Quality Manager Qms Iso13485

Quality Manager - QMS ISO 13485 Specialist

ISO 13485:2016 Quality Management System implementation, maintenance, and certification support for medical device organizations.

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Table of Contents

• QMS Implementation Workflow
• Document Control Workflow
• Internal Audit Workflow
• Process Validation Workflow
• Supplier Qualification Workflow
• QMS Process Reference
• Decision Frameworks
• Tools and References

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QMS Implementation Workflow

Implement ISO 13485:2016 compliant quality management system from gap analysis through certification.

Workflow: Initial QMS Implementation

1. Conduct gap analysis against ISO 13485:2016 requirements 2. Document current state vs. required state for each clause 3. Prioritize gaps by:

• Regulatory criticality
• Risk to product safety
• Resource requirements

4. Develop implementation roadmap with milestones 5. Establish Quality Manual per Clause 4.2.2:

• QMS scope with justified exclusions
• Process interactions
• Procedure references

6. Create required documented procedures — see Mandatory Documented Procedures for the full list 7. Deploy processes with training 8. Validation: Gap analysis complete; Quality Manual approved; all required procedures documented and trained

Use the Gap Analysis Matrix template in qms-process-templates.md to document clause-by-clause current state, gaps, priority, and actions.

QMS Structure

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Document Control Workflow

Establish and maintain document control per ISO 13485 Clause 4.2.3.

Workflow: Document Creation and Approval

1. Identify need for new document or revision 2. Assign document number per numbering convention:

• Format: [TYPE]-[AREA]-[SEQUENCE]-[REV]
• Example: SOP-02-001-01

3. Draft document using approved template 4. Route for review to subject matter experts 5. Collect and address review comments 6. Obtain required approvals based on document type 7. Update Document Master List 8. Validation: Document numbered correctly; all reviewers signed; Master List updated

Document Numbering Convention

Area Codes

Document Change Control

Document Review Schedule

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Internal Audit Workflow

Plan and execute internal audits per ISO 13485 Clause 8.2.4.

Workflow: Annual Audit Program

1. Identify processes and areas requiring audit coverage 2. Assess risk factors for audit frequency:

• Previous audit findings
• Regulatory changes
• Process changes
• Complaint trends

3. Assign qualified auditors (independent of area audited) 4. Develop annual audit schedule 5. Obtain management approval 6. Communicate schedule to process owners 7. Track completion and reschedule as needed 8. Validation: All processes covered; auditors qualified and independent; schedule approved

Use the Audit Program Template in qms-process-templates.md to schedule audits by clause and quarter across processes such as Document Control (4.2.3/4.2.4), Management Review (5.6), Design Control (7.3), Production (7.5), and CAPA (8.5.2/8.5.3).

Workflow: Individual Audit Execution

1. Prepare audit plan with scope, criteria, and schedule 2. Notify auditee minimum 1 week prior 3. Review procedures and previous audit results 4. Prepare audit checklist 5. Conduct opening meeting 6. Collect evidence through:

• Document review
• Record sampling
• Process observation
• Personnel interviews

7. Classify findings:

• Major NC: Absence or breakdown of system
• Minor NC: Single lapse or deviation
• Observation: Risk of future NC

8. Conduct closing meeting 9. Issue audit report within 5 business days 10. Validation: All checklist items addressed; findings supported by evidence; report distributed

Auditor Qualification Requirements

Finding Classification Guide

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Process Validation Workflow

Validate special processes per ISO 13485 Clause 7.5.6.

Workflow: Process Validation Protocol

1. Identify processes requiring validation:

• Output cannot be verified by inspection
• Deficiencies appear only in use
• Sterilization, welding, sealing, software

2. Form validation team with subject matter experts 3. Write validation protocol including:

• Process description and parameters
• Equipment and materials
• Acceptance criteria
• Statistical approach

4. Execute IQ: verify equipment installed correctly and document specifications 5. Execute OQ: test parameter ranges and verify process control 6. Execute PQ: run production conditions and verify output meets requirements 7. Write validation report with conclusions 8. Validation: IQ/OQ/PQ complete; acceptance criteria met; validation report approved

Validation Documentation Requirements

Revalidation Triggers

Special Process Examples

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Supplier Qualification Workflow

Evaluate and approve suppliers per ISO 13485 Clause 7.4.

Workflow: New Supplier Qualification

1. Identify supplier category:

• Category A: Critical (affects safety/performance)
• Category B: Major (affects quality)
• Category C: Minor (indirect impact)

2. Request supplier information:

• Quality certifications
• Product specifications
• Quality history

3. Evaluate supplier based on:

• Quality system (ISO certification)
• Technical capability
• Quality history
• Financial stability

4. For Category A suppliers:

• Conduct on-site audit
• Require quality agreement

5. Calculate qualification score 6. Make approval decision:

• >80: Approved
• 60-80: Conditional approval
• <60: Not approved

7. Add to Approved Supplier List 8. Validation: Evaluation criteria scored; qualification records complete; supplier categorized

Supplier Evaluation Criteria

Supplier Category Requirements

Supplier Performance Metrics

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QMS Process Reference

For detailed requirements and audit questions for each ISO 13485:2016 clause, see iso13485-clause-requirements.md.

