The ISO 13485 Internal Auditor Training equips participants with the skills to audit medical device quality management systems, ensuring compliance with ISO 13485 standards. It covers key aspects such as auditing techniques, process improvement, and regulatory requirements specific to the medical device industry. This course is ideal for Quality Managers, Internal Auditors, Regulatory Compliance Professionals, and anyone involved in implementing or auditing ISO 13485 systems within medical device organizations. There are no formal prerequisites for enrollment. Participants will benefit from expert-led training sessions, a digital delegate pack containing essential course materials, and a certification upon successful completion, ensuring both practical experience and a comprehensive understanding of ISO 13485 auditing principles
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ISO 13485 Internal Auditor
ISO 13485 Internal Auditor Course Outline
Module 1: Introduction to ISO 13485:2016
- Overview of ISO 13485:2016
- Benefits and applications of ISO 13485
- Steps to achieving compliance
- Definition of a medical device
- Purpose and principles of a Quality Management System (QMS)
- Importance of ISO 13485
- Practical exercise
Module 2: Understanding ISO 13485 Clauses 1 and 2
- Clause 1 – Scope
- Clause 2 – Normative References
- Clause 5 – Management Responsibilities
- Clause 6 – Resource Management
Module 3: Understanding ISO 13485 Clauses 3 and 4
- Clause 3– Terms and Definitions
- Clause 4 – Quality Management System
- General requirements
- Documentation requirements
- Practical exercise
Module 4: Key Quality System Requirements
- Management responsibilities (Clause 5)
- Resource management (Clause 6)
- Product realization (Clause 7)
- Measurement, analysis, and improvement (Clause 8)
- Practical exercise
Module 5: Overview of ISO 13485:2016 Requirements
- General and documentation requirements
- Management responsibility and resource allocation
- Product realization and infrastructure needs
- Risk management
Module 6: Implementing the ISO 13485 Framework
- Phases of implementation
- Conducting a gap analysis
- Process mapping techniques
Module 7: Certification Audit Process
- Overview of ISO 13485 certification audits
- Practical exercise
Module 8: ISO 13485 vs. ISO 9001
- Scope and focus differences
- Continual improvement strategies
- Key terminology distinctions
- Similarities and differences between the standards
Module 9: Internal Auditing Principles
- Objectives of internal auditing
- Essential auditing skills
- Steps in conducting internal audits
- Planning, preparation, and audit management
- Internal audit PDCA cycle
- Types of audits and audit techniques
- Practical exercise
Module 10: Internal Audit Planning
- Developing an audit plan
- Establishing audit criteria
Module 11: Audit Process and Execution
- Conducting process audits
- Defining scope and criteria
- Reporting audit findings
Module 12: Audit Evidence and Findings
- Collecting and classifying audit evidence
- Preparing closing reports
- Identifying and documenting nonconformities
- Practical exercise
Module 13: Roles and Responsibilities of an Internal
Auditor
- Responsibilities of an internal auditor
- Conducting closing meetings
Module 14: Resource Management and Product Realization
- Provision of resources and infrastructure
- Planning and development of medical device 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 Guatemala 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 Guatemala?
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 Guatemala?
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 Guatemala?
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 Guatemala?
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 Guatemala?
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 Guatemala?
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 Guatemala 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 Guatemala?
ISO 13485 Internal Auditor training in Guatemala 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 Guatemala?
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 Guatemala?
ISO 13485 Internal Auditor training in Guatemala 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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