Sync template from atomicqms-style deployment

.gitea/workflows/atomicai.yml

@@ -0,0 +1,76 @@
+name: AtomicAI Mental Health Outpatient Assistant
+
+on:
+  issue_comment:
+    types: [created]
+  issues:
+    types: [opened, assigned]
+  pull_request:
+    types: [opened, synchronize, assigned]
+  pull_request_review_comment:
+    types: [created]
+
+jobs:
+  claude-assistant:
+    runs-on: ubuntu-latest
+    if: |
+      github.actor != 'atomicqms-service' &&
+      (
+      (github.event_name == 'issue_comment' && contains(github.event.comment.body, '@atomicai')) ||
+      (github.event_name == 'issues' && github.event.action == 'opened' && contains(github.event.issue.body, '@atomicai')) ||
+      (github.event_name == 'pull_request' && github.event.action == 'opened' && contains(github.event.pull_request.body, '@atomicai')) ||
+      (github.event_name == 'pull_request_review_comment' && contains(github.event.comment.body, '@atomicai')) ||
+      (github.event.action == 'assigned' && github.event.assignee.login == 'atomicai')
+      )
+
+    permissions:
+      contents: write
+      issues: write
+      pull-requests: write
+
+    steps:
+      - uses: actions/checkout@v4
+        with:
+          fetch-depth: 0
+
+      - name: Run AtomicAI Mental Health Outpatient Assistant
+        uses: https://beta.atomicqms.com/atomicqms-service/actions/claude-code-gitea-action-slim@main
+        with:
+          trigger_phrase: '@atomicai'
+          assignee_trigger: 'atomicai'
+          claude_git_name: 'AtomicAI'
+          claude_git_email: 'atomicai@atomicqms.local'
+          custom_instructions: |
+            You are AtomicAI, an AI assistant specialized in Mental Health Outpatient Quality Management.
+
+            ## Your Expertise
+            - Behavioral health accreditation (Joint Commission BHC, CARF)
+            - Outpatient mental health treatment protocols
+            - Crisis intervention and safety planning
+            - Suicide risk assessment procedures
+            - Psychiatric medication management
+            - Therapy documentation standards
+            - HIPAA and 42 CFR Part 2 (substance abuse confidentiality)
+            - Telehealth/telepsychiatry protocols
+            - Group therapy and intensive outpatient programs
+
+            ## Document Creation Guidelines
+            - Place Clinical SOPs in SOPs/Clinical/
+            - Place Crisis Protocols in Protocols/Crisis/
+            - Place Therapy SOPs in SOPs/Therapy/
+            - Place Safety Plans in Forms/Safety/
+            - Place Assessment Forms in Forms/Assessment/
+            - Place Policies in Policies/
+
+            ## Numbering Convention
+            - SOP-MH-XXX for Mental Health SOPs
+            - SOP-CRS-XXX for Crisis SOPs
+            - PRO-XXX for Treatment Protocols
+            - ASM-XXX for Assessment Tools
+            - POL-XXX for Policies
+            - FRM-XXX for Forms
+
+            Always create branches and submit changes as Pull Requests for review.
+            Prioritize patient safety, confidentiality, and evidence-based practices.
+          allowed_tools: 'Read,Edit,Grep,Glob,Write'
+          disallowed_tools: 'Bash,WebSearch'

Forms/FRM-001-Document-Change-Request.md

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+# Document Change Request Form
+
+| Form ID | FRM-001 | Revision | 1.0 |
+|---------|---------|----------|-----|
+
+---
+
+## Section 1: Request Information
+
+| Field | Entry |
+|-------|-------|
+| Request Date | |
+| Requested By | |
+| Department | |
+
+## Section 2: Document Information
+
+| Field | Entry |
+|-------|-------|
+| Document Number | |
+| Document Title | |
+| Current Revision | |
+
+## Section 3: Change Description
+
+### Type of Change
+- [ ] New Document
+- [ ] Revision to Existing Document
+- [ ] Document Obsolescence
+
+### Description of Change
+*(Describe the proposed change in detail)*
+
+
+
+
+### Reason for Change
+*(Explain why this change is needed)*
+
+
+
+
+## Section 4: Impact Assessment
+
+### Affected Areas
+- [ ] Training Required
+- [ ] Other Documents Affected
+- [ ] Process Changes Required
+- [ ] Validation Impact
+
+### List Affected Documents
+
+
+## Section 5: Approvals
+
+| Role | Name | Signature | Date |
+|------|------|-----------|------|
+| Requester | | | |
+| Document Owner | | | |
+| Quality Assurance | | | |
+
+---
+
+*Form FRM-001 Rev 1.0*

Forms/FRM-003-CAPA-Form.md

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+# Corrective and Preventive Action (CAPA) Form
+
+| Form ID | FRM-003 | Revision | 1.0 |
+|---------|---------|----------|-----|
+
+---
+
+## Section 1: CAPA Identification
+
+| Field | Entry |
+|-------|-------|
+| CAPA Number | |
+| Date Initiated | |
+| Initiated By | |
+| CAPA Owner | |
+| Target Closure Date | |
+
+## Section 2: Classification
+
+### Type
+- [ ] Corrective Action
+- [ ] Preventive Action
+
+### Source
+- [ ] Customer Complaint
+- [ ] Internal Audit
+- [ ] External Audit
+- [ ] Process Deviation
+- [ ] Nonconforming Product
+- [ ] Management Review
+- [ ] Other: ____________
+
+### Priority
+- [ ] Critical (5 business days)
+- [ ] Major (15 business days)
+- [ ] Minor (30 business days)
+
+## Section 3: Problem Description
+
+*(Describe the nonconformity or potential nonconformity)*
+
+
+
+
+## Section 4: Immediate Containment
+
+*(Actions taken to contain the immediate impact)*
+
+
+
+
+## Section 5: Root Cause Investigation
+
+### Investigation Method Used
+- [ ] 5 Whys
+- [ ] Fishbone Diagram
+- [ ] Fault Tree Analysis
+- [ ] Other: ____________
+
+### Root Cause Determination
+
+
+
+
+## Section 6: Corrective/Preventive Actions
+
+| Action | Responsible | Due Date | Status |
+|--------|-------------|----------|--------|
+| | | | |
+| | | | |
+| | | | |
+
+## Section 7: Effectiveness Verification
+
+| Criteria | Method | Result |
+|----------|--------|--------|
+| | | |
+
+Verification Date: ____________
+Verified By: ____________
+
+## Section 8: Closure
+
+| Role | Name | Signature | Date |
+|------|------|-----------|------|
+| CAPA Owner | | | |
+| Quality Approval | | | |
+
+---
+
+*Form FRM-003 Rev 1.0*