Management Review Required Inputs (Clause 5.6.2)

Record Retention Requirements

⚠️ STATUS — QMSR transition (effective 2026-02-02): FDA's Quality Management System Regulation (QMSR) final rule (89 FR 7496) amended 21 CFR Part 820 to incorporate ISO 13485:2016 by reference and removed the legacy QSR subsection structure. The section numbers below (820.30/.181/.184/.198) no longer exist in the CFR — they are retained only as a familiar index. The current authority for record retention is ISO 13485:2016 §4.2.5 (retain "for at least the lifetime of the medical device as defined by the organization, but not less than two years"), with records additions in retained 21 CFR 820.35. Cite the ISO 13485 clauses — not the 820.x numbers — in current compliance documentation.

Decision discipline: This skill's checklists and tools structure QMS conformity assessment — they do not certify ISO 13485 / QMSR compliance. Final compliance determinations and record-retention decisions are yours to make and must be reviewed and signed off by the named QMR; route FDA-specific regulatory-classification questions to Regulatory Affairs and confirm current 21 CFR 820 / ISO 13485:2016 text at fda.gov before relying on any citation here.

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Decision Frameworks

Exclusion Justification (Clause 4.2.2)

Nonconformity Disposition Decision Tree

Nonconforming Product Identified
            │
            ▼
    Can it be reworked?
            │
       Yes──┴──No
        │       │
        ▼       ▼
    Is rework     Can it be used
    procedure     as is?
    available?        │
        │        Yes──┴──No
    Yes─┴─No     │       │
     │    │     ▼       ▼
     ▼    ▼  Concession  Scrap or
  Rework  Create    approval    return to
  per SOP  rework    needed?    supplier
          procedure     │
                    Yes─┴─No
                     │    │
                     ▼    ▼
                 Customer  Use as is
                 approval  with MRB
                          approval

CAPA Initiation Criteria

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Tools and References

Scripts

Audit Checklist Generator Features:

• Generate clause-specific checklists (e.g., --clause 7.3)
• Generate process-based checklists (e.g., --process design-control)
• Full system audit checklist (--audit-type system)
• Text or JSON output formats
• Interactive mode for guided selection

References

Quick Reference: Mandatory Documented Procedures

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Related Skills

ISO 13485:2016 Clause Requirements

Detailed requirements for each ISO 13485:2016 clause with implementation guidance and audit criteria.

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Table of Contents

• Clause 4: Quality Management System
• Clause 5: Management Responsibility
• Clause 6: Resource Management
• Clause 7: Product Realization
• Clause 8: Measurement, Analysis and Improvement

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Clause 4: Quality Management System

4.1 General Requirements

Audit Questions:

• How are QMS processes identified and documented?
• What criteria determine if processes are operating effectively?
• How is outsourced process control demonstrated?

4.2 Documentation Requirements

4.2.1 General

4.2.2 Quality Manual

Required Content: 1. Scope of QMS including justification for exclusions 2. Documented procedures or reference to them 3. Description of process interactions

Quality Manual Template Structure:

QUALITY MANUAL
1. Company Overview
   1.1 Company Description
   1.2 Scope of QMS
   1.3 Exclusions and Justification
2. Quality Policy
3. Quality Objectives
4. QMS Structure
   4.1 Process Map
   4.2 Process Interactions
   4.3 Organizational Chart
5. Procedure References
   5.1 Document Control
   5.2 Record Control
   5.3 Management Review
   5.4 Internal Audit
   5.5 Nonconformity Control
   5.6 CAPA
6. Appendices
   6.1 Glossary
   6.2 Regulatory Cross-Reference

4.2.3 Control of Documents

Document Numbering Convention:

[TYPE]-[AREA]-[SEQUENCE]-[REV]

TYPE:
  QM  = Quality Manual
  SOP = Standard Operating Procedure
  WI  = Work Instruction
  TF  = Template/Form
  POL = Policy

AREA:
  01 = Quality Management
  02 = Document Control
  03 = Training
  04 = Design
  05 = Purchasing
  06 = Production
  07 = Quality Control
  08 = CAPA

Example: SOP-02-001-03 = Document Control SOP, Revision 03

4.2.4 Control of Records

⚠️ STATUS — QMSR transition (effective 2026-02-02): Under FDA's Quality Management System Regulation (QMSR, 89 FR 7496), 21 CFR Part 820 now incorporates ISO 13485:2016 by reference and the legacy QSR subsection numbers below (820.30/.181/.184/.198) no longer exist in the CFR — they are shown only as a historical index. The current authority is ISO 13485:2016 §4.2.5 (control of records) plus retained 21 CFR 820.35 (records). Cite the ISO 13485 clause in current documentation.

