EDITIONEN·FR·ქართ

Accréditation Sans Frontières

International Accreditation of Healthcare Facilities

Standards › ASF Health Standards V11 › Standard 2

Standard 2 (Governance and Accountability), PDF

ASF-HS11-S02 · 1 November 2026 · 36 pages, A4. The same criteria as this page, for printing and assessors.

Download the PDF

Where this standard applies

Standard 2 is a core standard. It applies to every facility type. The table shows each criterion by facility type.

Criterion Hospital Ambulatory clinic Primary health clinic Long-term care Telemedicine Home care Fitness and wellness Dental clinic Aesthetic and procedure clinic
2.1 The Board Is Accountable Yes Yes Yes Yes Yes Yes Yes Yes Yes
2.2 There Is a Written Strategic Plan Yes Yes Yes Yes Yes Yes Yes Yes Yes
2.3 Policy Gets Followed Yes Yes Yes Yes Yes Yes Yes Yes Yes
2.4 Patient Data Is Kept Secure Yes Yes Yes Yes Yes Yes Yes Yes Yes
2.5 Records Are Kept Exactly as Long as Required Yes Yes Yes Yes Yes Yes Yes Yes Yes
2.6 Serious Incidents Get Properly Investigated Yes Yes Yes Yes Yes Yes Yes Yes Yes
2.7 Safety Culture Is Measured Yes Yes Yes Yes Yes Yes Yes Yes Yes
2.8 Patient Experience Is Measured Continuously, Not Only After Discharge Yes Yes Yes Yes Yes Yes Yes Yes Yes
2.9 An Ethics Consultation Process Exists Yes Yes Yes Yes Yes Yes Yes Yes Yes
2.10 Patients and Families Have a Voice in Governance Yes Yes Yes Yes Yes Yes Yes Yes Yes

Standard 2

Governance and Accountability

The base standard. Every facility meets it. It covers the governing body, strategy and policy, patient data, records, serious incidents, safety culture, patient experience, ethics and patient voice.

10
criteria
28
documents
12
e-learning courses
7
references

Criteria on this page

2.12.22.32.42.52.62.72.82.92.10

How to read the colours
Red: Must. Required in every setting. Criteria that protect life are always red.
Yellow: Medium. Required, adapted to what a transition setting can realistically do.
Green: Minimum. The lowest acceptable level in a humanitarian setting, where resources are very limited.

Each criterion is shown in three settings: Humanitarian settings, Transition and fragile, and Standard. In standard settings, every criterion is Must.

Reference, not a requirement. Every policy, SOP, form and course on this page is a draft to help you. Adapt it to your hospital, write your own, or upload your own documents. What the assessor checks is that the standard is met and that you can show how.
Training colours: red means essential, green recommended, yellow optional. Each course shows its level for each setting: humanitarian, transition and fragile, and standard.
2.1
The Board Is Accountable
Humanitarian settings: MediumTransition and fragile: MustStandard: Must

A governing body exists, with named members and clear, documented authority over safety and quality, clinical governance, and financial stewardship — not an informal ownership arrangement functioning without oversight structure.

Humanitarian settings
Medium
Transition and fragile
Must
Standard
Must

Rating: Medium in humanitarian settings; Must in transition and fragile settings; Must in standard settings.

Why it matters. A facility with no clearly accountable governing body has no one answerable for safety and quality when things go wrong. Named members with documented authority make that accountability real.

Questions the surveyor asks

  • Is there a named governing body with written terms of reference? The surveyor checks that every member is named and has a defined term of office. Have the terms of reference (GOV-POL-001) and the membership register (GOV-REG-001) ready.
  • Does the board meet on a fixed schedule, with minutes kept? Meetings must take place on the dates set in the procedure, and minutes must exist for each one. Have the minutes (GOV-FRM-003) ready for the last 12 months.
  • Does the board oversee quality, safety and finances? The minutes should show that the board reviews quality, safety and money at its meetings, not only once a year. Have the relevant minutes ready.

How the surveyor verifies this criterion

Sample. Review the governing body's records for the last 12 months, and its terms of reference.

1. A governing body with named members and defined terms exists.

Method. Check the terms of reference and the membership register for named members and their terms of office.

Evidence to show. GOV-POL-001 Governing Body Terms of Reference; GOV-REG-001 Register of Governing Body Members.

Pass when. Every member is named and has a defined term.

2. The body meets on a fixed schedule, with minutes kept.

Method. Compare the meeting dates in the minutes with the schedule set in the procedure.

Evidence to show. GOV-FRM-003 Governing Body Minutes Template, completed for each meeting.

Pass when. Meetings take place on the scheduled dates, and minutes exist for each one.

3. Quality, safety and financial oversight are assigned to the board.

Method. Read the minutes for a quality and safety review at each meeting, and check that clinical governance and financial stewardship are named board responsibilities.

Evidence to show. GOV-SOP-001 Governing Body Meetings and Decisions on Safety and Quality; minutes.

Pass when. Each meeting records a quality and safety review, and both responsibilities are named in the procedure.

Immediate fail (any one means the criterion is not met)

  • The governing body does not exist, or has no minutes for the last 12 months.

Staff, training and documents

Each occupation carries its ISCO-08 code. Each row is one document: read across to see who does each step. Training evidence: a verified micro-credential in your GMJ Academy micro-credential portfolio, or your own training certificate kept in the staff file.

Good practice. The governing body has named members, written terms of reference and a fixed meeting schedule. Its minutes record decisions on safety, quality and finance, and each member knows what they are accountable for.

Partial because. A governing body exists, but membership, authority or meeting records are incomplete, or the body does not clearly hold authority over safety and quality.

Staff responsible

Role Why it applies Level Training Documents
Chief executive ISCO 1120
ASF proposal
Carries operational accountability to the board Humanitarian: Essential
Transition: Essential
Standard: Essential
Governance & Management (H-07)
Safety Management System & Leadership (MGMT-01, Georgian version only)
Evidence: a verified micro-credential in your GMJ Academy micro-credential portfolio, or a training certificate in the staff file
GOV-SOP-001
GOV-FRM-003
GOV-REG-001
GOV-POL-001
Governing body members
ASF proposal
Holds the authority this criterion requires Humanitarian: Essential
Transition: Essential
Standard: Essential
Governance & Management (H-07)
Safety Management System & Leadership (MGMT-01, Georgian version only)
Evidence: a verified micro-credential in your GMJ Academy micro-credential portfolio, or a training certificate in the staff file
GOV-SOP-001
GOV-POL-001
Secretary ISCO 3344
ASF proposal
Keeps the register and the minutes Humanitarian: Essential
Transition: Essential
Standard: Essential
Evidence: a verified micro-credential in your GMJ Academy micro-credential portfolio, or a training certificate in the staff file GOV-SOP-001
GOV-FRM-003
GOV-REG-001
GOV-POL-001

E-learning: who must take each course.

E-learning course Who must take Who is recommended
Governance & Management (H-07)
GMJ Academy: English · Georgian
Chief executive (ISCO 1120), Governing body members None
Safety Management System & Leadership (MGMT-01, Georgian version only)
GMJ Academy: Georgian
Chief executive (ISCO 1120) Governing body members

Documents: who does each step

Document Writes Approves Fills in Checks and signs Files and uploads
GOV-SOP-001 · Governing Body Meetings and Decisions on Safety and Quality
Procedure (SOP) · To make sure the governing body meets regularly, takes decisions on safety and quality in the open, and records them so that actions can be followed up.
Chief executive (ISCO 1120) Governing body members Secretary (ISCO 3344) Chief executive (ISCO 1120) Secretary (ISCO 3344)
GOV-FRM-003 · Governing Body Minutes Template
Form (record) · Record every governing body meeting: attendance, quorum, declarations, decisions on safety and quality, actions and owners.
Manager (ISCO 1342) Chief executive (ISCO 1120) Secretary (ISCO 3344) Manager (ISCO 1342) Secretary (ISCO 3344)
GOV-REG-001 · Register of Governing Body Members
Register · The current list of named members of the governing body, their roles, terms and declared interests.
Secretary (ISCO 3344) Chief executive (ISCO 1120) Secretary (ISCO 3344) Manager (ISCO 1342) Secretary (ISCO 3344)
GOV-POL-001 · Governing Body Terms of Reference
Policy · To set out who governs the facility, what authority they hold, and how they hold the service to account for safety, quality and money.
Chief executive (ISCO 1120) Governing body members N/A Chief executive (ISCO 1120) Secretary (ISCO 3344)

References

  1. World Health Organization (2021). Hospital Safety Index: Guide for Evaluators, 2nd ed. Used for: Board oversight of safety and quality (2.1). https://news.gmj.ge/guideline/hospital-safety-index-guide-for-evaluators-2nd-ed/
2.2
There Is a Written Strategic Plan
Humanitarian settings: MediumTransition and fragile: MustStandard: Must

A documented plan states the facility's mission, values, and a code of conduct for staff behaviour, and guides resourcing decisions — not a one-page mission poster disconnected from how money and staff time get allocated, and not a mission statement with no accompanying statement of values or expected conduct.

