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12 changes: 8 additions & 4 deletions config/core.yaml
Original file line number Diff line number Diff line change
Expand Up @@ -43,7 +43,7 @@ clauses:
documents: [resource_plan, competence_matrix, communication_plan, documented_info_procedure]
- id: "8"
title: "Operation"
documents: [process_map, customer_requirements_procedure, nonconformity_procedure]
documents: [process_map, customer_requirements_procedure, supplier_evaluation, nonconformity_procedure]
- id: "9"
title: "Performance Evaluation"
documents: [internal_audit_procedure, management_review_procedure, kpi_dashboard]
Expand Down Expand Up @@ -81,7 +81,7 @@ documents:
# Clause 6
- id: risk_register
title: "Risk Register"
template: null
template: risk_register
clause: "6.1"
- id: opportunity_register
title: "Opportunity Register"
Expand All @@ -98,7 +98,7 @@ documents:
clause: "7.1"
- id: competence_matrix
title: "Competency Matrix"
template: null
template: competence_matrix
clause: "7.2"
- id: communication_plan
title: "Communication Plan"
Expand All @@ -117,6 +117,10 @@ documents:
title: "Procedure: Determination of Customer Requirements"
template: procedure
clause: "8.2"
- id: supplier_evaluation
title: "Supplier Evaluation"
template: supplier_evaluation
clause: "8.4"
- id: nonconformity_procedure
title: "Procedure: Control of Nonconforming Outputs"
template: procedure
Expand All @@ -132,7 +136,7 @@ documents:
clause: "9.3"
- id: kpi_dashboard
title: "KPI Dashboard / Performance Indicators"
template: null
template: kpi_dashboard
clause: "9.1"
# Clause 10
- id: capa_procedure
Expand Down
67 changes: 44 additions & 23 deletions templates/capa_form.md.j2
Original file line number Diff line number Diff line change
@@ -1,53 +1,74 @@
# CAPA Form — Corrective Action
# Corrective Action (CAPA) — {{ capa_id }}

| Field | Value |
|-------|-------|
| **CAPA ID** | {{ capa_id }} |
| **Organisation** | {{ org_name }} |
| **Opened** | {{ opened_date }} |
| **Opened by** | {{ opened_by }} |
| **Source (NC / Audit / other)** | {{ source_ref }} |
| **ISO Clause** | 10.2 |

---

## 1. Background
## 1. Problem Description

**Source (NC ID / Audit Finding / other trigger):** {{ source_ref }}
**Describe what happened, where, and when:**

**Problem Description:**
*(Factual, objective description — avoid assumptions about causes at this stage.)*

> **⚠ TODO:** describe the problem
**Extent:** ☐ Isolated incident ☐ Recurring issue ☐ Systemic / widespread

## 2. Immediate Correction
**Customer impact:** ☐ No impact ☐ Internal impact only ☐ Customer affected

**Action:** TODO
**Completed by:** TODO
**Completed on:** TODO
## 2. Immediate Containment

Actions taken to stop further impact before the root cause is addressed:

| Action | Responsible | Completed by |
|--------|-------------|--------------|
| | | |
| | | |

## 3. Root Cause Analysis

**Method:** ☐ 5-Why ☐ Ishikawa ☐ Other: TODO
**Method:** ☐ 5-Why ☐ Ishikawa ☐ Fault Tree ☐ Other: ___________

### 5-Why

| # | Question | Answer |
|---|----------|--------|
| 1 | Why did the problem occur? | |
| 2 | Why did that happen? | |
| 3 | Why did that happen? | |
| 4 | Why did that happen? | |
| 5 | Why did that happen? | |

**Root Cause (confirmed):**

*(State the root cause in one clear sentence. This is the basis for corrective actions.)*

## 4. Corrective Actions

**Root Cause Identified:**
| # | Action | Responsible | Due Date | Done |
|---|--------|-------------|----------|------|
| 1 | | | | ☐ |
| 2 | | | | ☐ |
| 3 | | | | ☐ |

> **⚠ TODO:** describe root cause
## 5. Effectiveness Verification

## 4. Corrective Action
**Planned review date:** ___________

| Action | Responsible | Due Date | Done |
|--------|-------------|----------|------|
| TODO | TODO | TODO | ☐ |
**Verification method:** ☐ Re-audit ☐ KPI trend review ☐ Process observation ☐ Other

## 5. Effectiveness Review
**Conducted by:** ___________ **Date:** ___________

**Review planned for:** TODO
**Review conducted on:** TODO
**Result:** ☐ Effective ☐ Not effective → new CAPA required
**Result:** ☐ Effective — close CAPA ☐ Not effective — open new CAPA: ___________

