Accréditation Sans Frontières

International Accreditation of Healthcare Facilities

Ambulatory Clinic Standards · Standard 7

Governance & Management

ASF-AMB-STD3-v3.0  ·  Published  ·  12 September 2026  ·  287 pages  ·  27 chapters

STANDARD 7

Governance & Management

MANDATORY

9 criteria

  Standard 7.1 NON-NEGOTIABLE · Standard 7: Governance & Management
Leadership Is Real and Accountable
ASSESSMENT
ASF-AMB-STD7-v3.0
ISO 9001:2015 §5 Leadership
CR ADAPTED TR FULL SM ADAPTED ST FULL
7.1
NON-NEGOTIABLE
L1
THE STANDARD
Leadership Is Real and Accountable
The clinic has clear, named clinical and operational leadership with defined authority over safety and quality — not an informal arrangement functioning without real oversight structure.
CLINIC SELF-ASSESSMENT Tick YES, PARTIAL, or NO for each question.
1 Is there a named person with defined authority over clinical safety and quality?
A specific name and defined authority, not an informal arrangement.
Doc: Leadership structure document
YES PARTIAL NO
2 Does this person actively review quality and safety matters, not only administrative ones?
Genuine engagement with quality, not administration alone.
Doc: Quality review record
YES PARTIAL NO
3 Is there a documented process for raising a safety concern to this leadership?
A specific, known pathway, not an assumption someone would eventually hear about it.
Doc: Escalation pathway document
YES PARTIAL NO

ALL YES Standard likely met. ANY PARTIAL Improvement plan required. ANY NO Blocks accreditation until resolved.

WHAT THE ASSESSOR DOES ON SITE no surprises, no hidden checks
DOCUMENT
Leadership structure review
Reviews the named leadership structure and defined authority.
ASK
Leadership engagement interview
Asks the named leader to describe a recent quality or safety issue they addressed.
OBSERVE
Escalation pathway check
Checks whether staff know how to raise a safety concern to leadership.

REFERENCES

  1. [35] Jha AK, Epstein AM. Hospital governance and the quality of care. Health Aff (Millwood). 2010;29(1):182-187.
  Standard 7.1 · Standard 7: Governance & Management
Guidance & Learning
GUIDANCE
ASF-AMB-STD7-v3.0
ISO 9001:2015 §5 Leadership
WHY THIS STANDARD EXISTS

Without clear leadership accountability, there is no mechanism above day-to-day clinical activity responsible for safety and quality — a small clinic can drift without anyone noticing precisely because no one is specifically responsible for noticing. For a genuine solo practitioner, Adapted does not mean this requirement is waived — it means the practitioner explicitly, formally acknowledges in writing that they hold this responsibility themselves, rather than it remaining an unstated assumption. For a small team of two to five, Adapted means one person is clearly named, even if that person also does clinical work.

The evidence: [35] Jha AK, Epstein AM. Hospital governance and the quality of care. Health Aff (Millwood). 2010;29(1):182-187.
WHAT GOOD LOOKS LIKE
✓ A named person holds clear, defined safety and quality authority.
✓ This person actively engages with real quality and safety matters.
✓ Staff know a specific pathway for raising a safety concern.
WHAT FAILURE LOOKS LIKE
✗ No specific person holds this authority; it's informally diffuse.
✗ Leadership engagement is limited to administrative matters.
✗ Staff are unsure how a safety concern would ever reach leadership.
MOST COMMON REASONS CLINICS SCORE PARTIAL

1 A named leader exists but spends most time on clinical duties, with little time for oversight.

A title without real time devoted to the function provides limited real oversight.

2 An escalation pathway exists but has never actually been used or tested.

An untested pathway may not translate smoothly into real use.

3 Leadership reviews quality data but rarely acts visibly on findings.

Review without visible action provides limited real improvement.

HOW TO IMPLEMENT IF YOU ARE STARTING FROM ZERO

Week 1 Confirm and document named leadership and defined authority.

Week 2 Establish a specific, communicated escalation pathway for safety concerns.

Week 3 Build genuine time for quality and safety oversight into leadership's role.

Ongoing Track leadership follow-through on identified issues.

For Micro (solo) Write a single, dated statement naming yourself as the accountable person for safety and quality at this practice, and set a recurring time on your own calendar to actually act on it — this alone satisfies the requirement genuinely.

FOR SURVEYORS — WHAT IS NOT OBVIOUS

Ask the named leader for a specific, real example of addressing a safety issue.

A real example reveals genuine engagement versus a title alone.

Ask front-line staff how they'd escalate a concern.

Staff-side confirmation reveals whether the pathway genuinely functions.

