Certified Internal Auditor - ISO 13485 Medical Device - Quality Management System

Internal Auditor - ISO 13485:2016

• As an ISO 13485 Internal Auditor you will be able to help your organization optimize its processes to produce the safest and most reliable medical devices. You will have the power to make a positive change by minimizing chances of defects, failures and inconsistencies in the system; by enhancing the Medical Devices Quality Management System (MD-QMS) of your organization. By achieving conformity with the ISO 13485 standards, manufacturers can achieve increased business opportunities owing to their goodwill and credibility in the marketplace.
• In this course, you will learn how to launch and conduct an effective ISO 13485 audit, record & report findings and perform follow-up audits. As an internal auditor, you would need to ensure that the MD-QMS is maintained in the firm, to ensure continued compliance with the ISO 13485 standard.
• Empirical approach to coaching will include detailed training material, assignments, case studies and presentations to assist students in analysis and synthesis of body of knowledge and to develop required skills.
• On completion of training, appear for the exam and qualify for Credentials Global’s ISO 13485 Internal Auditor certificate.
• This course is open to professionals performing or supervising internal audits for ISO 13485.

Key outcomes:

• Gain understanding of the ISO 13485 standard for MD-QMS
• Understand how the ISO 13485 framework is associated with other international standards and regulations
• Fully recognize the responsibilities of an Internal Auditor
• Appreciate how a successful ISO 13485 audit can contribute to ensuring patient safety and satisfaction
• Prepare for and handle a ISO 13485 internal audit, report findings, draft audit report, take remedial action, conduct follow up audit
• Ensure compliance with the ISO 13485 framework

Course Chapters:

Chapter 1 Introduction to Course
Chapter 2 Introduction to Standard & Quality Related Concepts
Chapter 3 Terms & Definition
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 Definition of Auditing
Chapter 10 Guidelines for Auditing Management Systems

Certified Internal Auditor - ISO 13485 Medical Device - Quality Management System e training online

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.