ISO 13485 is a Quality Management Standard for Medical Devices. It specifies requirements for a Quality Management System where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. While it is a stand-alone standard it is generally harmonized with ISO 9001.
Many medical device companies use this standard either because of its benefits or it gives them a competitive edge to market their products and services in certain regions. This practical and interactive two days course will provide you with all tools to perform an effective internal audit based on ISO 13485:2016 standard in your organization.
Duration: 02 Days
Who Should Attend?
- Quality control, production, supply chain & design Managers from Medical equipment industry
- Distributors of Medical devices
- Medical device quality professionals with knowledge of quality management systems and ISO 13485:2016
- Professionals interested in conducting first-party or second-party audits
Module 1 – ISO 13485:2003 Requirements
This topic will enable participants to understand the requirements of ISO 13485:2016, a standalone Quality Management Systems standard for Medical Device manufacturers, which has replaced the ISO 13485:2003, ISO 13485:1996, EN ISO 13485:2000 and the EN ISO 46001:1996 as a basis for regulatory assessments adopted by many countries worldwide. Changes and add-ons between ISO 9001:2015 and ISO 13485:2016 will be highlighted during the talk.
Module 2 – Auditing Techniques
This topic will provide knowledge to participants on the Auditing Techniques like
- Auditing Concepts
- Audit Planning
- Audit Execution
- Audit Reporting
This will be followed by a written examination
- Understand the application of Quality Management Principles in the context of ISO 13485:2016
- Understand the structure and scope of ISO 13485:2016 and its application in an organisation
- Understand the alignment and application of global regulatory requirements
- Strengthening of supplier control process
- Plan internal audit
- Equip internal auditors with confidence and ability to apply the audit assurance tools and techniques, methodology and desired behaviors that are relevant to the management system to conduct the audit.
The participant must have basic knowledge of ISO 9001 & ISO 13485 Standards.
Participants will be assessed through the course for punctuality, interactive approach, involvement in workshop in the course and finally through a written examination at the end of the course. Participants successfully completing the course will be presented with course completion certificate and others will receive attendance certificate.
TÜV SÜD South Asia’s certificate on “Internal Auditing based on ISO 13485:2016 standard” will be issued to participants only after successful completion based on performance during the course and in written examination.
Others who have not successfully completed the course will be issued a certificate of attendance