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### Course Description

## CQI-IRCA (MD-QMS) ISO 13485:2016 Lead Auditor in Nigeria

An intense learning programme called the Lead Auditor Course for Medical Device Quality Management System (MD-QMS) CQI I IRCA is created to give participants the information and abilities they need to carry out successful audits of medical device businesses. An introduction to the ISO 13485:2016 standard, which specifies the standards for a quality management system specifically for medical devices, is given at the beginning of the course. The main clauses of the standard will become clearer to the participants, and they will learn how to integrate them into their organization's QMS. Risk management, an essential part of the QMS in the medical device business, is covered in the course. Participants will gain knowledge of how to recognise, examine, and assess hazards related to medical devices, especially those related to patient safety and potential reputational damage. Another important component of the training is the design of quality management systems. Participants will get knowledge on how to create an efficient QMS that complies with ISO 13485:2016. To assure standard compliance and enhance the efficacy and efficiency of the QMS, this includes developing processes, policies, and work instructions. A crucial requirement of the ISO 13485:2016 standard is internal audits. Internal audits of the QMS will be planned, prepared for, and carried out by the participants. They will also learn how to summarize audit findings, offer recommendations for improvement, and report on audit outcomes. The course also covers supplier management, which is essential for making sure that the supply chain for medical devices is dependable and that the supplied goods and services adhere to the necessary standards. Participants will obtain knowledge on how to evaluate suppliers' performance in light of the needs of the organization.

MAXIMEDGE is one of the top leading ISO training and Certification providers in Nigeria. Our ISO 13485:2016lead auditors training in Nigeria is top notch,We provide the best ISO training, audit and Consultancy service in Lagos, Port Harcourt, Abuja, Kano, Ibadan, Benin City, Bayelsa, Warri, Nigeria and other major cities with the service of implementation, training, auditing, and registration. We provide different ISO Standards like ISO 27001, ISO 9001, ISO 14001, ISO 13485, ISO 22000, ISO 17025, ISO 45001, and many others ISO 9001 compliance can be achieved by any organization in Nigeria.

This course meets the training requirements for individual auditor certification.

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- About Course

  ### Do You Have Any Questions?

  Learning Activities
  Course work is based on theory and activity Tutor support Continuous Assessment Final Examination
  Training Methodology
  Training is delivered by Classroom (physical training) or Online training. The Physical training consists of physical lectures with a live tutor, videos, discussions, activities, assignments, and professional experiences among delegates and trainers. During this period, delegates will be guided by our Approved tutors, who are dedicated to ensuring sessions are successfully delivered. The Online training consists of various proven online learning techniques to ensure maximum understanding, comprehension, retention of the information presented. In online training, lectures are conducted the same way physical training is conducted except that it is virtual. Learners can pause, replay, rewind, fast forward a video, and enjoy a lecture from any location.
  Course Outline
  The course outline will be uploaded soon, In the mean time, you can request the course outline via E-mail maximedgeconsulting@gmail.com or call 0813 994 0012, 0803 5276612.
  Cost, Duration, Location And Other Details
  •Course Specification: Theoretical Content, Practical, exercise and class works •Type Of Training: Cooperate /Individual Training •Mode Of Training: Classroom Training, In-house/corporate training In-plant Training/Onsite Training, Virtual/Distance Leaning, Self-paced E-learning/Online Learning , Customized •Training Duration: 5 Days •Cost Per Delegate:Fees (Available at registeration portals) includes your attendance during the training Comprehensive course manual, Lunch and tea break the provision of Training completion certificate only. NOTE: Other logistics like accommodation, living costs, freight etc are Not Inclusive. •Certification: at the completion of training, course work and prescribed assessment, the delegate will be issue certificate of completion •Training Venue:Port Harcourt, Lagos, Abakiliki, Satellite center and Online •Start Date: (Available at registeration portals)
  Exam, Result and Certificate
  The examination consists of sections and requires a final score of 70% and above as pass mark. Results are released days after examination ans certificates are issued to sucessfull delegates.
  Need to speak with a course advisor?
  For further inquiry and registration, call 0813 994 0012, 0803 5276612. send email to maximedgeconsulting@gmail.com

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  ### Benefits Of This Training?

