Course details
COURSE DETAILS
- Introduction and Background
- Key Differences to ISO 13485: 2003
- Module 1: Scope
- Module 2: Normative References
- Module 3: Terms and Definitions
- Module 4: Quality Management System
- Module 5: Management Responsibility
- Module 6: Resource Management
- Module 7: Product Realization
- Module 8: Measurement, Analysis, and Improvement
- Module 9: Key – Plant Senior Management “buy in”
- Module10: Drafting Quality Manual and Policy Procedures
- Module11: Process Maps
- Module12:Exclusions to scope
- Module13 CMDAS Linkage
- Module14: Linkage to Medical device Directives and In Vitro Medical device Directives
- Team Exercises on both days
WHO SHOULD ATTEND
This course is designed for Senior Management, Quality Managers, Quality Engineers, QA and Regulatory personnel working on QMS’s in industry.
Updated on 08 November, 2015Course Location
About First Polymer Training Skillnet
First Polymer Training (FPT) Skillnet operates as a training network for the Plastics Industry in Ireland and is funded under the government’s Skillnets initiative. The aim of FPT Skillnet is to deliver training that is focused on the specific needs of the plastics industry and includes certification and development.
Initiated by Plastics Ireland, FPT Skillnet’s objective is to provide technical training to polymer processors, both at our centre in Athlone and in-company as required. Our administrative and course centre is now located at 7 Centre Court, Blyry Business and Commercial Park, Athlone.
A full range of plastics processing equipment is available including Fanuc (100 tonne Electric), Krauss Maffei (100 tonne Hydraulic) and Demag (25 tonne Hydraulic) moulding machines. They are delighted to announce Arburg UK have replaced the ARBURG ALLROUNDER 320C 500 170 50 tonne machine with a new ARBURG ALLROUNDER 420C 1000 290 100 tonne golden Edition machine. This machine is equipped with the latest SELOGICA Direct touch screen control.
Having a full range of plastics processing equipment on site allows FPT to deliver intensive hands on training.
How can They meet your company’s needs?
First Polymer Training Skillnet organises a calendar of courses which are delivered at our centre in Athlone. These courses are advertised regularly. HoTheyver, if your company has specific needs They can design a course to meet those needs or modify an existing course to deliver in-company.
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