ISO 13485:2016 Lead Auditor Training

About Course

40-hour medical-device QMS Lead Auditor course: 40 text lessons, seven written-response practical quizzes, five knowledge checks, 40-question final knowledge examination and four typed assignments. Covers clauses 4–8, device lifecycle/risk, design, suppliers, production/sterilization validation, measurement, release, traceability, feedback, audit leadership and corrective/preventive action. Includes individual observed practice and an instructor-released controlled final written case. All essential fictional evidence is embedded. AED 999. Exemplar Global Recognized Certificate.

LO01: Explain medical-device QMS purpose, regulatory roles and audit principles
LO02: Evaluate scope, documentation, leadership, resources and risk-based controls
LO03: Audit design, purchasing, production, validation and post-market controls
LO04: Reconcile quantities and evaluate yield, measurement and complaint evidence
LO05: Develop an objective programme and feasible audit plan
LO06: Collect and corroborate evidence through neutral interviews and protected sampling
LO07: Lead audits and demonstrate professional observed behaviour
LO08: Write defensible findings/reports and verify corrective/preventive action

Course Content

Medical-device QMS foundations
Purpose, regulatory roles, process approach and auditor conduct.

Purpose and device lifecycle
Standards, regulation and criteria
Process approach and risk-based controls
Auditor principles and competence
Practical 01: Lifecycle, criteria and authority

QMS, leadership and resources
Scope, documentation, management and competence.

Risk and design controls
Planning, inputs, verification, validation, transfer and change.

Purchasing and production controls
Suppliers, outsourcing, production and process validation.

Product identity and post-market controls
Traceability, preservation, measurement and feedback.

Audit programme and planning
Priorities, feasibility, team schedules and sampling.

Evidence collection and evaluation
Opening, interviewing, trails and quantitative evidence.

Leading the audit team
Coordination, difficult situations, observation and closing.

Performance, findings and reporting
Evaluation, review, findings and reporting.

Corrective action and final assessment
Cause, extent, effectiveness and final assessments.

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About Course

What Will You Learn?

Course Content

Medical-device QMS foundations Purpose, regulatory roles, process approach and auditor conduct.

Purpose and device lifecycle

Standards, regulation and criteria

Process approach and risk-based controls

Auditor principles and competence

Practical 01: Lifecycle, criteria and authority

QMS, leadership and resources Scope, documentation, management and competence.

Scope, outsourcing and applicability

Device files and controlled information

Management responsibilities

Competence, infrastructure and environment

Practical 02: Scope, documents and leadership

Knowledge Check 1

Risk and design controls Planning, inputs, verification, validation, transfer and change.

Realization and customer requirements

Product risk and feedback

Design planning, inputs and outputs

Verification, validation, transfer and change

Practical 03: Risk and design evidence

Purchasing and production controls Suppliers, outsourcing, production and process validation.

Purchasing and supplier evaluation

Outsourced critical processes

Production, cleanliness and service controls

Process and sterile-device validation

Practical 04: Suppliers, production and validation

Knowledge Check 2

Product identity and post-market controls Traceability, preservation, measurement and feedback.

Identification, status and traceability

Preservation and customer property

Measurement and product acceptance

Feedback, complaints and nonconforming product

Practical 05: Traceability, measurement and complaints

Audit programme and planning Priorities, feasibility, team schedules and sampling.

Risk-informed audit programmes

Audit types and readiness

Team audit planning

Sampling and protected evidence

Prepare a medical-device audit programme and two-day plan

Knowledge Check 3

Evidence collection and evaluation Opening, interviewing, trails and quantitative evidence.

Opening meeting

Neutral interviewing

Following a device audit trail

Quantitative audit evidence

Practical 07: Interviews and quantitative evidence

Leading the audit team Coordination, difficult situations, observation and closing.

Leading and coordinating auditors

Pressure, disagreement and authority

Observed individual simulation

Closing meeting

Observed individual medical-device audit simulation

Knowledge Check 4

Performance, findings and reporting Evaluation, review, findings and reporting.

Monitoring, analysis and internal audit

Management review and effectiveness

Defensible findings and grading

Reports and follow-up

Write findings and a supplier audit report

Corrective action and final assessment Cause, extent, effectiveness and final assessments.

Correction and corrective/preventive action

Verifying effectiveness and closure

Controlled final assessment preparation

Practical 10: Cause, extent and closure

Knowledge Check 5

Final ISO 13485 knowledge examination

Controlled final written lead auditor assessment

Portfolio and continuing competence

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