The ISO 13485:2016 Medical Devices Internal Auditor Training is designed to empower quality professionals with the skills and knowledge required to conduct rigorous, risk-based internal audits within the medical devices industry. This intensive training focuses on the crucial aspects of planning, executing, and reporting internal audits that are compliant with ISO 13485:2016 standards, ensuring that medical device manufacturers meet both customer expectations and regulatory requirements.
This two-day program is delivered using a combination of instructor-led lectures, case study and exercises on practical implementation of the concepts discussed within the training. The topics presented below define the areas of focus under the program.
At the end of the training, participants should be able to:
Comprehensive Audit Skills: Gain the ability to conduct full-scope internal audits from planning through execution and reporting.
Risk Management: Learn to identify, assess, and manage risks effectively throughout the audit process.
Regulatory Compliance: Ensure your organization meets all ISO 13485:2016 requirements and stays compliant with industry regulations.
Operational Improvement: Identify areas of improvement in your quality management system to enhance efficiency and effectiveness.
Professional Development: Enhance your credentials and career prospects as a certified internal auditor in the medical devices industry.
Target group
This training is ideal for:
Quality Assurance Managers and Auditors
Compliance Officers
Risk Managers
Regulatory Affairs Specialists
Anyone involved in the quality management of medical devices
Requirements
To fully benefit from this training, participants should have:
A foundational understanding of ISO 9001:2015 Quality Management Systems.
Some experience auditing practices is recommended but not mandatory.
No advanced technical skills are required, making this training accessible to anyone looking to enhance their auditing capabilities within the ISO 13485:2016 environment.
Training outline
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Module 1: Introduction to Internal Auditing
Role of Internal Auditors
Importance of Internal Auditing in Organizations
Internal Audit Vs External Audit
Code of Ethics and Professional Standards for Internal Auditors
Module 2: Internal Audit Functions and Objectives
Objectives of Internal Auditing
Scope and Coverage of Internal Audits
Risk-Based Approach to Auditing
Adding Value through Internal Audit
Audit Planning and Strategy
Module 3: Internal Audit Methodology
Internal Audit Cycle
Risk Assessment and Audit Planning
Audit Testing and Sampling Techniques
Gathering Audit Evidence
Documenting Audit Procedures and Findings
Module 4: Internal Audit Tools and Techniques
Data Analysis in Internal Auditing
Interviewing Techniques for Auditors
Observing and Inspecting Controls
Module 5: Internal Control Systems
Understanding Internal Controls
Types of Control Activities
Evaluating the Effectiveness of Internal Controls
Assessing Control Risks
Module 6: Audit Reporting and Communication
Preparing Audit Reports
Effective Communication of Audit Findings
Follow-Up and Action Plans
Communicating with Management and Stakeholders
Module 7: Audit Sampling Techniques
Sampling Methods in Auditing
Sample Size Determination
Applying Statistical Sampling
Clause 5: Management responsibility
Management Commitment
Customer Focus
Policy
Planning
RACI
Management Review
Clause 6: Resource Management
Provisioning
Human Resources
Infrastructure
Work Environment & Contamination Control
Clause 7: Product/service responsibility
Realization Planning
Customer related processes
Design & Development
Procurement
Product & Service Provisioning
Equipment Measurement and Monitoring Control
Clause 8: Measurement, Analysis and Improvement
General Requirements
Monitoring and Measurement
Non-Conforming Product Control
Analysis of Data
Improvement
References
ISO 9001:2015 references
General Regulations of Medical Device Management
Other information
For payment details and inquiries, please contact academy@phl.tuv.com. Our team will guide you through the payment process and answer any questions about schedules, content, or logistics.
ADDITIONAL INFORMATION
Training fees include materials and a certificate.
Unless stated otherwise, fees are subject to 12% VAT.
A 50% down payment is required before the first day of training. The balance is due on or before the last day.
We accept various payment methods; please reach out for instructions.
For Classroom Trainings, there will be an additional ₱ 1,000 for ancillary costs.
CANCELLATION POLICY
TÜV Rheinland Philippines reserves the right to postpone or cancel public courses due to valid reasons.
Unless cancelled by TÜV Rheinland Philippines, all fees are non-refundable once registration is confirmed.
Cancellations made five days or fewer before the training date are non-refundable; full fees will be charged.
You may nominate a substitute delegate at no extra cost. Please provide their details at least three business days beforehand.
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ISO 13485:2016 Medical Devices Internal Audit
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