PECB ISO 13485 Lead Auditor - Enhance Your Medical Audit Skills
Join our ISO 13485 Lead Auditor training to delve into the quality standards of medical devices. Explore key concepts and best practices, ensuring efficiency and safety in accordance with ISO 13485.
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- Duration : 5 Days
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About The Course PECB ISO 13485 Lead Auditor
The ISO 13485 Lead Auditor training is an intensive five-day program. The main objective of this training is to provide participants with in-depth knowledge of the principles, processes, and audit techniques that underlie the medical devices quality management system according to ISO 13485.
ISO 13485 is an internationally recognized quality management standard specifically dedicated to medical devices. It focuses on quality assurance at all stages of the product lifecycle, from design to delivery. This approach enables quality auditors to ensure the compliance and effectiveness of medical devices, regardless of their type or scale.
By the end of the ISO 13485 Lead Auditor training, you should be able to achieve the following objectives:
- Understand and explain the mechanisms of a Medical Devices Quality Management System (MDQMS);
- List and explain the key requirements of the ISO 13485:2016 standard in the context of an audit;
- Understand the links between ISO 13485 and other relevant standards and regulations;
- Understand the role of an auditor, including planning, conducting, and following up on a management system audit in accordance with ISO 19011;
- Be able to lead an audit and an audit team;
- Master the planning and conduct of an audit, audit report writing, and audit follow-up in accordance with ISO 19011;
- Successfully pass the ISO 13485 Lead Auditor exam and obtain one of the 4 associated PECB certifications.
Prerequisites
A basic understanding of quality management concepts and the ISO 13485 standard is recommended to make the most of this training. Prior experience in auditing or managing quality management systems in the medical device sector will also be beneficial.
Who Should Attend This Course?
The ISO 13485 Lead Auditor is an international standard that specifies requirements for a Quality Management System (QMS) for organizations involved in the complete life cycle of medical devices, from design to production to post-market maintenance. Its purpose is to ensure the compliance of medical devices with regulatory and quality requirements.
The ISO 13485 Lead Auditor training is intended for:
Quality professionals: Those who are already involved in the quality of medical devices and wish to deepen their knowledge and skills in auditing.
Internal auditors: Those who are already engaged in internal auditing and seek to expand their scope to include ISO 13485.
Consultants: Professionals who advise businesses on the implementation and maintenance of QMS in accordance with ISO 13485.
Course Program
The ISO 13485 Lead Auditor training follows a detailed intensive program, covering a variety of topics related to auditing medical devices' quality management systems. Here is an example of the structure of this training:
Day 1: Introduction to Quality Management and ISO 13485 Requirements
- Introduction to ISO 13485 standard and regulatory framework for medical devices.
- Fundamental principles of a Medical Devices Quality Management System.
- ISO 13485:2016 certification process.
- Operation of the Medical Devices Quality Management System.
- Key points of ISO 13485:2016 standard.
Day 2: Audit Principles and Preparation
- Concepts and fundamental principles of auditing.
- Evidence-based audit approach.
- Triggers for an audit.
- Audit stages (part 1).
- On-site audit preparation (part 1 and 2).
Day 3: On-site Audit Activities
- Audit stages (part 2).
- Communication during the audit.
- Audit procedures: observation, document review, interviews, sampling techniques, technical verification, collaboration, and evaluation.
- Writing audit test plans.
- Formulating audit conclusions.
- Writing audit findings and non-conformities.
Day 4: Audit Closure
- Audit documentation.
- Quality review.
- Closing an audit meeting.
- Assessor's action plan evaluation.
- Surveillance audit.
- Benefits of a pre-audit.
- Managing an internal audit program.
Last half-day: Exam Session
- Taking the ISO 13485 Lead Auditor certification exam (duration: 3 hours).
- Note: The exam and PECB ISO 13485 Lead Auditor course materials are available only in English.
Why Choose Our Course?
Choosing the ISO 13485 Lead Auditor training offers numerous advantages, especially if you work in the medical devices industry or aspire to do so. Here are some reasons why this training could be an excellent choice for you:
In-depth expertise: This training provides you with a detailed and comprehensive understanding of the ISO 13485 standard, an international standard for the quality management of medical devices.
Audit skills: You will learn the principles and practices of auditing quality management systems. This includes planning and conducting audits, writing audit reports, and follow-up on audits.
International recognition: ISO 13485 is internationally recognized. Having an ISO 13485 Lead Auditor certification can enhance your employability and help you stand out in a competitive job market.
Improvement of medical device quality: By applying the knowledge and skills gained in this training, you can contribute to improving the quality and safety of medical devices, which is crucial for patient well-being.
Career advancement: If you are already working in the medical devices industry, this training can help you advance in your career by allowing you to take on audit responsibilities.
Regulatory compliance: Understanding the ISO 13485 standard and being able to apply it can help your organization remain compliant with medical device regulations.
PECB Certification: By successfully passing the exam at the end of the training, you will obtain a certification from PECB, a respected organization that provides certifications in compliance and risk management.
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What Our Customers Say
Hicham Kandil
The ISO 13485 Lead Auditor training was a really beneficial experience for me. Not only did it give me an in-depth understanding of ISO 13485, but it also strengthened my auditing skills, which is essential in my role. The instructors were extremely knowledgeable, clearly explaining the principles of auditing and how they apply to ISO 13485. The case studies and audit simulations were very realistic, providing valuable practical experience. This training gave me the confidence to conduct effective audits and contribute to continuous quality improvement in my organization. I highly recommend this training to anyone involved in auditing medical device quality management systems.
Saad Berrada
The ISO 13485 Lead Auditor training was a very valuable experience. The educational approach used by the trainers allowed me to understand not only the details of the ISO 13485 standard, but also how to practically apply it when auditing quality management systems in the sector medical devices. I particularly enjoyed the practical exercises and case studies which made the learning process interactive and engaging. The training also covered important topics such as identifying non-conformities and audit reporting. I am now much more confident in my ability to conduct internal and external audits effectively and professionally. I highly recommend this training to those interested in improving their medical device auditing skills.