ISO 13485 Quality Management for Medical Devices
The model standard for the medical industry.
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ISO 13485 is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry. These are mainly referring to product safety, detailed documentation and burden of proof as well as the development of risk management.
ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services.
ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services.
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- Home
-
Our Services
- On-Site Training
- Off-Site Training
- Coaching
- Audit Support
-
Consultation Services
>
- Energy Management >
-
Management Systems
>
- ISO 50001 Energy Management System
- ISO 9001 Quality Management System
- ISO 14001 Environmental Management System
- ISO 45001 Occupational Health and Safety Management System
- IATF 16949 International Automotive Task Force
- ISO/IEC 17025 Testing and Calibration Laboratories
- ISO 13485 Quality Management for Medical Devices
- AS 9100 Quality Management System for Aerospace Industry
- ISO 20000 IT Service Management
- ISO 22301 Business Continuity Management
- ISO 31000 Risk Management
- ISO 37001 Anti-Bribery Management System
- ISO 55000 Asset Management
- TL 9000 The Telecom Quality Management System
- Food Safety Management System
- Integrated Management System (IMS)
- The Malaysian Standard for Sustainable Palm Oil Production (MSPO) >
- Business Continuity Management >
- Halal Certification >
- Safety and Health Officer Support
-
Training Courses
-
Soft Skills
>
- Leadership & Supervision Skills
- Motivation & Teambuilding
- Communication & Interpersonal Skills
- Presentation & Public Speaking Skills
- Clerical & Administrative Skills
- Customer Relationship Management Skills
- Negotiation Skills
- Sales & Marketing
- Creative Thinking & Problem Solving
- Human Resource
- Microsoft Office
- Business Management >
-
Manufacturing Operations
>
- ISO 50001 Energy Management System / Energy System
- ISO 9001 Quality Management System
- ISO 14001 Environmental Management System
- ISO 45001 Occupational Health and Safety Management System
- IATF 16949:2016 International Automotive Task Force
- ISO/IEC 17025 Testing and Calibration Laboratories
- ISO 13485 Quality Management System for Medical Devices
- AS 9100 Quality Management System for Aerospace Industry
- ISO 22000 IT Service Management
- ISO 22301 Business Continuity Management
- ISO 31000 Risk Management
- ISO 37001 Anti-Bribery Management System
- ISO 55000 Asset Management
- Food Safety Management System
- TL 9000 Telecom Quality Management System
- Integrated Management System
- Health & Safety >
- Malaysian Standard for Sustainable Palm Oil Production (MSPO)
-
Soft Skills
>
- Events
- External Info
- Contact Us