E-LEARNING academy.gmj.ge/amb-std7-1-leadership — 30 min · complete before self-assessment
  Standard 7.2 NON-NEGOTIABLE · Standard 7: Governance & Management
Policy Actually Gets Followed
ASSESSMENT
ASF-AMB-STD7-v3.0
ISO 9001:2015 §7 Support
CR FULL TR FULL SM FULL ST FULL
7.2
NON-NEGOTIABLE
L1
THE STANDARD
Policy Actually Gets Followed
A policy framework exists and staff can describe how it's genuinely applied in practice, not merely confirm that policies are filed and technically available.
CLINIC SELF-ASSESSMENT Tick YES, PARTIAL, or NO for each question.
1 Can staff describe how a specific, named policy is actually applied in their daily work?
Not whether they know a policy exists — whether they can describe applying it.
Doc: N/A — tested directly
YES PARTIAL NO
2 Is there a mechanism to check policy adherence, not just policy existence?
A genuine audit or spot-check process, distinct from confirming documents are filed.
Doc: Policy adherence audit record
YES PARTIAL NO
3 When a policy-practice gap is found, is there a defined response?
Identifying a gap without addressing it provides limited real value.
Doc: Gap resolution record
YES PARTIAL NO

ALL YES Standard likely met. ANY PARTIAL Improvement plan required. ANY NO Blocks accreditation until resolved.

WHAT THE ASSESSOR DOES ON SITE no surprises, no hidden checks
ASK
Staff application interview
Asks staff to describe how they actually apply a specific named policy.
DOCUMENT
Adherence audit review
Checks for evidence of a process verifying policy adherence.
OBSERVE
Practice-policy comparison
Observes an area and compares actual behaviour against stated policy.

REFERENCES

  1. [36] Policy-practice gaps are consistently identified in healthcare quality literature as a distinct failure mode from policy absence.
  Standard 7.2 · Standard 7: Governance & Management
Guidance & Learning
GUIDANCE
ASF-AMB-STD7-v3.0
ISO 9001:2015 §7 Support
WHY THIS STANDARD EXISTS

A policy nobody follows provides the appearance of governance without its function — the real question is whether staff behaviour actually reflects it, which is a fundamentally different, harder thing to verify than confirming a document exists.

The evidence: [36] Policy-practice gaps are consistently identified in healthcare quality literature as a distinct failure mode from policy absence.
WHAT GOOD LOOKS LIKE
✓ Staff describe genuine application of policy in their actual work.
✓ A real adherence-checking mechanism exists.
✓ Identified gaps trigger a defined, followed response.
WHAT FAILURE LOOKS LIKE
✗ Staff confirm policies exist but cannot describe how they apply.
✗ No mechanism exists to verify adherence beyond filing.
✗ Known gaps persist without any response.
MOST COMMON REASONS CLINICS SCORE PARTIAL

1 Policies are followed for established practices but not consistently for newer ones.

Habit reinforces old adherence; new policies need active reinforcement.

2 An adherence check exists but only samples an easily-prepared subset.

A narrow or predictable scope can miss where real gaps live.

3 Gaps are identified but corrective action isn't tracked to completion.

Identification without follow-through leaves the underlying gap unresolved.

HOW TO IMPLEMENT IF YOU ARE STARTING FROM ZERO

Week 1 Select key policies and ask a sample of staff to describe actual application.

Week 2 Establish a genuine adherence-checking mechanism.

Week 3 Build a tracked resolution process for identified gaps.

Ongoing Rotate which policies get checked.

FOR SURVEYORS — WHAT IS NOT OBVIOUS

Ask about application, not existence.

These surface very different answers.

Pick a policy area to observe directly, not just review on paper.

Direct observation reveals gaps document review cannot.

E-LEARNING academy.gmj.ge/amb-std7-2-policy-adherence — 30 min · complete before self-assessment
  Standard 7.3 NON-NEGOTIABLE · Standard 7: Governance & Management
Patient Information Stays Private
ASSESSMENT
ASF-AMB-STD7-v3.0
CR FULL TR FULL SM FULL ST FULL
7.3
NON-NEGOTIABLE
L1
THE STANDARD
Patient Information Stays Private
Confidentiality is protected physically and culturally throughout the clinic, not only referenced in a written policy that doesn't translate into actual practice.
CLINIC SELF-ASSESSMENT Tick YES, PARTIAL, or NO for each question.
1 Are screens and monitors positioned so patient information isn't visible to others?
Physical positioning, checked directly.
Doc: Photo audit of screen positioning
YES PARTIAL NO
2 Are clinical conversations conducted where they can't be overheard?
Doors or private spaces genuinely used, not just available.
Doc: N/A — tested directly
YES PARTIAL NO
3 Do staff apply confidentiality practices consistently, not only when reminded?
Habitual, not situational.
Doc: N/A — tested directly
YES PARTIAL NO

ALL YES Standard likely met. ANY PARTIAL Improvement plan required. ANY NO Blocks accreditation until resolved.