## 6. Closure
## 6. CAPA Closure

**Closed on:** TODO
**Closed by:** TODO
**Closed on:** ___________ **Closed by:** ___________

---

Expand Down
53 changes: 53 additions & 0 deletions templates/competence_matrix.md.j2
Original file line number Diff line number Diff line change
@@ -0,0 +1,53 @@
# Competence Matrix

| Field | Value |
|-------|-------|
| **Organisation** | {{ org_name }} |
| **Version** | {{ version }} |
| **Last Review** | {{ date }} |
| **Reviewed by** | {{ quality_officer }} |
| **ISO Clause** | 7.2 |

---

## Competence Level Legend

**R** = Required (awareness level) · **T** = Trained (can perform with guidance)
**E** = Expert (can perform independently and train others) · **—** = Not required

## Competence Matrix

| Competence | QMO | Management | Process Owner | Staff |
|------------|-----|------------|---------------|-------|
| ISO 9001:2015 awareness | E | R | R | R |
| Quality Policy and objectives | E | E | T | R |
| Document control (Clause 7.5) | E | T | T | R |
| Risk and opportunity assessment (Clause 6.1) | E | T | T | — |
| Internal audit methodology (Clause 9.2) | E | — | T | — |
| Nonconformity and CAPA process (Clause 10.2) | E | T | T | R |
| Customer requirements capture (Clause 8.2) | T | R | E | T |
| Product / service process knowledge | T | R | E | E |
| KPI measurement and analysis (Clause 9.1) | E | T | T | — |

> **⚠ Add role-specific technical competences relevant to your processes below.**

## Training Record

| Name | Role | Training | Date | Provider | Valid Until | Evidence |
|------|------|----------|------|----------|-------------|----------|
| | QMO | ISO 9001:2015 Lead Implementer | | | | Certificate |
| | QMO | Internal Auditor | | | | Certificate |
| | All | ISO 9001:2015 Awareness | | | | Attendance sheet |
| | Process Owner | Product / Process Training | | | | Sign-off sheet |

## Training Plan

| Training | Target Group | Planned Date | Status |
|----------|-------------|--------------|--------|
| ISO 9001:2015 awareness refresh | All staff | | ☐ Planned ☐ Done |
| Internal auditor re-qualification | QMO | | ☐ Planned ☐ Done |
| Onboarding QMS introduction | New staff | On hire | ☐ Planned ☐ Done |

---

*ISO 9001:2015 · Clause 7.2 · {{ org_name }}*
74 changes: 44 additions & 30 deletions templates/internal_audit_checklist.md.j2
Original file line number Diff line number Diff line change
Expand Up @@ -7,41 +7,55 @@
| **Auditor** | {{ auditor }} |
| **Audit Scope** | {{ audit_scope }} |
| **Contact Person** | {{ contact }} |
| **ISO Clause** | 9.2 |

---

## ISO 9001:2015 Checklist

| Clause | Check Point | Compliant | Observation / Finding |
|--------|-------------|-----------|----------------------|
| 4.1 | Context analysis documented and up to date? | ☐ Yes ☐ No ☐ N/A | |
| 4.2 | Interested parties register maintained? | ☐ Yes ☐ No ☐ N/A | |
| 4.3 | QMS scope defined? | ☐ Yes ☐ No ☐ N/A | |
| 5.2 | Quality policy communicated and understood? | ☐ Yes ☐ No ☐ N/A | |
| 5.3 | Roles and responsibilities clearly assigned? | ☐ Yes ☐ No ☐ N/A | |
| 6.1 | Risks and opportunities assessed? | ☐ Yes ☐ No ☐ N/A | |
| 6.2 | Quality objectives measurable and documented? | ☐ Yes ☐ No ☐ N/A | |
| 7.2 | Competency matrix current, training evidenced? | ☐ Yes ☐ No ☐ N/A | |
| 7.4 | Communication plan implemented? | ☐ Yes ☐ No ☐ N/A | |
| 7.5 | Document control procedure followed? | ☐ Yes ☐ No ☐ N/A | |
| 8.1 | Processes planned and controlled? | ☐ Yes ☐ No ☐ N/A | |
| 8.2 | Customer requirements determined and met? | ☐ Yes ☐ No ☐ N/A | |
| 8.7 | Nonconformities recorded and addressed? | ☐ Yes ☐ No ☐ N/A | |
| 9.1 | KPIs measured and evaluated? | ☐ Yes ☐ No ☐ N/A | |
| 9.3 | Management review conducted? | ☐ Yes ☐ No ☐ N/A | |
| 10.2 | CAPAs closed on time and verified effective? | ☐ Yes ☐ No ☐ N/A | |