Humanitarian settings
Medium
Transition and fragile
Must
Standard
Must

Rating: Medium in humanitarian settings; Must in transition and fragile settings; Must in standard settings.

Why it matters. A facility without a written plan drifts, and its resources follow whichever problem is loudest that week. A written plan with a mission, values and code of conduct sets the direction that staff and the board can be held to.

Questions the surveyor asks

  • Is there an approved strategic plan covering several years? The plan must state a mission, cover a multi-year period and show its approval. Have the strategic plan (GOV-PLN-001) ready.
  • Can a recent budget or staffing decision be traced to the plan? The surveyor picks one decision from the last year and checks that it links to an objective in the plan. Have that decision record ready.
  • Do staff know the code of conduct and how it guides their behaviour? Staff should describe the code of conduct in their own words, and it should be separate from the mission statement. Have the code of conduct (GOV-POL-002) ready.

How the surveyor verifies this criterion

Sample. Review the plan and the code of conduct currently in force, and the decisions made in the last year.

1. A written strategic plan covers at least several years.

Method. Check the plan's period, its approval record and its mission statement.

Evidence to show. GOV-PLN-001 Strategic Plan (template and approval).

Pass when. The plan is approved, covers a multi-year period and states a mission.

2. A resourcing decision can be traced to the plan.

Method. Select one budget or staffing decision from the last year and trace its link to a plan objective.

Evidence to show. The budget or staffing decision record, and the plan.

Pass when. The decision refers to a plan objective.

3. Values and a code of conduct guide staff behaviour.

Method. Ask staff to describe the code of conduct, and check that it is separate from the mission statement.

Evidence to show. GOV-POL-002 Code of Conduct for Staff.

Pass when. The code of conduct is approved, separate from the mission, and staff can describe its main points.

Immediate fail (any one means the criterion is not met)

  • The facility has no written strategic plan, or no code of conduct for staff.

Staff, training and documents

Each occupation carries its ISCO-08 code. Each row is one document: read across to see who does each step. Training evidence: a verified micro-credential in your GMJ Academy micro-credential portfolio, or your own training certificate kept in the staff file.

Good practice. The strategic plan states the mission, values and a code of conduct, and the budget and staffing decisions visibly follow from it. Staff can state the mission and the main priorities in their own words.

Partial because. A plan exists and states a mission, but values or the code of conduct are missing, or resourcing decisions do not follow from the plan.

Staff responsible

Role Why it applies Level Training Documents
Chief executive ISCO 1120
ASF proposal
Carries operational accountability to the board Humanitarian: Essential
Transition: Essential
Standard: Essential
Quality Management in Healthcare (A-02, Georgian version only)
Safety Management System & Leadership (MGMT-01, Georgian version only)
Evidence: a verified micro-credential in your GMJ Academy micro-credential portfolio, or a training certificate in the staff file
GOV-PLN-001
GOV-POL-002
Governing body members
ASF proposal
Holds the authority this criterion requires Humanitarian: Essential
Transition: Essential
Standard: Essential
Quality Management in Healthcare (A-02, Georgian version only)
Safety Management System & Leadership (MGMT-01, Georgian version only)
Evidence: a verified micro-credential in your GMJ Academy micro-credential portfolio, or a training certificate in the staff file
GOV-PLN-001
GOV-POL-002

E-learning: who must take each course.

E-learning course Who must take Who is recommended
Quality Management in Healthcare (A-02, Georgian version only)
GMJ Academy: Georgian
Chief executive (ISCO 1120) Governing body members
Safety Management System & Leadership (MGMT-01, Georgian version only)
GMJ Academy: Georgian
Chief executive (ISCO 1120) Governing body members

Documents: who does each step

Document Writes Approves Fills in Checks and signs Files and uploads
GOV-PLN-001 · Strategic Plan (template and approval)
Plan · To set out what the facility is for, what it values, how staff are expected to behave, and where resources will go over the coming years.
Chief executive (ISCO 1120) Governing body members Manager (ISCO 1342) Chief executive (ISCO 1120) Secretary (ISCO 3344)
GOV-POL-002 · Code of Conduct for Staff
Policy · To state the standards of personal and professional conduct expected of everyone who acts for the facility.
Chief executive (ISCO 1120) Governing body members N/A Chief executive (ISCO 1120) Secretary (ISCO 3344)

References

  1. World Health Organization (2021). Hospital Safety Index: Guide for Evaluators, 2nd ed. Used for: Strategic direction and safety priorities (2.2). https://news.gmj.ge/guideline/hospital-safety-index-guide-for-evaluators-2nd-ed/
2.3
Policy Gets Followed
Humanitarian settings: MediumTransition and fragile: MustStandard: Must

A policy framework exists and staff can describe how it is applied in practice, not merely confirm that policies are filed and technically available. The framework includes a formal, comprehensive quality improvement plan covering every part of the facility, with allocated responsibilities and defined performance indicators.

Humanitarian settings
Medium
Transition and fragile
Must
Standard
Must

Rating: Medium in humanitarian settings; Must in transition and fragile settings; Must in standard settings.

Why it matters. Many facilities have a complete set of policies that nobody follows. A policy that staff cannot explain in practice is a document, not a control.

Questions the surveyor asks

  • Can staff explain how a named policy is applied? The surveyor asks staff in two areas to explain one policy as it applies to their daily work, and checks the answer matches the written policy. Have the policy application audit form (GOV-FRM-002) ready.
  • Are gaps found in policy use recorded with an action? Every gap found in an audit must have a recorded action. Have the policy register (GOV-REG-002) and the audit records ready.
  • Is the quality improvement plan complete, approved and reviewed? The plan must cover five areas, name an owner and indicators for each, and show its approval and review dates. Have the quality improvement plan (GOV-PLN-002) ready.

How the surveyor verifies this criterion

Sample. Select three policies at random and check them against practice in the last 12 months.

1. Staff can describe how a named policy is applied.

Method. Ask staff in two areas to describe how one selected policy is applied in their daily work.

Evidence to show. GOV-FRM-002 Policy Application Audit Form, completed for each selected policy.

Pass when. Staff describe the policy as it is written.

2. Adherence is checked and gaps have a defined response.

Method. Read the audit records and check that each gap has an action recorded.

Evidence to show. GOV-REG-002 Policy Register; GOV-FRM-002 audit records.

Pass when. Every gap found has a recorded action.

3. The quality improvement plan is complete, authorised and reviewed.

Method. Check the plan for all five areas, its named owners and indicators, and its approval and review dates.

Evidence to show. GOV-PLN-002 Quality Improvement Plan; GOV-POL-003 Policy Development, Approval, Review and Application.

Pass when. The plan covers all areas, each has a named owner and an indicator, and approval and review are dated.

Immediate fail (any one means the criterion is not met)

  • A policy is in use with no adherence check, and no response when a policy-practice gap is found.

Staff, training and documents

Each occupation carries its ISCO-08 code. Each row is one document: read across to see who does each step. Training evidence: a verified micro-credential in your GMJ Academy micro-credential portfolio, or your own training certificate kept in the staff file.

Good practice. Staff can describe how each key policy is applied in their daily work. Policy application is audited, and the quality improvement plan covers every service with named owners and deadlines.

Partial because. Policies are written and filed, but staff cannot explain how they are applied, or the quality improvement plan covers only some services or has no owners.

Staff responsible

Role Why it applies Level Training Documents
Chief executive ISCO 1120
ASF proposal
Carries operational accountability to the board Humanitarian: Essential
Transition: Essential
Standard: Essential
Documentation Fundamentals (A-03, Georgian version only)
Evidence: a verified micro-credential in your GMJ Academy micro-credential portfolio, or a training certificate in the staff file
GOV-FRM-002
GOV-REG-002
GOV-PLN-002
GOV-POL-003
Manager ISCO 1342
ASF proposal
Runs the process this criterion measures Humanitarian: Essential
Transition: Essential
Standard: Essential
Documentation Fundamentals (A-03, Georgian version only)
Document Control and the Records System (T-02, Georgian version only)
Document Control Fundamentals (A-06)
Evidence: a verified micro-credential in your GMJ Academy micro-credential portfolio, or a training certificate in the staff file
GOV-FRM-002
GOV-REG-002
GOV-PLN-002

E-learning: who must take each course.

