ISO 13485 Lead Auditor Training

The primary objective of the Lead Auditor course is to equip participants with the necessary knowledge and abilities to conduct audits of medical device quality management systems. These audits encompass first, second, and third-party assessments, evaluating compliance with ISO 13485 and relevant international regulatory standards, while adhering to the principles outlined in ISO 19011 and ISO/IEC 17021. The prosperity of an organization, as well as the market reach and acceptance of its products and services, heavily relies on the consistent assurance, maintenance, and enhancement of MD-QMS requirements and regulatory compliance. To fulfill these crucial demands, the ISO 13485 Lead Auditor training program has been specifically designed.

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  • 28 Jul, 2024 / 28 Jul, 2024
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What is this ISO 13485 Lead Auditor training all about?

The training equips learners with the necessary knowledge and skills to conduct audits of a Medical Device Quality Management System (MD QMS) by ISO 13485:2016 while adhering to the guidelines outlined in ISO 19011 and ISO 17021. By completing this course, participants will acquire a thorough understanding of the principles and practices that underpin effective quality management system audits, specifically tailored to ISO 13485. By delving into the principles and practices of auditing, participants gain a deep understanding of ISO 13485 and the auditing process, enabling them to identify areas for improvement, detect non-conformities, and recommend corrective actions. The training emphasizes adherence to international standards and ensures auditors are proficient in conducting audits with professionalism and integrity.

Why is ISO 13485 Lead Auditor training essential?

ISO 13485 Lead Auditor training is crucial for several reasons. First of all, it gives people the information and abilities they need to successfully audit Medical Device Quality Management Systems (MD QMS) to ISO 13485 standards, assuring compliance and adherence to industry laws. With the help of this training, auditors may spot probable non-conformities, evaluate the efficiency of the quality management system, and suggest remedial measures, thereby raising the general standard of medical devices. Additionally, ISO 13485 Lead Auditor training supports MD QMS's continuous improvement, streamlines internal processes, increases market acceptance of goods and services, and adds to the accomplishments and goodwill of businesses engaged in the medical device industry.

Why do companies hire professionals with ISO 13485 Lead Auditor certification?

For several reasons, businesses look for individuals having ISO 13485 Lead Auditor certification. First off, this qualified personnel are well-versed in ISO 13485 standards and the auditing procedure, which enables them to evaluate the compliance and efficiency of MD QMS (Medical Device Quality Management Systems) in a precise manner. Employing individuals with this accreditation shows a business' dedication to quality and legal compliance, inspiring trust in stakeholders, customers, and regulatory bodies. Lead auditors certified to ISO 13485 can spot problem areas, spot non-conformities, and suggest remedial measures, all of which help to improve the MD QMS and raise the general standard of medical devices. Their knowledge guarantees that businesses can adhere to industry standards, reduce risks, and keep a step ahead of the competition.

Industry Trends

ISO 13485 Lead Auditor training has witnessed several industry trends in recent years. Firstly, there has been an increasing demand for professionals with ISO 13485 Lead Auditor certification, driven by the growing emphasis on quality and regulatory compliance in the medical device industry. Organizations are recognizing the value of having internal auditors who can effectively assess and enhance their Medical Device Quality Management Systems. Additionally, there is a rising trend towards blended learning approaches, incorporating online modules and interactive workshops to enhance accessibility and flexibility. Furthermore, the training programs are evolving to address emerging topics such as risk management, cybersecurity, and post-market surveillance, reflecting the evolving regulatory landscape and industry best practices. Overall, ISO 13485 Lead Auditor training continues to adapt to meet the evolving needs and challenges of the medical device industry.

Market trends

Due to the rising significance of quality management and regulatory compliance in the medical device business, there is a growing demand for experts with ISO 13485 Lead Auditor certification on a global scale. This demand is present in several industries, including those of manufacturers, suppliers, and regulatory agencies. In addition, more specialized training organizations are providing ISO 13485 Lead Auditor courses to meet the needs of the medical device sector. To make the training more applicable, these courses frequently include useful case studies and real-world problems. Additionally, the accessibility and reach of ISO 13485 Lead Auditor training have increased with the introduction of remote learning and virtual classrooms, enabling professionals from all over the world to take part in these programs. Overall, ISO 13485 Lead Auditor training highlights its increasing significance and the industry's commitment to quality and compliance.

Salary Trends

Professionals with ISO 13485 Lead Auditor training can expect to have excellent progress and rewarding prospects in their salaries. Companies are seeing the importance of these qualified persons' skills and are prepared to pay attractive compensation packages as the demand for them rises. Salary ranges for ISO 13485 Lead Auditors depend on several variables, including experience, geographic region, and the size and standing of the hiring organization. When compared to their peers in non-auditor professions, workers with ISO 13485 Lead Auditor certification may often anticipate earning earnings above average. Further pay increases may also result from career promotion and openings for more senior roles like quality management consultants or senior auditors. On average, the individual earns AED 30000 to AED 35000 yearly.

