ISO 9001 Ready · Ambulatory Clinic

163 documents, bilingual — every one downloadable

Blank masters, free for any healthcare organization. Or let ASF generate them with your names and logo through the intake.

79 procedures · 82 forms · index and audit · 76 universal, the rest by module · full package 43 MB

The line that never moves. ASF prepares organizations for ISO 9001. ASF does not certify them. The ISO 9001 certificate is issued by an independent, accredited certification body of the organization’s choice.

ASF supports healthcare organizations first and sells second. Every document in this library is free to download as a blank master, in English and Georgian, under CC BY-NC-SA 4.0: a clinic that wants to fill in the placeholders by hand may do so. What ASF sells is what most organizations do not have time for — the pack generated with their names, dates and logo after an expert review of the intake, the training, the assessments, the consultancy and the platform that runs it. The documents themselves belong to everyone.

Download the full package — all documents, EN + KA (zip) ↓Master document index (Excel) ↓

Master Index · 3

Code	Title	Type	Included when	Download
AUDIT-01	Full Pack Quality Audit Report	SOP/Policy	Always	EN · KA
INDEX	Records & Forms Index	Index	Always	EN · KA
MAP-01	Master Index & Document Map	SOP/Policy	Always	EN · KA

Tier 2 – Governance · 23

Code	Title	Type	Included when	Download
GOV-01	Nonconformity & Corrective Action	SOP/Policy	Always	EN · KA
GOV-01-F01	Nonconformity Report	Form	Always	EN · KA
GOV-01-F02	Corrective Action Plan (CAPA)	Form	Always	EN · KA
GOV-02	Internal Audit Program	SOP/Policy	Always	EN · KA
GOV-02-F01	Internal Audit Checklist	Form	Always	EN · KA
GOV-02-F02	Audit Finding Log	Form	Always	EN · KA
GOV-03	Management Review	SOP/Policy	Always	EN · KA
GOV-03-F01	Management Review Minutes	Form	Always	EN · KA
GOV-03-F02	Management Review Action Item Tracker	Form	Always	EN · KA
GOV-04	Document Control	SOP/Policy	Always	EN · KA
GOV-04-F01	Document Control Register	Form	Always	EN · KA
GOV-04-F02	Document Change Request Form	Form	Always	EN · KA
GOV-05	Risk Register	SOP/Policy	Always	EN · KA
GOV-05-F02	Risk Assessment Worksheet	Form	Always	EN · KA
GOV-06	GDPR Data Protection Policy	SOP/Policy	Always	EN · KA
GOV-06-F01	Data Subject Rights Request Log	Form	Always	EN · KA
GOV-07	Cybersecurity & IT Security Policy	SOP/Policy	Always	EN · KA
GOV-07-F01	Cybersecurity/IT Security Incident Report	Form	Always	EN · KA
GOV-08	Conflict of Interest Policy	SOP/Policy	Always	EN · KA
GOV-08-F01	Annual Disclosure & Attestation Form (COI / Anti-Bribery / Whistleblower Awareness)	Form	Always	EN · KA
GOV-09	Anti-Bribery & Anti-Corruption Policy	SOP/Policy	Always	EN · KA
GOV-10	Whistleblower Protection Policy	SOP/Policy	Always	EN · KA
GOV-11	Regulatory Crosswalk & Multi-Jurisdiction Equivalence Reference	SOP/Policy	Always	EN · KA