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Clause 5: Management Responsibility

5.1 Management Commitment

5.2 Customer Focus

5.3 Quality Policy

Policy Requirements:

• Appropriate to organization purpose
• Commitment to compliance and effectiveness
• Framework for quality objectives
• Communicated and understood
• Reviewed for continuing suitability

Sample Quality Policy Elements:

[Company Name] Quality Policy

We are committed to:
- Designing and manufacturing safe, effective medical devices
- Meeting customer and regulatory requirements
- Maintaining an effective Quality Management System
- Continuously improving our processes and products
- Providing resources for QMS effectiveness

Signed: [Executive]
Date: [Date]
Review Date: [Annual]

5.4 Planning

5.4.1 Quality Objectives

Objective Template:

QUALITY OBJECTIVE [Year]

Objective: [Statement]
Metric: [How measured]
Target: [Specific value]
Baseline: [Current performance]
Owner: [Responsible person]
Due Date: [Target date]
Reporting: [Frequency]

5.4.2 Quality Management System Planning

Planning Requirements:

• QMS meets general requirements (4.1)
• QMS meets quality objectives (5.4.1)
• Integrity maintained during changes

5.5 Responsibility, Authority and Communication

5.5.1 Responsibility and Authority

5.5.2 Management Representative

5.5.3 Internal Communication

5.6 Management Review

5.6.1 General

5.6.2 Review Input

5.6.3 Review Output

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Clause 6: Resource Management

6.1 Provision of Resources

Resource Categories:

• Human resources (competent personnel)
• Infrastructure (facilities, equipment, software)
• Work environment (environmental conditions)

6.2 Human Resources

Competency Matrix Template:

COMPETENCY MATRIX

Role: [Job Title]
Department: [Department]

Required Competencies:
| Competency | Requirement Level | Method | Verification |
|------------|------------------|--------|--------------|
| [Skill 1] | Expert/Proficient/Basic | Training/OJT | Assessment |
| [Skill 2] | Expert/Proficient/Basic | Training/OJT | Assessment |

Training Requirements:
| Training | Initial | Refresher | Record |
|----------|---------|-----------|--------|
| ISO 13485 Awareness | Yes | Annual | TR-001 |
| Document Control | Yes | On Change | TR-002 |

6.3 Infrastructure

6.4 Work Environment and Contamination Control

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Clause 7: Product Realization

7.1 Planning of Product Realization

7.2 Customer-Related Processes

7.2.1 Determination of Requirements

7.2.2 Review of Requirements

7.2.3 Communication

7.3 Design and Development

7.4 Purchasing

7.4.1 Purchasing Process

Supplier Classification:

Category A: Critical - Affects product safety/performance
  - Full qualification audit
  - Annual performance review
  - Quality agreement required

Category B: Major - Affects product quality
  - Qualification questionnaire
  - Periodic performance review
  - Quality requirements communicated

Category C: Minor - Indirect impact
  - Initial assessment
  - Issue-based review
  - Standard terms

7.4.2 Purchasing Information

7.4.3 Verification of Purchased Product

7.5 Production and Service Provision

7.5.1 Control of Production and Service Provision

7.5.2 Cleanliness of Product

7.5.3 Installation Activities

7.5.4 Servicing Activities

7.5.5 Particular Requirements for Sterile Medical Devices

7.5.6 Validation of Processes

Process Validation Elements:

• Equipment qualification (IQ/OQ/PQ)
• Process parameters
• Monitoring methods
• Operator qualification
• Revalidation criteria

7.5.7 Particular Requirements for Validation

7.5.8 Identification

7.5.9 Traceability

7.5.10 Customer Property

7.5.11 Preservation of Product

7.6 Control of Monitoring and Measuring Equipment

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Clause 8: Measurement, Analysis and Improvement

8.1 General

Monitoring and Measurement Requirements:

• Demonstrate product conformity
• Ensure QMS conformity
• Maintain QMS effectiveness

8.2 Monitoring and Measurement

8.2.1 Feedback

8.2.2 Complaint Handling

8.2.3 Reporting to Regulatory Authorities

8.2.4 Internal Audit

Audit Program Template:

ANNUAL INTERNAL AUDIT PROGRAM

Year: [Year]

| Audit # | Area/Process | Scope | Auditor | Planned Date | Status |
|---------|--------------|-------|---------|--------------|--------|
| IA-01 | Document Control | 4.2.3, 4.2.4 | [Name] | Q1 | |
| IA-02 | Design Control | 7.3 | [Name] | Q2 | |
| IA-03 | Production | 7.5 | [Name] | Q2 | |
| IA-04 | Purchasing | 7.4 | [Name] | Q3 | |
| IA-05 | CAPA | 8.5.2, 8.5.3 | [Name] | Q3 | |
| IA-06 | Management Review | 5.6 | [Name] | Q4 | |

Risk Considerations:
- Previous audit findings
- Regulatory changes
- Process changes
- Complaint trends