WHAT THE ASSESSOR DOES ON SITE no surprises, no hidden checks
OBSERVE
Physical privacy check
Walks through patient-facing areas checking screen positioning and conversation privacy.
OBSERVE
Conversation audibility check
Checks whether conversations can be overheard from adjacent areas.
ASK
Staff practice interview
Asks staff to describe specific privacy practices.

REFERENCES

  1. [37] Patient confidentiality protection frameworks consistently identify physical environment design and staff behaviour, not policy documentation alone, as the practical determinants of actual privacy protection.
  Standard 7.3 · Standard 7: Governance & Management
Guidance & Learning
GUIDANCE
ASF-AMB-STD7-v3.0
WHY THIS STANDARD EXISTS

A confidentiality policy that exists on paper while screens face waiting areas and conversations happen within earshot provides no real protection.

The evidence: [37] Patient confidentiality protection frameworks consistently identify physical environment design and staff behaviour, not policy documentation alone, as the practical determinants of actual privacy protection.
WHAT GOOD LOOKS LIKE
✓ Screens are consistently positioned away from public view.
✓ Clinical conversations happen in genuinely private spaces.
✓ Staff describe habitual privacy practices without prompting.
WHAT FAILURE LOOKS LIKE
✗ Screens face waiting areas, visible to anyone passing.
✗ Conversations are regularly audible to other patients.
✗ Staff can cite policy but describe no specific habits.
MOST COMMON REASONS CLINICS SCORE PARTIAL

1 Physical privacy is good in exam rooms but overlooked at the reception counter.

Privacy protection is often strongest where it was deliberately designed.

2 Staff are conscientious when reminded but inconsistent otherwise.

Habitual practice is more reliable than reminded practice.

3 A private space exists but isn't consistently used under time pressure.

Infrastructure for privacy doesn't guarantee its use during a busy day.

HOW TO IMPLEMENT IF YOU ARE STARTING FROM ZERO

Week 1 Audit screen positioning and conversation privacy across all patient-facing areas.

Week 2 Reposition screens and reinforce private space use where gaps are found.

Week 3 Brief staff on habitual, not just reminded, confidentiality practice.

Ongoing Spot-check physical privacy periodically.

FOR SURVEYORS — WHAT IS NOT OBVIOUS

Walk the space as a visitor would.

A familiar routine can make an obvious privacy gap invisible to staff.

Ask staff for specific examples of their own privacy practices.

Specific habits reveal genuine internalisation better than reciting policy.

E-LEARNING academy.gmj.ge/amb-std7-3-confidentiality — 30 min · complete before self-assessment
  Standard 7.4 NON-NEGOTIABLE · Standard 7: Governance & Management
Medical Records Are Complete and Secure
ASSESSMENT
ASF-AMB-STD7-v3.0
ISO 9001:2015 §7 Support
CR ADAPTED TR FULL SM FULL ST FULL
7.4
NON-NEGOTIABLE
L1
THE STANDARD
Medical Records Are Complete and Secure
Records contain all mandatory elements, are regularly audited for completeness, and are protected by access controls and a genuine breach response plan.
CLINIC SELF-ASSESSMENT Tick YES, PARTIAL, or NO for each question.
1 Is there a defined list of mandatory record elements, audited regularly?
A specific, checkable list and genuine audit, not assumed completeness.
Doc: Mandatory elements list and audit record
YES PARTIAL NO
2 Are access controls in place restricting data access to staff who need it for their role?
Role-based restriction, not general access available to anyone.
Doc: Access control policy and implementation
YES PARTIAL NO
3 Is there a documented, specific breach response plan?
A named process, not a general statement of concern.
Doc: Breach response plan document
YES PARTIAL NO

ALL YES Standard likely met. ANY PARTIAL Improvement plan required. ANY NO Blocks accreditation until resolved.

WHAT THE ASSESSOR DOES ON SITE no surprises, no hidden checks
DOCUMENT
Completeness audit review
Reviews audit records for genuine, regular practice.
DOCUMENT
Access control review
Reviews access control policy against actual staff access levels.
DOCUMENT
Breach response plan check
Reviews the plan for specificity and actionable steps.

REFERENCES

  1. [38] Health information security frameworks consistently identify access control and incident response planning, rather than technology sophistication alone, as the primary determinants of practical data protection in resource-constrained settings.
  Standard 7.4 · Standard 7: Governance & Management
Guidance & Learning
GUIDANCE
ASF-AMB-STD7-v3.0
ISO 9001:2015 §7 Support
WHY THIS STANDARD EXISTS

An incomplete or insecure record is a quiet risk — the information a future clinician needs might simply not be there, or might be exposed to someone with no legitimate need to see it.

