Environment & Shared Spaces
Environment & Shared Spaces
MANDATORY
6 criteria
| Standard 3.1 NON-NEGOTIABLE · Standard 3: Environment & Shared Spaces Water Supply Is Safe and Monitored |
ASSESSMENT ASF-AMB-STD3-v3.0 ISO 9001:2015 §8 Operation |
| CR ADAPTED | TR FULL | SM FULL | ST FULL |
| 3.1 NON-NEGOTIABLE L1 |
THE STANDARD Water Supply Is Safe and Monitored Water quality is tested on a defined schedule and a contingency plan exists for interruption — not an assumption that municipal supply is automatically safe. |
| CLINIC SELF-ASSESSMENT Tick YES, PARTIAL, or NO for each question. |
| 1 | Is water quality tested on a defined, regular schedule, with records kept? An assumption is not a verified fact. Doc: Water testing records |
YES | PARTIAL | NO |
| 2 | Is there a documented contingency plan for water supply interruption? A plan written during an actual interruption is not a contingency plan. Doc: Contingency plan document |
YES | PARTIAL | NO |
| 3 | Are test results reviewed and acted on, not just filed? A concerning result nobody reads is no better than not testing. Doc: Review 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 Testing record review |
Reviews water testing records for consistency and whether the schedule is followed. |
| DOCUMENT Contingency plan check |
Reviews the plan for a real, specific backup arrangement. |
| ASK Response protocol interview |
Asks staff what actually happens if a test result is concerning. |
REFERENCES
- [10] World Health Organization, UNICEF. Water, sanitation and hygiene in health care facilities: practical steps to achieve universal access to quality care. Geneva: WHO; 2019.
| Standard 3.1 · Standard 3: Environment & Shared Spaces Guidance & Learning |
GUIDANCE ASF-AMB-STD3-v3.0 ISO 9001:2015 §8 Operation |
| WHY THIS STANDARD EXISTS |
Water quality failures can silently undermine every other infection-control measure in the clinic. Testing and a contingency plan turn an assumption into a verified fact.
| WHAT GOOD LOOKS LIKE ✓ Testing happens on a defined schedule with consistent records. ✓ A specific, actionable contingency plan exists. ✓ Concerning results trigger a known, followed response process. |
WHAT FAILURE LOOKS LIKE ✗ No regular testing beyond an assumption of municipal safety. ✗ No contingency plan exists. ✗ Results, when they exist, are filed without review. |
| MOST COMMON REASONS CLINICS SCORE PARTIAL |
1 Testing happens but with gaps during busy periods.
Routine tasks without strong enforcement are often the first thing skipped.
2 A contingency plan exists but has never been reviewed since written.
An untested plan may not reflect current capacity.
3 Results are reviewed informally with no documented follow-up.
Informal review depends entirely on who happens to be paying attention.
| HOW TO IMPLEMENT IF YOU ARE STARTING FROM ZERO |
Week 1 Review current testing frequency for gaps.
Week 2 Establish a specific contingency plan for interruption.
Week 3 Define a clear response process for concerning results.
Ongoing Review testing consistency on a fixed schedule.
| FOR SURVEYORS — WHAT IS NOT OBVIOUS |
Ask for actual test records, not a general assurance.
Dated records are the only real evidence of a consistent schedule.
Ask what happened the last time a result was concerning.
A real example reveals more than a policy description.
| E-LEARNING academy.gmj.ge/amb-std3-1-water-safety — 30 min · complete before self-assessment |
| Standard 3.2 NON-NEGOTIABLE · Standard 3: Environment & Shared Spaces Medical Equipment Is Maintained on Schedule |
ASSESSMENT ASF-AMB-STD3-v3.0 ISO 9001:2015 §7 Support |
| CR ADAPTED | TR FULL | SM FULL | ST FULL |
| 3.2 NON-NEGOTIABLE L1 |
THE STANDARD Medical Equipment Is Maintained on Schedule A maintenance programme covers all clinical equipment on a defined schedule, and faulty equipment is genuinely removed from use, not kept in service pending eventual repair. |
| CLINIC SELF-ASSESSMENT Tick YES, PARTIAL, or NO for each question. |
| 1 | Is there a documented maintenance schedule covering all clinical equipment? A defined, proactive schedule, not reactive maintenance. Doc: Maintenance schedule and log |
YES | PARTIAL | NO |
| 2 | Is faulty equipment actually removed from use, not kept accessible awaiting repair? A tag alone isn't sufficient if the equipment remains physically accessible. Doc: Removal-from-service record |
YES | PARTIAL | NO |
| 3 | Is there a named person responsible for the maintenance programme? Diffuse responsibility usually means inconsistency. Doc: Role assignment 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 Maintenance schedule review |
Reviews the schedule and log for completeness and consistency. |
| OBSERVE Faulty equipment check |
Checks whether flagged equipment remains physically accessible. |
| ASK Responsible person interview |
Asks whoever is responsible to describe the actual process. |
REFERENCES
- [11] Biomedical equipment maintenance frameworks consistently identify scheduled preventive maintenance, combined with clear removal-from-service protocols, as the primary control against equipment-related patient harm.