8.2.5 Monitoring and Measurement of Processes

8.2.6 Monitoring and Measurement of Product

8.3 Control of Nonconforming Product

Nonconformity Disposition Options:

1. Use As Is (Concession)
   - Does not affect safety/performance
   - Customer approval if applicable
   - Documented justification

2. Rework
   - Per approved procedure
   - Reinspection required
   - Records maintained

3. Scrap/Reject
   - Physical destruction or marking
   - Prevented from reentry
   - Documented disposal

4. Return to Supplier
   - Communication with supplier
   - Replacement or credit
   - Root cause if systemic

8.4 Analysis of Data

8.5 Improvement

8.5.1 General

Improvement Sources:

• Quality policy
• Quality objectives
• Audit results
• Data analysis
• Corrective actions
• Preventive actions
• Management review

8.5.2 Corrective Action

8.5.3 Preventive Action

QMS Process Templates

Ready-to-use templates for ISO 13485 QMS processes including document control, internal audit, CAPA, and supplier management.

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Table of Contents

• Document Control Templates
• Internal Audit Templates
• CAPA Templates
• Supplier Management Templates
• Training Templates
• Nonconformity Templates

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Document Control Templates

Document Master List

DOCUMENT MASTER LIST

Organization: [Company Name]
Last Updated: [Date]
Maintained By: Document Control

| Doc # | Title | Rev | Effective Date | Status | Owner | Next Review |
|-------|-------|-----|----------------|--------|-------|-------------|
| QM-001 | Quality Manual | 03 | 2024-01-15 | Effective | QMR | 2025-01-15 |
| SOP-01-001 | Document Control | 04 | 2024-03-01 | Effective | QA Mgr | 2025-03-01 |
| SOP-01-002 | Record Control | 02 | 2024-02-01 | Effective | QA Mgr | 2025-02-01 |
| | | | | | | |

Status Values: Draft, Under Review, Effective, Obsolete

Document Change Request

DOCUMENT CHANGE REQUEST

DCR Number: DCR-[YYYY]-[NNN]
Date Submitted: [Date]
Submitted By: [Name]

DOCUMENT INFORMATION
Document Number: [Number]
Document Title: [Title]
Current Revision: [Rev]

CHANGE REQUEST
Change Type: [ ] Administrative [ ] Minor [ ] Major [ ] Emergency
Requested Change: [Description of change]

Reason for Change:
[ ] Regulatory requirement
[ ] Process improvement
[ ] Nonconformity/CAPA
[ ] Organizational change
[ ] Error correction
[ ] Other: [Specify]

Justification: [Detailed justification]

IMPACT ASSESSMENT
Training Required: [ ] Yes [ ] No
  If yes, who: [Roles/departments]
Other Documents Affected: [List]
Regulatory Filing Impact: [ ] Yes [ ] No
  If yes, details: [Explain]

APPROVALS
Requested By: _________________ Date: _______
Document Owner: _________________ Date: _______
QA Approval: _________________ Date: _______

COMPLETION
New Revision: [Rev]
Effective Date: [Date]
Training Completed: [ ] Yes [ ] N/A
Distribution Completed: [ ] Yes

Document Review Record

DOCUMENT REVIEW RECORD

Document Number: [Number]
Document Title: [Title]
Current Revision: [Rev]
Review Due Date: [Date]
Review Completed: [Date]

REVIEWERS
| Reviewer | Role | Review Date | Comments | Signature |
|----------|------|-------------|----------|-----------|
| [Name] | [Role] | [Date] | [Comments] | |
| [Name] | [Role] | [Date] | [Comments] | |

REVIEW OUTCOME
[ ] No changes required - document remains current
[ ] Minor changes required - see attached DCR
[ ] Major revision required - see attached DCR
[ ] Document obsolete - initiate retirement

NEXT REVIEW
Next Review Date: [Date]

APPROVAL
Review Completed By: _________________ Date: _______
Approved By: _________________ Date: _______

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Internal Audit Templates

Annual Audit Schedule

INTERNAL AUDIT SCHEDULE

Year: [Year]
Prepared By: [Name]
Approved By: [Name]
Date: [Date]

AUDIT SCHEDULE
| Audit # | Process/Area | ISO Clauses | Lead Auditor | Q1 | Q2 | Q3 | Q4 |
|---------|--------------|-------------|--------------|----|----|----|----|
| IA-001 | Document Control | 4.2.3, 4.2.4 | [Name] | X | | | |
| IA-002 | Management Review | 5.6 | [Name] | | X | | |
| IA-003 | Training | 6.2 | [Name] | | X | | |
| IA-004 | Design Control | 7.3 | [Name] | | | X | |
| IA-005 | Purchasing | 7.4 | [Name] | | | X | |
| IA-006 | Production | 7.5 | [Name] | | | | X |
| IA-007 | CAPA | 8.5.2, 8.5.3 | [Name] | | | | X |

RISK FACTORS CONSIDERED
[ ] Previous audit findings
[ ] Regulatory changes
[ ] Process changes
[ ] Complaint trends
[ ] Management concerns

