ISO 13485 outlines the requirements for a Quality Management System (QMS) in scenarios where an organization needs to demonstrate its capability to consistently provide medical devices and related services that meet customer and applicable regulatory standards. An ISO 13485 audit serves to assess the current status and effectiveness of your QMS and processes. This includes an independent and systematic process audit to evaluate the conformity or nonconformity of the QMS. This training session prepares participants with the auditing techniques for quality management systems in accordance with ISO 13485 and ISO 19011. Individuals who excel in auditing medical devices are likely to attain higher positions and broaden their professional networks in a short timeframe. Professionals in roles such as quality managers, regulatory affairs specialists, quality control officers, and those involved in internal quality audits within the medical device sector should strive to master the ISO 13485 Internal Auditor Training Course in India. In this 2-day ISO 13485 Internal Auditor Training course in India, participants will acquire in-depth knowledge of quality management systems and the process of conducting internal audits. Throughout the training, delegates will understand the responsibilities of management in making policy and financial decisions that support the QMS. They will also learn how to plan audits for medical devices and quality processes, along with the necessary documentation requirements.
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ISO 13485 Internal Auditor
ISO 13485 Internal Auditor Course Outline
Module 1: Introduction to ISO 13485:2016
- Course Overview
- Definition of ISO 13485:2016
- Advantages of Implementing ISO 13485
- Applications of ISO 13485
- Initial Steps Towards ISO 13485:2016 Compliance
- Understanding Medical Devices
- Purpose of a Quality Management System
- Significance of ISO 13485
- Fundamental Principles of ISO 13485
- Practical Exercise
Module 2: ISO 13485 Clauses 1 and 2
- Clause 1 – Scope
- Clause 5 - Management Responsibilities
- Clause 6 - Resource Management
- Clause 2 - Normative References
Module 3: ISO 13485 Clauses 3 and 4
- Clause 3 - Terms and Definitions
- Clause 4 - Quality Management System
- Clause 4.1 - General Requirements
- Clause 4.2 - Document Requirements
- Practical Exercise
Module 4: Requirements and Quality Systems
- Overview of Requirements and Quality Systems
- Clause 5 - Management Responsibilities
- Clause 6 - Resource Management
- Clause 7 - Product Realization
- Clause 8 - Measurement, Analysis, and Improvement
- Practical Exercise
Module 5: Overview of ISO 13485:2016 Requirements
- Key Requirements of ISO 13485:2016
- General Requirements
- Documentation Requirements
- Responsibilities of Management
- Resource Management
- Product Realization
- Infrastructure Requirements
- Risk Management
Module 6: Implementation Phases of the ISO 13485 Framework
- Steps to Implementation
- Conducting a Gap Analysis
- Process Mapping Techniques
Module 7: Conducting an ISO 13485 Certification Audit
- Overview of Certification Audits
- Practical Exercise
Module 8: Relationship Between ISO 13485 and ISO 9001
- Scope of Each Standard
- Areas of Focus
- Emphasis on Continual Improvement
- Key Terminology
- Differences Between the Standards
- Commonalities Between the Standards
Module 9: Internal Auditing
- Fundamentals of Internal Auditing
- Objectives of Internal Audits
- Essential Auditing Skills
- Steps Involved in Internal Auditing
- Planning, Preparing, and Managing Audits
- Internal Audit – PDCA Cycle
- Types of Audits
- Audit Techniques
- Practical Exercise
Module 10: Internal Audit Plan
- Developing an Audit Plan
- Establishing Criteria
Module 11: Audit Process
- Overview of the Audit Process
- Conducting Process Audits
- Defining Scope
- Establishing Criteria
- Reporting Audit Findings
Module 12: Internal Audit Evidence and Findings
- Gathering Evidence and Findings from Internal Audits
- Classification of Findings
- Preparing Closing Reports
- Addressing Nonconformities
- Documented Procedures
- Practical Exercise
Module 13: Roles and Responsibilities
- Responsibilities of Internal Auditors
- Conducting Closing Meetings
Module 14: Resource Management and Product Realization
- Provision of Necessary Resources
- Infrastructure Management
- Planning and Development of Products
Target Audience
• Quality Managers
• Quality Assurance Personnel
• Personnel Auditors
• Internal Auditors
IT Includes
1. 2 days interactive instructor-led 13485 internal auditor training
2. Training provided by highly qualified, certified, and accredited trainers from PECB
3. Certificate of ISO 13485 Internal Auditor course by PECB
4. ISO 13485 internal auditor certification
Exam Format
• Number of questions: 12
• Exam Mode: Online/Web-based open book
• Duration: 180 mins
• Exam format: Essay type
Training Delivery Modes
Mindbel learning offers 4 learning modes to choose
Classroom Training
Interactive sessions by expert and accredited trainers in classroom
Online Training
Industry experienced trainers led online sessions
Corporate group training for corporates
Flexible delivery methods are available depending on your learning style.
