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 and other inquiries, please contact Ms. Sarah Mayol, Sales Executive (Sarah.Mayol@tuv.com |+63 998-848-0707).
Additional Details
The fees cover training materials and a certificate.
A 12% VAT is included in the training fees.
Cancellation and Postponement Policy
TÜV Rheinland Philippines, Inc. holds the authority to delay or cancel public courses. The following points provide further detail:
Unless a course is cancelled by TÜV Rheinland Philippines, training fees are non-refundable.
Cancellations made five days or fewer before the scheduled training will not be eligible for a refund. The full training fee will be charged and invoiced.
Delegate Substitution
If you are unable to attend the training, you may nominate a substitute delegate to attend in your place. Please ensure to inform us of the substitute delegate’s name and title.
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