ISO 9001 Ready · Ambulatory Clinic
190 documents, English and Georgian — the structure and samples free, the pack on order
See every code and title, read the samples, then order the English pack or the Georgian edition — or run the free Simulation first.
90 procedures and policies · 97 forms · QMS core set · index and audit · 106 universal, the rest by module
ISO 9001:2026 update. ISO published the sixth edition of ISO 9001 on 16 September 2026; it replaces ISO 9001:2015. The ten-clause structure is unchanged and most requirements are the same. ISO 9001 Ready document packs and courses were built to ISO 9001:2015 and are being updated to the 2026 edition. The update covers separate registers for risks and for opportunities, quality culture and ethical behaviour, planning of changes, a defined objective for every internal audit, and the new management review input. Document and course titles that name the 2015 edition will change when the updated files are released. Certification to ISO 9001:2015 remains valid during the transition period set by the accreditation system.
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.
The structure is free and the samples are free, so that an organization can see exactly what it would receive and judge the quality with its own eyes before paying. The pack itself — every document for the type, in the edition you choose — is delivered after purchase, within one working day of the bank transfer. The English pack is ASF’s library; the Georgian edition is the Public Health Institute of Georgia’s adaptation to Georgian law and practice, and includes the English pack. The generated add-on puts your organization’s names, dates and logo in every document after an ASF expert reviews your intake.
Free
the structure (Excel index, this map) and the sample documents marked below
The pack
English € 290 · Georgian edition (PHIG-adapted, English included) € 590 · generated and verified + € 300
Master Index · 3
| Code | Title | Type | Included when | Download |
|---|---|---|---|---|
| AUDIT-01 | Full Pack Quality Audit Report | Index | Always | in the pack |
| INDEX | Records & Forms Index | Index | Always | in the pack |
| MAP-01 | Master Index & Document Map | Index | Always | Download sample (EN, .docx) → |
Tier 1 – QMS Core Set · 21
| Code | Title | Type | Included when | Download |
|---|---|---|---|---|
| QMS-00-F01 | 12-Week Implementation Plan | Form | Always | in the pack |
| QMS-01 | Context of the Organization and Interested Parties | SOP/Policy | Always | in the pack |
| QMS-01-F01 | Context and Interested-Parties Register | Form | Always | in the pack |
| QMS-02 | Scope of the Quality Management System | SOP/Policy | Always | in the pack |
| QMS-03 | Quality Policy | SOP/Policy | Always | in the pack |
| QMS-04 | Quality Objectives and Performance Indicators | SOP/Policy | Always | in the pack |
| QMS-04-F01 | Quality Objectives and KPI Plan | Form | Always | in the pack |
| QMS-04-F02 | Quarterly KPI Report | Form | Always | in the pack |
| QMS-05 | Process Map and Process Interactions | SOP/Policy | Always | in the pack |
| QMS-05-F01 | Process Register | Form | Always | in the pack |
| QMS-06 | Quality Manual | SOP/Policy | Always | in the pack |
| QMS-07 | Patient Satisfaction and Feedback Measurement | SOP/Policy | Always | in the pack |
| QMS-07-F01 | Patient Experience Survey (15 items) | Form | Always | in the pack |
| QMS-07-F02 | Quarterly Patient Feedback Summary | Form | Always | in the pack |
| QMS-08 | Control of Monitoring and Measuring Equipment | SOP/Policy | Always | in the pack |
| QMS-08-F01 | Equipment Inventory and Calibration Register | Form | Always | in the pack |
| QMS-08-F02 | Out-of-Calibration Report | Form | Always | in the pack |
| QMS-09 | Competence, Awareness and Training | SOP/Policy | Always | in the pack |
| QMS-09-F01 | Training Matrix by Role | Form | Always | in the pack |