The evidence: [38] Health information security frameworks consistently identify access control and incident response planning, rather than technology sophistication alone, as the primary determinants of practical data protection in resource-constrained settings.
WHAT GOOD LOOKS LIKE
✓ Regular, genuine completeness audits are conducted.
✓ Access controls are genuinely role-based.
✓ A specific, actionable breach response plan exists.
WHAT FAILURE LOOKS LIKE
✗ No audit process exists, or completeness is assumed.
✗ Data access is broadly available regardless of role.
✗ No breach response plan exists beyond vague concern.
MOST COMMON REASONS CLINICS SCORE PARTIAL

1 Audits happen but only sample a small, unrepresentative set of records.

A narrow sample can miss where real gaps concentrate.

2 Access controls exist for electronic records but not physical files.

Security attention often concentrates on digital systems.

3 A breach plan exists but has never been reviewed since written.

An unreviewed plan may not reflect current systems or risk.

HOW TO IMPLEMENT IF YOU ARE STARTING FROM ZERO

Week 1 Review the mandatory elements list and recent audit practice.

Week 2 Establish a genuine, regular completeness audit.

Week 3 Review access controls against actual staff roles.

Ongoing Review the breach response plan periodically.

FOR SURVEYORS — WHAT IS NOT OBVIOUS

Ask for actual audit records, not a description of intended process.

Dated findings are the only real evidence.

Check physical record access, not only electronic systems.

Security attention often skews toward digital systems while physical files remain loosely controlled.

E-LEARNING academy.gmj.ge/amb-std7-4-records-security — 30 min · complete before self-assessment
  Standard 7.5 NON-NEGOTIABLE · Standard 7: Governance & Management
Incidents Are Actually Reported
ASSESSMENT
ASF-AMB-STD7-v3.0
ISO 9001:2015 §10 Improvement
CR FULL TR FULL SM FULL ST FULL
7.5
NON-NEGOTIABLE
L1
THE STANDARD
Incidents Are Actually Reported
An accessible incident reporting system exists and staff genuinely use it — measured by real reporting volume and pattern, not merely by the system's technical availability.
CLINIC SELF-ASSESSMENT Tick YES, PARTIAL, or NO for each question.
1 Is the incident reporting system genuinely accessible to all staff?
Accessible at the point of work, not buried in an administrative system.
Doc: Reporting system access description
YES PARTIAL NO
2 Does actual reporting volume suggest genuine use?
A system receiving almost no reports over time suggests a use problem, not perfect safety.
Doc: Reporting volume data over time
YES PARTIAL NO
3 Do staff believe they can report without fear of punitive consequence?
Genuine psychological safety, not just a stated non-punitive policy.
Doc: N/A — tested directly
YES PARTIAL NO

ALL YES Standard likely met. ANY PARTIAL Improvement plan required. ANY NO Blocks accreditation until resolved.

WHAT THE ASSESSOR DOES ON SITE no surprises, no hidden checks
DOCUMENT
Reporting volume review
Reviews reporting volume and pattern over time for genuine use.
ASK
Psychological safety interview
Asks staff directly whether they feel safe reporting an incident, including one they caused.
OBSERVE
System accessibility check
Checks how accessible the reporting mechanism is at the actual point of work.

REFERENCES

  1. [39] Incident reporting culture, specifically the psychological safety staff feel around reporting without fear of punitive consequence, is consistently identified as the primary determinant of reporting volume, more so than system accessibility alone.
  Standard 7.5 · Standard 7: Governance & Management
Guidance & Learning
GUIDANCE
ASF-AMB-STD7-v3.0
ISO 9001:2015 §10 Improvement
WHY THIS STANDARD EXISTS

An incident reporting system nobody uses provides no safety value regardless of how well-designed it is — the real barrier to reporting is almost always fear of blame, not the mechanics of the form.

The evidence: [39] Incident reporting culture, specifically the psychological safety staff feel around reporting without fear of punitive consequence, is consistently identified as the primary determinant of reporting volume, more so than system accessibility alone.
WHAT GOOD LOOKS LIKE
✓ Reporting volume reflects genuine, ongoing use.
✓ Staff describe genuine confidence in reporting without punitive consequence.
✓ The system is accessible at the point of work.
WHAT FAILURE LOOKS LIKE
✗ Reporting volume is minimal or has dropped sharply with no explanation.
✗ Staff describe fear of blame as a reason they hesitate to report.
✗ The system is difficult to access in practice.
MOST COMMON REASONS CLINICS SCORE PARTIAL

1 Reporting happens for minor incidents but staff hesitate to report their own errors.

Psychological safety often varies by perceived personal exposure.