| Standard 3.2 · Standard 3: Environment & Shared Spaces Guidance & Learning |
GUIDANCE ASF-AMB-STD3-v3.0 ISO 9001:2015 §7 Support |
| WHY THIS STANDARD EXISTS |
Equipment that silently drifts out of calibration is often more dangerous than equipment that visibly fails, precisely because nothing signals the problem until it affects a patient.
| WHAT GOOD LOOKS LIKE ✓ A comprehensive schedule is consistently followed. ✓ Faulty equipment is physically removed from use immediately. ✓ A named person owns the programme confidently. |
WHAT FAILURE LOOKS LIKE ✗ Maintenance happens reactively, only after failure. ✗ Faulty equipment remains available and sometimes used. ✗ Nobody can identify who is responsible. |
| MOST COMMON REASONS CLINICS SCORE PARTIAL |
1 A schedule exists for major equipment but not smaller items.
Coverage often reflects value or visibility rather than actual risk.
2 Faulty equipment is tagged but not physically relocated.
A tag depends on every staff member noticing it every time.
3 Responsibility sits with someone who has since changed roles informally.
Ownership gaps often follow staff transitions.
| HOW TO IMPLEMENT IF YOU ARE STARTING FROM ZERO |
Week 1 Audit equipment against the maintenance schedule for gaps.
Week 2 Establish a process for physically removing faulty equipment.
Week 3 Name a specific owner of the programme.
Ongoing Review maintenance log currency against the schedule.
| FOR SURVEYORS — WHAT IS NOT OBVIOUS |
Look for equipment that should be flagged but isn't.
The absence of any flagged equipment is itself worth questioning.
Check whether tagged equipment is still physically reachable.
A tag alone doesn't prevent use if it sits in its normal location.
| E-LEARNING academy.gmj.ge/amb-std3-2-equipment-maintenance — 30 min · complete before self-assessment |
| Standard 3.3 CORE · Standard 3: Environment & Shared Spaces Shared Spaces Are Genuinely Clean |
ASSESSMENT ASF-AMB-STD3-v3.0 ISO 9001:2015 §8 Operation |
| CR ADAPTED | TR FULL | SM FULL | ST FULL |
| 3.3 CORE L1 |
THE STANDARD Shared Spaces Are Genuinely Clean Shared clinical and waiting areas are cleaned on a documented schedule, with cleanliness verified by more than a visual check on the day of assessment. |
| CLINIC SELF-ASSESSMENT Tick YES, PARTIAL, or NO for each question. |
| 1 | Is there a documented cleaning schedule with records kept? A specific, dated schedule, not a general statement. Doc: Cleaning schedule and log |
YES | PARTIAL | NO |
| 2 | Is cleaning verified through more than a visual check? Visual cleanliness and actual microbial cleanliness aren't the same thing. Doc: Verification or audit record |
YES | PARTIAL | NO |
| 3 | Are high-touch surfaces specifically included? Door handles and switches are easy to overlook relative to visible surfaces. Doc: High-touch surface schedule |
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 Cleaning schedule review |
Reviews the schedule against completion records. |
| OBSERVE High-touch surface check |
Checks whether high-touch surfaces are specifically addressed. |
| ASK Verification process interview |
Asks staff how cleanliness is actually verified. |
REFERENCES
- [12] Environmental cleanliness in shared healthcare spaces is a recognised contributing factor to healthcare-associated infection transmission risk, distinct from direct clinical contact precautions.
| Standard 3.3 · Standard 3: Environment & Shared Spaces Guidance & Learning |
GUIDANCE ASF-AMB-STD3-v3.0 ISO 9001:2015 §8 Operation |
| WHY THIS STANDARD EXISTS |
A space that looks clean on the day of an inspection and a space that is reliably clean are not always the same thing.
| WHAT GOOD LOOKS LIKE ✓ A documented, consistently followed schedule covers all shared spaces. ✓ High-touch surfaces are specifically addressed. ✓ Cleanliness is verified through a defined process. |
WHAT FAILURE LOOKS LIKE ✗ No documented schedule beyond good intentions. ✗ High-touch surfaces show visible neglect. ✗ Verification is undocumented and inconsistent. |
| MOST COMMON REASONS CLINICS SCORE PARTIAL |
1 A schedule exists for the waiting room but not less-visited areas.
Peripheral areas often receive less consistent attention.