| QMS-09-F02 | Training Record and Effectiveness Evaluation | Form | Always | in the pack |
| QMS-10 | ISO 9001:2015 Clause Crosswalk | SOP/Policy | Always | in the pack |
Tier 2 – Governance · 23
| Code | Title | Type | Included when | Download |
|---|---|---|---|---|
| GOV-01 | Nonconformity & Corrective Action | SOP/Policy | Always | in the pack |
| GOV-01-F01 | Nonconformity Report | Form | Always | in the pack |
| GOV-01-F02 | Corrective Action Plan (CAPA) | Form | Always | in the pack |
| GOV-02 | Internal Audit Program | SOP/Policy | Always | in the pack |
| GOV-02-F01 | Internal Audit Checklist | Form | Always | in the pack |
| GOV-02-F02 | Audit Finding Log | Form | Always | in the pack |
| GOV-03 | Management Review | SOP/Policy | Always | in the pack |
| GOV-03-F01 | Management Review Minutes | Form | Always | in the pack |
| GOV-03-F02 | Management Review Action Item Tracker | Form | Always | in the pack |
| GOV-04 | Document Control | SOP/Policy | Always | Download sample (EN, .docx) → |
| GOV-04-F01 | Document Control Register | Form | Always | Download sample (EN, .docx) → |
| GOV-04-F02 | Document Change Request Form | Form | Always | in the pack |
| GOV-05 | Risk Register | SOP/Policy | Always | in the pack |
| GOV-05-F02 | Risk Assessment Worksheet | Form | Always | in the pack |
| GOV-06 | GDPR Data Protection Policy | SOP/Policy | Always | in the pack |
| GOV-06-F01 | Data Subject Rights Request Log | Form | Always | in the pack |
| GOV-07 | Cybersecurity & IT Security Policy | SOP/Policy | Always | in the pack |
| GOV-07-F01 | Cybersecurity/IT Security Incident Report | Form | Always | in the pack |
| GOV-08 | Conflict of Interest Policy | SOP/Policy | Always | in the pack |
| GOV-08-F01 | Annual Disclosure & Attestation Form (COI / Anti-Bribery / Whistleblower Awareness) | Form | Always | in the pack |
| GOV-09 | Anti-Bribery & Anti-Corruption Policy | SOP/Policy | Always | in the pack |
| GOV-10 | Whistleblower Protection Policy | SOP/Policy | Always | in the pack |
| GOV-11 | Regulatory Crosswalk & Multi-Jurisdiction Equivalence Reference | SOP/Policy | Always | in the pack |
Tier 3 – General Clinical / IPC / Patient Safety / HIM / HR · 38
| Code | Title | Type | Included when | Download |
|---|---|---|---|---|
| SOP-HIM-01 | Patient Records Confidentiality | SOP/Policy | Always | in the pack |
| SOP-HIM-01-F01 | Medical Record Amendment Request | Form | Always | in the pack |
| SOP-HIM-01-F02 | Release of Information Authorization | Form | Always | in the pack |
| SOP-HR-01 | Physician & Clinical Staff Credentialing | SOP/Policy | Always | in the pack |
| SOP-HR-01-F01 | Physician Credentialing Checklist | Form | Always | in the pack |
| SOP-HR-01-F02 | Privileging Request Form | Form | Always | in the pack |
| SOP-HR-03 | Volunteer, Student & Trainee Supervision | SOP/Policy | Always | in the pack |
| SOP-HR-03-F01 | Volunteer/Student/Trainee Supervision Agreement & Checklist | Form | Always | in the pack |
| SOP-IPC-01 | Standard Precautions | SOP/Policy | Always | in the pack |
| SOP-IPC-01-F01 | Hand Hygiene Audit Checklist | Form | Always | in the pack |
| SOP-IPC-02 | Hand Hygiene | SOP/Policy | Always | Download sample (EN, .docx) → |
| SOP-IPC-03 | Personal Protective Equipment | SOP/Policy | Always | in the pack |
| SOP-IPC-04 | Respiratory Hygiene and Cough Etiquette | SOP/Policy | Always | in the pack |
| SOP-IPC-04-F01 | Respiratory Hygiene Signage and Supply Check | Form | Always | in the pack |
| SOP-IPC-05 | Transmission-Based (Isolation) Precautions | SOP/Policy | Always | in the pack |
| SOP-IPC-05-F01 | Transmission-Based Precautions Log | Form | Always | in the pack |
| SOP-IPC-06 | Safe Handling of Patient-Care Equipment, Linen and Waste | SOP/Policy | Always | in the pack |
| SOP-IPC-06-F01 | Equipment Cleaning Between Patients Log | Form | Always | in the pack |
| SOP-IPC-06-F02 | Waste Segregation Audit | Form | Always | in the pack |
| SOP-IPC-07 | Safe Injection Practices | SOP/Policy | Always | in the pack |