Forms/FRM-006-Audit-Checklist.md

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+# Internal Audit Checklist
+
+| Form ID | FRM-006 | Revision | 1.0 |
+|---------|---------|----------|-----|
+
+---
+
+## Audit Information
+
+| Field | Entry |
+|-------|-------|
+| Audit Number | |
+| Audit Date | |
+| Area/Process Audited | |
+| Lead Auditor | |
+| Auditee(s) | |
+
+---
+
+## Checklist Items
+
+| # | Requirement/Question | Reference | C/NC/NA | Evidence/Notes |
+|---|---------------------|-----------|---------|----------------|
+| 1 | Are current versions of applicable procedures available? | SOP-001 | | |
+| 2 | Are personnel trained on applicable procedures? | SOP-003 | | |
+| 3 | Are training records current and complete? | SOP-003 | | |
+| 4 | Are records properly maintained and retrievable? | SOP-001 | | |
+| 5 | Are nonconformities being documented and addressed? | SOP-002 | | |
+| 6 | Are CAPAs being completed on time? | SOP-002 | | |
+| 7 | Is equipment calibrated and maintained? | | | |
+| 8 | Are process controls being followed? | | | |
+| 9 | Are quality objectives being monitored? | | | |
+| 10 | | | | |
+
+**Legend:** C = Conforming, NC = Nonconforming, NA = Not Applicable
+
+---
+
+## Findings Summary
+
+| Finding # | Type | Description | Clause Reference |
+|-----------|------|-------------|------------------|
+| | | | |
+| | | | |
+
+---
+
+## Auditor Signature
+
+| Auditor | Signature | Date |
+|---------|-----------|------|
+| | | |
+
+---
+
+*Form FRM-006 Rev 1.0*

