Full program description
ISO 13485: 2016 Internal Auditor Training
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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.
Who Should Attend
- Appointed lead auditors/auditors and any personnel who wish to gain an in-depth understanding of internal auditing
- Personnel who are appointed as representatives in the ISO 13485 committee and wish to understand how auditors approach an audit are also encouraged to attend
- This training is designed for personnel from organisations which are implementing or certified to ISO 13485
- 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
Certification 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.
Persons with some industrial, business and/or service sector experience
Medium of Instruction & Trainer
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Prices are subject to other LHUB miscellaneous fees.