2 Senior staff report reliably; junior staff report far less.

Hierarchy can create very different real experiences within the same clinic.

3 A non-punitive policy exists but staff recall a past incident where reporting led to consequences.

A single remembered punitive response can undermine trust for a long time afterward.

HOW TO IMPLEMENT IF YOU ARE STARTING FROM ZERO

Week 1 Review reporting volume trends for concerning patterns.

Week 2 Interview a cross-section of staff, including junior staff, about reporting confidence.

Week 3 Address any specific past incident undermining psychological safety.

Ongoing Track reporting volume, investigating any significant drop.

FOR SURVEYORS — WHAT IS NOT OBVIOUS

Ask junior staff specifically, not only senior staff.

Hierarchy can create very different real experiences.

Ask about reporting one's own error specifically.

Self-reporting confidence is usually the harder, more revealing test.

E-LEARNING academy.gmj.ge/amb-std7-5-incident-reporting — 30 min · complete before self-assessment
  Standard 7.6 CORE · Standard 7: Governance & Management
Staff Scope of Practice Is Verified
ASSESSMENT
ASF-AMB-STD7-v3.0
ISO 9001:2015 §7 Support
CR ADAPTED TR FULL SM FULL ST FULL
7.6
CORE
L1
THE STANDARD
Staff Scope of Practice Is Verified
Every clinical staff member's actual duties are matched to their verified scope of practice and licence category, not assumed appropriate because they've been performing the role for some time.
CLINIC SELF-ASSESSMENT Tick YES, PARTIAL, or NO for each question.
1 Is each staff member's actual duties matched against their verified licence category and scope?
A specific comparison, not an assumption that current duties are appropriate.
Doc: Scope of practice review record
YES PARTIAL NO
2 Is this comparison repeated periodically, not only done once at hiring?
Duties can expand gradually over time without a formal decision ever being made.
Doc: Periodic review schedule
YES PARTIAL NO
3 Is there a defined process if a mismatch is found?
Identifying a mismatch without correcting it provides no real protection.
Doc: Correction process record
YES PARTIAL NO

ALL YES Standard likely met. ANY PARTIAL Improvement plan required. ANY NO Requires improvement plan.

WHAT THE ASSESSOR DOES ON SITE no surprises, no hidden checks
DOCUMENT
Scope comparison review
Reviews evidence that actual duties are compared against verified scope.
DOCUMENT
Periodic review schedule check
Checks whether this comparison is repeated periodically.
ASK
Correction process interview
Asks what happens if a mismatch between duties and scope is found.

REFERENCES

  1. [40] Scope-of-practice verification, distinct from initial credential checking, is an established governance requirement in healthcare workforce quality frameworks internationally.
  Standard 7.6 · Standard 7: Governance & Management
Guidance & Learning
GUIDANCE
ASF-AMB-STD7-v3.0
ISO 9001:2015 §7 Support
WHY THIS STANDARD EXISTS

A staff member performing tasks beyond their actual licensed scope — even competently, even for years — represents a real, unaddressed risk that only surfaces when something goes wrong, and by then the gap has often existed unnoticed for a long time.

The evidence: [40] Scope-of-practice verification, distinct from initial credential checking, is an established governance requirement in healthcare workforce quality frameworks internationally.
WHAT GOOD LOOKS LIKE
✓ Duties are specifically matched against verified scope for every staff member.
✓ This comparison is repeated periodically, not only at hiring.
✓ A defined correction process exists and is used when a mismatch is found.
WHAT FAILURE LOOKS LIKE
✗ No specific comparison exists beyond assumed appropriateness.
✗ Comparison happens only once, at hiring.
✗ No process exists to correct an identified mismatch.
MOST COMMON REASONS CLINICS SCORE PARTIAL

1 Comparison happens for physicians but less consistently for support clinical staff.

Attention often concentrates on the most visible role.

2 A mismatch was identified once but never actually corrected.

Identification without correction leaves the underlying risk in place.

3 Duties have gradually expanded informally without anyone reviewing scope.

Gradual, informal expansion is exactly the pattern this criterion exists to catch.

HOW TO IMPLEMENT IF YOU ARE STARTING FROM ZERO

Week 1 Review current duties against verified scope for all clinical staff.

Week 2 Correct any mismatch found.

Week 3 Establish a periodic review schedule.

Ongoing Repeat scope reviews on the defined schedule.

FOR SURVEYORS — WHAT IS NOT OBVIOUS

Ask a staff member to describe their actual daily duties in detail.

A detailed description can reveal drift a job title alone wouldn't show.

Check non-physician clinical staff specifically.

Scope drift often goes unnoticed longest in less closely supervised roles.