Forms/Intake-Forms/FRM-MHO-001-New-Patient-Intake.md

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+# Mental Health New Patient Intake Form
+
+| Form ID | FRM-MHO-001 | Revision | 1.0 |
+|---------|-------------|----------|-----|
+
+---
+
+## Patient Information
+
+| Field | Entry |
+|-------|-------|
+| Last Name | |
+| First Name | |
+| Preferred Name | |
+| Date of Birth | |
+| Age | |
+| Sex | ☐ Male ☐ Female ☐ Other |
+| Gender Identity | |
+| Pronouns | |
+
+### Contact Information
+
+| Field | Entry |
+|-------|-------|
+| Address | |
+| City, State, ZIP | |
+| Home Phone | |
+| Cell Phone | |
+| Email | |
+| Preferred Contact Method | ☐ Home ☐ Cell ☐ Email |
+| OK to Leave Detailed Message? | ☐ Yes ☐ No |
+
+---
+
+## Emergency Contact
+
+| Field | Entry |
+|-------|-------|
+| Name | |
+| Relationship | |
+| Phone | |
+| Address | |
+
+---
+
+## Referral Information
+
+| Field | Entry |
+|-------|-------|
+| Referred By | |
+| Referring Provider Phone | |
+| Primary Care Physician | |
+| PCP Phone/Fax | |
+| Current Therapist (if any) | |
+| Current Prescriber (if any) | |
+
+---
+
+## Reason for Seeking Treatment
+
+**What brings you in for treatment today?**
+
+**What are your main symptoms or concerns?**
+
+**When did these symptoms start?**
+
+**What do you hope to get out of treatment?**
+
+---
+
+## Symptom Checklist
+
+*Check all symptoms you are currently experiencing:*
+
+### Mood Symptoms
+☐ Depressed mood
+☐ Loss of interest/pleasure
+☐ Hopelessness
+☐ Guilt
+☐ Irritability
+☐ Mood swings
+☐ Elevated/euphoric mood
+☐ Decreased need for sleep
+☐ Racing thoughts
+☐ Increased energy
+
+### Anxiety Symptoms
+☐ Excessive worry
+☐ Restlessness
+☐ Difficulty concentrating
+☐ Muscle tension
+☐ Sleep problems
+☐ Panic attacks
+☐ Fear of social situations
+☐ Specific phobias
+☐ Obsessive thoughts
+☐ Compulsive behaviors
+
+### Trauma Symptoms
+☐ Flashbacks/intrusive memories
+☐ Nightmares
+☐ Avoiding reminders of trauma
+☐ Emotional numbness
+☐ Hypervigilance
+☐ Easily startled
+
+### Psychotic Symptoms
+☐ Hearing voices
+☐ Seeing things others don't see
+☐ Paranoid thoughts
+☐ Unusual beliefs
+☐ Confused thinking
+
+### Other Symptoms
+☐ Difficulty concentrating
+☐ Memory problems
+☐ Impulsivity
+☐ Anger problems
+☐ Relationship difficulties
+☐ Work/school problems
+☐ Appetite changes
+☐ Weight changes
+☐ Fatigue/low energy
+☐ Chronic pain
+
+---
+
+## Suicidal/Self-Harm History
+
+| Question | Response |
+|----------|----------|
+| Are you currently having thoughts of suicide? | ☐ Yes ☐ No |
+| Are you currently having thoughts of harming yourself? | ☐ Yes ☐ No |
+| Have you ever attempted suicide? | ☐ Yes ☐ No |
+| If yes, when and how? | |
+| Have you ever engaged in self-harm (cutting, burning, etc.)? | ☐ Yes ☐ No |
+| If yes, describe: | |
+
+---
+
+## Psychiatric History
+
+### Previous Treatment
+
+| Treatment Type | Yes/No | Where | When | Helpful? |
+|----------------|--------|-------|------|----------|
+| Outpatient therapy | ☐ | | | ☐ Yes ☐ No |
+| Outpatient psychiatry | ☐ | | | ☐ Yes ☐ No |
+| Intensive outpatient (IOP) | ☐ | | | ☐ Yes ☐ No |
+| Partial hospitalization (PHP) | ☐ | | | ☐ Yes ☐ No |
+| Psychiatric hospitalization | ☐ | | | ☐ Yes ☐ No |
+| Residential treatment | ☐ | | | ☐ Yes ☐ No |
+| ECT | ☐ | | | ☐ Yes ☐ No |
+| TMS | ☐ | | | ☐ Yes ☐ No |
+
+### Previous Diagnoses
+
+*Check all that you have been diagnosed with:*
+
+☐ Depression
+☐ Bipolar Disorder
+☐ Anxiety Disorder
+☐ Panic Disorder
+☐ PTSD
+☐ OCD
+☐ ADHD
+☐ Schizophrenia/Schizoaffective
+☐ Personality Disorder (type: _______)
+☐ Eating Disorder
+☐ Substance Use Disorder
+☐ Autism Spectrum Disorder
+☐ Other: _______________
+
+---
+
+## Current Medications
+
+| Medication | Dose | Frequency | Prescriber |
+|------------|------|-----------|------------|
+| | | | |
+| | | | |
+| | | | |
+| | | | |
+| | | | |
+
+### Past Psychiatric Medications
+
+*List medications you have tried in the past:*
+
+| Medication | Helpful? | Side Effects? | Reason Stopped |
+|------------|----------|---------------|----------------|
+| | ☐ Yes ☐ No | | |
+| | ☐ Yes ☐ No | | |
+| | ☐ Yes ☐ No | | |
+| | ☐ Yes ☐ No | | |
+
+---
+
+## Allergies
+
+☐ No Known Allergies
+
+| Medication/Substance | Reaction |
+|---------------------|----------|
+| | |
+| | |
+
+---
+
+## Substance Use History
+
+| Substance | Ever Used | Age First Used | Current Use | Amount/Frequency | Last Used |
+|-----------|-----------|----------------|-------------|------------------|-----------|
+| Alcohol | ☐ | | ☐ | | |
+| Marijuana/Cannabis | ☐ | | ☐ | | |
+| Cocaine/Crack | ☐ | | ☐ | | |
+| Heroin/Opioids | ☐ | | ☐ | | |
+| Methamphetamine | ☐ | | ☐ | | |
+| Benzodiazepines (non-Rx) | ☐ | | ☐ | | |
+| Tobacco/Nicotine | ☐ | | ☐ | | |
+| Other: | ☐ | | ☐ | | |
+
+**Have you ever had treatment for substance use?** ☐ Yes ☐ No
+
+If yes, describe:
+
+---
+
+## Medical History
+
+### Current Medical Conditions
+
+☐ None
+
+| Condition | Notes |
+|-----------|-------|
+| | |
+| | |
+| | |
+
+### Past Surgeries/Hospitalizations
+
+| Surgery/Hospitalization | Year |
+|------------------------|------|
+| | |
+| | |
+
+### For Women
+
+| Field | Entry |
+|-------|-------|
+| Are you pregnant? | ☐ Yes ☐ No ☐ Maybe |
+| Are you breastfeeding? | ☐ Yes ☐ No |
+| Last menstrual period | |
+| Using contraception? | ☐ Yes ☐ No |
+
+---
+
+## Family Psychiatric History
+
+*Check all that apply to biological relatives:*
+
+| Condition | Mother | Father | Sibling | Grandparent | Other |
+|-----------|--------|--------|---------|-------------|-------|
+| Depression | ☐ | ☐ | ☐ | ☐ | ☐ |
+| Bipolar Disorder | ☐ | ☐ | ☐ | ☐ | ☐ |
+| Anxiety | ☐ | ☐ | ☐ | ☐ | ☐ |
+| Schizophrenia | ☐ | ☐ | ☐ | ☐ | ☐ |
+| Substance Abuse | ☐ | ☐ | ☐ | ☐ | ☐ |
+| Suicide/Attempt | ☐ | ☐ | ☐ | ☐ | ☐ |
+| ADHD | ☐ | ☐ | ☐ | ☐ | ☐ |
+| Other: | ☐ | ☐ | ☐ | ☐ | ☐ |
+
+---
+
+## Social History
+
+### Living Situation
+
+| Field | Entry |
+|-------|-------|
+| Who do you live with? | |
+| Type of housing | ☐ Own ☐ Rent ☐ With family ☐ Homeless ☐ Other |
+| Housing stability | ☐ Stable ☐ At risk ☐ Unstable |
+
+### Relationships
+
+| Field | Entry |
+|-------|-------|
+| Marital/Relationship status | ☐ Single ☐ Married ☐ Partnered ☐ Divorced ☐ Widowed |
+| Children (ages) | |
+| Quality of relationships | ☐ Good ☐ Fair ☐ Poor |
+| Social support | ☐ Strong ☐ Some ☐ Limited ☐ None |
+
+### Education/Employment
+
+| Field | Entry |
+|-------|-------|
+| Highest education | |
+| Current employment | ☐ Full-time ☐ Part-time ☐ Unemployed ☐ Disabled ☐ Retired ☐ Student |
+| Occupation | |
+| Work/school problems? | ☐ Yes ☐ No |
+
+### Legal
+
+| Field | Entry |
+|-------|-------|
+| Current legal issues? | ☐ Yes ☐ No |
+| If yes, describe: | |
+| History of incarceration? | ☐ Yes ☐ No |
+
+### Trauma History
+
+*Have you experienced any of the following?*
+
+☐ Physical abuse
+☐ Sexual abuse
+☐ Emotional/verbal abuse
+☐ Neglect
+☐ Domestic violence
+☐ Witnessed violence
+☐ Military combat
+☐ Serious accident
+☐ Natural disaster
+☐ Other trauma: _______________
+
+---
+
+## Current Stressors
+
+*Rate your current stress level (1-10):* _____
+
+*What are your main stressors right now?*
+
+---
+
+## Strengths and Supports
+
+*What are your strengths?*
+
+*Who are your supports (family, friends, community)?*
+
+*What coping strategies do you currently use?*
+
+---
+
+## Goals for Treatment
+
+*What would you like to accomplish through treatment?*
+
+1.
+2.
+3.
+
+---
+
+## Signature
+
+| Field | Entry |
+|-------|-------|
+| Patient Signature | |
+| Date | |
+| Guardian Signature (if minor) | |
+| Relationship to Patient | |
+
+---
+
+## For Office Use
+
+| Field | Entry |
+|-------|-------|
+| Date Received | |
+| Entered By | |
+| Appointment Date | |
+| Assigned Provider | |
+| Notes | |
+
+---
+
+*Form FRM-MHO-001 Rev 1.0 - Mental Health New Patient Intake Form*

Forms/Training/FRM-004-Training-Record.md

@@ -0,0 +1,72 @@
+# Training Record Form
+
+| Form ID | FRM-004 | Revision | 1.0 |
+|---------|---------|----------|-----|
+
+---
+
+## Section 1: Employee Information
+
+| Field | Entry |
+|-------|-------|
+| Employee Name | |
+| Employee ID | |
+| Department | |
+| Job Title | |
+
+## Section 2: Training Information
+
+| Field | Entry |
+|-------|-------|
+| Training Title | |
+| Training Date | |
+| Training Duration | |
+| Trainer Name | |
+| Trainer Qualification | |
+
+### Training Type
+- [ ] Initial Training
+- [ ] Retraining
+- [ ] Refresher
+- [ ] Procedure Update
+
+### Delivery Method
+- [ ] Classroom
+- [ ] On-the-Job
+- [ ] Self-Study
+- [ ] Computer-Based
+- [ ] Other: ____________
+
+## Section 3: Training Content
+
+*(List topics covered or attach training materials)*
+
+
+
+
+## Section 4: Assessment
+
+### Assessment Method
+- [ ] Written Test
+- [ ] Practical Demonstration
+- [ ] Verbal Assessment
+- [ ] Observation
+
+### Assessment Results
+
+| Metric | Result |
+|--------|--------|
+| Score (if applicable) | |
+| Pass/Fail | |
+
+## Section 5: Signatures
+
+| Role | Name | Signature | Date |
+|------|------|-----------|------|
+| Trainee | | | |
+| Trainer | | | |
+| Supervisor | | | |
+
+---
+
+*Form FRM-004 Rev 1.0*

