Order №4/N provides three routes: international accreditation, ISO 9001 certification (for ambulatory providers) and ISO 15189 (for laboratories). They are not interchangeable: each one checks something different.
Quick comparison
| International accreditation (e.g. Accreditation Canada) | ISO 9001 | ISO 15189 | |
|---|---|---|---|
| Designed for | Healthcare specifically: hospitals, clinics, laboratories | Any organization’s quality management system | Medical laboratories |
| What it assesses | Clinical practice, patient safety, governance, infection control, people-centred care | Process management, documentation, customer satisfaction, improvement | Laboratory quality and technical competence: accuracy of results, equipment, staff competence |
| Who assesses | Healthcare surveyors (physicians, nurses, managers) | Certification body auditors | Laboratory assessors |
| Under Order №4/N | For all programme providers; exempts the laboratory from the ISO 15189 obligation | Accepted alternative for ambulatory providers | Mandatory for laboratories without international accreditation |
Which one do I need?
- Hospital: international accreditation. It covers the laboratory too, so a separate ISO 15189 is not needed.
- Outpatient clinic or day hospital: international accreditation or ISO 9001. If the clinic runs its own laboratory and is not pursuing accreditation, the laboratory will need ISO 15189.
- Stand-alone laboratory: ISO 15189 or international accreditation (e.g. Accreditation Canada’s diagnostic programme).
Why clinics choose accreditation even when ISO 9001 would do
- accreditation covers the clinic and its laboratory in a single process;
- the standards are written for healthcare and focus on patient safety;
- accreditation is recognised internationally by patients, insurers and partners;
- a local team prepares you in Georgian and supports you throughout the cycle.
Frequently asked questions
Can ISO 9001 replace accreditation?
For ambulatory providers, Order №4/N accepts ISO 9001 as an alternative. Inpatient providers need international accreditation.
Does a hospital laboratory need ISO 15189?
No, if the hospital holds international accreditation. In that case the laboratory is exempt from the ISO 15189 obligation.