Foundation Course - ISO 13485 Medical Device - Quality Management System

Foundation Course ISO 13485:2016

• A course aimed at giving you an overview of the key concepts, frameworks and regulations related to MDD - Quality Management systems, compliant to ISO 13485.Understand how ISO 13485 can be applied to enhance organizational performance and achieve operational excellence. The ISO 13485 framework also assists organizations in enhancing quality standards for meeting customer requirements.
• This course is open to anyone that plays a role in any process, for enhancing the MD-QMS in any organization.

Key Outcomes:

• Concepts, methodologies and principles of ISO 13485
• Gain insight into the key elements and processes for implementing a MD-QMS in line with ISO 13485
• Recognize that ISO 13485 standards help manufacturers and suppliers eliminate risks of failure, defects, wastage, malfunction in their processes
• Understand the correlation between ISO 13485 and other international standards

Course Chapters:

Chapter 1 Introduction to Course
Chapter 2 Introduction to Standard & Quality Related Concepts
Chapter 3 Requirements of Standard I
Chapter 4 Requirements of Standard II
Chapter 5 Requirements of Standard III

Course Foundation - ISO 13485 Medical Device - Quality Management System e training online

What is the course attendance criteria?

• A minimum attendance of 16 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.

What is the certification policy?

• Student who qualify for certificate of successful completion may be awarded a Certificate.
• Certification of successful completion are endorsed with the Credentials Global logo and ACCAB’s “Responsible Education Provider”™ Logo

What is complaints and appeals policy?

• Student May raise any complaint in writing or orally, both during the course and afterward.
• Contact information: Info@credentialsglobal.com

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

• Yes, 8 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 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.