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ISO 13485:2016 specifies requirements for a quality management system where organisations need to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Such organisations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device; and design and development or provision of associated activities (e.g. technical support).
ISO 13485:2016 can also be used by suppliers or external parties that provide a product, including quality management system-related services to such organisations.
This two days course is designed to develop you with in-depth knowledge and skills needed to audit, report and effective corrective action implementation of medical devices quality management systems. Upon completion of this course, you will able to plan and audit in accordance with ISO 13485:2016 including system and process approach. You will able to write non-conformance reports with reference to ISO 14971 (Risk management for medical devices).
Persons with some industrial, business and/or service sector experience
- Introduction to ISO 9001: 2015 & ISO 13485: 2016
- The relation between ISO 9001: 2015 and ISO 13485: 2016
- ISO 13485 requirements
- Cross-reference to ISO 14971: 2007 (Application of risk management to medical devices)
- Quality Management System Management Responsibility
- Resource Management
- Product Realisation
- Measurement, analysis and improvement
- Understanding ISO 13485:2016 auditing requirements
- Audit Process
- Preparation Phase
- Documentation Review
- Audit Checklist
- Performance Phase (Case Discussion)
- Non-Conformance Reporting
- Common Non-Conformances
- Reporting Phase
- Follow-up Phase
Certificate Obtained and Conferred by
Certificate of Competency from NTUC Learninghub
Note: Due date for all companies to transit to ISO 13485: 2016 is February 2019.
Medium of Instruction & Trainer
Trainer: Trainee Ratio 1: 20
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Prices are subject to other LHUB miscellaneous fees.