Focused One to One training
You will learn from qualified, accredited, certified and highly experienced trainers in classroom
Benefits of ISO 13485 Internal Auditor training with Mindbel
Average Salary
$110K
per annum
Expected Job growth rate
25%
Companies Hiring
Job Roles
- Quality Managers and Leaders
- Internal Auditors
- Regulatory Affairs Professionals
- Medical Device Professionals
- Compliance Officers
- Risk Management Personnel
- Quality Assurance Teams
- Process Improvement Professionals
- Professionals Transitioning to ISO 13485
- Management Representatives
Benefits
• Gain a thorough comprehension of the ISO 13485 standard, focusing on the specific requirements for quality management systems in the medical device industry.
• Develop strong auditing skills, enabling you to effectively plan, conduct, report, and follow-up on internal audits within your organization.
• Acquire knowledge to ensure your organization's compliance with international standards, fostering confidence among stakeholders and regulatory bodies.
• Learn to apply a risk-based approach to internal auditing, identifying and addressing critical areas that impact the quality management system.
• Enhance your ability to assess and improve quality management processes, contributing to increased efficiency and product/service quality.
• Develop skills to identify non-conformities, recommend corrective actions, and verify the implementation of solutions, ensuring continual improvement.
• Facilitate collaboration across departments by understanding how different functions contribute to the overall effectiveness of the quality management system.
• Attain a globally recognized certification that demonstrates your competence as an internal auditor, enhancing your professional credibility.
ISO 13485 Internal Auditor Training FAQs
What is the ISO 13485 Internal Auditor Course?
ISO 13485 Internal Auditor course is a training program in Fiji designed to provide participants with the knowledge and skills necessary to perform internal audits of a medical device quality management system (QMS) in accordance with the requirements of the ISO 13485:2016 standard.
Who is the target audience for ISO 13485 Internal Auditor Course in Fiji?
The target audience for the course is professionals who are involved in the maintenance and improvement of a medical device QMS, including quality managers, quality assurance personnel, and internal auditors.
What is the objective of ISO 13485 Internal Auditor Course in Fiji?
The objective of the course is to provide participants with the knowledge and skills necessary to perform internal audits of a medical device QMS that assess the effectiveness of the QMS and ensure it meets the requirements of the ISO 13485:2016 standard.
How long does the ISO 13485 Internal Auditor Course last in Fiji?
The duration of the course varies, but it is typically 2 days.
What are the prerequisites for attending ISO 13485 internal auditor training online in Fiji?
The prerequisites for attending the course vary, but participants typically should have a good understanding of quality management principles and the medical device industry.
What are the course topics covered in ISO 13485 Internal Auditor Course?
The course topics covered typically include the principles of auditing, the structure and content of the ISO 13485 internal auditor training course standard, and the steps involved in performing an internal audit.
What is the format of the ISO 13485 Internal Auditor Course in Fiji?
The course format may vary, but it typically includes lectures, group discussions, and hands-on exercises.
How is the ISO 13485 Internal Auditor Course evaluated?
The course is evaluated through assessments, exams, or practical exercises, which may be used to test participants' knowledge and understanding of the course material.
What is the benefit of attending ISO 13485 Internal Auditor Course in Fiji?
The benefits of attending the course include gaining a better understanding of the requirements of the ISO 13485 standard, developing the knowledge and skills necessary to perform internal audits, and improving the overall effectiveness of a medical device QMS.
Is ISO 13485 Internal Auditor certification recognized internationally?
Yes, ISO 13485 Internal Auditor certification in Fiji is recognized internationally and is a highly sought-after certification in the medical device industry.
How can ISO 13485 Internal Auditor training benefit organizations in Fiji?
ISO 13485 Internal Auditor training in Fiji can benefit organizations by ensuring they have in-house expertise to conduct effective internal audits, identify non-conformities, and implement corrective actions.
What are the typical challenges faced by ISO 13485 Internal Auditors?
Challenges include understanding complex processes, conducting objective assessments, managing potential conflicts of interest, and maintaining up-to-date knowledge of the ISO 13485 standard.
How does ISO 13485 address risk-based auditing in Fiji?
ISO 13485 promotes a risk-based approach to auditing, where auditors focus on areas with higher risk and potential impact on the quality and safety of medical devices.
How does an ISO 13485 Internal Auditor assess compliance with regulatory requirements?
ISO 13485 Internal Auditors assess compliance with regulatory requirements by comparing the organization's quality management system to both the ISO13485 internal auditor certification standard and relevant medical device regulations.
How does ISO 13485 Internal Auditor training support career development in Fiji?
ISO 13485 Internal Auditor training in Fiji enhances an individual's auditing skills, which are highly valued in the medical device industry and can lead to career advancement and increased responsibilities.
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