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CMDCAS - Training
Thank you for providing an excellent course and thought provoking discussions on the Canadian Medical Devices Regulations. It was one of the most enjoyable training sessions I’ve attended in years.

Beverly G. Whitaker
Indigo Consulting Group, LLC
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implementing a quality, an environmental and/or a health and safety management system, for organizations in all sectors;

auditor training, quality, laboratory, environment and health and safety, both internal and external;

process control and performance improvements.


 Complementary services
Consulting services
Tailoring services

 CYBERCOURSES - All times shown are Montreal, Canada times
AS9100: Transition Revision B to C
Key changes and their impact
Attention:
What are cybercourses?
Discovering ISO 9001:2008
An introduction to the ISO 9000 series of standards
Course updated in 2011
Introduction and overview of the Canadian Medical Devices Regulations
For manufacturers, importers and distributors of Medical Devices sold in Canada
The Process Approach
that forms the basis for the international management system standards
The Process identity card
A tool that is useful to define a process and to improve its management

 Awareness and information
ISO 9001:2000
Top management awareness
Quality management system
Understanding ISO 9001:2008

 Management systems
Environmental management system
For a successful implementation
ISO 14001:2004
Quality management system
To understand and know how to use
ISO 9001:2008

 Auditing the management system
Internal auditors – All Quality management systems
Advanced training – Internal auditors
Using the process approach
ISO 14001:2004 and OHSAS 18001:2007
EMS and OH&SMS internal auditor training
ISO 9001 and other QMS standards
External Auditor Training
Training for auditing suppliers’ QMS
ISO/IEC 17025:2005
Internal auditing course
For laboratories
Internal auditors - ISO 9001:2008
Internal auditing of processes
Adding value with the PDCA approach
Internal auditors - any QMS
On-the-job internal auditing of processes
Adding value with the PDCA approach
ISO 9001:2008
QMS lead auditor training course 
 

 Aviation, Space and Defense
Internal auditors – AS9100C
Advanced training – Internal auditors
Using the process approach
Process Failure Mode and Effects Analysis
[PFMEA]

 Medical devices
CMDCAS - Training
Recognized by Health Canada's Medical Devices Bureau
Presented in Frankfurt, Germany
CMDCAS - Training
Recognized by Health Canada's Medical Devices Bureau
For Manufacturers
The CMDR & ISO 13485:2003
Meeting the Canadian requirements
 

 Laboratories
ISO/IEC 17025:2005
Internal auditing course
For laboratories
Overview of
ISO/IEC 17025:2005
For scientific and technical personnel (forensic labs)
For a successful implementation
ISO/IEC 17025:2005
Overview of
ISO/IEC 17025:2005
For scientific and technical personnel
ISO/IEC 17025:2005
Technical assessor course
 

 Automotive industry
Advanced Product Quality Planning
[APQP]
Overview of the
Core tools - Automotive Industry
APQP, FMEA, SPC, MSA, PPAP
Failure Mode and Effects Analysis
[FMEA]
ISO/TS 16949:2009
For a successful implementation
Production Part Approval Process
[PPAP]
 

 Tools for continuous improvement
Process Approach
Improvement of work processes
Process approach
Mapping and documenting processes
Management system
Process Approach
Statiscal control of work processes
 

 Specialties
Introduction to
Sterilization processes
Medical devices
 

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