed by a literature review and stakeholder consultation, so that standards remain current and evidence-based; its latest edition moves toward a risk-based assessment approach[9]. Each sub-standard was drafted to be measurable and verifiable, and the framework is version-controlled and scheduled for periodic review.

Every sub-standard in the tool carries a plain-language statement; an explanation of why it matters; a risk rating; a means of verification (what document, observation or practice demonstrates compliance); and a citation to the guidance or law from which it derives.

The seven core standards

Standard 1 — Access & Arrival

The facility is easy to find, reach and enter safely — including for people with disabilities.

Standard 2 — Reception & Information

People are received respectfully and given clear, honest information about services, prices and their rights.

Standard 3 — Environment & Shared Spaces

Shared areas are clean, safe, well-ventilated and properly maintained.

Standard 4 — Care & Treatment

Care is delivered safely and competently — with proper hygiene, sterilisation, consent and qualified staff.

Standard 5 — Safety & Emergency Preparedness

The facility identifies and controls risks, and is ready to respond to emergencies.

Standard 6 — Aftercare & Follow-up

People receive clear aftercare and referral when needed, and can give feedback or raise a complaint.

Standard 7 — Governance & Management

The facility is well run — with proper records, policies, data protection and continuous improvement.

How a facility is assessed

Facilities pursue one of two tiers. Basic is an online self-assessment against every sub-standard, with supporting evidence reviewed by our team. Gold adds an independent on-site visit and unlocks the highest grade. Each sub-standard is confirmed either by documentary or photographic proof or by on-site observation; no result is awarded automatically. Results are graded Accredited · Excellent, Accredited · Good, or Provisional · Developing, with critical items capping the grade. A certificate is valid for twelve months and covers one physical address.

Verification, integrity and review

Assessors confirm each criterion individually, recording the basis (proof or on-site) and notes. Decisions are made on the evidence, never on payment. The standard itself is reviewed periodically and whenever the underlying international guidance or Georgian law changes, with each revision version-controlled.

The evidence base

This standard is built on published international guidance, Georgian law and the peer-reviewed evidence base. The following sets out why we use accreditation, the frameworks we drew on, and the evidence behind the key Standards — together with an honest account of its limits.

Why accreditation?

Accreditation is a public recognition by an accreditation body that a healthcare organisation has met defined standards, demonstrated through an independent external peer assessment[13]. The evidence on its effects is encouraging but should be read with care. A large 2021 systematic review found a consistent positive effect of accreditation on safety culture, process-related performance, efficiency and patient length of stay, while results for mortality and healthcare-associated infections were mixed[11]. A review across the recognised dimensions of quality similarly concluded that accreditation may have a positive impact on efficiency, safety, effectiveness, timeliness and patient-centredness[12]. At the same time, a 2023 review emphasised that findings remain inconsistent and that strong evidence of effectiveness is still limited[13], a caution echoed in the Cochrane review of external inspection of standards[14].

We therefore present accreditation honestly: as a quality-improvement and assurance tool with good evidence for improving processes, culture and organisation — not as a guarantee of clinical outcomes.

The frameworks we drew on

World Health Organization. The WHO Global Patient Safety Action Plan 2021–2030 sets the vision that no one should be harmed in health care and every patient should receive safe, respectful care[1]. WHO guidance on infection prevention and hand hygiene underpins our hygiene Standards[2,3].

ISO. ISO 7101:2023 is the first international consensus standard for healthcare quality management, setting requirements for care that is safe, effective, timely, efficient, equitable and people-centred[6]. ISO 9001 and recognised sterilisation standards inform our governance and treatment Standards[7,8].

ISQua / IEEA. The Guidelines and Principles for the Development of Health and Social Care Standards informed how our standard is written, structured and reviewed[9].

Accreditation Canada / HSO. Internationally recognised accreditation methodology, provided as technical support through the AC Georgia office[10].

Evidence behind the key standards

Reception, information & consent (Standard 2). Grounded in the WHO Declaration on the Promotion of Patients’ Rights in Europe (1994), the European Charter of Patients’ Rights (2002), the Council of Europe Oviedo Convention (1997), and Georgian law, which adopted the Law on Health Care in 1997 and the Law on the Rights of the Patient in 2000[15,16,17,20,21].

Environment, hygiene & infection control (Standards 3–4). Grounded in the WHO Guidelines on Hand Hygiene in Health Care (2009), the WHO core-components guidance for infection prevention and control (2016), and the WHO Global Action Plan on Antimicrobial Resistance (2015)[2,3,4,5].