Tier 3 – General Clinical / IPC / Patient Safety / HIM / HR · 31

Code	Title	Type	Included when	Download
SOP-HIM-01	Patient Records Confidentiality	SOP/Policy	Always	EN · KA
SOP-HIM-01-F01	Medical Record Amendment Request	Form	Always	EN · KA
SOP-HIM-01-F02	Release of Information Authorization	Form	Always	EN · KA
SOP-HR-01	Physician & Clinical Staff Credentialing	SOP/Policy	Always	EN · KA
SOP-HR-01-F01	Physician Credentialing Checklist	Form	Always	EN · KA
SOP-HR-01-F02	Privileging Request Form	Form	Always	EN · KA
SOP-HR-03	Volunteer, Student & Trainee Supervision	SOP/Policy	Always	EN · KA
SOP-HR-03-F01	Volunteer/Student/Trainee Supervision Agreement & Checklist	Form	Always	EN · KA
SOP-IPC-01	Standard Precautions	SOP/Policy	Always	EN · KA
SOP-IPC-01-F01	Hand Hygiene Audit Checklist	Form	Always	EN · KA
SOP-IPC-02	Hand Hygiene	SOP/Policy	Always	EN · KA
SOP-IPC-03	Personal Protective Equipment	SOP/Policy	Always	EN · KA
SOP-IPC-07	Safe Injection Practices	SOP/Policy	Always	EN · KA
SOP-IPC-08	Sharps Safety	SOP/Policy	Always	EN · KA
SOP-IPC-08-F01	Sharps Injury Log	Form	Always	EN · KA
SOP-IPC-09	Post-Exposure Prophylaxis (Needlestick/Bloodborne)	SOP/Policy	Always	EN · KA
SOP-IPC-09-F01	Post-Exposure Prophylaxis Incident Report	Form	Always	EN · KA
SOP-MED-01	Medication Management	SOP/Policy	Always	EN · KA
SOP-MED-01-F01	Medication Error Report	Form	Always	EN · KA
SOP-MED-01-F02	High-Alert Medication Double-Check Log	Form	Always	EN · KA
SOP-MED-02	Controlled Substances Security & Diversion Prevention	SOP/Policy	Controlled substances	EN · KA
SOP-MED-02-F01	Controlled Substance Inventory & Count Log	Form	Controlled substances	EN · KA
SOP-PR-01	General Informed Consent	SOP/Policy	Always	EN · KA
SOP-PR-01-F01	General Informed Consent Form	Form	Always	EN · KA
SOP-PS-01	Patient Identification	SOP/Policy	Always	EN · KA
SOP-PS-01-F01	Patient Identification Verification Checklist	Form	Always	EN · KA
SOP-PS-02	Clinical Incident & Adverse Event Reporting	SOP/Policy	Always	EN · KA
SOP-PS-02-F01	Clinical Incident / Adverse Event Report	Form	Always	EN · KA
SOP-STR-01	Instrument Reprocessing & Sterilization	SOP/Policy	Sterilization	EN · KA
SOP-STR-01-F01	Sterilization Cycle Log (BI/CI Results)	Form	Sterilization	EN · KA
SOP-STR-01-F02	Instrument Tray Content Checklist	Form	Sterilization	EN · KA

Tier 3 – Patient Rights · 10

Code	Title	Type	Included when	Download
PR-01	Patient Rights	SOP/Policy	Always	EN · KA
PR-02	Interpreter Language Access	SOP/Policy	Always	EN · KA
PR-02-F01	Interpreter Use Log	Form	Always	EN · KA
PR-03	Religious Dietary Accommodation Policy	SOP/Policy	Always	EN · KA
PR-03-F01	Patient Accommodation Request	Form	Always	EN · KA
PR-04	Advance Directives Resuscitation Status Policy	SOP/Policy	Always	EN · KA
PR-04-F01	Advance Directive Documentation	Form	Always	EN · KA
PR-05	Accessibility Disability Access Policy	SOP/Policy	Always	EN · KA
PR-05-F01	Accessibility Accommodation Request	Form	Always	EN · KA
PR-06	Migrant Refugee Inclusive Care	SOP/Policy	Always	EN · KA

