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Quality Manager - QMS ISO 13485 Specialist

Domain: Regulatory & Quality | Skill: quality-manager-qms-iso13485 | Source: ra-qm-team/quality-manager-qms-iso13485/SKILL.md

Quality Manager - QMS ISO 13485 Specialist

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

Table of Contents

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:
  4. Regulatory criticality
  5. Risk to product safety
  6. Resource requirements
  7. Develop implementation roadmap with milestones
  8. Establish Quality Manual per Clause 4.2.2:
  9. QMS scope with justified exclusions
  10. Process interactions
  11. Procedure references
  12. Create required documented procedures — see Mandatory Documented Procedures for the full list
  13. Deploy processes with training
  14. 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

Level Document Type Example
1 Quality Manual QM-001
2 Procedures SOP-02-001
3 Work Instructions WI-06-012
4 Records Training records

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:
  3. Format: [TYPE]-[AREA]-[SEQUENCE]-[REV]
  4. Example: SOP-02-001-01
  5. Draft document using approved template
  6. Route for review to subject matter experts
  7. Collect and address review comments
  8. Obtain required approvals based on document type
  9. Update Document Master List
  10. Validation: Document numbered correctly; all reviewers signed; Master List updated

Document Numbering Convention

Prefix Document Type Approval Authority
QM Quality Manual Management Rep + CEO
POL Policy Department Head + QA
SOP Procedure Process Owner + QA
WI Work Instruction Supervisor + QA
TF Template/Form Process Owner
SPEC Specification Engineering + QA

Area Codes

Code Area Examples
01 Quality Management Quality Manual, policy
02 Document Control This procedure
03 Training Competency procedures
04 Design Design control
05 Purchasing Supplier management
06 Production Manufacturing
07 Quality Control Inspection, testing
08 CAPA Corrective actions

Document Change Control

Change Type Approval Level Examples
Administrative Document Control Typos, formatting
Minor Process Owner + QA Clarifications
Major Full review cycle Process changes
Emergency Expedited + retrospective Safety issues

Document Review Schedule

Document Type Review Period Trigger for Unscheduled Review
Quality Manual Annual Organizational change
Procedures Annual Audit finding, regulation change
Work Instructions 2 years Process change
Forms 2 years User feedback

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:
  3. Previous audit findings
  4. Regulatory changes
  5. Process changes
  6. Complaint trends
  7. Assign qualified auditors (independent of area audited)
  8. Develop annual audit schedule
  9. Obtain management approval
  10. Communicate schedule to process owners
  11. Track completion and reschedule as needed
  12. 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 (4.2.¾.2.4), 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:
  7. Document review
  8. Record sampling
  9. Process observation
  10. Personnel interviews
  11. Classify findings:
  12. Major NC: Absence or breakdown of system
  13. Minor NC: Single lapse or deviation
  14. Observation: Risk of future NC
  15. Conduct closing meeting
  16. Issue audit report within 5 business days
  17. Validation: All checklist items addressed; findings supported by evidence; report distributed

Auditor Qualification Requirements

Criterion Requirement
Training ISO 13485 awareness + auditor training
Experience Minimum 1 audit as observer
Independence Not auditing own work area
Competence Understanding of audited process

Finding Classification Guide

Classification Criteria Response Time
Major NC System absence, total breakdown, regulatory violation 30 days for CAPA
Minor NC Single instance, partial compliance 60 days for CAPA
Observation Potential risk, improvement opportunity Track in next audit

Process Validation Workflow

Validate special processes per ISO 13485 Clause 7.5.6.

Workflow: Process Validation Protocol

  1. Identify processes requiring validation:
  2. Output cannot be verified by inspection
  3. Deficiencies appear only in use
  4. Sterilization, welding, sealing, software
  5. Form validation team with subject matter experts
  6. Write validation protocol including:
  7. Process description and parameters
  8. Equipment and materials
  9. Acceptance criteria
  10. Statistical approach
  11. Execute IQ: verify equipment installed correctly and document specifications
  12. Execute OQ: test parameter ranges and verify process control
  13. Execute PQ: run production conditions and verify output meets requirements
  14. Write validation report with conclusions
  15. Validation: IQ/OQ/PQ complete; acceptance criteria met; validation report approved

Validation Documentation Requirements

Phase Content Evidence
Protocol Objectives, methods, criteria Approved protocol
IQ Equipment verification Installation records
OQ Parameter verification Test results
PQ Performance verification Production data
Report Summary, conclusions Approval signatures

Revalidation Triggers

Trigger Action Required
Equipment change Assess impact, revalidate affected phases
Parameter change OQ and PQ minimum
Material change Assess impact, PQ minimum
Process failure Full revalidation
Periodic Per validation schedule (typically 3 years)

Special Process Examples

Process Validation Standard Critical Parameters
EO Sterilization ISO 11135 Temperature, humidity, EO concentration, time
Steam Sterilization ISO 17665 Temperature, pressure, time
Radiation Sterilization ISO 11137 Dose, dose uniformity
Sealing Internal Temperature, pressure, dwell time
Welding ISO 11607 Heat, pressure, speed

Supplier Qualification Workflow

Evaluate and approve suppliers per ISO 13485 Clause 7.4.