 

Demand & Opportunities

ISO 13485 Lead Auditor training is in high demand due to several key factors. Firstly, the medical device industry places significant importance on quality management and regulatory compliance. Organizations seek professionals with ISO 13485 Lead Auditor certification to ensure their Medical Device Quality Management Systems (MD QMS) meet the rigorous standards set by ISO 13485. Additionally, regulatory bodies and authorities require audits by qualified lead auditors to assess compliance with industry regulations. The demand for ISO 13485 Lead Auditors is further enhanced by the need for continuous improvement and the ability to identify non-conformities, recommend corrective actions, and contribute to the overall enhancement of MD QMS. The specialized knowledge and skills acquired through ISO 13485 Lead Auditor training are essential in meeting these demands and ensuring the quality and regulatory compliance of medical device processes.

Here are some of the roles that benefit from our ISO 13485 Lead Auditor training (as observed in popular job portals):

  1. Lead Auditor - Conduct audits of Medical Device Quality Management Systems (MD QMS) against ISO 13485 standards and regulatory requirements.

  2. Quality Assurance Manager - Oversee the implementation and maintenance of MD QMS, ensuring compliance with ISO 13485 and driving continuous improvement.

  3. Regulatory Affairs Specialis - Navigate the complex regulatory landscape, ensuring compliance with applicable laws and regulations for medical devices.

  4. Compliance Officer - Develop and enforce policies and procedures to ensure adherence to ISO 13485 standards and regulatory requirements.

  5. Quality Management Consultant - Provide expert guidance and support to organizations in establishing and optimizing their MD QMS, including conducting audits and recommending improvements.

Course Outcome

Completing the ISO 13485 Lead Auditor training will enable you to:

  • Develop a comprehensive knowledge of the ISO 13485 standard and its requirements for Medical Device Quality Management Systems (MD QMS).
  • Acquire the skills and techniques necessary to plan, conduct, and report on audits of MD QMS, following ISO 19011 guidelines.
  • Gain the ability to assess the compliance of MD QMS with ISO 13485 and relevant regulatory standards, identifying areas for improvement and potential non-conformities.
  • Learn how to recommend appropriate corrective actions and improvement measures to address identified non-conformities and enhance the overall quality of MD QMS.
  • Contribute to the continuous improvement of MD QMS by providing valuable insights, identifying opportunities for enhancement, and promoting a culture of quality and compliance within organizations.

Course Module

  • Knowledge of the following quality management principles and concepts:

    • The Plan, Do, Check, Act (PDCA) cycle.

    • The relationship between quality management and customer satisfaction

    • Commonly used quality management terms and definitions and the 8 Quality Principles as given in ISO 9000.

    • The process approach is used in quality management.

    • The Model of a Process Based Quality Management System, the structure and content of ISO 13485.

    • Knowledge of the requirements of ISO 13485.

  • Auditing Objectives
  • Types of Audits
  • Audit Life Cycle
  • Terms and Definition
  • Principle of Auditing
  • Annex A – Guidance of Auditors
  • Pre-Audit Planning
  • Reviewing Documentation
  • Developing an Audit Plan
  • Preparing Checklists or Working Documents
  • Communication Factors
  • Conducting the Closing Meeting 
  • Preparing the Audit Report
  • Distributing the Audit Report 
  • The Registration Processes
  • Surveillance Audits 
  • Purpose and benefits of MD-QMS-Requirements for Regulatory Purposes including an understanding of the basic MD-QMS principles
  • Terms, Fundamentals, and Principles 
  • Process Approach with PDCA 
  • Mandatory Documents for Regulatory Purposes
  • Difference between Compliance and Conformance
  • Relationship between IMDRF and GHTF
  • Principles of IMDRF
  • MDR European Union Regulations 
  • MD-QMS Requirements (Clause 1 to 8)
  • Audit Programme Objectives
  • The Auditees Responsibilities
  • The Lead Auditors’ Responsibilities
  • Auditors' Qualifications and Certifications
  • Opening Meeting
  • Collecting Objective/Audit Evidence 
  • Effective Interviewing Techniques
  • Identifying and Recording Nonconformities
  • Preparing for the Closing Meeting 
  • Corrective Action Responsibilities
  • Follow up Scheduling
  • Monitoring Corrective Action 

Program Dates

28 Jul
  • 02:00 PM
  • Sun
  • Online Live
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Expert Instructors & Teaching Methods

 

 

We, at Learners Point, take immense pride in our teaching methods and instructors. Our instructors are some of the best experts in their fields and employ a practical approach to learning. Many of them are globally recognised and have a diverse set of experience in their field of expertise. You are always sure to have the best in the industry as your teachers who are ready to guide you at every step and make the experience informative yet enjoyable.  Apart from the focus on learning your chosen course, our instructors also encourage students to develop communication skills and interpersonal skills necessary to excel in the practical world.

