ISO 13485 Documentation Training

The purpose of this training is to clarify the requirements of ISO 13485 Standard and share necessary information on how these requirements should be documented and recorded. Training will be done through example documents and records.

What is a document? What is a record?
Which subjects should be documented according to the standard?
Which subjects should be recorded according to the standard?
What is an update? What is a revision?
How to construct a procedure, instruction, protocol, form, plan, list?
What are the points that should be taken into consideration?
What are the points that you should take into consideration when you assort, hold and archive
constructed documents and records?
How should the documents be archived? For how long should you keep the documents?

Employees who work in quality, management, production, design and development departments
ISO 13485 Standard internal audit candidates

Each attendant will receive an “ISO 13485 Standard Certification Training Participation Certification”.