Certified Lead Auditor Conversion/Transition Course ISO 13485:2016

Lead Auditor Conversion/Transition Course - ISO 13485: 2016:

• Credential Global’s Lead Auditor Transition/Conversion Training and Certification is intended to train experienced Lead Auditors with the knowledge needed to assess and report on the conformance and effective implementation of the Medical Devices Quality Management System Standard.
• Receive state of the art training & qualify for Credentials Global’s ISO 13485:2016 Lead Auditor Certification. By achieving a Credentials Global Lead Auditor Transition /Conversion Certificate, you will be able to demonstrate that you have the practical knowledge and professional capabilities to conduct First, Second and Third Party Medical Devices Quality Management Systems audits.
• On course completion, appear for the exam and qualify for Credentials Global’s ISO 13485:2016 Lead Auditor Certification.
• This course is open to professionals that seek to spearhead audits conforming to the ISO 13485:2016 standard, in self/customer/client organizations.

Key outcomes:

• Awareness of the intent and value of an ISO 13845:2016 audit
• Understand how the ISO 13485:2016 standard relates to other standards and global regulations
• Apply the concepts of the ISO 13485:2016 framework to the context of an audit, organization, industry
• Understand theoretical concepts as well as best practices relevant to a QMS audit for medical devices
• Develop competency to manage an ISO 13485:2016 audit from start to finish.

Course Chapters:

• Chapter 1 Introduction to Course
• Chapter 2 Introduction to Standard & Quality Related Concepts
• Chapter 3 Terms & Definitions
• Chapter 4 Process Mapping
• Chapter 5 High Level Structure
• Chapter 6 Requirements of Standard Part I
• Chapter 7 Requirements of Standard Part II
• Chapter 8 Requirements of Standard Part III
• Chapter 9 Understanding the terms and Definitions of Auditing
• Chapter 10 Guidelines for Auditing Management System.

What is the course attendance criteria?

• A minimum attendance of 32 hrs on Learning Management System (LMS) activity for the duration of course is required.
• However, we encourage students to log in maximum number of hrs within a given course duration to take maximum benefit of learning material.

How assignments will be evaluated/graded?

• Assignments will not be graded.
• Assignments will consist of Descriptive Type Questions and Case Studies.

What is the nature of qualifying examination?

• Qualifying examination consist of Multiple Choice Questions.

What is the examination eligibility criteria?

• An open book test can be scheduled once student completes minimum 32 hrs on LMS and completes all given Assignments.

How assignments will be evaluated/graded?

• Assignments will not be graded.
• Assignments will consist of Multiple Choice Questions, True or False, Match the Pairs, Descriptive Types and Case Studies.
• Only Multiple Choice Questions- Auto Diagnostics Feedback is given.

How examination results are presented?

• The designations P (Pass) and NP (Not Pass) are used. No grades are reported.

What are the examination pass norm?

• It is expected that at least 80% of students attending this course should pass at first attempt.

What are the documents permitted during the open book examination?

• Course material
• Copy of ISO 13485 standard
• Copy of ISO 19011 standard

What is the certification policy?

• Certification will be given to student who completes all assignments satisfactorily and clears the examination with the designation P.
• Certification of successful completion are endorsed with the Credentials Global logo and ACCAB’s “Responsible Education Provider”™ Logo
• Student who does not qualify for certificate of successful completion may be awarded a letter of attendance.

What is the re-examination policy?

• A student who gets a letter of attendance after the initial course may apply to be allowed to sit for a re-examination within 1 month from the issuing of the results. A candidate who fails re-examination is required to take the course again paying full fees.

What is complaints and appeals policy?

• Student May raise any complaint in writing or orally, both during the course and afterward. Student is also given the opportunity to raise any issues of the concern during the formal evaluation at the end of the course.
• Contact information: Info@credentialsglobal.com

Do I receive Professional Development Units (PDUs) for the course?

• Yes, 16 PDUs

Is this course accredited?

The Credentials Global education provider accredited with the Accreditation Commission of Conformity Assessment Bodies (ACCAB) www.accab.org

ACCAB’s Responsible Education Provider Accreditation is a voluntary quality assurance scheme for independent private sector Further Education & Training Institutions(FETIs) including Independent Higher Education Providers, Distance Learning Institutions, Professional Short Course Providers and Specialty Tutorial Schools & Colleges.

The objectives of ACCAB’s “Responsible Education Provider” ™ Accreditation Scheme are:

• FETIs have appropriate management systems in place and control over their processes;
• Personnel that are employed by FETIs have required competencies to perform their duties;
• FETIs follow rigorous and consistent processes to educate, train and evaluate students;
• To enable FETIs to state publicly that they have voluntary accepted ACCAB’s “Responsible Education Provider” ™ Accreditation Scheme for maintenance and continual improvement of their services delivery