SCHEDULE REVISION LOG
| Rev | Date | Change | Approved By |
|-----|------|--------|-------------|
| 00 | [Date] | Initial release | [Name] |

Audit Plan

INTERNAL AUDIT PLAN

Audit Number: IA-[YYYY]-[NNN]
Audit Date(s): [Date(s)]
Audit Type: [ ] Process [ ] System [ ] Product

SCOPE
Process/Area: [Name]
ISO 13485 Clauses: [List]
Regulatory Requirements: [If applicable]
Locations: [Locations]

AUDIT TEAM
Lead Auditor: [Name]
Auditor(s): [Names]
Observer(s): [If any]

AUDITEE CONTACTS
Process Owner: [Name]
Other Contacts: [Names]

AUDIT CRITERIA
- ISO 13485:2016
- [Organization procedures]
- [Regulatory requirements]

AUDIT SCHEDULE
| Time | Activity | Participants |
|------|----------|--------------|
| 09:00 | Opening meeting | All |
| 09:30 | Document review | Auditor, Doc Control |
| 10:30 | Process observation | Auditor, Operators |
| 12:00 | Lunch | |
| 13:00 | Record review | Auditor, QA |
| 14:30 | Interviews | Selected personnel |
| 15:30 | Auditor caucus | Audit team |
| 16:00 | Closing meeting | All |

PREPARATION CHECKLIST
[ ] Previous audit reports reviewed
[ ] Procedures reviewed
[ ] Checklist prepared
[ ] Auditees notified
[ ] Resources arranged

Audit Checklist Template

INTERNAL AUDIT CHECKLIST

Audit Number: IA-[YYYY]-[NNN]
Process: [Process Name]
Auditor: [Name]
Date: [Date]

INSTRUCTIONS
C = Conforming, NC = Nonconforming, OBS = Observation, N/A = Not Applicable

CHECKLIST
| # | Requirement | Reference | Evidence Reviewed | Finding | Notes |
|---|-------------|-----------|-------------------|---------|-------|
| 1 | Is the procedure current and approved? | 4.2.3 | [Evidence] | C/NC/OBS | |
| 2 | Are personnel trained on the procedure? | 6.2 | [Evidence] | C/NC/OBS | |
| 3 | Are records maintained as required? | 4.2.4 | [Evidence] | C/NC/OBS | |
| 4 | Is the process performed as documented? | 4.1 | [Evidence] | C/NC/OBS | |
| 5 | Are monitoring activities performed? | 8.2.5 | [Evidence] | C/NC/OBS | |

INTERVIEWS CONDUCTED
| Person | Role | Topics Discussed |
|--------|------|------------------|
| [Name] | [Role] | [Topics] |

DOCUMENTS REVIEWED
| Document # | Title | Rev | Findings |
|------------|-------|-----|----------|
| [Number] | [Title] | [Rev] | [Findings] |

RECORDS SAMPLED
| Record Type | Sample Size | Sample IDs | Findings |
|-------------|-------------|------------|----------|
| [Type] | [N] | [IDs] | [Findings] |

AUDITOR SIGNATURE: _________________ Date: _______

Audit Report

INTERNAL AUDIT REPORT

Audit Number: IA-[YYYY]-[NNN]
Report Date: [Date]
Report Status: [ ] Draft [ ] Final

AUDIT SUMMARY
Audit Date(s): [Date(s)]
Process/Area: [Name]
ISO Clauses Covered: [List]
Lead Auditor: [Name]
Audit Team: [Names]

AUDIT SCOPE
[Description of scope]

AUDIT OBJECTIVES
[List objectives]

EXECUTIVE SUMMARY
[Brief summary of audit results]

FINDINGS SUMMARY
| Type | Count |
|------|-------|
| Major Nonconformity | [N] |
| Minor Nonconformity | [N] |
| Observation | [N] |
| Opportunity for Improvement | [N] |

DETAILED FINDINGS

FINDING 1
Number: IA-[YYYY]-[NNN]-F01
Classification: [ ] Major NC [ ] Minor NC [ ] Observation [ ] OFI
Requirement: [Clause/requirement reference]
Statement: [Objective description of finding]
Evidence: [Evidence supporting finding]
Auditee Response Due: [Date]

[Repeat for each finding]

POSITIVE OBSERVATIONS
[List areas of good practice observed]

CONCLUSION
[Overall conclusion on process effectiveness]

REPORT DISTRIBUTION
| Name | Role | Date |
|------|------|------|
| [Name] | Process Owner | [Date] |
| [Name] | QA Manager | [Date] |
| [Name] | Management Rep | [Date] |

APPROVALS
Lead Auditor: _________________ Date: _______
QA Manager: _________________ Date: _______

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CAPA Templates

CAPA Request Form

CORRECTIVE AND PREVENTIVE ACTION REQUEST

CAPA Number: CAPA-[YYYY]-[NNN]
Date Opened: [Date]
Initiated By: [Name]