E-learning course Who must take Who is recommended
Documentation Fundamentals (A-03, Georgian version only)
GMJ Academy: Georgian
Manager (ISCO 1342) Chief executive (ISCO 1120)
Document Control and the Records System (T-02, Georgian version only)
GMJ Academy: Georgian
Manager (ISCO 1342) None
Document Control Fundamentals (A-06)
GMJ Academy: English · Georgian
Manager (ISCO 1342) None

Documents: who does each step

Document Writes Approves Fills in Checks and signs Files and uploads
GOV-FRM-002 · Policy Application Audit Form
Form (record) · To check, in practice, how staff apply a sampled policy. Complete one form per policy.
Manager (ISCO 1342) Chief executive (ISCO 1120) Secretary (ISCO 3344) Manager (ISCO 1342) Secretary (ISCO 3344)
GOV-REG-002 · Policy Register
Register · The list of every policy, its owner, version, approval, review date and status.
Secretary (ISCO 3344) Chief executive (ISCO 1120) Secretary (ISCO 3344) Manager (ISCO 1342) Secretary (ISCO 3344)
GOV-PLN-002 · Quality Improvement Plan
Plan · To set out how the facility measures and improves quality in every part of the service, with responsibilities and indicators.
Chief executive (ISCO 1120) Governing body members Manager (ISCO 1342) Chief executive (ISCO 1120) Secretary (ISCO 3344)
GOV-POL-003 · Policy Development, Approval, Review and Application
Policy · To make sure policies are written, approved, kept current and applied in practice, not only filed.
Chief executive (ISCO 1120) Governing body members N/A Chief executive (ISCO 1120) Secretary (ISCO 3344)

References

  1. World Health Organization (2021). Hospital Safety Index: Guide for Evaluators, 2nd ed. Used for: Policy application and quality improvement (2.3). https://news.gmj.ge/guideline/hospital-safety-index-guide-for-evaluators-2nd-ed/
2.4
Patient Data Is Kept Secure
Humanitarian settings: MediumTransition and fragile: MustStandard: Must

Health information is protected with defined access controls and a breach response plan, using practical, achievable security measures appropriate to the facility's resources.

Humanitarian settings
Medium
Transition and fragile
Must
Standard
Must

Rating: Medium in humanitarian settings; Must in transition and fragile settings; Must in standard settings.

Why it matters. Patient health information is sensitive, and a breach can harm patients and families. Defined access controls and a breach response plan keep it protected, even in a temporary setting.

Questions the surveyor asks

  • Is access to patient data limited to staff who need it? The surveyor compares the access list with each person’s role, to check that no one can see data their job does not need. Have the information security and access control policy (DIG-POL-001) ready.
  • Is there a written plan for a data breach? The breach response procedure must name the steps, the person responsible and how a breach is reported. Have the procedure (DIG-SOP-001) ready.
  • Have the access controls and the breach plan been tested? The surveyor checks the date and result of the most recent test or review. Have the breach response test record (DIG-FRM-001) ready.

How the surveyor verifies this criterion

Sample. Review the access controls and the breach response plan currently in force.

1. Access to patient data is restricted by role.

Method. Check the access list against staff roles for a sample of systems and paper records.

Evidence to show. DIG-POL-001 Information Security and Access Control Policy.

Pass when. Every person with access has a role that needs it.

2. A breach response plan exists and is actionable.

Method. Read the procedure and check that it names the steps, the responsible person and the reporting route.

Evidence to show. DIG-SOP-001 Patient Data Breach Response Procedure.

Pass when. The procedure names who acts, what they do and how it is reported.

3. Access controls and the breach plan have been tested.

Method. Check the date and result of the most recent test or review.

Evidence to show. DIG-FRM-001 Breach Response Test Record.

Pass when. A test or review is recorded within the last 12 months, with actions closed.

Immediate fail (any one means the criterion is not met)

  • Patient records can be accessed by staff with no role-based need, and no breach response plan exists.

Staff, training and documents

Each occupation carries its ISCO-08 code. Each row is one document: read across to see who does each step. Training evidence: a verified micro-credential in your GMJ Academy micro-credential portfolio, or your own training certificate kept in the staff file.

Good practice. Access to health information is limited by role and recorded, and a breach response plan has been tested. Measures are proportionate to the facility's resources and are checked at regular intervals.

Partial because. Access controls exist for the main records system, but some records are shared informally, or the breach response plan has not been tested.

Staff responsible

Role Why it applies Level Training Documents
Chief executive ISCO 1120
ASF proposal
Carries operational accountability to the board Humanitarian: Essential
Transition: Essential
Standard: Essential
Records, Confidentiality and Data Protection (T-11)
Evidence: a verified micro-credential in your GMJ Academy micro-credential portfolio, or a training certificate in the staff file
DIG-SOP-001
DIG-FRM-001
DIG-POL-001
Manager ISCO 1342
ASF proposal
Runs the process this criterion measures Humanitarian: Essential
Transition: Essential
Standard: Essential
Records, Confidentiality and Data Protection (T-11)
Security Protocols & Incident Response (SEC-01, Georgian version only)
Evidence: a verified micro-credential in your GMJ Academy micro-credential portfolio, or a training certificate in the staff file
DIG-SOP-001
DIG-FRM-001

E-learning: who must take each course.

E-learning course Who must take Who is recommended
Records, Confidentiality and Data Protection (T-11)
GMJ Academy: English · Georgian
Manager (ISCO 1342) Chief executive (ISCO 1120)
Security Protocols & Incident Response (SEC-01, Georgian version only)
GMJ Academy: Georgian
Manager (ISCO 1342) None

Documents: who does each step

Document Writes Approves Fills in Checks and signs Files and uploads
DIG-SOP-001 · Patient Data Breach Response Procedure
Procedure (SOP) · To make sure any breach of patient information is contained, assessed, reported where required, and used to strengthen controls.
Manager (ISCO 1342) Chief executive (ISCO 1120) Manager (ISCO 1342) Chief executive (ISCO 1120) Secretary (ISCO 3344)
DIG-FRM-001 · Breach Response Test Record
Form (record) · To record the yearly test of the breach response plan: a simulated breach, the steps taken and the time to complete each step.
Manager (ISCO 1342) Chief executive (ISCO 1120) Secretary (ISCO 3344) Manager (ISCO 1342) Secretary (ISCO 3344)
DIG-POL-001 · Information Security and Access Control Policy
Policy · To protect patient health information from unauthorised access, loss, change or disclosure, using practical security measures.
Chief executive (ISCO 1120) Governing body members N/A Chief executive (ISCO 1120) Secretary (ISCO 3344)

References

  1. WHO SMART Trust. Ethical Considerations and Data Protection Principles. Used for: confidentiality, access restriction and security of health data (2.4). https://smart.who.int/trust/ethical_principles.html
  2. ISO 27799:2016. Health informatics: Information security management in health using ISO/IEC 27002. Used for: information security controls for patient data (2.4). https://www.iso.org/standard/62777.html
  3. International Agency for Research on Cancer (WHO). Confidentiality of medical records, section 3: Access to and storage of data. Used for: written list of authorised staff, lockable storage and confidential handling of records (2.4). https://gicr.iarc.who.int/static/public/docs/Confidentiality%20IACR-IARC%20(Tech%20Rep%202004-3).pdf
2.5
Records Are Kept Exactly as Long as Required
Humanitarian settings: MediumTransition and fragile: MustStandard: Must

A retention policy governs how long records are kept and how they are disposed of, aligned with a stated requirement for the country where the facility operates, not a generic assumption.

Humanitarian settings
Medium
Transition and fragile
Must
Standard
Must

Rating: Medium in humanitarian settings; Must in transition and fragile settings; Must in standard settings.

Why it matters. Keeping records forever is costly and risky, and destroying them too early can break the law and remove evidence a patient needs. A retention policy sets the period for each record type, and the disposal is recorded.

Questions the surveyor asks

  • Does every record type have a written retention period? The retention policy must list each record type with how long it is kept. Have the retention policy and the record register ready.
  • Are the periods at least as long as the national legal requirement? Each period must meet or exceed the legal minimum for the country where the facility operates. Have the national requirement cited in the policy ready.
  • Are records disposed of securely and recorded? Each disposal must record the date, the method and the person who approved it. Have the records disposal record (REC-FRM-003) ready.

How the surveyor verifies this criterion

Sample. Review the retention policy and the disposal records for the last 12 months.

1. A written retention policy sets periods for each record type.

Method. Check that the policy lists each record type with its retention period.

Evidence to show. The retention policy and the record register.

Pass when. Each record type has a stated period.

2. The periods match the national requirement.

Method. Compare the periods with the legal requirement for the country where the facility operates.

Evidence to show. The national requirement cited in the policy.

Pass when. Each period is at least the national requirement.

3. Disposal is secure and documented.

Method. Select disposal records and check the date, method and authoriser.

Evidence to show. REC-FRM-003 Records Disposal Record.

Pass when. Each disposal is recorded with its date, method and authoriser.

Immediate fail (any one means the criterion is not met)

  • Records are disposed of with no retention policy, or are destroyed before the retention period ends.

Staff, training and documents

Each occupation carries its ISCO-08 code. Each row is one document: read across to see who does each step. Training evidence: a verified micro-credential in your GMJ Academy micro-credential portfolio, or your own training certificate kept in the staff file.

Good practice. A retention policy sets a period for each record type, aligned with the national requirement. Disposal is recorded with the date, method and authorising person.

Partial because. A retention policy exists but does not set periods for each record type, or disposal is not recorded.