| SOP-IPC-08 | Sharps Safety | SOP/Policy | Always | in the pack |
| SOP-IPC-08-F01 | Sharps Injury Log | Form | Always | in the pack |
| SOP-IPC-09 | Post-Exposure Prophylaxis (Needlestick/Bloodborne) | SOP/Policy | Always | in the pack |
| SOP-IPC-09-F01 | Post-Exposure Prophylaxis Incident Report | Form | Always | in the pack |
| SOP-MED-01 | Medication Management | SOP/Policy | Always | in the pack |
| SOP-MED-01-F01 | Medication Error Report | Form | Always | in the pack |
| SOP-MED-01-F02 | High-Alert Medication Double-Check Log | Form | Always | in the pack |
| SOP-MED-02 | Controlled Substances Security & Diversion Prevention | SOP/Policy | Controlled substances | in the pack |
| SOP-MED-02-F01 | Controlled Substance Inventory & Count Log | Form | Controlled substances | in the pack |
| SOP-PR-01 | General Informed Consent | SOP/Policy | Always | in the pack |
| SOP-PR-01-F01 | General Informed Consent Form | Form | Always | in the pack |
| SOP-PS-01 | Patient Identification | SOP/Policy | Always | in the pack |
| SOP-PS-01-F01 | Patient Identification Verification Checklist | Form | Always | in the pack |
| SOP-PS-02 | Clinical Incident & Adverse Event Reporting | SOP/Policy | Always | in the pack |
| SOP-PS-02-F01 | Clinical Incident / Adverse Event Report | Form | Always | in the pack |
| SOP-STR-01 | Instrument Reprocessing & Sterilization | SOP/Policy | Sterilization | in the pack |
| SOP-STR-01-F01 | Sterilization Cycle Log (BI/CI Results) | Form | Sterilization | in the pack |
| SOP-STR-01-F02 | Instrument Tray Content Checklist | Form | Sterilization | in the pack |
Patient Rights · 10
| Code | Title | Type | Included when | Download |
|---|---|---|---|---|
| PR-01 | Patient Rights & Responsibilities | SOP/Policy | Always | Download sample (EN, .docx) → |
| PR-02 | Interpreter & Language Access | SOP/Policy | Always | in the pack |
| PR-02-F01 | Interpreter Use Log | Form | Always | in the pack |
| PR-03 | Religious & Dietary Accommodation Policy | SOP/Policy | Always | in the pack |
| PR-03-F01 | Religious & Dietary Accommodation Request Form | Form | Always | in the pack |
| PR-04 | Advance Directives & Resuscitation Status Policy | SOP/Policy | Always | in the pack |
| PR-04-F01 | Advance Directive / Resuscitation Status Documentation Form | Form | Always | in the pack |
| PR-05 | Accessibility & Disability Access Policy | SOP/Policy | Always | in the pack |
| PR-05-F01 | Accessibility Accommodation Request Form | Form | Always | in the pack |
| PR-06 | Migrant & Refugee-Inclusive Care Policy | SOP/Policy | Always | in the pack |
Tier 4 – Laboratory & Diagnostics · 37
| Code | Title | Type | Included when | Download |
|---|---|---|---|---|
| SOP-LAB-01 | Specimen Collection & Chain of Custody | SOP/Policy | In-house laboratory | in the pack |
| SOP-LAB-01-F01 | Specimen Collection Label/Requisition | Form | In-house laboratory | in the pack |
| SOP-LAB-02 | Laboratory Internal Quality Control | SOP/Policy | In-house laboratory | in the pack |
| SOP-LAB-02-F01 | Daily Internal QC Log | Form | In-house laboratory | in the pack |
| SOP-LAB-02-F02 | QC Out-of-Range Investigation Form | Form | In-house laboratory | in the pack |
| SOP-LAB-03 | Specimen Rejection Criteria | SOP/Policy | In-house laboratory | in the pack |
| SOP-LAB-03-F01 | Specimen Rejection Log | Form | In-house laboratory | in the pack |
| SOP-LAB-04 | Diagnostic Imaging Quality Assurance | SOP/Policy | Diagnostic imaging | in the pack |
| SOP-LAB-04-F01 | Imaging Equipment QA Checklist | Form | Diagnostic imaging | in the pack |
| SOP-LAB-05 | Point-of-Care Testing Governance | SOP/Policy | In-house laboratory | in the pack |
| SOP-LAB-05-F01 | POCT Device Competency Checklist | Form | In-house laboratory | in the pack |
| SOP-LAB-05-F02 | POCT Daily QC Log | Form | In-house laboratory | in the pack |
| SOP-LAB-06 | Reference Laboratory & Send-Out Testing | SOP/Policy | In-house laboratory | in the pack |