CAPA TYPE
[ ] Corrective Action (response to existing nonconformity)
[ ] Preventive Action (prevent potential nonconformity)

SOURCE
[ ] Customer complaint: Reference #_______
[ ] Internal audit: Audit #_______
[ ] External audit: Audit #_______
[ ] Nonconformity: NC #_______
[ ] Process deviation
[ ] Management review action
[ ] Trend analysis
[ ] Risk assessment
[ ] Other: _______

CLASSIFICATION
Severity: [ ] Critical [ ] Major [ ] Minor
Regulatory Reportable: [ ] Yes [ ] No

PROBLEM DESCRIPTION
[Detailed description of the problem or potential problem]

IMMEDIATE CONTAINMENT (if applicable)
Actions Taken: [Description]
Date: [Date]
Responsible: [Name]

ASSIGNMENT
Process Owner: [Name]
CAPA Owner: [Name]
Due Date for Root Cause: [Date]
Target Closure Date: [Date]

APPROVAL TO PROCEED
Approved By: _________________ Date: _______

Root Cause Analysis Record

ROOT CAUSE ANALYSIS

CAPA Number: CAPA-[YYYY]-[NNN]
Analysis Date: [Date]
Analyst: [Name]

PROBLEM STATEMENT
[Clear, specific statement of the problem]

INVESTIGATION TEAM
| Name | Role | Contribution |
|------|------|--------------|
| [Name] | [Role] | [Area of expertise] |

INVESTIGATION METHOD
[ ] 5 Why Analysis
[ ] Fishbone Diagram
[ ] Fault Tree Analysis
[ ] Human Factors Analysis
[ ] Other: _______

INVESTIGATION DETAILS

5 WHY ANALYSIS
Why 1: [First why]
Answer: [Answer]
Why 2: [Second why based on answer]
Answer: [Answer]
Why 3: [Third why based on answer]
Answer: [Answer]
Why 4: [Fourth why based on answer]
Answer: [Answer]
Why 5: [Fifth why based on answer]
Answer: [Answer]

ROOT CAUSE STATEMENT
[Clear statement of identified root cause]

ROOT CAUSE CATEGORY
[ ] Process/Procedure
[ ] Training/Competency
[ ] Equipment/Material
[ ] Design
[ ] Human Error
[ ] Communication
[ ] Management System
[ ] External Factor

CONTRIBUTING FACTORS
[List any contributing factors]

EVIDENCE SUPPORTING ROOT CAUSE
[List evidence]

APPROVAL
Analysis By: _________________ Date: _______
Reviewed By: _________________ Date: _______

CAPA Action Plan

CAPA ACTION PLAN

CAPA Number: CAPA-[YYYY]-[NNN]
Root Cause: [Brief statement]
Plan Date: [Date]
Plan Owner: [Name]

CORRECTIVE/PREVENTIVE ACTIONS

Action 1:
Description: [Detailed action description]
Responsible: [Name]
Due Date: [Date]
Resources Required: [Resources]
Success Criteria: [How completion verified]

Action 2:
Description: [Detailed action description]
Responsible: [Name]
Due Date: [Date]
Resources Required: [Resources]
Success Criteria: [How completion verified]

[Continue for additional actions]

RELATED CHANGES
Documents Affected: [List]
Training Required: [Description]
Process Changes: [Description]
Equipment Changes: [Description]

RISK ASSESSMENT
Residual Risk After Implementation: [ ] High [ ] Medium [ ] Low
Justification: [Explanation]

APPROVAL
Plan Developed By: _________________ Date: _______
Approved By: _________________ Date: _______

CAPA Effectiveness Verification

CAPA EFFECTIVENESS VERIFICATION

CAPA Number: CAPA-[YYYY]-[NNN]
Verification Date: [Date]
Verified By: [Name]

ACTIONS COMPLETED
| Action | Completion Date | Evidence |
|--------|-----------------|----------|
| [Action 1] | [Date] | [Reference] |
| [Action 2] | [Date] | [Reference] |

EFFECTIVENESS CRITERIA
[Criteria established during action planning]

VERIFICATION METHOD
[ ] Data analysis (trends, metrics)
[ ] Process audit
[ ] Record review
[ ] Product inspection
[ ] Customer feedback review
[ ] Other: _______

VERIFICATION PERIOD
From: [Date] To: [Date]

VERIFICATION RESULTS
[Detailed results of verification activities]

DATA/EVIDENCE REVIEWED
| Data Type | Period | Result |
|-----------|--------|--------|
| [Type] | [Period] | [Result] |

EFFECTIVENESS CONCLUSION
[ ] Effective - Root cause eliminated, problem resolved
[ ] Partially Effective - Improvement noted, additional action needed
[ ] Not Effective - Problem persists, reopen CAPA

If not effective, describe additional actions:
[Description]

CAPA CLOSURE
[ ] Approved for closure
[ ] Not approved - additional action required

Verified By: _________________ Date: _______
Approved By: _________________ Date: _______