Our cutting edge teaching methods make every program an immersive and productive experience for the learners. Our learning methods are research-driven and are continuously updated to stay relevant to present times as well as the future. You will enjoy practical applications of everything learned through theory and regular mock examinations to help monitor your progress. Our courses are led by an instructor in a classroom setup and we do offer online high-quality sessions as well for individuals. We also monitor the training sessions with a progress tracker to maintain high standards of instruction & ethics.

Our Trainers

 

We, at Learners Point, take immense pride in our teaching methods and instructors. Our instructors are some of the best experts in their fields and employ a practical approach to learning. Many of them are globally recognised and have a diverse set of experience in their field of expertise. You are always sure to have the best in the industry as your teachers who are ready to guide you at every step and make the experience informative yet enjoyable.  Apart from the focus on learning your chosen course, our instructors also encourage students to develop communication skills and interpersonal skills necessary to excel in the practical world.

Our cutting edge teaching methods make every program an immersive and productive experience for the learners. Our learning methods are research-driven and are continuously updated to stay relevant to present times as well as the future. You will enjoy practical applications of everything learned through theory and regular mock examinations to help monitor your progress. Our courses are led by an instructor in a classroom setup and we do offer online high-quality sessions as well for individuals. We also monitor the training sessions with a progress tracker to maintain high standards of instruction & ethics.

Our Trainers

Why Count on Learners Point?

Learners Point Academy provides top-notch ISO 13485 Lead Auditor training, providing professionals with the necessary skills and experience to excel in the field.

What to expect if you join our ISO 13485 Lead Auditor training:

  • We consider real-world scenarios that organizations face and tailor our ISO 13485 Lead Auditor training and structure to meet those needs.

  • Aside from theoretical knowledge, we focus on practical case studies to give you a reality check and insight into what will be expected of you while working in a demanding role.

  • Our customized ISO 13485 Lead Auditor training also provides you with hands-on experience by assigning tasks that are relevant to your current job.

  • In addition to group sessions, we offer one-on-one sessions to improve the quality of our ISO 13485 Lead Auditor training.

  • We also take a discrete approach to career counseling so that one can be successfully placed as a professional.

Learners Experience

"The ISO 13485 Lead Auditor Training was an eye-opening experience. It provided me with the knowledge and skills needed to ensure our medical device company complies with industry standards. The practical exercises and real-world examples made the training invaluable. I'm now confident in my role as a Quality Assurance Manager."

Lina K

Quality Assurance Manager

"The ISO 13485 Lead Auditor Training was a comprehensive and well-structured program. The trainers were industry experts who shared their practical experiences, which added immense value to the course. The training materials were top-notch, and the mock audits helped me gain confidence in my auditing abilities. I'm grateful for this opportunity to enhance my professional capabilities."

Luan Shi

Compliance Officer

"Completing the ISO 13485 Lead Auditor Training was a turning point in my professional journey. The course not only expanded my understanding of the standard but also honed my auditing skills. The interactive sessions and case studies enabled me to apply the concepts in practical scenarios. This training has opened doors to new career prospects, and I feel ready to contribute to quality management systems in the medical device industry."

Noora Ali

Regulatory Affairs Specialis

"I highly recommend the ISO 13485 Lead Auditor Training to anyone looking to advance their career in the medical device field. The comprehensive course covered all aspects of auditing, including regulatory requirements and best practices. The instructors were knowledgeable and provided real-world examples that made the content relatable. I'm grateful for this valuable learning opportunity."

David J

Quality Assurance Manager

"The ISO 13485 Lead Auditor Training has been a game-changer for me. It equipped me with the knowledge and skills required to effectively conduct audits in the medical device industry. The course was well-structured, and the practical exercises gave me hands-on experience. I feel confident and prepared to take on lead auditor responsibilities."

Mariom Stall

Lead Auditor

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FAQs on ISO 13485 Lead Auditor Training

An ISO 13485 Lead Auditor is responsible for conducting audits of medical device quality management systems against ISO 13485 standards, ensuring compliance, and identifying areas for improvement.

Yes, ISO 13485 Lead Auditor training is globally recognized and provides individuals with the necessary skills to conduct audits in compliance with international standards.

The training sessions at Learners Point are an interactive, immersive, and intensive hands-on program. We offer three modes of delivery and participants can choose from instructor-led classroom-based group coaching, one-to-one training session, or high-quality live and interactive online sessions as per convenience.

ISO 13485 Lead Auditor training is essential to develop the necessary knowledge and skills to effectively audit medical device quality management systems, contributing to regulatory compliance and continuous improvement.

Yes, many training providers offer ISO 13485 Lead Auditor courses online, allowing participants to complete the training remotely at their own pace.

At Learners Point Academy, if a participant doesn’t wish to proceed with the training after the registration due to any reason, he or she is entitled to a 100% refund. However, the refund will be issued only if we are notified in writing within two days from the date of registration. The refund will be processed within four weeks from the day of exit.

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