Staff responsible

Role Why it applies Level Training Documents
Manager ISCO 1342
ASF proposal
Runs the process this criterion measures Humanitarian: Essential
Transition: Essential
Standard: Essential
Records, Confidentiality and Data Protection (T-11)
Evidence: a verified micro-credential in your GMJ Academy micro-credential portfolio, or a training certificate in the staff file
REC-FRM-003
Secretary ISCO 3344
ASF proposal
Keeps the register and the minutes Humanitarian: Essential
Transition: Essential
Standard: Essential
Records, Confidentiality and Data Protection (T-11)
Document Control and the Records System (T-02, Georgian version only)
Evidence: a verified micro-credential in your GMJ Academy micro-credential portfolio, or a training certificate in the staff file
REC-FRM-003

E-learning: who must take each course.

E-learning course Who must take Who is recommended
Records, Confidentiality and Data Protection (T-11)
GMJ Academy: English · Georgian
Secretary (ISCO 3344) Manager (ISCO 1342)
Document Control and the Records System (T-02, Georgian version only)
GMJ Academy: Georgian
Secretary (ISCO 3344) None

Documents: who does each step

Document Writes Approves Fills in Checks and signs Files and uploads
REC-FRM-003 · Records Disposal Record
Form (record) · The record of every disposal of patient or governance records, showing that the retention period had been met and how the record was destroyed.
Manager (ISCO 1342) Chief executive (ISCO 1120) Secretary (ISCO 3344) Manager (ISCO 1342) Secretary (ISCO 3344)

References

  1. International Agency for Research on Cancer (WHO). Confidentiality of medical records, section 3: Access to and storage of data. Used for: retention of records for a stated period, secure disposal by shredding, and confidential waste (2.5). https://gicr.iarc.who.int/static/public/docs/Confidentiality%20IACR-IARC%20(Tech%20Rep%202004-3).pdf
2.6
Serious Incidents Get Properly Investigated
Humanitarian settings: MediumTransition and fragile: MustStandard: Must

Root cause analysis is used for serious incidents, with a resulting, tracked action plan — not a brief note explaining what happened without examining why it happened.

Humanitarian settings
Medium
Transition and fragile
Must
Standard
Must

Rating: Medium in humanitarian settings; Must in transition and fragile settings; Must in standard settings.

Why it matters. Root cause analysis finds why an incident happened, not who was involved. A tracked action plan that is followed through is what makes the investigation worth doing.

Questions the surveyor asks

  • Is every serious incident investigated with a root cause analysis? The analysis must find the underlying causes, not only what happened on the day. Have the root cause analysis procedure (INC-SOP-001) and the analysis records (INC-FRM-001) ready.
  • Does each investigation produce actions with an owner and a date? Every action must have a named owner and a due date in the incident action tracker (INC-REG-001).
  • Are those actions completed on time? Each action must be closed by its due date, or have a recorded reason for the delay. Check the incident action tracker (INC-REG-001).

How the surveyor verifies this criterion

Sample. Select every serious incident from the last 12 months.

1. A structured root cause analysis is used.

Method. Read the analysis for each serious incident and check that it follows the procedure.

Evidence to show. INC-SOP-001 Root Cause Analysis of Serious Incidents; INC-FRM-001 Root Cause Analysis Record.

Pass when. Each analysis follows the procedure and identifies root causes, not only the immediate event.

2. The analysis produces a tracked action plan.

Method. Check each action in the tracker for an owner, a date and a status.

Evidence to show. INC-REG-001 Incident Action Tracker.

Pass when. Every action has an owner and a date.

3. Actions are followed through to completion.

Method. Check the status of each action against its due date.

Evidence to show. INC-REG-001 Incident Action Tracker.

Pass when. Every action is closed or has a recorded reason for the delay.

Immediate fail (any one means the criterion is not met)

  • A serious incident is closed with no root cause analysis, or its action plan is left open with no owner.

Staff, training and documents

Each occupation carries its ISCO-08 code. Each row is one document: read across to see who does each step. Training evidence: a verified micro-credential in your GMJ Academy micro-credential portfolio, or your own training certificate kept in the staff file.

Good practice. Each serious incident has a root cause analysis that looks at system causes, and the action plan has owners, deadlines and follow-up. Staff who were involved take part in the review.

Partial because. Incidents are investigated and described, but the analysis stops at individual actions, or the action plan is not tracked to completion.

Staff responsible

Role Why it applies Level Training Documents
Chief executive ISCO 1120
ASF proposal
Carries operational accountability to the board Humanitarian: Essential
Transition: Essential
Standard: Essential
Incident Reporting, Just Culture and Open Disclosure (T-09)
Nonconformity, Corrective Action and Risk (T-04)
Evidence: a verified micro-credential in your GMJ Academy micro-credential portfolio, or a training certificate in the staff file
INC-SOP-001
INC-FRM-001
INC-REG-001
Manager ISCO 1342
ASF proposal
Runs the process this criterion measures Humanitarian: Essential
Transition: Essential
Standard: Essential
Incident Reporting, Just Culture and Open Disclosure (T-09)
Nonconformity, Corrective Action and Risk (T-04)
Evidence: a verified micro-credential in your GMJ Academy micro-credential portfolio, or a training certificate in the staff file
INC-SOP-001
INC-FRM-001
INC-REG-001

E-learning: who must take each course.

E-learning course Who must take Who is recommended
Incident Reporting, Just Culture and Open Disclosure (T-09)
GMJ Academy: English · Georgian
Manager (ISCO 1342) Chief executive (ISCO 1120)
Nonconformity, Corrective Action and Risk (T-04)
GMJ Academy: English · Georgian
Manager (ISCO 1342) Chief executive (ISCO 1120)

Documents: who does each step

Document Writes Approves Fills in Checks and signs Files and uploads
INC-SOP-001 · Root Cause Analysis of Serious Incidents
Procedure (SOP) · To find out why a serious incident happened, change the system so it does not happen again, and track the change until it is complete.
Manager (ISCO 1342) Chief executive (ISCO 1120) Manager (ISCO 1342) Chief executive (ISCO 1120) Secretary (ISCO 3344)
INC-FRM-001 · Root Cause Analysis Record
Form (record) · To record a serious incident review: facts, timeline, root causes, actions and the sign-off.
Manager (ISCO 1342) Chief executive (ISCO 1120) Secretary (ISCO 3344) Manager (ISCO 1342) Secretary (ISCO 3344)
INC-REG-001 · Incident Action Tracker
Register · The log of every action from a serious incident review, showing owner, due date and status until closed.
Secretary (ISCO 3344) Chief executive (ISCO 1120) Secretary (ISCO 3344) Manager (ISCO 1342) Secretary (ISCO 3344)

References

  1. World Health Organization (2021). Hospital Safety Index: Guide for Evaluators, 2nd ed. Used for: Incident review and learning (2.6). https://news.gmj.ge/guideline/hospital-safety-index-guide-for-evaluators-2nd-ed/
  2. World Health Organization (2020). Patient Engagement: Technical Series on Safer Primary Care. Used for: Learning from patient safety events (2.6). https://news.gmj.ge/guideline/patient-engagement-technical-series-on-safer-primary-care/
  3. World Health Organization (2020). Patient Engagement: Technical Series on Safer Primary Care. Used for: Patient safety learning. https://news.gmj.ge/guideline/patient-engagement-technical-series-on-safer-primary-care/
2.7
Safety Culture Is Measured
Humanitarian settings: MediumTransition and fragile: MustStandard: Must

A validated survey measures whether staff feel safe raising concerns, conducted regularly and acted on, not assumed from the absence of complaints.

Humanitarian settings
Medium
Transition and fragile
Must
Standard
Must

Rating: Medium in humanitarian settings; Must in transition and fragile settings; Must in standard settings.

Why it matters. Staff who are afraid to raise a concern will stay silent about the mistake that harms a patient. A validated survey, repeated and acted on, shows whether they feel able to speak up.

Questions the surveyor asks

  • Is the safety culture survey a recognised, validated tool? The surveyor checks that the survey is a tool that has been tested for reliability, not one made up for the facility. Have the survey template (QUA-FRM-001) and the procedure (QUA-SOP-001) ready.
  • Does the survey run on the scheduled dates? Surveys must take place on the dates set in the procedure. Have the survey records held under QUA-SOP-001 ready.
  • Are survey results reviewed and acted on? Each result that needs follow-up must have an action in the safety culture action plan register (QUA-REG-001), and staff should be able to see it.

How the surveyor verifies this criterion

Sample. Review the survey records and action plans for the last 12 months.

1. A validated safety culture survey is used.

Method. Check the survey instrument and the procedure for its use.

Evidence to show. QUA-FRM-001 Safety Culture Survey (template); QUA-SOP-001 Safety Culture Survey Procedure.

Pass when. The instrument is a recognised, validated tool and the procedure is approved.

2. The survey runs on a defined schedule.

Method. Compare the survey dates with the schedule in the procedure.

Evidence to show. Survey records held under QUA-SOP-001 .

Pass when. Surveys run on the scheduled dates.

3. Results are reviewed and acted on.

Method. Check the action register for each result that needed follow-up.

Evidence to show. QUA-REG-001 Safety Culture Action Plan Register.

Pass when. Each result has a reviewed action, and follow-up is visible to staff.

Immediate fail (any one means the criterion is not met)

  • No safety culture survey has been conducted in the last 12 months.