2 Cleaning happens but high-touch surfaces aren't specifically called out.
A general routine can miss the surfaces that matter most.
3 Verification exists informally with no documentation.
An informal check depends entirely on who happens to be paying attention.
| HOW TO IMPLEMENT IF YOU ARE STARTING FROM ZERO |
Week 1 Review current schedules for coverage gaps.
Week 2 Add specific high-touch surface cleaning to the schedule.
Week 3 Establish a simple verification step.
Ongoing Audit cleaning log completeness periodically.
| FOR SURVEYORS — WHAT IS NOT OBVIOUS |
Check high-touch surfaces specifically.
Door handles and switches reveal more than open floor areas.
Ask for the log, not a general assurance.
Dated records are the only real evidence.
| E-LEARNING academy.gmj.ge/amb-std3-3-cleanliness — 30 min · complete before self-assessment |
| Standard 3.4 NON-NEGOTIABLE · Standard 3: Environment & Shared Spaces Facility Risks Are Tracked in One Integrated Register |
ASSESSMENT ASF-AMB-STD3-v3.0 ISO 9001:2015 §6 Planning |
| CR ADAPTED | TR FULL | SM ADAPTED | ST FULL |
| 3.4 NON-NEGOTIABLE L1 |
THE STANDARD Facility Risks Are Tracked in One Integrated Register Water safety, fire safety, and equipment maintenance data feed into one integrated risk register, not separate untracked lists. |
| CLINIC SELF-ASSESSMENT Tick YES, PARTIAL, or NO for each question. |
| 1 | Do water safety, fire safety, and equipment data feed into one register? A single place to see the whole risk picture, not scattered logs. Doc: Integrated risk register document |
YES | PARTIAL | NO |
| 2 | Is the register reviewed on a defined schedule by clinic leadership? Review at a level that can act across domains. Doc: Review meeting record |
YES | PARTIAL | NO |
| 3 | Does the register prioritise risks, not just list them? A genuine tool ranks what needs attention first. Doc: Risk prioritisation criteria |
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 Register completeness review |
Reviews integration across safety domains. |
| DOCUMENT Review schedule check |
Checks for evidence of defined-schedule review. |
| ASK Prioritisation interview |
Asks how risks are prioritised, not just logged. |
REFERENCES
- [13] Integrated environment-of-care risk management, tying individual facility safety domains into one reviewed register, is an established approach in international facility safety frameworks.
| Standard 3.4 · Standard 3: Environment & Shared Spaces Guidance & Learning |
GUIDANCE ASF-AMB-STD3-v3.0 ISO 9001:2015 §6 Planning |
| WHY THIS STANDARD EXISTS |
Individual safety checks can each look fine in isolation while the overall risk picture goes unexamined. An integrated register lets leadership see the whole picture at once.
| WHAT GOOD LOOKS LIKE ✓ Facility risks feed into one integrated register. ✓ The register is reviewed on a defined schedule. ✓ Risks are prioritised, with highest-risk items addressed first. |
WHAT FAILURE LOOKS LIKE ✗ Records exist as entirely separate, unconnected logs. ✗ No defined review schedule exists. ✗ All items are treated with equal, undifferentiated priority. |
| MOST COMMON REASONS CLINICS SCORE PARTIAL |
1 Individual domain tracking is strong but nothing integrates them.
Good individual records don't automatically produce a combined view.
2 A register exists but review happens irregularly.
An ad hoc pattern risks the register becoming stale.
3 The register lists risks without ranking them.
A list without prioritisation provides less real value.
| HOW TO IMPLEMENT IF YOU ARE STARTING FROM ZERO |
Week 1 Inventory current safety tracking across domains.
Week 2 Consolidate into one integrated register.
Week 3 Establish a defined review schedule.
Ongoing Review and reprioritise on schedule.
| FOR SURVEYORS — WHAT IS NOT OBVIOUS |
Ask to see the register itself, not descriptions of individual tracking.
Integration itself is what this checks.
Ask who reviews it and how often, specifically.