E-LEARNING academy.gmj.ge/amb-std7-6-scope-of-practice — 30 min · complete before self-assessment
  Standard 7.7 NON-NEGOTIABLE · Standard 7: Governance & Management
Leadership Reviews Overall Performance at Planned Intervals
ASSESSMENT
ASF-AMB-STD7-v3.0
ISO 9001:2015 §9 Performance Evaluation
CR ADAPTED TR FULL SM ADAPTED ST FULL
7.7
NON-NEGOTIABLE
L1
THE STANDARD
Leadership Reviews Overall Performance at Planned Intervals
Clinic leadership formally reviews overall quality and safety performance at a defined, regular interval — not only in reaction to an individual incident — covering trends, not single events.
CLINIC SELF-ASSESSMENT Tick YES, PARTIAL, or NO for each question.
1 Does leadership review overall quality and safety performance at a defined, regular interval?
A specific, planned interval, not only when something goes wrong.
Doc: Management review schedule and minutes
YES PARTIAL NO
2 Does the review cover trends and patterns, not only a list of individual incidents?
Trend analysis reveals patterns a single-incident view misses entirely.
Doc: Trend analysis documentation
YES PARTIAL NO
3 Does the review lead to documented decisions or actions, not just discussion?
Review without resulting action provides limited real value.
Doc: Review outcome and action record
YES PARTIAL NO

ALL YES Standard likely met. ANY PARTIAL Improvement plan required. ANY NO Blocks accreditation until resolved.

WHAT THE ASSESSOR DOES ON SITE no surprises, no hidden checks
DOCUMENT
Review schedule and minutes review
Reviews evidence of a genuine, planned-interval management review, not only reactive incident discussion.
DOCUMENT
Trend coverage check
Checks whether reviews cover trends and patterns, not only individual events.
ASK
Outcome interview
Asks leadership for a specific example of a decision or action resulting from a review.

REFERENCES

  1. [41] International Organization for Standardization. ISO 9001:2015 — Quality management systems — Requirements. 5th ed. Geneva: ISO; 2015 — Clause 9.3 requires management review of the quality management system's performance at planned intervals, distinct from reactive incident response.
  Standard 7.7 · Standard 7: Governance & Management
Guidance & Learning
GUIDANCE
ASF-AMB-STD7-v3.0
ISO 9001:2015 §9 Performance Evaluation
WHY THIS STANDARD EXISTS

Reacting to individual incidents as they happen is necessary but not sufficient — without a periodic step back to review the whole picture, a slow decline across many small, individually unremarkable events can go unnoticed until it becomes a serious pattern. For a genuine solo practitioner, Adapted does not mean skipping this because there is no one to review with — it means blocking real, dedicated time, alone, on a fixed schedule, to look back through recent cases, complaints, and near-misses as a genuine reviewer of your own practice, not just as the clinician who lived through each one individually.

The evidence: [41] International Organization for Standardization. ISO 9001:2015 — Quality management systems — Requirements. 5th ed. Geneva: ISO; 2015 — Clause 9.3 requires management review of the quality management system's performance at planned intervals, distinct from reactive incident response.
WHAT GOOD LOOKS LIKE
✓ Reviews happen at a genuine, defined, regular interval.
✓ Reviews cover trends and patterns across time.
✓ Reviews lead to documented decisions or actions.
WHAT FAILURE LOOKS LIKE
✗ No planned review exists beyond reacting to individual incidents.
✗ Reviews, if they happen, only list individual events without trend analysis.
✗ Reviews produce discussion but no documented follow-through.
MOST COMMON REASONS CLINICS SCORE PARTIAL

1 A review happens but only when leadership happens to have time, not on a fixed schedule.

An irregular pattern risks the review being deprioritised indefinitely during busy periods.

2 Trends are informally noticed but never formally analysed or documented.

Undocumented pattern recognition is hard to distinguish from coincidence.

3 Decisions are made during review but not tracked to completion afterward.

A decision without follow-through tracking often quietly doesn't happen.

HOW TO IMPLEMENT IF YOU ARE STARTING FROM ZERO

Week 1 Establish a specific, regular interval for a genuine performance review.

Week 2 Build a simple trend-analysis method covering incidents, complaints, and quality data together.

Week 3 Define how review decisions will be tracked to completion.

Ongoing Hold the review on schedule and track action completion.

For Micro (solo) Block a specific, recurring date on your own calendar — quarterly is reasonable — and use that time to read back through the last quarter's incidents, complaints, and near-misses as a reviewer would, not as you experienced them in the moment.

FOR SURVEYORS — WHAT IS NOT OBVIOUS

Ask for the actual review schedule and minutes, not a description of intended practice.

Dated records are the only real evidence of a consistent, planned process.

Ask for a specific example of a decision that came from a review, not an incident.