Staff, training and documents

Each occupation carries its ISCO-08 code. Each row is one document: read across to see who does each step. Training evidence: a verified micro-credential in your GMJ Academy micro-credential portfolio, or your own training certificate kept in the staff file.

Good practice. A validated safety culture survey is run at a fixed interval. Results are shared with staff, and the action plan that follows is tracked and reported to the governing body.

Partial because. A survey is run, but it is not validated, is not repeated at a fixed interval, or its results are not acted on.

Staff responsible

Role Why it applies Level Training Documents
Chief executive ISCO 1120
ASF proposal
Carries operational accountability to the board Humanitarian: Essential
Transition: Essential
Standard: Essential
Incident Reporting, Just Culture and Open Disclosure (T-09)
Safety Management System & Leadership (MGMT-01, Georgian version only)
Evidence: a verified micro-credential in your GMJ Academy micro-credential portfolio, or a training certificate in the staff file
QUA-SOP-001
QUA-FRM-001
QUA-REG-001
Manager ISCO 1342
ASF proposal
Runs the process this criterion measures Humanitarian: Essential
Transition: Essential
Standard: Essential
Incident Reporting, Just Culture and Open Disclosure (T-09)
Safety Management System & Leadership (MGMT-01, Georgian version only)
Evidence: a verified micro-credential in your GMJ Academy micro-credential portfolio, or a training certificate in the staff file
QUA-SOP-001
QUA-FRM-001
QUA-REG-001

E-learning: who must take each course.

E-learning course Who must take Who is recommended
Incident Reporting, Just Culture and Open Disclosure (T-09)
GMJ Academy: English · Georgian
Manager (ISCO 1342) Chief executive (ISCO 1120)
Safety Management System & Leadership (MGMT-01, Georgian version only)
GMJ Academy: Georgian
Chief executive (ISCO 1120) Manager (ISCO 1342)

Documents: who does each step

Document Writes Approves Fills in Checks and signs Files and uploads
QUA-SOP-001 · Safety Culture Survey Procedure
Procedure (SOP) · To measure whether staff feel safe to report errors and concerns, and to act on what the survey shows.
Manager (ISCO 1342) Chief executive (ISCO 1120) Manager (ISCO 1342) Chief executive (ISCO 1120) Secretary (ISCO 3344)
QUA-FRM-001 · Safety Culture Survey (template)
Form (record) · Template for the staff safety culture survey. The committee replaces the sample items below with the items of the validated tool selected, without changing its wording.
Manager (ISCO 1342) Chief executive (ISCO 1120) Secretary (ISCO 3344) Manager (ISCO 1342) Secretary (ISCO 3344)
QUA-REG-001 · Safety Culture Action Plan Register
Register · Tracks each action from the safety culture survey to completion.
Secretary (ISCO 3344) Chief executive (ISCO 1120) Secretary (ISCO 3344) Manager (ISCO 1342) Secretary (ISCO 3344)

References

  1. World Health Organization (2021). Hospital Safety Index: Guide for Evaluators, 2nd ed. Used for: Safety culture (2.7). https://news.gmj.ge/guideline/hospital-safety-index-guide-for-evaluators-2nd-ed/
2.8
Patient Experience Is Measured Continuously, Not Only After Discharge
Humanitarian settings: MinimumTransition and fragile: MediumStandard: Must

Patient experience is measured through structured, ongoing feedback during the course of care — not only through the post-discharge complaint channel required elsewhere in this document, which by definition only captures concerns raised after the fact.

Humanitarian settings
Minimum
Transition and fragile
Medium
Standard
Must

Rating: Minimum in humanitarian settings; Medium in transition and fragile settings; Must in standard settings.

Why it matters. Patients who ask only after they leave may not say what went wrong during their stay. Feedback gathered during care, while there is still time to act, improves the care the patient is actually getting.

Questions the surveyor asks

  • Is feedback collected while the patient is still in the facility? Patients should be asked for feedback during their stay, not only after they leave. Have the in-stay feedback form (CON-FRM-004) and the procedure (CON-SOP-002) ready.
  • Are patients who do not volunteer feedback also asked? The surveyor compares the number of forms with the number of patients, to check that quieter patients were asked too. Have the forms ready for the period.
  • Is the feedback used to make a change? The quarterly summary must show at least one improvement made from patient feedback. Have the patient feedback summary (QUA-REG-002) ready.

How the surveyor verifies this criterion

Sample. Review the feedback collected in the last quarter.

1. Feedback is collected during the stay.

Method. Check that the structured feedback form is used during the stay, not only after discharge.

Evidence to show. CON-FRM-004 Structured In-Stay Feedback Form; CON-SOP-002 In-Stay Patient Experience Feedback Procedure.

Pass when. Forms are completed during the stay.

2. Feedback is collected broadly.

Method. Compare the number of forms with the number of patients in the period, and check that patients who did not volunteer feedback were asked.

Evidence to show. CON-FRM-004 forms.

Pass when. Feedback is sought from patients who did not volunteer it.

3. Feedback is used to improve care.

Method. Read the quarterly summary and check for at least one improvement made from it.

Evidence to show. QUA-REG-002 Patient Feedback Summary (quarterly).

Pass when. The quarterly summary records a resulting improvement.

Immediate fail (any one means the criterion is not met)

  • Patient experience is measured only after discharge, with no feedback during the stay.

Staff, training and documents

Each occupation carries its ISCO-08 code. Each row is one document: read across to see who does each step. Training evidence: a verified micro-credential in your GMJ Academy micro-credential portfolio, or your own training certificate kept in the staff file.

Good practice. Patients are asked about their experience during their stay, through a structured method. Responses are reviewed regularly and change care while the patient is still in it.

Partial because. Feedback is collected, but only after discharge or only through complaints, so concerns raised during care are not captured.

Staff responsible

Role Why it applies Level Training Documents
Manager ISCO 1342
ASF proposal
Runs the process this criterion measures Humanitarian: Recommended
Transition: Recommended
Standard: Recommended
Complaints Handling and Patient Feedback (T-12)
Evidence: a verified micro-credential in your GMJ Academy micro-credential portfolio, or a training certificate in the staff file
CON-SOP-002
CON-FRM-004
QUA-REG-002

E-learning: who must take each course.

E-learning course Who must take Who is recommended
Complaints Handling and Patient Feedback (T-12)
GMJ Academy: English · Georgian
None Manager (ISCO 1342)

Documents: who does each step

Document Writes Approves Fills in Checks and signs Files and uploads
CON-SOP-002 · In-Stay Patient Experience Feedback Procedure
Procedure (SOP) · To learn about the patient’s experience while they are receiving care, so problems can be fixed before the patient leaves, not only through complaints after discharge.
Manager (ISCO 1342) Chief executive (ISCO 1120) Manager (ISCO 1342) Chief executive (ISCO 1120) Secretary (ISCO 3344)
CON-FRM-004 · Structured In-Stay Feedback Form
Form (record) · To record a patient’s answers to fixed questions during their stay or day-care visit. The patient may decline any question.
Manager (ISCO 1342) Chief executive (ISCO 1120) Secretary (ISCO 3344) Manager (ISCO 1342) Secretary (ISCO 3344)
QUA-REG-002 · Patient Feedback Summary (quarterly)
Register · Quarterly summary of in-stay patient feedback for each service, for the governing body.
Secretary (ISCO 3344) Chief executive (ISCO 1120) Secretary (ISCO 3344) Manager (ISCO 1342) Secretary (ISCO 3344)

References

  1. World Health Organization (2020). Patient Engagement: Technical Series on Safer Primary Care. Used for: Patient experience and feedback (2.8). https://news.gmj.ge/guideline/patient-engagement-technical-series-on-safer-primary-care/
2.9
An Ethics Consultation Process Exists
Humanitarian settings: MinimumTransition and fragile: MediumStandard: Must

Staff facing an ethical dilemma in patient care have access to a usable ethics consultation process — a committee, a named resource, or an external arrangement — not left to resolve difficult cases alone or through informal corridor conversations.

Humanitarian settings
Minimum
Transition and fragile
Medium
Standard
Must

Rating: Minimum in humanitarian settings; Medium in transition and fragile settings; Must in standard settings.

Why it matters. Clinical staff sometimes face decisions about care that are hard to make alone, such as when treatment should stop. A usable ethics consultation route gives them somewhere to go before a poor decision is made.

Questions the surveyor asks

  • Is there a route for staff to ask for an ethics consultation? The policy and terms of reference (GOV-POL-004) must name a route that staff can use, such as a committee or an outside adviser.
  • Do staff know how to request a consultation? Staff should be able to describe the steps in the procedure (GOV-SOP-002) without help.
  • Has the process been used, or is there a recorded reason it was not needed? The consultation log (GOV-REG-003) must show at least one consultation in the last 12 months, or a recorded reason none was needed.

How the surveyor verifies this criterion

Sample. Review the consultation log for the last 12 months.

1. An ethics consultation process is in place.

Method. Check the policy and the terms of reference for the committee, named resource or external arrangement.

Evidence to show. GOV-POL-004 Clinical Ethics Consultation Policy and Terms of Reference.

Pass when. The policy names a route that staff can use.