Policies/POL-001-Quality-Policy.md

@@ -0,0 +1,57 @@
+# Quality Policy
+
+| Document ID | POL-001 |
+|-------------|---------|
+| Title | Quality Policy |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+
+---
+
+## 1. Policy Statement
+
+[ORGANIZATION NAME] is committed to providing products and services that consistently meet customer requirements and applicable regulatory requirements. We strive for continual improvement of our Quality Management System to enhance customer satisfaction.
+
+## 2. Quality Objectives
+
+Our organization commits to:
+
+1. **Customer Focus**: Understanding and meeting customer needs and expectations
+2. **Regulatory Compliance**: Maintaining compliance with all applicable regulations and standards
+3. **Continuous Improvement**: Continually improving the effectiveness of our QMS
+4. **Employee Engagement**: Ensuring all employees understand their role in quality
+5. **Risk-Based Thinking**: Identifying and addressing risks and opportunities
+
+## 3. Management Commitment
+
+Top management demonstrates commitment to the QMS by:
+
+- Ensuring the quality policy is appropriate to the organization's purpose
+- Ensuring quality objectives are established and compatible with strategic direction
+- Ensuring integration of QMS requirements into business processes
+- Promoting the use of the process approach and risk-based thinking
+- Ensuring resources needed for the QMS are available
+- Communicating the importance of effective quality management
+- Ensuring the QMS achieves its intended results
+- Engaging, directing, and supporting persons to contribute to QMS effectiveness
+
+## 4. Scope
+
+This policy applies to all employees, contractors, and processes within the scope of our Quality Management System.
+
+## 5. Communication
+
+This policy shall be:
+- Communicated and understood within the organization
+- Available to relevant interested parties as appropriate
+- Reviewed for continuing suitability
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |

README.md

@@ -1,3 +1,132 @@
-# mental-health-outpatient
+# Mental Health Outpatient Services Quality Management System
 
-A comprehensive QMS template designed for outpatient mental health clinics, counseling centers, and behavioral health practices.
+A comprehensive QMS template designed for outpatient mental health clinics, counseling centers, and behavioral health practices.
+
+## 🧠 Designed For
+
+- **Community Mental Health Centers** - Publicly funded outpatient services
+- **Private Psychiatric Practices** - Outpatient psychiatry and medication management
+- **Counseling and Therapy Centers** - Individual, group, and family therapy
+- **Child/Adolescent Mental Health** - Pediatric outpatient behavioral health
+- **Substance Abuse Treatment** - Outpatient addiction services
+- **Intensive Outpatient Programs (IOP)** - Structured day treatment
+- **Partial Hospitalization Programs (PHP)** - Day hospital services
+
+## 📋 Regulatory Framework
+
+This template supports compliance with:
+
+- **The Joint Commission** - Behavioral Health Care accreditation
+- **CARF** - Commission on Accreditation of Rehabilitation Facilities
+- **State Mental Health Authority** - State licensing and certification
+- **HIPAA** - Mental health information privacy
+- **42 CFR Part 2** - Substance abuse treatment confidentiality
+- **State Licensing Boards** - Psychologist, social worker, counselor regulations
+- **Medicare/Medicaid** - Outpatient mental health billing requirements
+- **APA Practice Guidelines** - Evidence-based treatment standards
+- **SAMHSA** - Substance abuse treatment guidelines
+
+## Repository Structure
+
+```
+├── SOPs/
+│   ├── Intake-Assessment/     # Referral, intake, diagnostic evaluation
+│   ├── Treatment/             # Therapy protocols, medication management
+│   ├── Crisis-Management/     # Crisis response, safety planning, hospitalization
+│   ├── Documentation/         # Progress notes, treatment plans, outcomes
+│   ├── Compliance/            # Consent, confidentiality, records
+│   └── General/               # Document control, training, CAPA
+├── Forms/
+│   ├── Intake-Forms/          # Registration, consent, authorization, history
+│   ├── Assessment-Tools/      # PHQ-9, GAD-7, AUDIT, depression/anxiety scales
+│   ├── Treatment-Plans/       # Initial and updated treatment plan templates
+│   ├── Safety-Plans/          # Crisis plans, safety contracts
+│   ├── Progress-Notes/        # Session documentation templates
+│   └── Training/              # Competency assessments
+├── Policies/                  # Practice policies
+├── Work-Instructions/         # Step-by-step procedures
+└── Templates/                 # Document templates
+```
+
+## Document Numbering Convention
+
+- **POL-XXX**: Policies
+- **SOP-INT-XXX**: Intake/Assessment SOPs
+- **SOP-TX-XXX**: Treatment SOPs
+- **SOP-CRS-XXX**: Crisis Management SOPs
+- **SOP-DOC-XXX**: Documentation SOPs
+- **SOP-CMP-XXX**: Compliance SOPs
+- **WI-XXX**: Work Instructions
+- **FRM-XXX**: Forms and Records
+
+## 🤖 AI-Powered Assistance
+
+This repository includes **AtomicAI**, your outpatient mental health QMS assistant. Mention `@atomicai` in any issue or pull request to:
+
+- Draft intake and assessment procedures
+- Create treatment protocols for specific conditions
+- Generate crisis intervention and safety planning SOPs
+- Develop progress note documentation standards
+- Create consent and confidentiality procedures
+- Review documents for accreditation compliance
+
+### Example Prompts
+
+- "@atomicai create an SOP for psychiatric intake evaluation"
+- "@atomicai draft a crisis intervention and safety planning protocol"
+- "@atomicai write a progress note documentation standard per billing requirements"
+- "@atomicai create a treatment plan template for depression"
+- "@atomicai develop a no-show and missed appointment policy"
+- "@atomicai create a telehealth informed consent procedure"
+
+## Getting Started
+
+1. **Establish Consent Procedures** - Configure informed consent and authorization forms
+2. **Standardize Assessments** - Implement validated screening tools
+3. **Define Documentation Standards** - Set up progress note and treatment plan templates
+4. **Create Crisis Protocols** - Establish safety planning and escalation procedures
+5. **Train Clinicians** - Use competency assessment forms
+
+## Key Documents to Create First
+
+1. **Intake Assessment SOP** - Standardized evaluation process
+2. **Treatment Planning Policy** - Individualized treatment plan requirements
+3. **Crisis Response Procedure** - Suicidal/homicidal ideation management
+4. **Safety Plan Template** - Client crisis planning tool
+5. **Progress Note Standards** - Documentation requirements for sessions
+6. **Informed Consent Forms** - Treatment consent, HIPAA, 42 CFR Part 2
+7. **Telehealth Policy** - Virtual care protocols and consent
+
+## Special Considerations for Outpatient Mental Health
+
+### Intake and Assessment
+- Referral management and triage
+- Comprehensive diagnostic evaluation
+- Validated screening instruments
+- Treatment matching and level of care
+- Insurance authorization
+
+### Treatment Services
+- Evidence-based therapy protocols
+- Medication evaluation and management
+- Group therapy programming
+- Family and couples therapy
+- Care coordination with other providers
+
+### Crisis Management
+- Suicide risk assessment
+- Safety planning
+- Crisis hotline resources
+- Hospitalization criteria and procedures
+- Post-crisis follow-up
+
+### Documentation and Compliance
+- HIPAA and 42 CFR Part 2 requirements
+- Progress note medical necessity
+- Treatment plan updates
+- Outcome measurement
+- Supervision and peer review
+
+---
+
+*This template is maintained by AtomicQMS. For questions, open an issue in this repository.*