This distinguishes genuine systematic review from incident-reactive management alone.

E-LEARNING academy.gmj.ge/amb-std7-7-management-review — 30 min · complete before self-assessment
  Standard 7.8 CORE · Standard 7: Governance & Management
Quality Objectives Are Set, Specific, and Tracked
ASSESSMENT
ASF-AMB-STD7-v3.0
ISO 9001:2015 §6 Planning
CR ADAPTED TR FULL SM ADAPTED ST FULL
7.8
CORE
L1
THE STANDARD
Quality Objectives Are Set, Specific, and Tracked
The clinic sets specific, measurable quality objectives for the coming period, and tracks progress against them — not a general aspiration to "provide good care" with no way to know if it's actually happening.
CLINIC SELF-ASSESSMENT Tick YES, PARTIAL, or NO for each question.
1 Are there specific, measurable quality objectives set for the coming period?
A specific, numeric or otherwise measurable target, not a general aspiration.
Doc: Quality objectives document
YES PARTIAL NO
2 Is progress against these objectives actually tracked?
Tracked progress, not an assumption things are improving.
Doc: Progress tracking record
YES PARTIAL NO
3 Are objectives communicated to relevant staff, not held only by leadership?
Staff who don't know the objective can't meaningfully contribute to it.
Doc: N/A — tested directly
YES PARTIAL NO

ALL YES Standard likely met. ANY PARTIAL Improvement plan required. ANY NO Requires improvement plan.

WHAT THE ASSESSOR DOES ON SITE no surprises, no hidden checks
DOCUMENT
Objectives specificity review
Reviews whether objectives are genuinely specific and measurable, not general aspirations.
DOCUMENT
Progress tracking review
Reviews evidence of actual tracked progress against objectives.
ASK
Staff awareness interview
Asks relevant staff whether they know the clinic's current quality objectives.

REFERENCES

  1. [42] International Organization for Standardization. ISO 9001:2015 — Quality management systems — Requirements. 5th ed. Geneva: ISO; 2015 — Clause 6.2 requires quality objectives that are measurable, monitored, and communicated, distinct from general quality aspirations.
  Standard 7.8 · Standard 7: Governance & Management
Guidance & Learning
GUIDANCE
ASF-AMB-STD7-v3.0
ISO 9001:2015 §6 Planning
WHY THIS STANDARD EXISTS

A general commitment to quality provides no way to know whether things are actually improving, staying flat, or quietly getting worse — specific, measurable objectives are what make quality something the clinic can actually manage, not just hope for. For a genuine solo practitioner, Adapted means the objective is written down and specific even though only one person will ever see it — a private, specific goal still counts, and still needs to be genuinely measurable, not a vague intention.

The evidence: [42] International Organization for Standardization. ISO 9001:2015 — Quality management systems — Requirements. 5th ed. Geneva: ISO; 2015 — Clause 6.2 requires quality objectives that are measurable, monitored, and communicated, distinct from general quality aspirations.
WHAT GOOD LOOKS LIKE
✓ Objectives are specific and genuinely measurable.
✓ Progress is actively tracked, not assumed.
✓ Relevant staff know the current objectives.
WHAT FAILURE LOOKS LIKE
✗ Objectives, if stated, are general aspirations with no measurable target.
✗ No tracking exists beyond a general sense of how things are going.
✗ Staff are unaware any specific objectives exist.
MOST COMMON REASONS CLINICS SCORE PARTIAL

1 Objectives are set but not revisited until the following year.

Infrequent revisiting limits the ability to course-correct during the period.

2 Objectives are measurable but tracking happens informally without documentation.

Undocumented tracking is hard to distinguish from not tracking at all.

3 Leadership knows the objectives but they were never communicated to front-line staff.

Objectives staff don't know about can't meaningfully shape their daily work.

HOW TO IMPLEMENT IF YOU ARE STARTING FROM ZERO

Week 1 Review current quality objectives, if any, for genuine specificity and measurability.

Week 2 Set or refine specific, measurable objectives for the coming period.

Week 3 Communicate objectives to relevant staff and establish a tracking method.

Ongoing Track progress and revisit objectives at defined intervals.

For Micro (solo) Write one or two specific, measurable objectives for the coming period, even though you're the only person who will track them — for example, a specific target for test-result turnaround time or patient complaint response time.

FOR SURVEYORS — WHAT IS NOT OBVIOUS

Ask for the actual objectives, with numbers or specific targets, not a general statement.

Specificity is what distinguishes a real objective from an aspiration.

Ask a front-line staff member if they know the current objective.

This reveals whether objectives genuinely reach beyond leadership.