| SOP-LAB-06-F01 | Chain of Custody Form (Specimen Send-Out) | Form | In-house laboratory | in the pack |
| SOP-LAB-07 | Laboratory Equipment Calibration & Maintenance | SOP/Policy | In-house laboratory | in the pack |
| SOP-LAB-07-F01 | Equipment Calibration/Maintenance Log | Form | In-house laboratory | in the pack |
| SOP-LAB-07-F02 | Calibration Verification Record | Form | In-house laboratory | in the pack |
| SOP-LAB-08 | Reagent & Consumable Management | SOP/Policy | In-house laboratory | in the pack |
| SOP-LAB-08-F01 | Reagent/Consumable Lot Receipt Log | Form | In-house laboratory | in the pack |
| SOP-LAB-09 | Result Reporting, Verification & Amendment | SOP/Policy | In-house laboratory | in the pack |
| SOP-LAB-09-F01 | Result Amendment Record | Form | In-house laboratory | in the pack |
| SOP-LAB-10 | Laboratory Biosafety & Biohazardous Waste | SOP/Policy | In-house laboratory | in the pack |
| SOP-LAB-10-F01 | Biohazard Waste Manifest Tracking Log | Form | In-house laboratory | in the pack |
| SOP-LAB-11 | Laboratory Personnel Competency Assessment | SOP/Policy | In-house laboratory | in the pack |
| SOP-LAB-11-F01 | Six-Element Competency Assessment Checklist | Form | In-house laboratory | in the pack |
| SOP-LAB-12 | Clinical Microbiology Testing | SOP/Policy | In-house laboratory | in the pack |
| SOP-LAB-12-F01 | Gram Stain/Culture Worksheet | Form | In-house laboratory | in the pack |
| SOP-LAB-13 | Molecular (PCR) Testing | SOP/Policy | In-house laboratory | in the pack |
| SOP-LAB-13-F01 | PCR Negative Control / Contamination Log | Form | In-house laboratory | in the pack |
| SOP-LAB-14 | Test Menu & Scope of Testing | SOP/Policy | In-house laboratory | in the pack |
| SOP-LAB-15 | Method Validation & Verification | SOP/Policy | In-house laboratory | in the pack |
| SOP-LAB-15-F01 | Method Validation/Verification Report Template | Form | In-house laboratory | in the pack |
| SOP-LAB-16 | Laboratory Data Integrity | SOP/Policy | In-house laboratory | in the pack |
| SOP-LAB-16-F01 | Audit Trail Review Checklist | Form | In-house laboratory | in the pack |
| SOP-LAB-16-F02 | Backup/Restore Test Log | Form | In-house laboratory | in the pack |
| SOP-LAB-17 | Critical Lab Value Notification | SOP/Policy | In-house laboratory | in the pack |
| SOP-LAB-17-F01 | Critical Value Notification Log | Form | In-house laboratory | in the pack |
Tier 5 – Oncology · 15
| Code | Title | Type | Included when | Download |
|---|---|---|---|---|
| ONC-01 | Hazardous Drug Handling & Safety | SOP/Policy | Oncology | in the pack |
| ONC-01-F01 | Hazardous Drug Spill Report | Form | Oncology | in the pack |
| ONC-02 | Extravasation Management | SOP/Policy | Oncology | in the pack |
| ONC-02-F01 | Extravasation Event Report | Form | Oncology | in the pack |
| ONC-03 | Oncology-Specific Informed Consent | SOP/Policy | Oncology | in the pack |
| ONC-03-F01 | Oncology Informed Consent (with Fertility Discussion) | Form | Oncology | in the pack |
| ONC-04 | Cytotoxic Waste Disposal | SOP/Policy | Oncology | in the pack |
| ONC-04-F01 | Cytotoxic Waste Manifest | Form | Oncology | in the pack |
| ONC-05 | Neutropenic Fever Protocol | SOP/Policy | Oncology | in the pack |
| ONC-05-F01 | Neutropenic Fever Recognition & Transfer Checklist | Form | Oncology | in the pack |
| ONC-06 | Chemotherapy Order Verification | SOP/Policy | Oncology | in the pack |
| ONC-06-F01 | Chemotherapy Order Verification Sheet (4-Point) | Form | Oncology | in the pack |
| ONC-06-F02 | BSA Calculation Worksheet | Form | Oncology | in the pack |
| ONC-07 | Central Venous Access Device (Port) Care | SOP/Policy | Oncology | in the pack |
| ONC-07-F01 | Port Access/Flush Log | Form | Oncology | in the pack |
Tier 6 – Pediatric · 8
| Code | Title | Type | Included when | Download |
|---|---|---|---|---|
| PED-01 | Pediatric Consent & Guardian Authorization | SOP/Policy | Pediatric patients | in the pack |