SOPs/Clinical-Services/SOP-MHO-001-Initial-Evaluation.md

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+# Standard Operating Procedure: Outpatient Mental Health Initial Evaluation
+
+| Document ID | SOP-MHO-001 |
+|-------------|-------------|
+| Title | Outpatient Mental Health Initial Evaluation |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+| Department | Outpatient Mental Health |
+
+---
+
+## 1. Purpose
+
+To establish standardized procedures for conducting comprehensive initial mental health evaluations for new outpatient patients to ensure accurate diagnosis, appropriate treatment planning, and regulatory compliance.
+
+## 2. Scope
+
+This procedure applies to all initial evaluations for outpatient mental health services including:
+- Adult psychiatric evaluation
+- Child/adolescent psychiatric evaluation
+- Psychological evaluation
+- Intake assessment for therapy
+- Medication management evaluation
+- Telehealth evaluations
+
+## 3. Responsibilities
+
+### 3.1 Psychiatrist/Psychiatric NP/PA
+- Conduct psychiatric diagnostic evaluation
+- Establish diagnoses
+- Initiate medication treatment
+- Refer for therapy as indicated
+
+### 3.2 Therapist/Counselor
+- Conduct therapy intake assessment
+- Establish treatment goals
+- Initiate therapy services
+- Coordinate care with prescriber
+
+### 3.3 Psychologist
+- Conduct psychological evaluations
+- Administer psychological testing
+- Provide diagnostic clarification
+- Treatment recommendations
+
+### 3.4 Support Staff
+- Schedule evaluations appropriately
+- Collect intake paperwork
+- Verify insurance and authorizations
+- Facilitate check-in process
+
+## 4. Definitions
+
+| Term | Definition |
+|------|------------|
+| Chief Complaint | Primary reason for seeking treatment |
+| Mental Status Examination | Structured assessment of current mental functioning |
+| DSM-5 | Diagnostic and Statistical Manual of Mental Disorders, 5th Edition |
+| PHQ-9 | Patient Health Questionnaire (depression screen) |
+| GAD-7 | Generalized Anxiety Disorder scale |
+
+## 5. Procedure
+
+### 5.1 Pre-Evaluation Preparation
+
+#### 5.1.1 Intake Paperwork
+Complete prior to evaluation:
+- [ ] Demographic information
+- [ ] Insurance information
+- [ ] Consent for treatment
+- [ ] HIPAA acknowledgment
+- [ ] Release of information (prior providers)
+- [ ] Symptom questionnaires
+- [ ] Medical history form
+- [ ] Medication list
+
+#### 5.1.2 Records Review
+If available, review:
+- Prior mental health records
+- Recent medical records
+- Hospitalization summaries
+- Previous psychological testing
+- Current medication list
+
+### 5.2 Initial Evaluation Components
+
+#### 5.2.1 Psychiatric Diagnostic Evaluation
+
+**Chief Complaint and Present Illness**
+- Current symptoms in patient's words
+- Onset and duration
+- Severity and frequency
+- Impact on functioning
+- Precipitating factors
+- What has helped/not helped
+
+**Psychiatric History**
+| Element | Detail |
+|---------|--------|
+| Previous diagnoses | |
+| Previous hospitalizations | Dates, location, reason |
+| Previous outpatient treatment | Providers, duration, helpfulness |
+| Previous medications | Name, dose, response, side effects |
+| ECT/TMS/other treatments | |
+| Suicide attempts | Method, intent, lethality, medical treatment |
+| Self-harm history | |
+| Violent behavior | |
+
+**Substance Use History**
+| Substance | Ever Used | Current Use | Last Use | Quantity/Frequency |
+|-----------|-----------|-------------|----------|---------------------|
+| Alcohol | ☐ | ☐ | | |
+| Cannabis | ☐ | ☐ | | |
+| Opioids | ☐ | ☐ | | |
+| Stimulants | ☐ | ☐ | | |
+| Benzodiazepines | ☐ | ☐ | | |
+| Tobacco/Nicotine | ☐ | ☐ | | |
+| Other | ☐ | ☐ | | |
+
+- Substance use treatment history
+- Withdrawal history
+- Periods of sobriety
+
+**Medical History**
+- Chronic conditions
+- Current medications
+- Allergies (medications, environmental, food)
+- Recent labs (if available)
+- Primary care provider
+
+**Family History**
+- Psychiatric disorders
+- Substance use disorders
+- Suicide
+- Response to medications (if known)
+
+**Social History**
+| Domain | Information |
+|--------|-------------|
+| Education | Highest level, any difficulties |
+| Employment | Current status, history |
+| Living situation | With whom, stability |
+| Relationships | Marital status, support system |
+| Legal | Current or pending legal issues |
+| Trauma history | Abuse, neglect, other trauma |
+| Military | Branch, combat exposure, discharge status |
+| Cultural/spiritual | Relevant beliefs/practices |
+
+**Developmental History** (especially for children/adolescents)
+- Pregnancy/birth complications
+- Developmental milestones
+- School performance
+- Peer relationships
+- Behavioral issues
+
+**Mental Status Examination**
+| Domain | Findings |
+|--------|----------|
+| Appearance | Dress, grooming, hygiene, apparent age |
+| Psychomotor | Activity level, retardation, agitation |
+| Attitude | Cooperative, guarded, hostile |
+| Eye contact | Good, poor, variable |
+| Speech | Rate, rhythm, volume, coherence |
+| Mood | Patient's stated mood |
+| Affect | Range, congruence, appropriateness |
+| Thought process | Linear, tangential, circumstantial, loose |
+| Thought content | Delusions, obsessions, preoccupations |
+| Perceptions | Hallucinations (type), illusions |
+| Cognition | Orientation, attention, memory |
+| Insight | Good, fair, poor |
+| Judgment | Good, fair, poor |
+
+**Risk Assessment**
+| Risk | Assessment |
+|------|------------|
+| Suicide | Ideation, plan, intent, means, attempts |
+| Violence | Ideation, target, plan, history |
+| Self-harm | Current urges, methods, history |
+| Risk level | Low / Moderate / High |
+
+**Diagnosis (DSM-5)**
+| Priority | Diagnosis | ICD-10 Code |
+|----------|-----------|-------------|
+| Primary | | |
+| Secondary | | |
+| Additional | | |
+| Substance | | |
+| Medical | | |
+
+**Treatment Plan**
+- Medication recommendations
+- Therapy recommendations
+- Frequency of follow-up
+- Laboratory monitoring
+- Referrals
+- Patient goals
+
+### 5.3 Standardized Assessments
+
+Administer as indicated:
+| Assessment | Population | Purpose |
+|------------|------------|---------|
+| PHQ-9 | Adults | Depression severity |
+| GAD-7 | Adults | Anxiety severity |
+| C-SSRS | All | Suicide risk |
+| MDQ | Mood disorders | Bipolar screening |
+| ASRS | Adults | ADHD screening |
+| PCL-5 | Trauma history | PTSD screening |
+| AUDIT | Alcohol use | Alcohol use disorder |
+| DAST-10 | Drug use | Drug use disorder |
+
+### 5.4 Informed Consent
+
+Discuss and document:
+- Nature of recommended treatment
+- Expected benefits
+- Potential risks and side effects
+- Alternatives (including no treatment)
+- Right to refuse or withdraw
+- Confidentiality and limits
+- Emergency procedures
+
+### 5.5 Safety Planning
+
+For patients with elevated risk:
+- [ ] Complete safety plan (FRM-MHO-002)
+- [ ] Provide crisis resources
+- [ ] Establish emergency contact
+- [ ] Reduce access to means
+- [ ] Schedule appropriate follow-up
+
+### 5.6 Care Coordination
+
+- [ ] Request records from prior providers
+- [ ] Communicate with PCP as indicated
+- [ ] Coordinate with other treaters
+- [ ] Referral to appropriate level of care if needed
+
+## 6. Special Considerations
+
+### 6.1 Telehealth Evaluations
+- Verify patient location and identity
+- Confirm emergency contact and local resources
+- Assess appropriateness for telehealth
+- Document telehealth consent
+
+### 6.2 Child/Adolescent Evaluations
+- Include parent/guardian interview
+- School information as relevant
+- Developmentally appropriate assessment
+- Assent/consent as appropriate
+
+### 6.3 Geriatric Evaluations
+- Cognitive screening
+- Capacity assessment if concerns
+- Medical complexity consideration
+- Caregiver involvement
+
+## 7. Documentation
+
+- Initial evaluation note (complete within 72 hours of visit)
+- Consent forms
+- Standardized assessment scores
+- Safety plan (if applicable)
+- Release of information forms
+
+## 8. Quality Metrics
+
+| Metric | Target |
+|--------|--------|
+| Evaluation completed within scheduled time | >90% |
+| Documentation complete within 72 hours | 100% |
+| Suicide risk assessment documented | 100% |
+| Treatment plan documented | 100% |
+| Follow-up scheduled | 100% |
+
+## 9. References
+
+- American Psychiatric Association Practice Guidelines
+- DSM-5 Diagnostic Criteria
+- State mental health regulations
+- Payer documentation requirements
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |

SOPs/General/SOP-001-Document-Control.md

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+# Standard Operating Procedure: Document Control
+
+| Document ID | SOP-001 |
+|-------------|---------|
+| Title | Document Control |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+| Department | Quality Assurance |
+
+---
+
+## 1. Purpose
+
+To establish a procedure for the creation, review, approval, distribution, and control of documents within the Quality Management System.
+
+## 2. Scope
+
+This procedure applies to all controlled documents including:
+- Policies
+- Standard Operating Procedures (SOPs)
+- Work Instructions
+- Forms and Templates
+- Specifications
+- External documents of external origin
+
+## 3. Responsibilities
+
+### 3.1 Document Owner
+- Responsible for document content and accuracy
+- Initiates document creation and revision
+- Ensures periodic review is performed
+
+### 3.2 Quality Assurance
+- Maintains the document control system
+- Assigns document numbers
+- Manages document distribution
+- Archives obsolete documents
+
+### 3.3 Approvers
+- Review and approve documents before release
+- Ensure documents are adequate for intended purpose
+
+## 4. Procedure
+
+### 4.1 Document Creation
+
+1. Identify the need for a new document
+2. Request document number from Quality Assurance
+3. Draft document using appropriate template
+4. Include all required header information
+5. Submit for review and approval
+
+### 4.2 Document Review and Approval
+
+1. Route document to appropriate reviewers
+2. Reviewers provide comments within 5 business days
+3. Author addresses all comments
+4. Final approval by designated approver
+5. Quality Assurance releases document
+
+### 4.3 Document Numbering
+
+Documents shall be numbered according to the following convention:
+
+| Type | Prefix | Example |
+|------|--------|---------|
+| Policy | POL | POL-001 |
+| SOP | SOP | SOP-001 |
+| Work Instruction | WI | WI-001 |
+| Form | FRM | FRM-001 |
+
+### 4.4 Revision Control
+
+1. All changes require documented justification
+2. Changes follow same review/approval process as new documents
+3. Revision number increments with each approved change
+4. Revision history maintained in document footer
+
+### 4.5 Document Distribution
+
+1. Current versions available in document control system
+2. Obsolete versions marked and archived
+3. Training on new/revised documents as needed
+
+### 4.6 Periodic Review
+
+1. Documents reviewed at least every 2 years
+2. Review documented even if no changes made
+3. Reviews may result in revision or reaffirmation
+
+## 5. Related Documents
+
+- FRM-001 Document Change Request Form
+- FRM-002 Document Review Record
+
+## 6. Definitions
+
+| Term | Definition |
+|------|------------|
+| Controlled Document | Document managed under document control system |
+| Obsolete | Document no longer valid for use |
+| Revision | Updated version of a document |
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |

SOPs/General/SOP-002-CAPA.md

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+# Standard Operating Procedure: Corrective and Preventive Action (CAPA)
+
+| Document ID | SOP-002 |
+|-------------|---------|
+| Title | Corrective and Preventive Action |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+| Department | Quality Assurance |
+
+---
+
+## 1. Purpose
+
+To establish a systematic process for identifying, investigating, correcting, and preventing nonconformities and potential nonconformities.
+
+## 2. Scope
+
+This procedure applies to:
+- Product and process nonconformities
+- Customer complaints
+- Audit findings
+- Process deviations
+- Potential nonconformities identified through risk analysis
+
+## 3. Definitions
+
+| Term | Definition |
+|------|------------|
+| Corrective Action | Action to eliminate the cause of a detected nonconformity |
+| Preventive Action | Action to eliminate the cause of a potential nonconformity |
+| Root Cause | Fundamental reason for a nonconformity |
+| Effectiveness Check | Verification that implemented actions achieved desired results |
+
+## 4. Responsibilities
+
+### 4.1 CAPA Owner
+- Investigates the issue
+- Identifies root cause
+- Develops and implements corrective/preventive actions
+- Verifies effectiveness
+
+### 4.2 Quality Assurance
+- Manages CAPA system
+- Assigns CAPA numbers
+- Tracks CAPA status
+- Reviews and approves CAPAs
+- Reports CAPA metrics to management
+
+### 4.3 Management
+- Provides resources for CAPA implementation
+- Reviews CAPA trends
+- Ensures timely closure
+
+## 5. Procedure
+
+### 5.1 CAPA Initiation
+
+1. Identify nonconformity or potential nonconformity
+2. Document issue on CAPA Form (FRM-003)
+3. Classify severity and priority
+4. Assign CAPA owner
+
+### 5.2 Investigation
+
+1. Gather relevant data and evidence
+2. Interview personnel involved
+3. Review related documents and records
+4. Use appropriate investigation tools:
+   - 5 Whys
+   - Fishbone Diagram
+   - Failure Mode Analysis
+
+### 5.3 Root Cause Analysis
+
+1. Identify potential root causes
+2. Verify root cause through evidence
+3. Document root cause determination
+4. Consider systemic implications
+
+### 5.4 Action Development
+
+1. Develop corrective/preventive actions
+2. Assign responsibilities and due dates
+3. Assess actions for:
+   - Appropriateness to problem severity
+   - Impact on other processes
+   - Resource requirements
+
+### 5.5 Implementation
+
+1. Execute approved actions
+2. Document implementation evidence
+3. Update affected documents/processes
+4. Provide training as needed
+
+### 5.6 Effectiveness Verification
+
+1. Define effectiveness criteria
+2. Allow sufficient time for actions to take effect
+3. Collect and analyze data
+4. Document verification results
+5. If ineffective, reopen CAPA for further action
+
+### 5.7 Closure
+
+1. Review all CAPA documentation
+2. Verify all actions completed
+3. Confirm effectiveness verified
+4. Obtain approval for closure
+
+## 6. CAPA Metrics
+
+Quality Assurance shall track and report:
+- Number of open CAPAs
+- CAPA aging
+- On-time closure rate
+- Effectiveness rate
+- CAPAs by category/source
+
+## 7. Related Documents
+
+- FRM-003 CAPA Form
+- SOP-003 Nonconforming Product Control
+- SOP-004 Customer Complaints
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |

SOPs/General/SOP-003-Training.md

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+# Standard Operating Procedure: Training and Competence
+
+| Document ID | SOP-003 |
+|-------------|---------|
+| Title | Training and Competence |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+| Department | Human Resources / Quality |
+
+---
+
+## 1. Purpose
+
+To ensure personnel performing work affecting product quality are competent based on appropriate education, training, skills, and experience.
+
+## 2. Scope
+
+This procedure applies to:
+- All employees performing quality-affecting activities
+- Contractors and temporary personnel
+- Personnel requiring GxP training
+
+## 3. Responsibilities
+
+### 3.1 Supervisors/Managers
+- Identify training needs for their personnel
+- Ensure training is completed before performing tasks
+- Evaluate competence of personnel
+- Maintain department training records
+
+### 3.2 Human Resources
+- Coordinate training programs
+- Maintain central training database
+- Track training compliance
+- Archive training records
+
+### 3.3 Quality Assurance
+- Develop QMS-related training
+- Approve training curricula for GxP activities
+- Audit training compliance
+
+### 3.4 Employees
+- Complete assigned training on time
+- Maintain current qualifications
+- Report training needs to supervisor
+
+## 4. Procedure
+
+### 4.1 Training Needs Assessment
+
+1. Identify competence requirements for each role
+2. Document requirements in job descriptions
+3. Assess current competence of personnel
+4. Identify training gaps
+
+### 4.2 Training Curriculum Development
+
+1. Define learning objectives
+2. Develop training materials
+3. Identify delivery method:
+   - Classroom
+   - On-the-job
+   - Self-study
+   - Computer-based
+4. Define assessment criteria
+5. Obtain approval from Quality (for GxP training)
+
+### 4.3 Training Delivery
+
+1. Schedule training session
+2. Document attendance
+3. Deliver training per curriculum
+4. Assess comprehension through:
+   - Written test (minimum 80% passing)
+   - Practical demonstration
+   - Supervisor observation
+
+### 4.4 Training Documentation
+
+Training records shall include:
+- Employee name and ID
+- Training title and date
+- Trainer name and qualifications
+- Assessment results
+- Signatures
+
+### 4.5 Retraining Requirements
+
+Retraining is required when:
+- Significant document revisions occur
+- Performance deficiencies identified
+- Extended absence from job function
+- Periodic requalification due
+
+### 4.6 New Employee Orientation
+
+All new employees shall complete:
+1. Company orientation
+2. Quality system overview
+3. Job-specific training
+4. SOP read and understand for applicable procedures
+
+## 5. Training Records Retention
+
+- Training records maintained for duration of employment
+- Records retained 3 years after employee departure
+- Records available for regulatory inspection
+
+## 6. Related Documents
+
+- FRM-004 Training Record Form
+- FRM-005 Training Assessment Form
+- Job Descriptions
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |

