Documenting ISO 9001:2015  Quality Management  System

Course Content

• Introduction.
• Overview of management system standard
• Annex SL.
• Documentation requirements of ISO 9001 
• 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-conformances.
• Integrated management  with ISO 13485:2016

Overview /Outcomes

To become accredited to ISO 9001:2015  Quality management system  is essential to develop a comprehensive and effective documentation system. Organizations that already have a certified management system (e.g. ISO 9001) may wish to expand this to meet the requirements of additional standards (e.g. ISO 13485:2016).  

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.