Workflow: New Supplier Qualification

  1. Identify supplier category:
  2. Category A: Critical (affects safety/performance)
  3. Category B: Major (affects quality)
  4. Category C: Minor (indirect impact)
  5. Request supplier information:
  6. Quality certifications
  7. Product specifications
  8. Quality history
  9. Evaluate supplier based on:
  10. Quality system (ISO certification)
  11. Technical capability
  12. Quality history
  13. Financial stability
  14. For Category A suppliers:
  15. Conduct on-site audit
  16. Require quality agreement
  17. Calculate qualification score
  18. Make approval decision:

  19. 80: Approved

  20. 60-80: Conditional approval
  21. <60: Not approved
  22. Add to Approved Supplier List
  23. Validation: Evaluation criteria scored; qualification records complete; supplier categorized

Supplier Evaluation Criteria

Criterion Weight Scoring
Quality System 30% ISO 13485=30, ISO 9001=20, Documented=10, None=0
Quality History 25% Reject rate: <1%=25, 1-3%=15, >3%=0
Delivery 20% On-time: >95%=20, 90-95%=10, <90%=0
Technical Capability 15% Exceeds=15, Meets=10, Marginal=5
Financial Stability 10% Strong=10, Adequate=5, Questionable=0

Supplier Category Requirements

Category Qualification Monitoring Agreement
A - Critical On-site audit Annual review Quality agreement
B - Major Questionnaire Semi-annual review Quality requirements
C - Minor Assessment Issue-based Standard terms

Supplier Performance Metrics

Metric Target Calculation
Accept Rate >98% (Accepted lots / Total lots) × 100
On-Time Delivery >95% (On-time / Total orders) × 100
Response Time <5 days Average days to resolve issues
Documentation 100% (Complete CoCs / Required CoCs) × 100

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)

Input Source Prepared By
Audit results Internal and external audits QA Manager
Customer feedback Complaints, surveys Customer Quality
Process performance Process metrics Process Owners
Product conformity Inspection data, NCs QC Manager
CAPA status CAPA system CAPA Officer
Previous actions Prior review records QMR
Changes affecting QMS Regulatory, organizational RA Manager
Recommendations All sources All Managers

Record Retention Requirements

Record Type Minimum Retention Regulatory Basis
Device Master Record Life of device + 2 years 21 CFR 820.181
Device History Record Life of device + 2 years 21 CFR 820.184
Design History File Life of device + 2 years 21 CFR 820.30
Complaint Records Life of device + 2 years 21 CFR 820.198
Training Records Employment + 3 years Best practice
Audit Records 7 years Best practice
CAPA Records 7 years Best practice
Calibration Records Equipment life + 2 years Best practice

Decision Frameworks

Exclusion Justification (Clause 4.2.2)

Clause Permissible Exclusion Justification Required
6.4.2 Contamination control Product not affected by contamination
7.3 Design and development Organization does not design products
7.5.2 Product cleanliness No cleanliness requirements
7.5.3 Installation No installation activities
7.5.4 Servicing No servicing activities
7.5.5 Sterile products No sterile products

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

Source Automatic CAPA Evaluate for CAPA
Customer complaint Safety-related All others
External audit Major NC Minor NC
Internal audit Major NC Repeat minor NC
Product NC Field failure Trend exceeds threshold
Process deviation Safety impact Repeated deviations

Tools and References

Scripts

Tool Purpose Usage
qms_audit_checklist.py Generate audit checklists by clause or process python qms_audit_checklist.py --help

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

Document Content
iso13485-clause-requirements.md Detailed requirements for each ISO 13485:2016 clause with audit questions
qms-process-templates.md Ready-to-use templates for gap analysis, audit program, document control, CAPA, supplier, training

Quick Reference: Mandatory Documented Procedures

Procedure Clause Key Elements
Document Control 4.2.3 Approval, distribution, obsolete control
Record Control 4.2.4 Identification, retention, disposal
Internal Audit 8.2.4 Program, auditor qualification, reporting
NC Product Control 8.3 Identification, segregation, disposition
Corrective Action 8.5.2 Root cause, implementation, verification
Preventive Action 8.5.3 Risk identification, implementation
Skill Integration Point
quality-manager-qmr Management review, quality policy
capa-officer CAPA system management
qms-audit-expert Advanced audit techniques
quality-documentation-manager DHF, DMR, DHR management
risk-management-specialist ISO 14971 integration