Tier 4 – Laboratory & Diagnostics · 37

Code	Title	Type	Included when	Download
SOP-LAB-01	Specimen Collection & Chain of Custody	SOP/Policy	In-house laboratory	EN · KA
SOP-LAB-01-F01	Specimen Collection Label/Requisition	Form	In-house laboratory	EN · KA
SOP-LAB-02	Laboratory Internal Quality Control	SOP/Policy	In-house laboratory	EN · KA
SOP-LAB-02-F01	Daily Internal QC Log	Form	In-house laboratory	EN · KA
SOP-LAB-02-F02	QC Out-of-Range Investigation Form	Form	In-house laboratory	EN · KA
SOP-LAB-03	Specimen Rejection Criteria	SOP/Policy	In-house laboratory	EN · KA
SOP-LAB-03-F01	Specimen Rejection Log	Form	In-house laboratory	EN · KA
SOP-LAB-04	Diagnostic Imaging Quality Assurance	SOP/Policy	Diagnostic imaging	EN · KA
SOP-LAB-04-F01	Imaging Equipment QA Checklist	Form	Diagnostic imaging	EN · KA
SOP-LAB-05	Point-of-Care Testing Governance	SOP/Policy	In-house laboratory	EN · KA
SOP-LAB-05-F01	POCT Device Competency Checklist	Form	In-house laboratory	EN · KA
SOP-LAB-05-F02	POCT Daily QC Log	Form	In-house laboratory	EN · KA
SOP-LAB-06	Reference Laboratory & Send-Out Testing	SOP/Policy	In-house laboratory	EN · KA
SOP-LAB-06-F01	Chain of Custody Form (Specimen Send-Out)	Form	In-house laboratory	EN · KA
SOP-LAB-07	Laboratory Equipment Calibration & Maintenance	SOP/Policy	In-house laboratory	EN · KA
SOP-LAB-07-F01	Equipment Calibration/Maintenance Log	Form	In-house laboratory	EN · KA
SOP-LAB-07-F02	Calibration Verification Record	Form	In-house laboratory	EN · KA
SOP-LAB-08	Reagent & Consumable Management	SOP/Policy	In-house laboratory	EN · KA
SOP-LAB-08-F01	Reagent/Consumable Lot Receipt Log	Form	In-house laboratory	EN · KA
SOP-LAB-09	Result Reporting, Verification & Amendment	SOP/Policy	In-house laboratory	EN · KA
SOP-LAB-09-F01	Result Amendment Record	Form	In-house laboratory	EN · KA
SOP-LAB-10	Laboratory Biosafety & Biohazardous Waste	SOP/Policy	In-house laboratory	EN · KA
SOP-LAB-10-F01	Biohazard Waste Manifest Tracking Log	Form	In-house laboratory	EN · KA
SOP-LAB-11	Laboratory Personnel Competency Assessment	SOP/Policy	In-house laboratory	EN · KA
SOP-LAB-11-F01	Six-Element Competency Assessment Checklist	Form	In-house laboratory	EN · KA
SOP-LAB-12	Clinical Microbiology Testing	SOP/Policy	In-house laboratory	EN · KA
SOP-LAB-12-F01	Gram Stain/Culture Worksheet	Form	In-house laboratory	EN · KA
SOP-LAB-13	Molecular (PCR) Testing	SOP/Policy	In-house laboratory	EN · KA
SOP-LAB-13-F01	PCR Negative Control / Contamination Log	Form	In-house laboratory	EN · KA
SOP-LAB-14	Test Menu & Scope of Testing	SOP/Policy	In-house laboratory	EN · KA
SOP-LAB-15	Method Validation & Verification	SOP/Policy	In-house laboratory	EN · KA
SOP-LAB-15-F01	Method Validation/Verification Report Template	Form	In-house laboratory	EN · KA
SOP-LAB-16	Laboratory Data Integrity	SOP/Policy	In-house laboratory	EN · KA
SOP-LAB-16-F01	Audit Trail Review Checklist	Form	In-house laboratory	EN · KA
SOP-LAB-16-F02	Backup/Restore Test Log	Form	In-house laboratory	EN · KA
SOP-LAB-17	Critical Lab Value Notification	SOP/Policy	In-house laboratory	EN · KA
SOP-LAB-17-F01	Critical Value Notification Log	Form	In-house laboratory	EN · KA

Tier 5 – Oncology · 16

Code	Title	Type	Included when	Download
ONC-01	Hazardous Drug Handling & Safety	SOP/Policy	Oncology	EN · KA
ONC-01-F01	Hazardous Drug Spill Report	Form	Oncology	EN · KA
ONC-02	Extravasation Management	SOP/Policy	Oncology	EN · KA
ONC-02-F01	Extravasation Event Report	Form	Oncology	EN · KA
ONC-03	Oncology-Specific Informed Consent	SOP/Policy	Oncology	EN · KA
ONC-03	Oncology-Specific Informed Consent	SOP/Policy	Oncology	EN · KA
ONC-03-F01	Oncology Informed Consent (with Fertility Discussion)	Form	Oncology	EN · KA
ONC-04	Cytotoxic Waste Disposal	SOP/Policy	Oncology	EN · KA
ONC-04-F01	Cytotoxic Waste Manifest	Form	Oncology	EN · KA
ONC-05	Neutropenic Fever Protocol	SOP/Policy	Oncology	EN · KA
ONC-05-F01	Neutropenic Fever Recognition & Transfer Checklist	Form	Oncology	EN · KA
ONC-06	Chemotherapy Order Verification	SOP/Policy	Oncology	EN · KA
ONC-06-F01	Chemotherapy Order Verification Sheet (4-Point)	Form	Oncology	EN · KA
ONC-06-F02	BSA Calculation Worksheet	Form	Oncology	EN · KA
ONC-07	Central Venous Access Device (Port) Care	SOP/Policy	Oncology	EN · KA
ONC-07-F01	Port Access/Flush Log	Form	Oncology	EN · KA