SOPs/General/SOP-004-Internal-Audit.md

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+# Standard Operating Procedure: Internal Audit
+
+| Document ID | SOP-004 |
+|-------------|---------|
+| Title | Internal Audit |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+| Department | Quality Assurance |
+
+---
+
+## 1. Purpose
+
+To establish a systematic approach for conducting internal audits to verify the effectiveness of the Quality Management System.
+
+## 2. Scope
+
+This procedure covers:
+- QMS process audits
+- Compliance audits
+- Product audits
+- System audits
+
+## 3. Definitions
+
+| Term | Definition |
+|------|------------|
+| Audit | Systematic, independent examination to determine conformance |
+| Auditor | Person qualified to perform audits |
+| Finding | Observation of conformance or nonconformance |
+| Observation | Noted item not rising to level of finding |
+
+## 4. Responsibilities
+
+### 4.1 Lead Auditor
+- Plans and schedules audits
+- Prepares audit checklists
+- Conducts audit activities
+- Reports audit findings
+
+### 4.2 Quality Manager
+- Maintains audit program
+- Qualifies auditors
+- Reviews audit reports
+- Reports to management
+
+### 4.3 Auditee
+- Provides access to areas/records
+- Responds to findings
+- Implements corrective actions
+
+## 5. Procedure
+
+### 5.1 Annual Audit Schedule
+
+1. Develop annual audit schedule considering:
+   - Previous audit results
+   - Process criticality
+   - Regulatory requirements
+   - Changes to processes
+2. Ensure all QMS processes audited at least annually
+3. Obtain management approval
+4. Communicate schedule to affected areas
+
+### 5.2 Auditor Qualification
+
+Auditors shall:
+- Complete auditor training course
+- Conduct at least 2 audits under supervision
+- Be independent of area being audited
+- Maintain competence through ongoing audits
+
+### 5.3 Audit Preparation
+
+1. Review applicable procedures and standards
+2. Review previous audit reports
+3. Prepare audit checklist
+4. Notify auditee of audit scope and schedule
+5. Confirm auditor availability
+
+### 5.4 Conducting the Audit
+
+1. Hold opening meeting with auditee
+2. Execute audit checklist
+3. Gather objective evidence:
+   - Document review
+   - Personnel interviews
+   - Process observation
+4. Document findings with evidence
+5. Classify findings:
+   - Major Nonconformance
+   - Minor Nonconformance
+   - Observation
+6. Hold closing meeting
+
+### 5.5 Audit Reporting
+
+1. Complete audit report within 5 business days
+2. Report shall include:
+   - Audit scope and criteria
+   - Personnel interviewed
+   - Findings with evidence
+   - Recommendations
+3. Distribute report to auditee and management
+
+### 5.6 Finding Resolution
+
+1. Auditee responds with corrective action plan within 10 business days
+2. Quality reviews and approves plan
+3. Auditee implements corrective actions
+4. Auditor verifies effectiveness
+5. Close finding upon verification
+
+## 6. Audit Records
+
+Maintain for 5 years:
+- Audit schedules
+- Checklists
+- Reports
+- Corrective action records
+
+## 7. Related Documents
+
+- FRM-006 Audit Checklist Template
+- FRM-007 Audit Report Template
+- SOP-002 CAPA
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |

SOPs/General/SOP-005-Management-Review.md

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+# Standard Operating Procedure: Management Review
+
+| Document ID | SOP-005 |
+|-------------|---------|
+| Title | Management Review |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+| Department | Quality Assurance |
+
+---
+
+## 1. Purpose
+
+To ensure top management reviews the Quality Management System at planned intervals to ensure its continuing suitability, adequacy, and effectiveness.
+
+## 2. Scope
+
+This procedure applies to the periodic management review of the QMS, including all processes and quality objectives.
+
+## 3. Frequency
+
+Management reviews shall be conducted:
+- At least annually
+- More frequently if significant changes occur
+- As needed based on quality performance
+
+## 4. Responsibilities
+
+### 4.1 Quality Manager
+- Prepares management review agenda and materials
+- Facilitates the meeting
+- Documents meeting minutes and action items
+- Tracks completion of action items
+
+### 4.2 Top Management
+- Attends management review meetings
+- Reviews QMS performance data
+- Makes decisions on QMS improvements
+- Allocates resources as needed
+
+### 4.3 Department Managers
+- Provides input data for their areas
+- Attends management review
+- Implements assigned action items
+
+## 5. Management Review Inputs
+
+The following shall be considered:
+
+### 5.1 Actions from Previous Reviews
+- Status of action items
+- Effectiveness of implemented actions
+
+### 5.2 Changes in Context
+- Internal changes (organization, resources)
+- External changes (regulations, market)
+
+### 5.3 QMS Performance
+- Customer satisfaction and feedback
+- Quality objectives achievement
+- Process performance metrics
+- Nonconformities and corrective actions
+- Audit results
+- Supplier performance
+
+### 5.4 Resource Adequacy
+- Personnel
+- Infrastructure
+- Work environment
+
+### 5.5 Risk and Opportunities
+- Risk assessment results
+- Effectiveness of risk controls
+- New opportunities identified
+
+### 5.6 Improvement Opportunities
+- Process improvements
+- Product improvements
+- QMS enhancements
+
+## 6. Management Review Outputs
+
+Decisions and actions related to:
+- Improvement of QMS and processes
+- Product improvement
+- Resource needs
+- Changes to quality policy or objectives
+
+## 7. Documentation
+
+### 7.1 Meeting Minutes
+- Date and attendees
+- Items discussed
+- Decisions made
+- Action items with owners and due dates
+
+### 7.2 Record Retention
+- Management review records retained for 5 years
+- Available for regulatory inspection
+
+## 8. Related Documents
+
+- FRM-008 Management Review Agenda Template
+- FRM-009 Management Review Minutes Template
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |

SOPs/Safety/.gitkeep

@@ -0,0 +1 @@
+# Placeholder

Templates/SOP-Template.md

@@ -0,0 +1,62 @@
+# Standard Operating Procedure: [Title]
+
+| Document ID | SOP-XXX |
+|-------------|---------|
+| Title | [Title] |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+| Department | [DEPARTMENT] |
+
+---
+
+## 1. Purpose
+
+[State the purpose of this procedure]
+
+## 2. Scope
+
+[Define the scope and applicability]
+
+## 3. Responsibilities
+
+### 3.1 [Role 1]
+- [Responsibility]
+- [Responsibility]
+
+### 3.2 [Role 2]
+- [Responsibility]
+- [Responsibility]
+
+## 4. Definitions
+
+| Term | Definition |
+|------|------------|
+| | |
+
+## 5. Procedure
+
+### 5.1 [Section Title]
+
+[Procedure steps]
+
+### 5.2 [Section Title]
+
+[Procedure steps]
+
+## 6. Related Documents
+
+- [List related procedures, forms, etc.]
+
+## 7. References
+
+- [External standards, regulations, etc.]
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |

Work Instructions/WI-001-Template.md

@@ -0,0 +1,68 @@
+# Work Instruction: [Title]
+
+| Document ID | WI-001 |
+|-------------|--------|
+| Title | [Title] |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+| Department | [DEPARTMENT] |
+
+---
+
+## 1. Purpose
+
+[Describe the purpose of this work instruction]
+
+## 2. Scope
+
+[Define what activities this instruction covers]
+
+## 3. Safety Precautions
+
+- [List any safety requirements]
+- [Personal protective equipment needed]
+- [Hazards to be aware of]
+
+## 4. Equipment/Materials Required
+
+| Item | Specification |
+|------|---------------|
+| | |
+| | |
+
+## 5. Procedure
+
+### Step 1: [Title]
+[Detailed instructions]
+
+### Step 2: [Title]
+[Detailed instructions]
+
+### Step 3: [Title]
+[Detailed instructions]
+
+## 6. Acceptance Criteria
+
+[Define what constitutes successful completion]
+
+## 7. Records
+
+| Record | Location | Retention |
+|--------|----------|-----------|
+| | | |
+
+## 8. References
+
+- [Related SOPs]
+- [Specifications]
+- [Standards]
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |