Certified Lead Implementer - ISO 13485 Medical Device - Quality Management System

Lead Implementer - ISO 13485:2016

• A course intended to prepare professionals to successfully implement a QMS audit for Medical devices conforming to the ISO 13485 framework. By implementing the ISO 13485 standard, manufacturers and suppliers can improve their reliability rating in the marketplace. The certification verifies that the client organization conforms to the ISO 13485 standards; and the medical devices produced are superior, not just in quality but also in safety measures.
• 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 course completion, you can appear for the exam to qualify for Credentials Global’s ISO 13485 Lead Implementer certification.
• This course is open to professionals, technical specialists, MDQMS team members, managers and leaders that seek to spearhead the implementation of and ensure conformity to ISO 13485 standards.

Key Outcomes:

• Understand the correlation between international regulations, standards and ISO 13485
• Acquire the skills to interpret the ISO 13485 standard and apply it to specific business issues in an organization
• Grasp the strategy to organize, implement, sustain and refine QMS for medical devices with compliance to the ISO 13485 framework for an organization
• Build competence to guide and support organizations to implement best practices in line with the ISO 13485 framework
• Identify requirements for ensuring compliance with ISO 13485 standards
• Improve process efficiency from blueprint to delivery stage for medical devices
• Analyse findings from the audit and initiate reforms.

Course Chapters:

• Chapter 1 Introduction to Course
• Chapter 2 High Level Structure
• Chapter 3 Introduction to Standard & Related Terms and definition
• Chapter 4 Process Mapping.
• Chapter 5 Quality management system
• Chapter 6 Management responsibility
• Chapter 7 Resource management
• Chapter 8 Product Realization I
• Chapter 9 Product Realization II
• Chapter 10 Product Realization III
• Chapter 11 Product Realization IV
• Chapter 12 Competence and Awareness and Organizational Communication
• Chapter 13 Monitoring measurement and Data Analysis
• Chapter 14 Performance Evaluation
• Chapter 15 Improvement
• Chapter 16 Managing Management System Implementation Project
• Chapter 17 Consulting Skills for Management System Implementation

Certified Lead Implementer - ISO 13485 Medical Device - Quality Management System e training online

What is the course attendance criteria?

• A minimum attendance of 80 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 80 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, 40 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.