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Supplier Management Templates

Approved Supplier List

APPROVED SUPPLIER LIST

Organization: [Company Name]
Last Updated: [Date]
Maintained By: [Name]

| Supplier | Supplier # | Category | Products/Services | Status | Qualification Date | Next Review |
|----------|-----------|----------|-------------------|--------|-------------------|-------------|
| [Name] | SUP-001 | A | [Products] | Approved | [Date] | [Date] |
| [Name] | SUP-002 | B | [Products] | Conditional | [Date] | [Date] |

Category:
  A = Critical (affects safety/performance)
  B = Major (affects quality)
  C = Minor (indirect impact)

Status:
  Approved = Full use authorized
  Conditional = Limited use, monitoring
  Probation = Performance issues, enhanced monitoring
  Disqualified = Use not authorized

Revision History:
| Rev | Date | Change | Approved By |
|-----|------|--------|-------------|
| 01 | [Date] | Initial release | [Name] |

Supplier Evaluation Form

SUPPLIER EVALUATION

Supplier Name: [Name]
Supplier Number: [Number]
Evaluation Date: [Date]
Evaluated By: [Name]
Evaluation Type: [ ] Initial [ ] Periodic [ ] For Cause

SUPPLIER INFORMATION
Address: [Address]
Contact: [Name, Title]
Phone: [Phone]
Email: [Email]
Products/Services: [Description]

PROPOSED CATEGORY
[ ] A - Critical (affects safety/performance)
[ ] B - Major (affects quality)
[ ] C - Minor (indirect impact)

EVALUATION CRITERIA

1. QUALITY MANAGEMENT SYSTEM (30 points max)
[ ] ISO 13485 Certified (30 pts)
[ ] ISO 9001 Certified (20 pts)
[ ] Documented QMS (10 pts)
[ ] No formal QMS (0 pts)
Score: ___/30

2. QUALITY HISTORY (25 points max)
Reject Rate: ___% (0-1% = 25 pts, 1-3% = 15 pts, >3% = 0 pts)
Score: ___/25

3. DELIVERY PERFORMANCE (20 points max)
On-Time Delivery: ___% (>95% = 20 pts, 90-95% = 10 pts, <90% = 0 pts)
Score: ___/20

4. TECHNICAL CAPABILITY (15 points max)
[ ] Exceeds requirements (15 pts)
[ ] Meets requirements (10 pts)
[ ] Marginally meets (5 pts)
Score: ___/15

5. FINANCIAL STABILITY (10 points max)
[ ] Strong (10 pts)
[ ] Adequate (5 pts)
[ ] Questionable (0 pts)
Score: ___/10

TOTAL SCORE: ___/100

QUALIFICATION DECISION
>80 = Approved
60-80 = Conditional (monitoring required)
<60 = Not Approved

Decision: [ ] Approved [ ] Conditional [ ] Not Approved

APPROVAL
Evaluated By: _________________ Date: _______
QA Approval: _________________ Date: _______

Supplier Performance Scorecard

SUPPLIER PERFORMANCE SCORECARD

Supplier: [Name]
Supplier #: [Number]
Period: [Q1/Q2/Q3/Q4] [Year]
Prepared By: [Name]

PERFORMANCE METRICS

1. QUALITY (40% weight)
Total Lots Received: [N]
Lots Rejected: [N]
Accept Rate: ___% Target: >98%
Score: ___/40

2. DELIVERY (30% weight)
Total Orders: [N]
On-Time Deliveries: [N]
On-Time Rate: ___% Target: >95%
Score: ___/30

3. RESPONSIVENESS (15% weight)
Issues Reported: [N]
Resolved <5 days: [N]
Response Rate: ___% Target: >90%
Score: ___/15

4. DOCUMENTATION (15% weight)
CoC Required: [N]
CoC Complete: [N]
Documentation Rate: ___% Target: 100%
Score: ___/15

TOTAL SCORE: ___/100

PERFORMANCE TREND
| Period | Quality | Delivery | Response | Docs | Total |
|--------|---------|----------|----------|------|-------|
| Q1 | | | | | |
| Q2 | | | | | |
| Q3 | | | | | |
| Q4 | | | | | |

ISSUES/CONCERNS
[List any quality or delivery issues during period]

ACTIONS REQUIRED
[ ] None - Performance acceptable
[ ] Enhanced monitoring
[ ] Supplier corrective action request
[ ] Supplier audit
[ ] Consider alternative supplier

NEXT REVIEW: [Date]

Prepared By: _________________ Date: _______
Reviewed By: _________________ Date: _______

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Training Templates

Training Record

EMPLOYEE TRAINING RECORD

Employee Name: [Name]
Employee ID: [ID]
Department: [Department]
Job Title: [Title]
Date of Hire: [Date]