E-LEARNING academy.gmj.ge/amb-std7-8-quality-objectives — 30 min · complete before self-assessment
  Standard 7.9 CORE · Standard 7: Governance & Management
A Continual Improvement Process Exists, Not Only Reaction to Individual Incidents
ASSESSMENT
ASF-AMB-STD7-v3.0
ISO 9001:2015 §10 Improvement
CR N/A TR FULL SM ADAPTED ST FULL
7.9
CORE
L1
THE STANDARD
A Continual Improvement Process Exists, Not Only Reaction to Individual Incidents
The clinic has a defined process for identifying and acting on improvement opportunities generally, separate from and in addition to responding to specific incidents as they occur.
CLINIC SELF-ASSESSMENT Tick YES, PARTIAL, or NO for each question.
1 Is there a defined process for identifying improvement opportunities, separate from incident response?
A proactive process, not only reaction to something having gone wrong.
Doc: Continual improvement process document
YES PARTIAL NO
2 Have any improvements been made through this process recently, not only through incident-driven correction?
A real, recent example distinguishes genuine practice from a policy on paper.
Doc: Recent improvement example
YES PARTIAL NO
3 Are staff able to suggest improvement ideas through a known channel?
Front-line staff often see improvement opportunities leadership doesn't.
Doc: Staff suggestion channel
YES PARTIAL NO

ALL YES Standard likely met. ANY PARTIAL Improvement plan required. ANY NO Requires improvement plan.

WHAT THE ASSESSOR DOES ON SITE no surprises, no hidden checks
DOCUMENT
Improvement process review
Reviews the defined process for identifying improvement opportunities separate from incidents.
DOCUMENT
Recent example review
Reviews for a real, recent example of proactive, non-incident-driven improvement.
ASK
Staff suggestion channel interview
Asks staff whether they know how to suggest an improvement idea.

REFERENCES

  1. [43] International Organization for Standardization. ISO 9001:2015 — Quality management systems — Requirements. 5th ed. Geneva: ISO; 2015 — Clause 10.3 requires continual improvement of the quality management system's suitability, adequacy, and effectiveness, as a distinct requirement from corrective action on nonconformities.
  Standard 7.9 · Standard 7: Governance & Management
Guidance & Learning
GUIDANCE
ASF-AMB-STD7-v3.0
ISO 9001:2015 §10 Improvement
WHY THIS STANDARD EXISTS

Reacting only to incidents means the clinic only improves in response to something already having gone wrong — a genuine continual improvement process looks for opportunities to get better even where nothing has yet failed. For a genuine solo practitioner, Adapted means replacing team-based suggestion mechanisms with a real substitute — patient feedback is often the most honest and available source of improvement ideas when there's no colleague to raise them with you.

The evidence: [43] International Organization for Standardization. ISO 9001:2015 — Quality management systems — Requirements. 5th ed. Geneva: ISO; 2015 — Clause 10.3 requires continual improvement of the quality management system's suitability, adequacy, and effectiveness, as a distinct requirement from corrective action on nonconformities.
WHAT GOOD LOOKS LIKE
✓ A defined, proactive improvement process exists, distinct from incident response.
✓ A real, recent example of proactive improvement can be shown.
✓ Staff know a specific channel for suggesting improvements.
WHAT FAILURE LOOKS LIKE
✗ No improvement happens outside of reacting to specific incidents.
✗ No recent example of proactive improvement exists.
✗ Staff have no known way to suggest an improvement idea.
MOST COMMON REASONS CLINICS SCORE PARTIAL

1 A suggestion channel exists but has never actually been used.

An unused channel may not be genuinely known or trusted by staff.

2 Improvement happens but is driven entirely by leadership, without staff input.

Front-line perspective often surfaces different opportunities than leadership sees.

3 A process exists on paper but the clinic cannot point to a real recent example.

A theoretical process and a genuinely functioning one are different things.

HOW TO IMPLEMENT IF YOU ARE STARTING FROM ZERO

Week 1 Review current practice for any proactive, non-incident-driven improvement activity.

Week 2 Establish a specific staff suggestion channel if none exists.

Week 3 Define a process for evaluating and acting on improvement suggestions.

Ongoing Track and document real examples of proactive improvement.

For Micro (solo) Use patient feedback specifically as your improvement input channel — actively ask a few patients each month what could have gone better, and keep a simple, dated log of ideas this surfaces and what you actually changed as a result.

FOR SURVEYORS — WHAT IS NOT OBVIOUS

Ask for a real, recent example that wasn't triggered by an incident.

This is the clearest test of whether improvement is genuinely proactive.

Ask a front-line staff member how they'd suggest an improvement idea.

A confident, specific answer reveals whether the channel is genuinely known.

E-LEARNING academy.gmj.ge/amb-std7-9-continual-improvement — 30 min · complete before self-assessment

Test your facility against this standard

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