ISO 13485 Quality Management System implementation and maintenance for medical device organizations. Provides QMS design, documentation control, internal auditing, CAPA management, and certification support. Use when working with medical device quality systems, preparing for ISO 13485 audits, managing regulatory compliance documentation, setting up corrective actions, or building audit preparation programs. Useful for quality management, audit preparation, regulatory compliance, medical device documentation, and corrective action workflows.
ISO 13485
QMS implementation
quality management system
document control
internal audit
management review
quality manual
CAPA process
process validation
design control
supplier qualification
quality records
Quality Manager - QMS ISO 13485 Specialist
ISO 13485:2016 Quality Management System implementation, maintenance, and certification support for medical device organizations.
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
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
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
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
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 IQ: verify equipment installed correctly and document specifications
Execute OQ: test parameter ranges and verify process control
Execute PQ: run production conditions and verify output meets requirements
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