2. Staff know how to access it.

Method. Ask staff how they would request an ethics consultation.

Evidence to show. GOV-SOP-002 Ethics Consultation Procedure.

Pass when. Staff describe the route correctly.

3. The process has been used.

Method. Check the log for any consultation in the last 12 months.

Evidence to show. GOV-REG-003 Ethics Consultation Log.

Pass when. At least one consultation is recorded, or the reason none was needed is recorded.

Immediate fail (any one means the criterion is not met)

  • No ethics consultation route exists, or it has never been used.

Staff, training and documents

Each occupation carries its ISCO-08 code. Each row is one document: read across to see who does each step. Training evidence: a verified micro-credential in your GMJ Academy micro-credential portfolio, or your own training certificate kept in the staff file.

Good practice. Staff know how to request an ethics consultation, and the route is written and has been used. Consultations are logged, and the outcomes are reviewed.

Partial because. An ethics route exists on paper, but staff do not know how to use it or it has never been used.

Staff responsible

Role Why it applies Level Training Documents
Governing body members
ASF proposal
Holds the authority this criterion requires Humanitarian: Recommended
Transition: Recommended
Standard: Recommended
Healthcare Ethics for ASF Accreditation (A-07, Georgian version only)
Evidence: a verified micro-credential in your GMJ Academy micro-credential portfolio, or a training certificate in the staff file
GOV-SOP-002
GOV-POL-004
Chief executive ISCO 1120
ASF proposal
Carries operational accountability to the board Humanitarian: Recommended
Transition: Recommended
Standard: Recommended
Healthcare Ethics for ASF Accreditation (A-07, Georgian version only)
Evidence: a verified micro-credential in your GMJ Academy micro-credential portfolio, or a training certificate in the staff file
GOV-SOP-002
GOV-REG-003
GOV-POL-004

E-learning: who must take each course.

E-learning course Who must take Who is recommended
Healthcare Ethics for ASF Accreditation (A-07, Georgian version only)
GMJ Academy: Georgian
None Governing body members, Chief executive (ISCO 1120)

Documents: who does each step

Document Writes Approves Fills in Checks and signs Files and uploads
GOV-SOP-002 · Ethics Consultation Procedure
Procedure (SOP) · To describe step by step how a staff member or family asks for ethics advice and what happens next.
Chief executive (ISCO 1120) Governing body members Secretary (ISCO 3344) Chief executive (ISCO 1120) Secretary (ISCO 3344)
GOV-REG-003 · Ethics Consultation Log
Register · Records each ethics consultation, without patient identifiers, so the route can be shown to work and reviewed.
Secretary (ISCO 3344) Chief executive (ISCO 1120) Secretary (ISCO 3344) Manager (ISCO 1342) Secretary (ISCO 3344)
GOV-POL-004 · Clinical Ethics Consultation Policy and Terms of Reference
Policy · To give staff a usable route to ethical advice on difficult patient care decisions, so that they are not left to resolve these alone.
Chief executive (ISCO 1120) Governing body members N/A Chief executive (ISCO 1120) Secretary (ISCO 3344)

References

  1. Pan American Health Organization (2020). Ethics guidance for the use of scarce resources in the delivery of critical health care during the COVID-19 pandemic. Used for: Ethics support for difficult decisions (2.9). https://news.gmj.ge/guideline/ethics-guidance-for-the-use-of-scarce-resources-in-the-delivery-of-critical-health-care-during-the-covid-19-pandemic/
  2. Pan American Health Organization (2020). Template and operational guidance for the ethics review and oversight of COVID-19-related research. Used for: Ethics review and oversight process (2.9). https://news.gmj.ge/guideline/template-and-operational-guidance-for-the-ethics-review-and-oversight-of-covid-19-related-research/
  3. Pan American Health Organization (2020). Ethics guidance for the use of scarce resources in the delivery of critical health care during the COVID-19 pandemic. Used for: Ethics consultation. https://news.gmj.ge/guideline/ethics-guidance-for-the-use-of-scarce-resources-in-the-delivery-of-critical-health-care-during-the-covid-19-pandemic/
  4. Pan American Health Organization (2020). Template and operational guidance for the ethics review and oversight of COVID-19-related research. Used for: Ethics review process. https://news.gmj.ge/guideline/template-and-operational-guidance-for-the-ethics-review-and-oversight-of-covid-19-related-research/
2.10
Patients and Families Have a Voice in Governance
Humanitarian settings: MinimumTransition and fragile: MediumStandard: Must

At least one patient or family representative has a structured role in quality review or governance discussions — not a governance and quality structure that is entirely staff and board-facing, with patient input arriving only indirectly through complaints or surveys.

Humanitarian settings
Minimum
Transition and fragile
Medium
Standard
Must

Rating: Minimum in humanitarian settings; Medium in transition and fragile settings; Must in standard settings.

Why it matters. A service designed without the people who use it misses what matters to them. A patient or family representative in governance brings the view from outside the staff room.

Questions the surveyor asks

  • Is there a written role for a patient or family representative in governance? The role must be described in policy, with duties in governance or quality review (GOV-POL-005).
  • Does the representative attend and take part in discussion? The attendance register and the minutes should show that the representative speaks and contributes, not only attends (GOV-REG-004).
  • Has patient or family input changed a decision? The surveyor asks for one decision in the minutes where patient or family input shaped the outcome.

How the surveyor verifies this criterion

Sample. Review the attendance register and minutes for the last 12 months.

1. A patient or family representative has a defined role.

Method. Check the role description in the policy.

Evidence to show. GOV-POL-005 Patient and Family Representative Role in Governance.

Pass when. The role is written, with duties in governance or quality review.

2. The representative takes part in discussion.

Method. Check the attendance register and the minutes for their contributions.

Evidence to show. GOV-REG-004 Attendance Register (governance meetings); minutes.

Pass when. The representative attends and contributes, not only observes.

3. Input has changed a decision.

Method. Ask for one recorded decision where patient or family input shaped the outcome.

Evidence to show. Minutes showing the decision.

Pass when. At least one decision is traceable to patient or family input.

Immediate fail (any one means the criterion is not met)

  • No patient or family representative takes part in quality review or governance discussion.

Staff, training and documents

Each occupation carries its ISCO-08 code. Each row is one document: read across to see who does each step. Training evidence: a verified micro-credential in your GMJ Academy micro-credential portfolio, or your own training certificate kept in the staff file.

Good practice. At least one patient or family representative sits on a quality or governance committee with a written role, and their input is recorded in the minutes.

Partial because. Patient or family views reach governance only through complaints or surveys, or a representative is named but has no written role.

Staff responsible

Role Why it applies Level Training Documents
Governing body members
ASF proposal
Holds the authority this criterion requires Humanitarian: Recommended
Transition: Recommended
Standard: Recommended
Complaints Handling and Patient Feedback (T-12)
Evidence: a verified micro-credential in your GMJ Academy micro-credential portfolio, or a training certificate in the staff file
GOV-POL-005
Secretary ISCO 3344
ASF proposal
Keeps the register and the minutes Humanitarian: Recommended
Transition: Recommended
Standard: Recommended
Evidence: a verified micro-credential in your GMJ Academy micro-credential portfolio, or a training certificate in the staff file GOV-REG-004
GOV-POL-005

E-learning: who must take each course.

E-learning course Who must take Who is recommended
Complaints Handling and Patient Feedback (T-12)
GMJ Academy: English · Georgian
None Governing body members

Documents: who does each step

Document Writes Approves Fills in Checks and signs Files and uploads
GOV-REG-004 · Attendance Register (governance meetings)
Register · Records who attended each governance and quality meeting, including the patient or family representative.
Secretary (ISCO 3344) Chief executive (ISCO 1120) Secretary (ISCO 3344) Manager (ISCO 1342) Secretary (ISCO 3344)
GOV-POL-005 · Patient and Family Representative Role in Governance
Policy · To make sure patients and families have a structured role in improving governance and quality, not only indirect input through complaints and surveys.
Chief executive (ISCO 1120) Governing body members N/A Chief executive (ISCO 1120) Secretary (ISCO 3344)

References

  1. World Health Organization (2020). Patient Engagement: Technical Series on Safer Primary Care. Used for: Patient and family involvement (2.10). https://news.gmj.ge/guideline/patient-engagement-technical-series-on-safer-primary-care/

Role details: reporting, supervision and training

Each role links to its own terms of reference, which holds the full reporting line, supervision, training and competency record.

