Documenting ISO13485:2016 Quality Management System

 Agenda

• Introduction.
• Overview of management system standard
• Documentation requirements of ISO 13485:2016
• Document control.
• The categories of documents applicable to a management system and their issue and approval.
• Methods of circulation control, change control and the setting up of master files.
• Drafting process maps, procedures and work instructions.
• How documentation systems are audited and some common non-conformanc

Over view /Outcomes

To become accredited to ISO 13485:2016 Quality management system  is essential to develop a comprehensive and effective documentation system. 

This one-day course will be of interest to companies who are at an early stage of developing a quality management system  and who wish to identify the documentation requirements and develop an action plan to get started.  This course aims to provide learners with an understanding of the documentation requirements of these standards and how these can apply to their organisation.