## Audit Result

**Overall Assessment:** ☐ Conforming ☐ Conditionally conforming ☐ Non-conforming

**Key Findings:**

> **⚠ TODO:** describe findings

**Recommendations:**

> **⚠ TODO:** recommendations
**Result codes:** C = Conforming · NC = Nonconformity · OB = Observation · N/A = Not applicable

| Clause | Check Point | Result | Finding / Evidence |
|--------|-------------|--------|--------------------|
| 4.1 | Context analysis documented and kept up to date? | | |
| 4.2 | Interested parties register maintained and reviewed? | | |
| 4.3 | QMS scope defined, documented, and justified? | | |
| 4.4 | QMS processes identified with inputs, outputs, owners? | | |
| 5.1 | Leadership demonstrates commitment to QMS? | | |
| 5.2 | Quality policy communicated, understood by staff? | | |
| 5.3 | Roles, responsibilities, and authorities defined? | | |
| 6.1 | Risks and opportunities assessed and addressed? | | |
| 6.2 | Quality objectives measurable, monitored, communicated? | | |
| 7.1 | Resources (people, infrastructure, environment) adequate? | | |
| 7.2 | Competence matrix current; training records available? | | |
| 7.4 | Internal and external communication controlled? | | |
| 7.5 | Document control procedure followed; records retained? | | |
| 8.1 | Operational processes planned, executed, controlled? | | |
| 8.2 | Customer requirements determined, reviewed, met? | | |
| 8.4 | Externally provided products/services controlled? | | |
| 8.7 | Nonconforming outputs identified, segregated, recorded? | | |
| 9.1 | KPIs measured, analysed, and evaluated regularly? | | |
| 9.2 | Internal audit programme implemented as planned? | | |
| 9.3 | Management review conducted with all required inputs? | | |
| 10.2 | CAPAs opened for all NCs; effectiveness verified? | | |
| 10.3 | Continual improvement activities evidenced? | | |

## Nonconformities Raised

| NC ID | Clause | Description | Severity |
|-------|--------|-------------|----------|
| | | | ☐ Major ☐ Minor |
| | | | ☐ Major ☐ Minor |

## Audit Summary

**Overall Result:** ☐ Conforming ☐ Conditionally conforming ☐ Non-conforming

**Strengths observed:**

**Key findings / recommendations:**

**Follow-up required by:** ___________

---

Expand Down
59 changes: 59 additions & 0 deletions templates/kpi_dashboard.md.j2
Original file line number Diff line number Diff line change
@@ -0,0 +1,59 @@
# KPI Dashboard

| Field | Value |
|-------|-------|
| **Organisation** | {{ org_name }} |
| **Reporting Period** | {{ date }} |
| **Prepared by** | {{ quality_officer }} |
| **ISO Clause** | 9.1 |

---

## Performance Overview

**Status:** ✓ On target · ⚠ At risk · ✗ Off target · Trend: ↑ Improving · → Stable · ↓ Declining

| KPI | Clause | Target | Actual | Status | Trend | Action Required |
|-----|--------|--------|--------|--------|-------|-----------------|
| Customer Satisfaction Score (1–5) | 9.1.2 | ≥ 4.0 | | ☐ ✓ ☐ ⚠ ☐ ✗ | | |
| Number of Nonconformities | 9.1 | < prev. period | | ☐ ✓ ☐ ⚠ ☐ ✗ | | |
| CAPA Closure Rate | 10.2 | ≥ 90 % | | ☐ ✓ ☐ ⚠ ☐ ✗ | | |
| Audit Plan Completion | 9.2 | 100 % | | ☐ ✓ ☐ ⚠ ☐ ✗ | | |
| Training Plan Completion | 7.2 | ≥ 95 % | | ☐ ✓ ☐ ⚠ ☐ ✗ | | |

## Customer Feedback

| Source | Volume | Positive | Complaints | Avg. Score |
|--------|--------|----------|------------|------------|
| Customer surveys | | | | |
| Direct feedback / calls | | | | |
| Returns / escalations | | | | |
| **Total** | | | | |

## CAPA Status

| Status | Count |
|--------|-------|
| Open | |
| In Progress | |
| Effectiveness Review | |
| Closed this period | |
| Overdue | |

## Actions Required

| KPI | Issue | Action | Owner | Due Date |
|-----|-------|--------|-------|----------|
| | | | | |

## Trend History

| KPI | Q1 | Q2 | Q3 | Q4 |
|-----|----|----|----|----|
| Customer Satisfaction | | | | |
| Nonconformities | | | | |
| CAPA Closure Rate | | | | |

---

*ISO 9001:2015 · Clause 9.1 · {{ org_name }}*
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