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Training Programs > PECB > ISO 13485 Medical Devices Quality Management System
Training Programs > PECB > ISO 13485 Medical Devices Quality Management System
ISO 13485 Medical Devices Quality Management System

ISO 13485 determines the requirements for the medical devices industry. This standard was established to be used by companies during the life cycle of medical devices, from the production to post-production, including decommission and disposal. However, ISO 13485 can also be operated by other parties such as certification bodies which can assist in the certification processes. ISO 13485 serves as a tool for organizations to develop and retain their processes efficiently. Organizations that are striving for continuous improvement will benefit from this standard by being able to provide safe and competent medical devices and achieve the trust of customers.

ISO 13485 Medical Devices Quality Management System

Develop the necessary expertise to support an organization in establishing, implementing, managing and maintaining a Medical Devices Quality Management System (MDQMS) based on ISO 13485.

Learning Formats

Why Should You Attend?
ISO 13485 Foundation training enables you to learn the basic elements to implement and manage a Medical Devices Quality Management System (MDQMS) as specified in ISO 13485. During this training course, you will be able to understand the different modules of a MDQMS, including MDQMS policy, procedures, performance measurements, management commitment, internal audit, management review and continual improvement.
After completing this course, you can sit for the exam and apply for the “PECB Certificate Holder in ISO 13485 Foundation” certificate. A PECB Foundation Certificate shows that you have understood the fundamental methodologies, requirements, framework and management approach.
Who should attend?

  • Individuals involved in Medical Devices Quality Management.

  • Individuals seeking to gain knowledge about the main processes of Medical Devices Quality Management Systems (MDQMS).

  • Individuals interested to pursue a career in Medical Devices Quality Management.

Learning Objectives

  • Understand the elements and operations of a Medical Devices Quality Management System (MDQMS).

  • Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks.

  • Understand the approaches, methods and techniques used for the implementation and management of a MDQMS.

Educational Approach

  • Lecture sessions are illustrated with practical questions and examples.

  • Practical exercises include examples and discussions.

  • Practice tests are similar to the Certificate Exam.

Prerequisites
None
Available Learning Formats
Self Study/ Self-Paced
  • Official PECB PDF Materials.
  • Official PECB Online Exam.
  • Official PECB Certification.
  • Free Retake if needed.
Download Brochure

Physical Classroom/ Instructor-Led

  • Attendance of a physical face to face training.
  • Official PECB PDF Materials.
  • Official PECB Online Exam.
  • Official PECB Certification & Attendance Record.
  • Free Retake if needed
Download Brochure
Virtual Classroom/ Instructor-Led
  • Attendance of an online live training.
  • Official PECB PDF Materials.
  • Official PECB Online Exam.
  • Official PECB Certification & Attendance Record.
  • Free Retake if needed
Download Brochure
Enroll Now

Learning Formats

Why Should You Attend?

ISO 13485 Lead Implementer training enables you to develop the necessary expertise to support an organization in establishing, implementing, managing and maintaining a Medical Devices Quality Management System (MDQMS) based on ISO 13485. During this training course, you will also gain a thorough understanding of the best practices of Medical Devices Quality Management Systems and be able to improve an organization`s overall performance by consistently providing safe and qualitative medical devices.

After mastering all the necessary concepts of Medical Devices Quality Management Systems, you can sit for the exam and apply for a “PECB Certified ISO 13485 Lead Implementer” credential. By holding a PECB Lead Implementer Certificate, you will be able to demonstrate that you have the practical knowledge and professional capabilities to implement ISO 13485 in an organization.
Who Should Attend?

  • Managers or consultants involved in Medical Devices Quality Management.

  • Expert advisors seeking to master the implementation of a Medical Devices Quality Management System.

  • Individuals responsible for maintaining conformance with MDQMS requirements.

  • MDQMS team members.

Learning Objectives

  • Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks.

  • Master the concepts, approaches, methods, and techniques used for the implementation and effective management of a MDQMS.

  • Learn how to interpret the ISO 13485 requirements in the specific context of an organization.

  • Learn how to support an organization to effectively plan, implement, manage, monitor, and maintain a MDQMS.

  • Acquire the expertise to advise an organization in implementing Medical Devices Quality Management System best practices.

Educational Approach

  • This training is based on both theory and best practices used in the implementation of a MDQMS.

  • Lecture sessions are illustrated with examples based on case studies.

  • Practical exercises are based on a case study which includes role playing and discussions.

  • Practice tests are similar to the Certification Exam.

