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 Major High Create program

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 7.5

X

[Name]

IA-005 CAPA 8.5.2, 8.5.3

X [Name]

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 Supplier control, purchasing info, verification

7.5 Production Control, cleanliness, validation, identification, traceability

7.6 Monitoring Equipment Calibration, control

8.1 Measurement Planning Monitoring and analysis planning

8.2 Monitoring Feedback, complaints, reporting, audits, process, product

8.3 Nonconforming Product Control, disposition

8.4 Data Analysis Trend analysis

8.5 Improvement CAPA

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 document control, audit, 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

Related Skills

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