A specific process is the real evidence of active use.
| E-LEARNING academy.gmj.ge/amb-std3-4-risk-register — 30 min · complete before self-assessment |
| Standard 3.5 CORE · Standard 3: Environment & Shared Spaces Diagnostic Equipment On-Site Is Calibrated, Not Just Maintained |
ASSESSMENT ASF-AMB-STD3-v3.0 ISO 9001:2015 §7 Support |
| CR ADAPTED | TR FULL | SM FULL | ST FULL |
| 3.5 CORE L1 |
THE STANDARD Diagnostic Equipment On-Site Is Calibrated, Not Just Maintained Any diagnostic equipment on-site — X-ray, ultrasound, ECG — is calibrated against a defined schedule, verified for accuracy, not just confirmed to be running. |
| CLINIC SELF-ASSESSMENT Tick YES, PARTIAL, or NO for each question. |
| 1 | Is diagnostic equipment calibrated against a defined schedule, not just confirmed to be running? Calibration verifies accuracy; maintenance only verifies function. Doc: Calibration schedule and log |
YES | PARTIAL | NO |
| 2 | Is calibration performed or verified by a qualified, external or certified source? Self-assessed calibration by untrained staff doesn't meet this. Doc: Calibration certificate |
YES | PARTIAL | NO |
| 3 | Is equipment found out of calibration removed from use until corrected? Continuing to use miscalibrated equipment defeats the purpose of checking at all. Doc: Removal-from-service 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 Calibration record review |
Reviews calibration certificates and schedule adherence. |
| DOCUMENT Qualified source check |
Confirms calibration is performed by a qualified, certified source. |
| OBSERVE Out-of-calibration handling check |
Checks whether equipment found miscalibrated is genuinely removed from use. |
REFERENCES
- [14] Calibration verification, distinct from general equipment maintenance, is an established requirement in diagnostic equipment quality frameworks specifically because functional equipment can still produce inaccurate output.
| Standard 3.5 · Standard 3: Environment & Shared Spaces Guidance & Learning |
GUIDANCE ASF-AMB-STD3-v3.0 ISO 9001:2015 §7 Support |
| WHY THIS STANDARD EXISTS |
Equipment that runs perfectly can still output an incorrect value if never calibrated — an X-ray machine can deliver the wrong radiation dose, an ECG can misreport a rhythm, while appearing to function normally the entire time.
| WHAT GOOD LOOKS LIKE ✓ Equipment is calibrated on a defined schedule by a qualified source. ✓ Calibration certificates are current and retained. ✓ Miscalibrated equipment is genuinely removed from use until corrected. |
WHAT FAILURE LOOKS LIKE ✗ No calibration schedule exists beyond general maintenance. ✗ Calibration, if claimed, has no verifiable certificate. ✗ Equipment continues in use despite known calibration issues. |
| MOST COMMON REASONS CLINICS SCORE PARTIAL |
1 Calibration happens for the primary diagnostic device but not secondary equipment.
Attention often concentrates on the most visible or expensive equipment.
2 Calibration certificates exist but are past their valid period.
An expired certificate provides no current assurance.
3 Miscalibration is noted but correction is delayed without removing the equipment from use.
A delay in correction with continued use still exposes patients to inaccurate results.
| HOW TO IMPLEMENT IF YOU ARE STARTING FROM ZERO |
Week 1 Inventory all diagnostic equipment and current calibration status.
Week 2 Schedule calibration with a qualified source for any equipment overdue.
Week 3 Establish a removal-from-service rule for miscalibrated equipment.
Ongoing Track calibration certificate expiry proactively.
| FOR SURVEYORS — WHAT IS NOT OBVIOUS |
Ask for the calibration certificate itself, not a statement that equipment works.
A certificate from a qualified source is the only real evidence of genuine calibration.
Check certificate dates against the actual current date.
An expired certificate is a common, specific gap worth checking directly.
| E-LEARNING academy.gmj.ge/amb-std3-5-calibration — 30 min · complete before self-assessment |
| Standard 3.6 NON-NEGOTIABLE · Standard 3: Environment & Shared Spaces Point-of-Care Testing Has Real Quality Control, Not Just a Working Device |
ASSESSMENT ASF-AMB-STD3-v3.0 ISO 9001:2015 §8 Operation |
| CR ADAPTED | TR FULL | SM FULL | ST FULL |
| 3.6 NON-NEGOTIABLE L1 |
THE STANDARD Point-of-Care Testing Has Real Quality Control, Not Just a Working Device Any point-of-care test performed on-site — rapid strep, glucose, pregnancy, or similar — is run against a documented quality control process, not assumed accurate because the device powers on. |
| CLINIC SELF-ASSESSMENT Tick YES, PARTIAL, or NO for each question. |
| 1 | Is a documented quality control process run for each point-of-care test type, not just assumed from the device working? A specific control sample check, not confirmation the device turns on. Doc: Quality control log |
YES | PARTIAL | NO |
| 2 | Are staff performing point-of-care tests specifically trained and assessed as competent? Training specific to the test, not general clinical competence. Doc: Staff training and competency record |
YES | PARTIAL | NO |
| 3 | Are quality control failures acted on before patient results are reported? A failed control that doesn't stop patient testing provides no real protection. Doc: Quality control failure response 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 Quality control log review |
Reviews the quality control log for consistency and completeness per test type. |
| DOCUMENT Staff competency review |
Reviews training and competency assessment records for staff performing point-of-care testing. |
| ASK Failure response interview |
Asks staff what happens when a quality control check fails. |
REFERENCES
- [15] International Organization for Standardization. ISO 15189:2022 — Medical laboratories: requirements for quality and competence. Geneva: ISO; 2022 — establishes quality control requirements specifically applicable to point-of-care testing, distinct from centralised laboratory testing.
