Ashbrooke QA Ltd.
78038 - 3295 Coast Meridian
Port Coquitlam, B.C.
Canada V3B 7H5
Phone 604 - 552 - 0496
Fax 604 - 552 - 0497
Email ashbrooke@ashbrooke.com
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:
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Continual Improvement
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Root Cause Analysis
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Risk Assessment
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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.
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This page was last updated: May 23, 2010