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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
- Document Control Workflow
- Internal Audit Workflow
- Process Validation Workflow
- Supplier Qualification Workflow
- QMS Process Reference
- Decision Frameworks
- Tools and References
QMS Implementation Workflow
Implement ISO 13485:2016 compliant quality management system from gap analysis through certification.
Workflow: Initial QMS Implementation
- Conduct gap analysis against ISO 13485:2016 requirements
- Document current state vs. required state for each clause
- Prioritize gaps by:
- Regulatory criticality
- Risk to product safety
- Resource requirements
- Develop implementation roadmap with milestones
- Establish Quality Manual per Clause 4.2.2:
- QMS scope with justified exclusions
- Process interactions
- Procedure references
- Create required documented procedures:
- Document control (4.2.3)
- Record control (4.2.4)
- Internal audit (8.2.4)
- Nonconforming product (8.3)
- Corrective action (8.5.2)
- Preventive action (8.5.3)
- Deploy processes with training
- Validation: Gap analysis complete; Quality Manual approved; all required procedures documented and trained
Gap Analysis Matrix
| Clause | Requirement | Current State | Gap | Priority | Action |
|---|
| 4.2.2 | Quality Manual | Not documented | Major | High | Create QM |
| 4.2.3 | Document control | Informal | Moderate | High | Formalize SOP |
| 5.6 | Management review | Ad hoc | Major | High | Establish schedule |
| 7.3 | Design control | Partial | Moderate | Medium | Complete procedures |
| 8.2.4 | Internal audit | None |
QMS Structure
| Level | Document Type | Purpose | Example |
|---|
| 1 | Quality Manual | QMS overview, policy | QM-001 |
| 2 | Procedures | How processes work | SOP-02-001 |
| 3 | Work Instructions | Task-level detail | WI-06-012 |
| 4 | Records | Evidence of conformity | Training records |
Required Procedure List
| Clause | Procedure | Minimum Content |
|---|
| 4.2.3 | Document Control | Approval, review, distribution, obsolete control |
| 4.2.4 | Record Control | Identification, storage, retention, disposal |
| 8.2.4 | Internal Audit | Program, auditor qualification, reporting |
| 8.3 | Nonconforming Product | Identification, segregation, disposition |
| 8.5.2 | Corrective Action | Investigation, root cause, effectiveness |
| 8.5.3 | Preventive Action | Risk identification, implementation, verification |
Document Control Workflow
Establish and maintain document control per ISO 13485 Clause 4.2.3.
Workflow: Document Creation and Approval
- Identify need for new document or revision
- Assign document number per numbering convention:
- Format:
[TYPE]-[AREA]-[SEQUENCE]-[REV]
- Example:
SOP-02-001-01
- Draft document using approved template
- Route for review to subject matter experts
- Collect and address review comments
- Obtain required approvals based on document type
- Update Document Master List
- 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
- Identify processes and areas requiring audit coverage
- Assess risk factors for audit frequency:
- Previous audit findings
- Regulatory changes
- Process changes
- Complaint trends
- Assign qualified auditors (independent of area audited)
- Develop annual audit schedule
- Obtain management approval
- Communicate schedule to process owners
- Track completion and reschedule as needed
- Validation: All processes covered; auditors qualified and independent; schedule approved
Workflow: Individual Audit Execution
- Prepare audit plan with scope, criteria, and schedule
- Notify auditee minimum 1 week prior
- Review procedures and previous audit results
- Prepare audit checklist
- Conduct opening meeting
- Collect evidence through:
- Document review
- Record sampling
- Process observation
- Personnel interviews
- Classify findings:
- Major NC: Absence or breakdown of system
- Minor NC: Single lapse or deviation
- Observation: Risk of future NC
- Conduct closing meeting
- Issue audit report within 5 business days
- Validation: All checklist items addressed; findings supported by evidence; report distributed
Audit Program Template
| Audit # | Process | Clauses | Q1 | Q2 | Q3 | Q4 | Auditor |
|---|
| IA-001 | Document Control | 4.2.3, 4.2.4 | X | | | | [Name] |
| IA-002 | Management Review | 5.6 | | X | | | [Name] |
| IA-003 | Design Control | 7.3 | | X | | | [Name] |
| IA-004 | Production |
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
- Identify processes requiring validation:
- Output cannot be verified by inspection
- Deficiencies appear only in use
- Sterilization, welding, sealing, software
- Form validation team with subject matter experts
- Write validation protocol including:
- Process description and parameters
- Equipment and materials
- Acceptance criteria
- Statistical approach
- Execute Installation Qualification (IQ):
- Verify equipment installed correctly
- Document equipment specifications
- Execute Operational Qualification (OQ):
- Test parameter ranges
- Verify process control
- Execute Performance Qualification (PQ):
- Run production conditions
- Verify output meets requirements
- Write validation report with conclusions
- 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
- Identify supplier category:
- Category A: Critical (affects safety/performance)
- Category B: Major (affects quality)
- Category C: Minor (indirect impact)
- Request supplier information:
- Quality certifications
- Product specifications
- Quality history
- Evaluate supplier based on:
- Quality system (ISO certification)
- Technical capability
- Quality history
- Financial stability
- For Category A suppliers:
- Conduct on-site audit
- Require quality agreement
- Calculate qualification score
- Make approval decision:
-
80: Approved
-
60-80: Conditional approval
-
<60: Not approved
- Add to Approved Supplier List
- 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
ISO 13485 Clause Structure
| Clause | Title | Key Requirements |
|---|
| 4.1 | General Requirements | Process identification, interaction, outsourcing |
| 4.2 | Documentation | Quality Manual, procedures, records |
| 5.1-5.5 | Management Responsibility | Commitment, policy, objectives, organization |
| 5.6 | Management Review | Inputs, outputs, records |
| 6.1-6.4 | Resource Management | Personnel, infrastructure, environment |
| 7.1 | Product Realization Planning | Quality plan, risk management |
| 7.2 | Customer Requirements | Determination, review, communication |
| 7.3 | Design and Development | Planning, inputs, outputs, review, V&V, transfer, changes |
| 7.4 | Purchasing |
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
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 |
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