ISO 13485:2016 Design, Development & Production, Service Provision

Description

ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. ISO 13485 supports medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistency in design, development, production, installation, and delivery of medical devices that are safe for their intended purpose. One of the main clauses in ISO 13485 is Product Realisation that includes design & development and production & service provision.

This is an enhanced course module that takes a step-by-step approach to understanding Design and Development of ISO 13485 based on the type of medical device and nature of work process. It will cover specific contents in design and development such as stages, review, verification, validation and design transfer activities. Besides that, it will look through in a case study manner, specific process related to identification, traceability, sterilisation monitoring and measuring devices used. This training is also important for client’s that do not carry out any Design and Development in the work environment but engages a consultant to understand further the requirements of ISO 13485.

Objectives

The programme aims to provide delegates with learning how to:

• Describe the core requirements of ISO 13485:2016 related to design & development and production & service provision under clause 7.

• Perform gap analysis on the relevant work process based on ISO 13485:2016.

• Relate and harmonise delegate’s in-house work process to the relevant requirements of ISO 13485:2016.

• Conduct and perform on specific key processes such sterilization, identification, traceability and others in an accurate manner as required by ISO 13485:2016.

Audience

Management, ISO committee and other members involved in certification

Prior ISO 13485:2016 Requirements knowledge is recommended for this course.