Role Reports to Supervises Core training
Chief executive ISCO 1120 The board of directors. The executive team (COO, CMO, CNO, CFO, CQO, CHRO, CIO, CSO), and the legal, data protection, compliance and communications leads. Governance & Management
Safety Management System & Leadership
Quality Management in Healthcare
Documentation Fundamentals
Records, Confidentiality and Data Protection
Incident Reporting, Just Culture and Open Disclosure
Nonconformity, Corrective Action and Risk
Healthcare Ethics for ASF Accreditation
Governing body members Shareholders or owners of the organisation. The chief executive officer. The board chair leads the board. Governance & Management
Safety Management System & Leadership
Quality Management in Healthcare
Healthcare Ethics for ASF Accreditation
Complaints Handling and Patient Feedback
Manager ISCO 1342 The chief quality and safety officer (CQO). Quality assurance, patient safety, accreditation, clinical audit, infection prevention and complaints teams. Documentation Fundamentals
Document Control and the Records System
Document Control Fundamentals
Records, Confidentiality and Data Protection
Security Protocols & Incident Response
Incident Reporting, Just Culture and Open Disclosure
Nonconformity, Corrective Action and Risk
Safety Management System & Leadership
Complaints Handling and Patient Feedback
Secretary ISCO 3344 The head of department (per specialty). No direct reports. Records, Confidentiality and Data Protection
Document Control and the Records System

Who is responsible for Standard 2

Each criterion below names the positions responsible for it.

Criterion Positions responsible or involved
2.1 The Board Is Accountable Chief executive · Governing body members · Secretary
2.2 There Is a Written Strategic Plan Chief executive · Governing body members
2.3 Policy Gets Followed Chief executive · Manager
2.4 Patient Data Is Kept Secure Chief executive · Manager
2.5 Records Are Kept Exactly as Long as Required Manager · Secretary
2.6 Serious Incidents Get Properly Investigated Chief executive · Manager
2.7 Safety Culture Is Measured Chief executive · Manager
2.8 Patient Experience Is Measured Continuously, Not Only After Discharge Manager
2.9 An Ethics Consultation Process Exists Governing body members · Chief executive
2.10 Patients and Families Have a Voice in Governance Governing body members · Secretary

Quality oversight

The quality chain keeps this standard under review, from the governing body down to the teams that run each process.

Questions and answers

The criterion text is the authority. These answers summarise it.

Do I need to meet every criterion in Standard 2?

Yes. Standard 2 is the base governance standard, so every facility meets all ten criteria, in every setting. Each criterion has its own pass rule and its own immediate-fail rule. Meeting nine out of ten does not pass the standard: a failure on any one criterion means that criterion is not met. Because the criteria are separate, the facility should check each one against its own evidence rather than assuming that good practice in one area covers another. The rating shown on each criterion tells you how strict the requirement is in humanitarian, transition and fragile, and standard settings.

What is an immediate fail?

An immediate fail is one event or finding that means a criterion is not met, even if everything else in that criterion is in place. For example, if the governing body has no minutes for the last 12 months, criterion 2.1 fails outright, whatever the quality of the terms of reference. Each criterion on this page lists its own immediate fail under “Immediate fail”. Facilities should read these before the survey, because they are the points on which the outcome is decided most quickly.

Which documents do I submit?

The documents are the forms, policies and procedures listed under each criterion in the “Documents: who does each step” table. Registers and records, such as the Register of Governing Body Members (GOV-REG-001) or the Incident Action Tracker (INC-REG-001), are kept as working files with one row for each entry. Policies and procedures are signed documents that show the version, date, owner and approver. Upload or have them ready before the survey, and check that each one covers the period stated in its criterion, usually the last 12 months. You may use your own document if it meets the same check, as long as it is clearly the same record.

What must the governing body record?

The governing body must have named members with written terms of office, a set of terms of reference that gives it authority over safety, quality, clinical governance and finance, and minutes for every scheduled meeting. The terms of reference are GOV-POL-001, the register of members is GOV-REG-001, and the minutes use the template GOV-FRM-003. The minutes must show that quality, safety and financial oversight were on the agenda and that decisions were followed up at the next meeting, because a body that meets without recording what it decided cannot show that it governs.

What must the strategic plan include?

The written strategic plan (template GOV-PLN-001) must set out the facility’s mission and values, and it must cover several years rather than a single year. It should be possible to trace resourcing decisions back to the plan: when the budget or a staffing decision is made, the minutes or decision record should show how it follows from the plan. The plan is supported by a code of conduct for staff behaviour (GOV-POL-002), which sets out the values in practice. A mission statement with no values, no code of conduct and no link to budget decisions does not meet the criterion.

How is policy application checked?

The criterion has three checks. First, staff can describe how a named policy is applied in their daily work, not only confirm that it exists. Second, adherence is checked, using the Policy Application Audit Form (GOV-FRM-002), and any gap has a defined response. Third, the quality improvement plan is complete, authorised and reviewed, covering every service in the facility, with named owners and dates (GOV-PLN-002). The policy framework itself is in GOV-POL-003 and the register of policies in GOV-REG-002. A policy that is filed but not followed fails this criterion.

How is patient data protected?

Access to patient health information must be restricted by role, so that only staff with a current need can open a record, and the access must be recorded. The breach response procedure (DIG-SOP-001) sets out what happens if information is lost, shared in error or accessed without need, and it must be tested. The test is recorded on the Breach Response Test Record (DIG-FRM-001), and the rules themselves are in the Information Security and Access Control Policy (DIG-POL-001). A facility with a breach plan on paper that has never been tested cannot show that the plan works.

How long do we keep records?

Each record type should have a stated retention period, set by the national requirement for the country where the facility operates. A written retention policy must give a period for each type of record, not a single general period. When records are disposed of, the disposal must be secure and documented on the Records Disposal Record (REC-FRM-003), showing the date, method and the person who authorised it. Records destroyed before their retention period ends, or disposed of with no policy at all, fail the criterion.

How are serious incidents investigated?

Every serious incident must go through a structured root cause analysis (INC-SOP-001), recorded on the Root Cause Analysis Record (INC-FRM-001). The analysis looks at why the incident happened, not who was involved, and it produces an action plan. Each action is tracked on the Incident Action Tracker (INC-REG-001) until it is completed. A serious incident that is closed with no analysis, or whose action plan is left open with no owner, is an immediate fail, so the surveyor will usually select incidents from the last 12 months and check the full trail for each one.

How is safety culture measured?

A safety culture survey must use a validated tool, run on a defined schedule (QUA-SOP-001), and recorded on the survey template (QUA-FRM-001). Results must be reviewed and acted on, and each action is tracked on the Safety Culture Action Plan Register (QUA-REG-001). A survey that is not validated, is not repeated on schedule, or has no action after the results is not enough. If no survey has been run in the last 12 months, the criterion fails immediately.

How is patient experience measured during care?

The criterion expects feedback from patients while they are still in the facility, so that problems can be fixed during the stay. Feedback is collected with the structured in-stay form (CON-FRM-004), following the in-stay procedure (CON-SOP-002). It should be gathered from a broad range of patients, not only the most satisfied ones, and the results are summarised each quarter (QUA-REG-002). The post-discharge complaint route is still needed, but it does not replace feedback during care. A facility that measures only after discharge fails this criterion.

How can staff get an ethics consultation?

Staff facing a difficult decision in patient care, such as when treatment should stop, must have a usable route to an ethics consultation. The route is set out in the Ethics Consultation Procedure (GOV-SOP-002) and the Clinical Ethics Consultation Policy (GOV-POL-004). Each consultation is logged on the Ethics Consultation Log (GOV-REG-003). The surveyor will check that staff know how to use the route, not only that a policy exists, and that the route has actually been used. A route that exists on paper but has never been used does not meet the criterion.

How do patients and families take part in governance?

At least one patient or family representative must have a defined role in quality review or governance discussion. The role is set out in the Patient and Family Representative Role policy (GOV-POL-005), and attendance is recorded on the governance attendance register (GOV-REG-004). The representative should take part in the discussion, and the minutes should show that their input was considered and, where relevant, changed a decision. A representative who is named but does not take part, or no representative at all, fails the criterion.

What do the colours mean?

Red means Must: the criterion is required in every setting, and criteria that protect life are always red. Yellow means Medium: the criterion is required, but adapted to what a transition setting can realistically do. Green means Minimum: the lowest acceptable level in a humanitarian setting, where resources are very limited. In standard settings every criterion is Must. Each criterion shows its rating for each of the three settings, so a facility can see exactly what applies to it.

Do we have to use your forms and policies?

No. Every policy, procedure, form and course on this page is a reference draft to help you meet the criterion. You can adapt it to your facility, write your own, or upload your own documents. What the assessor checks is that the standard is met and that you can show how. If you use your own document, make sure it covers the same content as the reference and that it is current, signed and dated, so that the assessor can match it to the criterion without difficulty.

What does essential or recommended training mean for my staff?

In the training tables, red means essential: the course is required for that role in that setting. Green means recommended: the course is advised for that role. Yellow means optional. Each course shows its level for humanitarian, transition and fragile, and standard settings, because the requirement can differ between them. Staff evidence is a verified micro-credential in the GMJ Academy micro-credential portfolio, or a training certificate kept in the staff file.

Do we have to use ISCO-08 codes?

The staff tables give each occupation its ISCO-08 code, so that roles can be compared between facilities and countries. You are not required to change your job titles. What matters is that each role named in the standard can be matched to the person who does that job and to the training they have had. If your titles differ, record the match in your staff file so that the assessor can follow it.

Which training do staff need?

The e-learning table under each criterion shows who must take each course and who is recommended. The table is read together with the staff table, which shows the level for each setting. Staff can show evidence through a verified micro-credential in the GMJ Academy micro-credential portfolio, or through a training certificate kept in the staff file.