Care, treatment & sterilisation (Standard 4). Grounded in the Spaulding classification for instrument reprocessing and recognised sterilisation standards, alongside consent requirements in Georgian law[8,19,21].

Safety & emergency preparedness (Standard 5). Grounded in patient-safety guidance and current resuscitation guidelines[1,18].

Governance & management (Standard 7). Grounded in ISO 7101:2023 and the organisational-quality principles of ISQua[6,9].

The full, linked reference for each sub-standard is also shown inside the self-assessment, beside the question it supports.

Limitations

Accreditation reflects an assessment at a point in time and depends on the accuracy of what a facility declares. The published evidence is heterogeneous, and improvement in processes does not automatically translate into improved clinical outcomes. We state this openly so the public understands what a SheniEkimi mark does — and does not — mean.

Our principles

The scheme is voluntary, transparent and improvement-oriented — not a regulator and not a punishment. A facility self-declares its information and retains full responsibility for its services; SheniEkimi confirms the assessment and, for Gold, the on-site visit. It does not approve any individual drug or product.

References to WHO, ISO, ISQua and Accreditation Canada describe external guidance that informed this standard. They do not imply endorsement, sponsorship, certification, affiliation with, or accreditation by those organisations.

References

  1. World Health Organization. Global Patient Safety Action Plan 2021–2030. Geneva: WHO; 2021. ISBN 978-92-4-003270-5.
  2. World Health Organization. WHO Guidelines on Hand Hygiene in Health Care: Clean Care is Safer Care. Geneva: WHO; 2009.
  3. World Health Organization. Guidelines on core components of infection prevention and control programmes at the national and acute health care facility level. Geneva: WHO; 2016.
  4. World Health Organization. Global action plan on antimicrobial resistance. Geneva: WHO; 2015.
  5. Pittet D, Donaldson L. Clean Care is Safer Care: a worldwide priority. Lancet. 2005;366(9493):1246–7.
  6. International Organization for Standardization. ISO 7101:2023 Healthcare organization management — Management systems for quality in healthcare organizations — Requirements. Geneva: ISO; 2023.
  7. International Organization for Standardization. ISO 9001:2015 Quality management systems — Requirements. Geneva: ISO; 2015.
  8. International Organization for Standardization. ISO 17665 Sterilization of health care products — Moist heat. Geneva: ISO.
  9. ISQua External Evaluation Association. Guidelines and Principles for the Development of Health and Social Care Standards. Dublin/Geneva: ISQua EEA.
  10. Health Standards Organization / Accreditation Canada. Qmentum International accreditation programme. Ottawa: HSO/AC.
  11. Hussein M, Pavlova M, Ghalwash M, Groot W. The impact of hospital accreditation on the quality of healthcare: a systematic literature review. BMC Health Serv Res. 2021;21:1057.
  12. Araujo CAS, Siqueira MM, Malik AM. Hospital accreditation impact on healthcare quality dimensions: a systematic review. Int J Qual Health Care. 2020;32(8):531–44.
  13. Alhawajreh MJ, Paterson AS, Jackson WJ. Impact of hospital accreditation on quality improvement in healthcare: a systematic review. PLoS One. 2023;18(12):e0294180.
  14. Flodgren G, Gonçalves-Bradley DC, Pomey MP. External inspection of compliance with standards for improved healthcare outcomes. Cochrane Database Syst Rev. 2016;(12):CD008992.
  15. WHO Regional Office for Europe. Declaration on the Promotion of Patients’ Rights in Europe. Amsterdam; 1994.
  16. Active Citizenship Network. European Charter of Patients’ Rights. Rome; 2002.
  17. Council of Europe. Convention on Human Rights and Biomedicine (Oviedo Convention). 1997.
  18. European Resuscitation Council. ERC Guidelines for Resuscitation 2021. Resuscitation. 2021;161.
  19. Spaulding EH. Chemical disinfection of medical and surgical materials. In: Disinfection, Sterilization and Preservation. Philadelphia: Lea & Febiger; 1968.
  20. Parliament of Georgia. Law of Georgia on Health Care. 1997 (as amended).
  21. Parliament of Georgia. Law of Georgia on the Rights of the Patient. 2000 (as amended).
  22. Parliament of Georgia. Law of Georgia on Personal Data Protection. 2023.