REQUIRED TRAINING
| Training | Requirement | Initial Date | Last Date | Next Due | Status |
|----------|-------------|--------------|-----------|----------|--------|
| ISO 13485 Awareness | Initial + Annual | [Date] | [Date] | [Date] | Current |
| Document Control | Initial + On Change | [Date] | [Date] | [Date] | Current |
| CAPA Procedure | Initial + On Change | [Date] | [Date] | [Date] | Due |
| Job-Specific | Per competency matrix | [Date] | [Date] | [Date] | Current |

TRAINING HISTORY
| Date | Training | Method | Duration | Trainer | Assessment | Result |
|------|----------|--------|----------|---------|------------|--------|
| [Date] | [Title] | Classroom | 2 hrs | [Name] | Written test | Pass |
| [Date] | [Title] | OJT | 4 hrs | [Name] | Observation | Pass |

COMPETENCY VERIFICATION
| Competency | Method | Date | Verified By | Result |
|------------|--------|------|-------------|--------|
| [Skill] | Observation | [Date] | [Name] | Qualified |
| [Skill] | Test | [Date] | [Name] | Qualified |

Employee Signature: _________________ Date: _______
Supervisor Signature: _________________ Date: _______

Training Attendance Record

TRAINING ATTENDANCE RECORD

Training Title: [Title]
Training Date: [Date]
Trainer: [Name]
Location: [Location]
Duration: [Hours]

TRAINING CONTENT
[Brief description of content covered]

ATTENDEES
| Name | Employee ID | Department | Signature | Assessment Result |
|------|-------------|------------|-----------|-------------------|
| [Name] | [ID] | [Dept] | | Pass/Fail |
| [Name] | [ID] | [Dept] | | Pass/Fail |

ASSESSMENT METHOD
[ ] Written test (attach copy)
[ ] Practical demonstration
[ ] Verbal Q&A
[ ] Observation
[ ] N/A

TRAINING MATERIALS
[ ] Presentation: [Reference]
[ ] Procedure: [Reference]
[ ] Other: [Reference]

Trainer Signature: _________________ Date: _______
Training Coordinator: _________________ Date: _______

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Nonconformity Templates

Nonconformity Report

NONCONFORMITY REPORT

NC Number: NC-[YYYY]-[NNN]
Date Identified: [Date]
Identified By: [Name]

NONCONFORMITY TYPE
[ ] Product [ ] Process [ ] Document [ ] System

NONCONFORMITY SOURCE
[ ] Incoming inspection
[ ] In-process inspection
[ ] Final inspection
[ ] Customer complaint
[ ] Internal audit
[ ] External audit
[ ] Other: _______

PRODUCT IDENTIFICATION (if applicable)
Product Name: [Name]
Part Number: [Number]
Lot/Batch: [Number]
Quantity Affected: [N]

NONCONFORMITY DESCRIPTION
[Detailed, objective description of the nonconformity]

REQUIREMENT
[Reference to requirement that was not met]

CONTAINMENT ACTION
Action Taken: [Description]
Quantity Contained: [N]
Location: [Location]
Date: [Date]
By: [Name]

DISPOSITION
[ ] Use As Is - Justification: _______
[ ] Rework - Per procedure: _______
[ ] Scrap - Method: _______
[ ] Return to Supplier - RMA #: _______
[ ] Other: _______

Disposition By: [Name]
Disposition Date: [Date]

CAPA REQUIRED?
[ ] Yes - CAPA #: _______
[ ] No - Justification: _______

CLOSURE
All actions complete: [ ] Yes
NC Closed By: _________________ Date: _______
QA Approval: _________________ Date: _______

Material Review Board Record

MATERIAL REVIEW BOARD (MRB) RECORD

MRB Number: MRB-[YYYY]-[NNN]
Date: [Date]
NC Reference: NC-[YYYY]-[NNN]

NONCONFORMING MATERIAL
Product: [Name]
Part Number: [Number]
Lot/Batch: [Number]
Quantity: [N]

NONCONFORMITY DESCRIPTION
[Description from NC report]

MRB PARTICIPANTS
| Name | Role | Signature |
|------|------|-----------|
| [Name] | QA Representative | |
| [Name] | Engineering | |
| [Name] | Production | |
| [Name] | Other | |

DISPOSITION OPTIONS CONSIDERED
1. Use As Is
   Technical Justification: [Justification]
   Risk Assessment: [Assessment]

2. Rework
   Procedure: [Reference]
   Feasibility: [Assessment]

3. Scrap
   Cost Impact: [Amount]

MRB DECISION
[ ] Use As Is - Customer notification required: [ ] Yes [ ] No
[ ] Rework per: [Procedure reference]
[ ] Scrap
[ ] Return to Supplier

RATIONALE
[Detailed rationale for decision]

APPROVALS
| Role | Name | Signature | Date |
|------|------|-----------|------|
| QA | [Name] | | [Date] |
| Engineering | [Name] | | [Date] |
| Production | [Name] | | [Date] |

FOLLOW-UP ACTIONS
[ ] CAPA initiated: CAPA-_______
[ ] Customer notified: Date: _______
[ ] Supplier notified: Date: _______
[ ] Other: _______