Tier 6 – Pediatric · 8

Code	Title	Type	Included when	Download
PED-01	Pediatric Consent & Guardian Authorization	SOP/Policy	Pediatric patients	EN · KA
PED-01-F01	Pediatric Consent/Assent Form	Form	Pediatric patients	EN · KA
PED-02	Pediatric Dosing Safety	SOP/Policy	Pediatric patients	EN · KA
PED-02-F01	Weight-Based Dosing Calculation Worksheet	Form	Pediatric patients	EN · KA
PED-03	Safeguarding	SOP/Policy	Pediatric patients	EN · KA
PED-03-F01	Safeguarding Concern Report	Form	Pediatric patients	EN · KA
PED-04	Vaccine Cold Chain Management	SOP/Policy	Pediatric patients	EN · KA
PED-04-F01	Vaccine Cold Chain Temperature Log	Form	Pediatric patients	EN · KA

Tier C – Dialysis · 10

Code	Title	Type	Included when	Download
DIAL-01	Vascular Access Care	SOP/Policy	Dialysis	EN · KA
DIAL-01-F01	Vascular Access Daily Assessment Log	Form	Dialysis	EN · KA
DIAL-02	Water Treatment & Dialysate Quality	SOP/Policy	Dialysis	EN · KA
DIAL-02-F01	Water/Dialysate Monthly Microbiological Test Log	Form	Dialysis	EN · KA
DIAL-03	Dialyzer Use — Single-Use vs. Reprocessing	SOP/Policy	Dialysis	EN · KA
DIAL-03-F01	Dialyzer Use Record	Form	Dialysis	EN · KA
DIAL-04	Bloodborne Pathogen Segregation (Dialysis)	SOP/Policy	Dialysis	EN · KA
DIAL-04-F01	HBsAg/HCV Testing Schedule Tracker	Form	Dialysis	EN · KA
DIAL-05	Intradialytic Emergency Response	SOP/Policy	Dialysis	EN · KA
DIAL-05-F01	Intradialytic Event Report	Form	Dialysis	EN · KA

Tier 7 – Cross-Cutting · 25

Code	Title	Type	Included when	Download
CC-01	Emergency Preparedness	SOP/Policy	Always	EN · KA
CC-01-F01	Emergency Drill Report	Form	Always	EN · KA
CC-02	Supplier Evaluation	SOP/Policy	Always	EN · KA
CC-02-F01	Supplier Evaluation Scorecard	Form	Always	EN · KA
CC-03	Complaints Handling	SOP/Policy	Always	EN · KA
CC-03-F01	Patient Complaint Intake Form	Form	Always	EN · KA
CC-04	Business Continuity	SOP/Policy	Always	EN · KA
CC-04-F01	Business Continuity Test Report	Form	Always	EN · KA
CC-05	Environmental Cleaning & Disinfection	SOP/Policy	Always	EN · KA
CC-05-F01	Terminal Cleaning Verification Checklist	Form	Always	EN · KA
CC-06	Radiation Safety Program	SOP/Policy	Diagnostic imaging	EN · KA
CC-06-F01	Radiation Dosimetry Log	Form	Diagnostic imaging	EN · KA
CC-06-F02	Pre-Examination Pregnancy Determination Form	Form	Diagnostic imaging	EN · KA
CC-07	Anaphylaxis / Acute Allergic Reaction Management	SOP/Policy	Always	EN · KA
CC-07-F01	Anaphylaxis Event Report	Form	Always	EN · KA
CC-08	General Facility & Fire Safety	SOP/Policy	Always	EN · KA
CC-08-F01	Fire Drill Report	Form	Always	EN · KA
CC-09	Medical Tourism & International Patient Coordination	SOP/Policy	International patients	EN · KA
CC-09-F01	International Patient Intake & Coordination Form	Form	International patients	EN · KA
CC-10	Continuity of Care for Returning/Relocating Patients	SOP/Policy	International patients	EN · KA
CC-10-F01	Continuity-of-Care Summary	Form	International patients	EN · KA
CC-11	Telehealth / Telemedicine	SOP/Policy	Telehealth	EN · KA
CC-11-F01	Telehealth Informed Consent & Encounter Log	Form	Telehealth	EN · KA
CC-12	Electrical Safety & Backup Power	SOP/Policy	Always	EN · KA
CC-12-F01	Backup Power / Generator Test Log	Form	Always	EN · KA

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ISO 9001 Ready — Ambulatory Clinic Document Library