What will the surveyor see on the day?

The surveyor works through the criteria, following the “Sample” and “Checks” given for each one. For example, for the governance criteria the surveyor reviews the last 12 months of minutes, the terms of reference and the policy register, and checks how they match practice. The surveyor may also speak with staff to test whether they understand the policies and their own roles, and may look at records and practice directly. The surveyor records whether each check is passed and whether any immediate-fail rule applies. Accreditation surveys commonly follow the patient or a process through the facility (a “tracer”) to see how the standards work in practice.

How does the surveyor choose which records to check?

Each criterion states its own sample, such as “Select every serious incident from the last 12 months” or “Select three policies at random”. The surveyor uses the sample given on the criterion page rather than choosing records to suit the facility. Preparing for the survey means keeping the records for the whole period stated, organised so that any item in the sample can be produced quickly. A facility that cannot produce the sampled records loses the criterion, whatever else it has in place.

What if we do not have the written protocol yet?

A criterion cannot be met on the basis of an unwritten or informal arrangement, because the assessor needs something to check against. If a protocol does not yet exist, write one before the survey, using the reference draft or your own version, and make sure it is signed, dated and in use. Staff must be able to explain it in practice.

Where can I get the full text?

The full text of each criterion, with its rating, why it matters, the assessor checks, the immediate-fail rule and the documents, is on this page. A PDF with the same criteria, for printing and for assessors, can be downloaded from the box at the top of this page. The questions and answers on this page summarise the criteria, and if they ever differ, the criterion text is the authority.

Who can I ask about this standard?

For questions about this standard, contact Accréditation Sans Frontières through the Contact page of this website. Please give the standard number and the criterion (for example 2.4) so that your question can be answered against the right text.

E-learning by standard

These are the GMJ Academy courses named in the criteria of this standard. Each course name opens the course page in the academy. Where a course is published in English and in Georgian, both versions are linked. Evidence of completion is a verified micro-credential in the GMJ Academy micro-credential portfolio, or a training certificate in the staff file.

E-learning course Who must take Who is recommended Criteria
Governance & Management (H-07)
GMJ Academy: English · Georgian
Chief executive (ISCO 1120), Governing body members None 2.1
Safety Management System & Leadership (MGMT-01, Georgian version only)
GMJ Academy: Georgian
Chief executive (ISCO 1120) Governing body members 2.1, 2.2, 2.7
Quality Management in Healthcare (A-02, Georgian version only)
GMJ Academy: Georgian
Chief executive (ISCO 1120) Governing body members 2.2
Documentation Fundamentals (A-03, Georgian version only)
GMJ Academy: Georgian
Manager (ISCO 1342) Chief executive (ISCO 1120) 2.3
Document Control and the Records System (T-02, Georgian version only)
GMJ Academy: Georgian
Manager (ISCO 1342) None 2.3, 2.5
Document Control Fundamentals (A-06)
GMJ Academy: English · Georgian
Manager (ISCO 1342) None 2.3
Records, Confidentiality and Data Protection (T-11)
GMJ Academy: English · Georgian
Manager (ISCO 1342) Chief executive (ISCO 1120) 2.4, 2.5
Security Protocols & Incident Response (SEC-01, Georgian version only)
GMJ Academy: Georgian
Manager (ISCO 1342) None 2.4
Incident Reporting, Just Culture and Open Disclosure (T-09)
GMJ Academy: English · Georgian
Manager (ISCO 1342) Chief executive (ISCO 1120) 2.6, 2.7
Nonconformity, Corrective Action and Risk (T-04)
GMJ Academy: English · Georgian
Manager (ISCO 1342) Chief executive (ISCO 1120) 2.6
Complaints Handling and Patient Feedback (T-12)
GMJ Academy: English · Georgian
None Manager (ISCO 1342) 2.8, 2.10
Healthcare Ethics for ASF Accreditation (A-07, Georgian version only)
GMJ Academy: Georgian
None Governing body members, Chief executive (ISCO 1120) 2.9

Related courses in the GMJ Academy

These courses cover the same subjects in more depth or for a specific type of facility. They are optional. They are not required by the criteria.

Course Subject Criteria
Governance & Management for Ambulatory Clinics (AMB-07)
GMJ Academy: English · Georgian
Governance course for your facility type 2.1
Governance & Staffing for Small Primary Care Practices (PHC-07)
GMJ Academy: English · Georgian
Governance course for your facility type 2.1
Governance & Staffing for Long-Term Care Accreditation (LTC-07)
GMJ Academy: English · Georgian
Governance course for your facility type 2.1
Governance & Staffing for Home-Based Care (HC-07)
GMJ Academy: English · Georgian
Governance course for your facility type 2.1
Governance & Provider Credentialing for Telemedicine (TM-07)
GMJ Academy: English · Georgian
Governance course for your facility type 2.1
Governance & Document Control for Laboratory Accreditation (LAB-01)
GMJ Academy: English · Georgian
Governance course for your facility type 2.1
Governance & Management for ASF Accreditation (MT-07)
GMJ Academy: English · Georgian
Governance course for your facility type 2.1
Leadership, policy, objectives and management review (T-02)
GMJ Academy: English
Leadership, policy and management review 2.2, 2.3
Management Review: Inputs, Outputs, and Real Decisions (T-05)
GMJ Academy: English · Georgian
Leadership, policy and management review 2.2, 2.3
Understanding ISO 9001 in a Clinic (T-01)
GMJ Academy: English · Georgian
Leadership, policy and management review 2.2, 2.3
Document Control and Record Management (ISO-04)
GMJ Academy: English
Document and record control 2.3, 2.5
Data Privacy & Patient Confidentiality (TM-06)
GMJ Academy: English · Georgian
Data privacy and system security 2.4
Technology Platform Reliability & Security (TM-01)
GMJ Academy: English · Georgian
Data privacy and system security 2.4
Nonconformity, Corrective Action and CAPA (ISO-10)
GMJ Academy: English
Corrective action, risk and audit 2.6
Risk-Based Thinking and the Risk Register (ISO-05)
GMJ Academy: English
Corrective action, risk and audit 2.6
Internal Audit — Planning, Performing, Reporting (T-03)
GMJ Academy: English · Georgian
Corrective action, risk and audit 2.6
Raising and Resolving Workplace Concerns
GMJ Academy: English
Staff voice and workplace concerns 2.7
Workforce Feedback and Action (BAS-13)
GMJ Academy: English
Staff voice and workplace concerns 2.7
Customer Satisfaction and Complaints (ISO-11)
GMJ Academy: English
Patient feedback and patient representatives 2.8, 2.10
PC-01: Patient Council Chair Training (PC-01)
GMJ Academy: English · Georgian
Patient feedback and patient representatives 2.8, 2.10
Patient Identification, Informed Consent and Patient Rights (T-07)
GMJ Academy: English · Georgian
Consent, rights and difficult care decisions 2.9
Withdrawal of Care and End-of-Life Decisions (WD-01)
GMJ Academy: English
Consent, rights and difficult care decisions 2.9

Back to ASF Health Standards V11 · Standards Map · E-learning by standard · References

References and guidelines for this standard

The guidelines and references cited in the criteria above are listed here. Each link opens the full text.

  1. World Health Organization (2021). Hospital Safety Index: Guide for Evaluators, 2nd ed. Used for: Board oversight of safety and quality (2.1). https://news.gmj.ge/guideline/hospital-safety-index-guide-for-evaluators-2nd-ed/
  2. WHO SMART Trust. Ethical Considerations and Data Protection Principles. Used for: confidentiality, access restriction and security of health data (2.4). https://smart.who.int/trust/ethical_principles.html
  3. ISO 27799:2016. Health informatics: Information security management in health using ISO/IEC 27002. Used for: information security controls for patient data (2.4). https://www.iso.org/standard/62777.html
  4. International Agency for Research on Cancer (WHO). Confidentiality of medical records, section 3: Access to and storage of data. Used for: written list of authorised staff, lockable storage and confidential handling of records (2.4). https://gicr.iarc.who.int/static/public/docs/Confidentiality%20IACR-IARC%20(Tech%20Rep%202004-3).pdf
  5. World Health Organization (2020). Patient Engagement: Technical Series on Safer Primary Care. Used for: Learning from patient safety events (2.6). https://news.gmj.ge/guideline/patient-engagement-technical-series-on-safer-primary-care/
  6. Pan American Health Organization (2020). Ethics guidance for the use of scarce resources in the delivery of critical health care during the COVID-19 pandemic. Used for: Ethics support for difficult decisions (2.9). https://news.gmj.ge/guideline/ethics-guidance-for-the-use-of-scarce-resources-in-the-delivery-of-critical-health-care-during-the-covid-19-pandemic/
  7. Pan American Health Organization (2020). Template and operational guidance for the ethics review and oversight of COVID-19-related research. Used for: Ethics review and oversight process (2.9). https://news.gmj.ge/guideline/template-and-operational-guidance-for-the-ethics-review-and-oversight-of-covid-19-related-research/