ISO 13485:2003 Foundation Training Course

(1 Day)

Objective

The successful delegate will understand the ISO 13485:2003 requirements, its underlying philosophy and principles, and concepts.

The 1-day course opens with a discussion about Quality Management Systems. This is followed by discussions on:

Benefits to organizations using ISO 13485:2003
Quality Management Process Model
Quality Management Principles
ISO 13485:2003 components

Persons who should attend this course include:

Those responsible for managing their current Quality Management Systems
Individuals designing and implementing new Quality Management Systems, and
Persons who may be training others in the disciplines of the ISO 13485:2003

Overview

ISO 13485:2003 Standard represents the latest result of the medical devices industry’s adaptation of ISO 9001:2000 (2008).

This International Standard specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services.

It can also be used by internal and external parties, including Certification Bodies / Registrars, to assess the organization’s ability to meet customer and regulatory requirements.

In addition to the specifics of the individual Standard clauses, this 1-day course discusses the following issues … and more:

Continual Improvement
Root Cause Analysis
Risk Assessment
Quality Management Principles

This course examines these issues, identifies areas Quality Management Systems – Medical Devices must review to ensure conformance, and assists Quality Management Systems during their development.

This course contains two workshops designed to examine and explore the eight Quality Management Principles and the ISO 13485:2003 Standard.

Published course dates are subject to change or cancellation. Ashbrooke Quality Assurance Ltd. is not responsible for any expenses incurred prior to confirmation that the course is running. Student initiated date change or cancellation is permitted only with written notice received into Ashbrooke's offices not less than ten working days prior to course commencement.

Please note that course dates are subject to change without notice.

Our activities extend from Canada to Europe to Asia to Africa to Middle East.

Ashbrooke Quality Assurance Ltd. | British Columbia | Canada

ISO 13485:2003 Foundation Training Course Overview

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