  Are you looking for a comprehensive course on Medical Device Quality Management Systems? Look no further! Our ISO 13485:2016 MD-QMS CQI | IRCA Lead Auditor Training provides a wide range of benefits to help you understand and implement this important system. Here are some key benefits of our course:

  - Get up to date with the latest medical device quality management systems and regulations.
  - Learn how to develop, implement, and maintain an ISO 13485:2016 compliant quality management system.
  - Understand the requirements of the ISO 13485:2016 standard and how to audit it effectively
  - Acquire the necessary skills to become an CQI | IRCA Lead Auditor in Medical Device Quality Management Systems
  - Get access to valuable resources, such as case studies, templates, sample documents, and more.
  - Get certified as a Registered Lead Auditor/Certified Lead auditor by examining bodies such as CQI-IRCA, Examplar Global or PECB approved training providers.
  - Become proficient in managing non-conformances through appropriate corrective actions following international standards like ISO 19011 guidelines for best results.
  - Develop a better understanding of legal compliance obligations related to the environment based on regional legislation

  ### Training Objectives

  Explain the purpose of an Medical Device Quality Management Systems, its standards, management system audits, third-party certification, and the business benefits of better Medical Device Quality Management Systems performance.

  - Provide an understanding of the principles and requirements of ISO 13485:2016 and related regulatory requirements for medical devices.
  - Develop practical auditing skills that can be applied in various auditing situations..
  - Enable participants to plan, conduct, report, and follow up on an audit of a medical device QMS against ISO 13485:2016 requirements.
  - Enhance participants' ability to analyze and evaluate medical device QMS documentation and audit evidence.
  - Be equipped with knowledge of ISO 13485:2016 Lead Auditor certification process.
  - Allow participants to develop essential skills needed when conducting first or second-party (internal) audits as well as third-party certification body assessments using exam simulations conducted during exercises throughout the course.
  - Develop participants' skills in communicating effectively with auditees and stakeholders during the audit process.
  - Schedule, conduct, report on, and follow up on an audit of an environmental management system to determine compliance (or lack thereof) with ISO 14001, ISO 19011, and ISO/IEC 17021-1, as appropriate.

  ### Which topics are covered in the ISO 13485:2016 MD-QMS lead auditor course?

  The training encourages active participation and will help participants advance their skills. The actual application of assessment information and skills is prioritized. Delegates can apply their skills and knowledge to all phases of the evaluation process by using realistic case studies. This course was created with input and feedback from numerous trainers, clients, and training consultants from around the world.

  ### Content of the ISO 13485:2016 MD-QMS lead Auditor's Course:

  Learn to identify the principles of a Quality Management System according to ISO 9001:2015.

  - A set of ISO 13485 standards
  - Auditing criteria for the ISO 13485:2016 Standard, including the PDCA Cycle
  - Examining the documentation of medical device quality management systems
  - Checking compliance with ISO 19011 standards
  - Audit Planning: Audit Plan Checklists, Non-Conformance Reports Auditing Roles and Responsibilities of the Auditor
  - Exercises, case studies, and follow-up verification are all included in the audit reporting process.
  - Exercises, case studies, accreditation, certification, and auditor registration are all included in the final team meeting.
  - The course evaluation.

  ### Who Should Attend?

  This MAXIMEDGE training course is ideal to a wide range of professionals but will greatly benefit:

  - A Lead Assessor or Third Party Assessor
  - Accountable for conducting supplier and subcontractor audits
  - Responsible for putting audit programmes and internal audits into effect
  - Accountable for putting the ISO 13485:2016 series of requirements into practise
  - Directors, supervisors, manager and those in management systems
  - Quality executives or managers
  - Representatives of the management
  - Internal MD-QMS auditors currently employed
  - Medical personnel working as ISO Consultants who want to pursue careers in MD-QMS auditing, such as those with a - B.Tech., M.Tech., BSC, MSC, MCA, or MBA.
  - Professionals in total quality & environmental management

  ### Course Duration & Structure:

  5 Days Course, typically starts at 9:30 A.M. and ends by 6:30 P.M (IST). Available batch will be confirmed after registerations. Presentations, Examples, Exercises requiring group work, Brainstorming, Readings, and Sharing of Practical Experiences are all included in the course. A 45-minute lunch break each day

  ### Why Us

  - More elaborated training
  - Blended training
  - Cost Effectiveness
  - Preferential treatment
  - On facility training
  - Customized Training
  - Flexible timing
  - Hand-on-practice
  - Tea Break & Quality Lunch
  - Timely certificate delivery

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  ### 1 comment on “ISO 13485:2016 | CQI and IRCA Lead Auditor Training Courses”

  Admin December 3, 2020 at 8:30 am

  what is the duration of this training

  Reply

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