| Standard 3.6 · Standard 3: Environment & Shared Spaces Guidance & Learning |
GUIDANCE ASF-AMB-STD3-v3.0 ISO 9001:2015 §8 Operation |
| WHY THIS STANDARD EXISTS |
Point-of-care devices are operated by staff who are often not laboratory-trained, in a decentralised setting without a laboratory's usual oversight — a device that appears to work can still give a false result without a specific quality-control process to catch it.
| WHAT GOOD LOOKS LIKE ✓ A documented quality control process runs consistently for every point-of-care test type. ✓ Staff are specifically trained and assessed as competent for the tests they perform. ✓ A quality control failure stops patient testing until resolved. |
WHAT FAILURE LOOKS LIKE ✗ No quality control process exists beyond the device appearing to work. ✗ Staff perform tests with no specific training or competency assessment. ✗ Quality control failures, if noticed, don't stop patient testing. |
| MOST COMMON REASONS CLINICS SCORE PARTIAL |
1 Quality control is run for the most frequently used test but not less common ones.
Attention concentrates on high-volume tests, leaving others under-checked.
2 Staff were trained once at introduction but never reassessed.
Competency can drift without periodic reassessment.
3 A failed control is documented but patient testing continues regardless.
Documentation without stopping testing provides no real protection.
| HOW TO IMPLEMENT IF YOU ARE STARTING FROM ZERO |
Week 1 Inventory all point-of-care tests performed and current quality control practice.
Week 2 Establish a documented quality control process for every test type.
Week 3 Train and formally assess staff competency for each test performed.
Ongoing Audit quality control log completeness periodically.
| FOR SURVEYORS — WHAT IS NOT OBVIOUS |
Ask for the actual quality control log, not a description of the testing process.
Dated records are the only real evidence of a consistent process.
Ask what happens specifically when a control fails.
A real, specific answer reveals whether this is genuine practice or assumed.
| E-LEARNING academy.gmj.ge/amb-std3-6-poct-quality — 30 min · complete before self-assessment |

Ambulatory Clinic Standards — overviewFacility Classification — Which Type of Facility Are You?Standard 1 — Access & ArrivalStandard 2 — Reception & InformationStandard 3 — Environment & Shared SpacesStandard 4 — Care & TreatmentStandard 5 — Safety & Emergency PreparednessStandard 6 — Aftercare & Follow-upStandard 7 — Governance & ManagementStandard 8 — Dental PracticeStandard 9 — Aesthetic & Injectable MedicineStandard 10 — Longevity & IV TherapyStandard 11 — Oncology & Infusion TherapyStandard 12 — Dialysis & Renal Replacement TherapyStandard 13 — Fertility & IVFStandard 14 — Cardiology & Cardiac CatheterizationStandard 15 — Ophthalmology & Day SurgeryStandard 16 — Diagnostic ImagingStandard 17 — DermatologyStandard 18 — Allergy & ImmunotherapyStandard 19 — Plastic & Cosmetic SurgeryStandard 20 — Psychiatry & Mental HealthStandard 21 — Narcology & Addiction TreatmentStandard 22 — Gastroenterology & EndoscopyStandard 23 — Pediatric Ambulatory CareStandard 24 — Medical TourismStandard 25 — Refugee & Migrant HealthReferences & Index
STANDARD 3Environment & Shared Spaces3.1 Water Supply Is Safe and Monitored3.2 Medical Equipment Is Maintained on Schedule3.3 Shared Spaces Are Genuinely Clean3.4 Facility Risks Are Tracked in One Integrated Register3.5 Diagnostic Equipment On-Site Is Calibrated, Not Just Maintained3.6 Point-of-Care Testing Has Real Quality Control, Not Just a Working Device
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