• Provide an overview of the stages for developing, implementing and maintaining an ISO 13485-compliant QMS for medical devices

• Make delegates aware of how they can help their organisation review its existing processes and systems, and plan how to implement the standard

• The issues, challenges, and benefits associated with the process approach to managing the QMS..

 

The course provides an overview of ISO 13485 standard, and touches on ISO 14971 and ISO 15189 designed to support customers within the Medical Devices Industry in relation to quality and risk management for medical laboratories.

 

Who Should Attend

 

• Members of QMS teams

• Those involved in QMS implementation, operation, and maintenance

• Auditors, whose role calls for them to audit QM systems for medical devices.

• Senior executives and business unit managers involved in, and/ or affected by, the

      outcome of QMS audits

• Those considering QMS certification to the ISO 13485 standard.

 

Learning Objectives

 

On completion of this course, delegates will be able to:

• Articulate the terminology related with the standard

• Articulate concepts, such as “the process approach” and “the PDCA cycle”

• Apply the process approach to managing the company’s quality system for medical devices, its control and effectiveness.

• Interpret the basic requirements of ISO 13485 as it relates to QMS in the context of medical devices.

• Compare ISO 13485 with ISO 9001 and the FDA’s QSR requirements, with the view of adopting and implementing the standard.

• Identify the importance of Design Control, Corrective and Preventative Action (CAPA) and Production and Process Control (P&PC) and how these can add value to the business and its customers.

• Interpret how the requirements of the standard apply in practice.

• Understand the relationship between the QMS and compliance with specified requirements

• Understand how ISO 14385 is linked with other ISO standards, such as the 9001, 14971, and 151899

• Contribute in the development, implementation, and certification, (or re-certification) of a QMS for medical devices.

• Appreciate the technical challenges likely to be encountered in implementing the above QMS.

 

Course Agenda and Content

 

Key topics include:

• Introduction to ISO 13485 and overview of its requirements

• Comparison of the requirements of ISO13485 with the corresponding requirements of FDA’S

      QSR and ISO 9001

• Introduction to the Guide ISO/ TR14969

• Risk management requirements and ISO 14791

• The implications of ISO 13485 for the Medical Device Industry in maintaining registration and

       market approval.

• How ISO13485 is the equivalent to QSR

• Analysis of a process-based management system and the impact this may have on a company’s procedural based system.

• The approach of Regulators.

 

Prerequisites

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The following are general prerequisites for attending our training courses:

• Proficiency in the English language

• Consideration for other course participants

• Willingness to actively participate during the training sessions, and an open mind to learn new ways of working.

 

Basic understanding related to the medical devices industry is recommended.

 

Training Approach

 

The course covers both theory and practice:

• Slide-based training sessions, illustrated with examples

• Business cases

• Preparation for the Foundation exam

• Practice test (mock exam) similar to the certification exam.

 

Examination

 

• Duration: 45 min.

• Format: closed book, 30 multiple-choice questions

• Pass mark: 70% (21 correct answers)

 

Competence Domains Being Tested

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• Fundamental principles and concepts of Quality Management as it relates to the medical devices industry

• ISO 13485 requirements for Quality Management Systems (QMS)

 

Certification

 

The ISO 13485 Foundation certificate will be issued to delegates passing the exam.

 

General Course Information

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For general course information please click on the link here.

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N.B. Please read our Terms & Conditions (T&Cs) and ask for clarifications, if any, before booking your training event.

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