Prerequisites
A fundamental understanding of ISO 13485 and comprehensive knowledge of implementation principles.
Available Learning Formats
Self Study/ Self-Paced
  • Official PECB PDF Materials.
  • Official PECB Online Exam.
  • Official PECB Certification.
  • Free Retake if needed.
Download Brochure

Physical Classroom/ Instructor-Led

  • Attendance of a physical face to face training.
  • Official PECB PDF Materials.
  • Official PECB Online Exam.
  • Official PECB Certification & Attendance Record.
  • Free Retake if needed
Download Brochure
Virtual Classroom/ Instructor-Led
  • Attendance of an online live training.
  • Official PECB PDF Materials.
  • Official PECB Online Exam.
  • Official PECB Certification & Attendance Record.
  • Free Retake if needed
Download Brochure
Enroll Now

Learning Formats

ISO 13485 Lead Auditor
ISO 13485 Lead Auditor training enables you to develop the necessary expertise to perform a Medical Devices Quality Management System (MDQMS) audit by applying widely recognized audit principles, procedures, and techniques.
Why should you attend?
During this training course, you will acquire the knowledge and skills to plan and carry out internal and external audits in compliance with ISO 19011 and ISO/IEC 17021-1 certification process.
Based on practical exercises, you will be able to master audit techniques and become competent to manage an audit program, audit team, communication with customers, and conflict resolution.
After acquiring the necessary expertise to perform this audit, you can sit for the exam and apply for a “PECB Certified ISO 13485 Lead Auditor” credential. By holding a PECB Lead Auditor Certificate, you will demonstrate that you have the capabilities and competencies to audit organizations based on best practices.
Who should attend?

  • Auditors seeking to perform and lead Medical Devices Quality Management System (MDQMS) certification audits.

  • Managers or consultants seeking to master a Medical Devices Quality Management System audit process.

  • Individuals responsible for maintaining conformance with Medical Devices Quality Management System requirements.

  • Technical experts seeking to prepare for a Medical Devices Quality Management System audit.

  • Expert advisors in Medical Devices Quality Management.

Learning Objectives

  • Understand the operations of a Medical Devices Quality Management System based on ISO 13485.

  • Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks.

  • Understand an auditor’s role to: plan, lead and follow-up on a management system audit in accordance with ISO 19011.

  • Learn how to lead an audit and audit team.

  • Learn how to interpret the requirements of ISO 13485 in the context of a MDQMS audit.

  • Acquire the competencies of an auditor to: plan an audit, lead an audit, draft reports, and follow-up on an audit in compliance with ISO 19011.

Educational Approach

  • This training is based on both theory and best practices used in MDQMS audits.

  • Lecture sessions are illustrated with examples based on case studies.

  • Practical exercises are based on a case study which includes role playing and discussions.

  • Practice tests are similar to the Certification Exam.

Prerequisites
A fundamental understanding of ISO 13485 and comprehensive knowledge of audit principles.
Available Learning Formats
Self Study/ Self-Paced
  • Official PECB PDF Materials.
  • Official PECB Online Exam.
  • Official PECB Certification.
  • Free Retake if needed.
Download Brochure

Physical Classroom/ Instructor-Led

  • Attendance of a physical face to face training.
  • Official PECB PDF Materials.
  • Official PECB Online Exam.
  • Official PECB Certification & Attendance Record.
  • Free Retake if needed
Download Brochure
Virtual Classroom/ Instructor-Led
  • Attendance of an online live training.
  • Official PECB PDF Materials.
  • Official PECB Online Exam.
  • Official PECB Certification & Attendance Record.
  • Free Retake if needed
Download Brochure
Enroll Now

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    “AAC provided us with a state of art quality management system including policies, procedures and work instructions for all our departments and clinics. In addition, AAC worked on restructuring our center by analyzing the current situation, assessing the associated risks, drafting the organizational structure, building HR procedures and policies, developing the competencies required for each job position, buillding the job descriptions and salary scale based on international standards.
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    We can say that the consultancy services we have been provided by AAC exceeded our expectations and we are very happy with the results of the project on our center in terms of performance and quality. ”

    Dr. Mohammad Sarhan, General Manager, Bio Medical Clinics

    “We would like to recommend the consultancy services provided by AAC MENA/ Aswar Akka Consultancy.
    AAC helped us in developing quality & environmental management systems including related procedures, policies, and forms along with building our HR procedures, organizational structure and drafting the job descriptions for all job positions.
    We have received extremely great service in terms of quality and time and we highly recommend working with AAC as they offer your company the best consultancy service you can ask for.”

    Eng. Ahmad Shrouf, General Manager, Green Has Jordan

    “We have attended two PECB certified courses with AAC: Six Sigma Green Belt and Root Cause Analysis. The courses were very informative in terms of content and presentation. Our employees were enthusiastic about the topics discussed and have developed required skills after the training. We will certainly attend upcoming courses with AAC in the future.”

    Anas Diab,AES Jordan PSC

    “I can honestly say that you are one of the best PECB training providers in Jordan. High level of maturity, honesty and integrity. Highly recommended and best of luck! Thank you for your efforts, its highly appreciated really!”

    Haneen Adnan ,Nuqul Group

    “I would like to thank Noor Diab form Aswar Akka Consultancy for the PECB Certified ISO 9001:2015 Lead Implementer course I attended in Feb 2018. The training material, instructor and facility were excellent and exceed my expectations. I have been able to share what I’ve learnt with my team and back to the material when needed. In summary, I would highly recommend this course to those who are working in Quality Management System field and looking for organized, comprehensive and effective training.”

    Asma Al-Labadi,ETQ

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