| PED-01-F01 | Pediatric Consent/Assent Form | Form | Pediatric patients | in the pack |
| PED-02 | Pediatric Dosing Safety | SOP/Policy | Pediatric patients | in the pack |
| PED-02-F01 | Weight-Based Dosing Calculation Worksheet | Form | Pediatric patients | in the pack |
| PED-03 | Safeguarding | SOP/Policy | Pediatric patients | in the pack |
| PED-03-F01 | Safeguarding Concern Report | Form | Pediatric patients | in the pack |
| PED-04 | Vaccine Cold Chain Management | SOP/Policy | Pediatric patients | in the pack |
| PED-04-F01 | Vaccine Cold Chain Temperature Log | Form | Pediatric patients | in the pack |
Tier C – Dialysis · 10
| Code | Title | Type | Included when | Download |
|---|---|---|---|---|
| DIAL-01 | Vascular Access Care | SOP/Policy | Dialysis | in the pack |
| DIAL-01-F01 | Vascular Access Daily Assessment Log | Form | Dialysis | in the pack |
| DIAL-02 | Water Treatment & Dialysate Quality | SOP/Policy | Dialysis | in the pack |
| DIAL-02-F01 | Water/Dialysate Monthly Microbiological Test Log | Form | Dialysis | in the pack |
| DIAL-03 | Dialyzer Use — Single-Use vs. Reprocessing | SOP/Policy | Dialysis | in the pack |
| DIAL-03-F01 | Dialyzer Use Record | Form | Dialysis | in the pack |
| DIAL-04 | Bloodborne Pathogen Segregation (Dialysis) | SOP/Policy | Dialysis | in the pack |
| DIAL-04-F01 | HBsAg/HCV Testing Schedule Tracker | Form | Dialysis | in the pack |
| DIAL-05 | Intradialytic Emergency Response | SOP/Policy | Dialysis | in the pack |
| DIAL-05-F01 | Intradialytic Event Report | Form | Dialysis | in the pack |
Tier 7 – Cross-Cutting · 25
| Code | Title | Type | Included when | Download |
|---|---|---|---|---|
| CC-01 | Emergency Preparedness | SOP/Policy | Always | in the pack |
| CC-01-F01 | Emergency Drill Report | Form | Always | in the pack |
| CC-02 | Supplier Evaluation | SOP/Policy | Always | in the pack |
| CC-02-F01 | Supplier Evaluation Scorecard | Form | Always | in the pack |
| CC-03 | Complaints Handling | SOP/Policy | Always | Download sample (EN, .docx) → |
| CC-03-F01 | Patient Complaint Intake Form | Form | Always | in the pack |
| CC-04 | Business Continuity | SOP/Policy | Always | in the pack |
| CC-04-F01 | Business Continuity Test Report | Form | Always | in the pack |
| CC-05 | Environmental Cleaning & Disinfection | SOP/Policy | Always | in the pack |
| CC-05-F01 | Terminal Cleaning Verification Checklist | Form | Always | in the pack |
| CC-06 | Radiation Safety Program | SOP/Policy | Diagnostic imaging | in the pack |
| CC-06-F01 | Radiation Dosimetry Log | Form | Diagnostic imaging | in the pack |
| CC-06-F02 | Pre-Examination Pregnancy Determination Form | Form | Diagnostic imaging | in the pack |
| CC-07 | Anaphylaxis / Acute Allergic Reaction Management | SOP/Policy | Always | in the pack |
| CC-07-F01 | Anaphylaxis Event Report | Form | Always | in the pack |
| CC-08 | General Facility & Fire Safety | SOP/Policy | Always | in the pack |
| CC-08-F01 | Fire Drill Report | Form | Always | in the pack |
| CC-09 | Medical Tourism & International Patient Coordination | SOP/Policy | International patients | in the pack |
| CC-09-F01 | International Patient Intake & Coordination Form | Form | International patients | in the pack |
| CC-10 | Continuity of Care for Returning/Relocating Patients | SOP/Policy | International patients | in the pack |
| CC-10-F01 | Continuity-of-Care Summary | Form | International patients | in the pack |
| CC-11 | Telehealth / Telemedicine | SOP/Policy | Telehealth | in the pack |
| CC-11-F01 | Telehealth Informed Consent & Encounter Log | Form | Telehealth | in the pack |
| CC-12 | Electrical Safety & Backup Power | SOP/Policy | Always | in the pack |
| CC-12-F01 | Backup Power / Generator Test Log | Form | Always | in the pack |
Order the pack
English or Georgian edition; add the generated pack for your names and logo in every document.
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