ISO 13485:2016 Medical Devices QMS Internal Auditor

About Course

Develop internal audit skills for medical-device quality management. Includes 36 original text lessons with written exercises and feedback, a 40-question examination and an assessed case on release, validation, suppliers, complaints, traceability and CAPA. Workload: 14 hours excluding breaks. Price: AED 499. Training does not confer product approval, regulatory authority or external auditor accreditation.

LO01: Explain the purpose, structure and applicability of ISO 13485:2016.
LO02: Trace processes, outsourced work, medical device files, documents and records.
LO03: Evaluate management responsibility, review, competence and work environment controls.
LO04: Audit realization planning, risk management and customer requirements.
LO05: Distinguish design review, verification, validation, transfer and change controls.
LO06: Evaluate supplier selection, monitoring, purchasing information and incoming verification.
LO07: Audit production, servicing, special processes and applicable sterile-device controls.
LO08: Follow identification, traceability, preservation, calibration and product release evidence.
LO09: Evaluate complaints, regulatory reporting routes, nonconforming product, CAPA and analysis.
LO10: Prepare a risk-based audit plan, criteria, checklist and defensible sample.
LO11: Collect reliable evidence, interview effectively and write supported findings.
LO12: Communicate conclusions, review corrective action and verify effectiveness.

Course Content

Medical-device QMS foundations
Explain the purpose, structure and applicability of ISO 13485:2016.

Purpose and boundaries of ISO 13485
Structure, terminology and evidence
Applicability and justified exclusions

QMS processes and controlled information
Trace processes, outsourced work, medical device files, documents and records.

Leadership, competence and resources
Evaluate management responsibility, review, competence and work environment controls.

Realization planning and risk
Audit realization planning, risk management and customer requirements.

Design and development
Distinguish design review, verification, validation, transfer and change controls.

Purchasing and supplier assurance
Evaluate supplier selection, monitoring, purchasing information and incoming verification.

Production and process validation
Audit production, servicing, special processes and applicable sterile-device controls.

Traceability, measurement and release
Follow identification, traceability, preservation, calibration and product release evidence.

Feedback, nonconformity and improvement
Evaluate complaints, regulatory reporting routes, nonconforming product, CAPA and analysis.

Planning an internal audit
Prepare a risk-based audit plan, criteria, checklist and defensible sample.

Conducting the audit
Collect reliable evidence, interview effectively and write supported findings.

Reporting and follow-up
Communicate conclusions, review corrective action and verify effectiveness.

Assessment

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About Course

What Will You Learn?

Course Content

Medical-device QMS foundations Explain the purpose, structure and applicability of ISO 13485:2016.

Purpose and boundaries of ISO 13485

Structure, terminology and evidence

Applicability and justified exclusions

QMS processes and controlled information Trace processes, outsourced work, medical device files, documents and records.

Process interactions and outsourced work

Medical device files and document control

Records and QMS software validation

Leadership, competence and resources Evaluate management responsibility, review, competence and work environment controls.

Management responsibility and planning

Management review and follow-through

Competence, infrastructure and environment

Realization planning and risk Audit realization planning, risk management and customer requirements.

Product realization planning

Risk management through realization

Customer requirements and communication

Design and development Distinguish design review, verification, validation, transfer and change controls.

Design planning, inputs and outputs

Review, verification and validation

Transfer, design changes and design files

Purchasing and supplier assurance Evaluate supplier selection, monitoring, purchasing information and incoming verification.

Supplier selection and monitoring

Purchasing information and change agreements

Verification of purchased product

Production and process validation Audit production, servicing, special processes and applicable sterile-device controls.

Controlled production, installation and servicing

Process validation and revalidation

Sterile devices and contamination controls

Traceability, measurement and release Follow identification, traceability, preservation, calibration and product release evidence.

Identification, traceability and property

Preservation and measurement equipment

Product monitoring and authorized release

Feedback, nonconformity and improvement Evaluate complaints, regulatory reporting routes, nonconforming product, CAPA and analysis.

Feedback, complaints and regulatory reporting

Nonconforming product and rework

Data analysis, corrective and preventive action

Planning an internal audit Prepare a risk-based audit plan, criteria, checklist and defensible sample.

Audit programme and independence

Objectives, scope, criteria and audit plan

Checklist design and sampling

Conducting the audit Collect reliable evidence, interview effectively and write supported findings.

Opening meeting and interviewing

Evidence trails and balanced evaluation

Writing supported audit findings

Reporting and follow-up Communicate conclusions, review corrective action and verify effectiveness.

Closing meeting and report

Reviewing corrective action proposals

Effectiveness verification and course application