ISO 9001 Defining the procedures

Unfortunately, I do not believe that there is a best way to precisely define what procedures should be implemented in organizations. Organizations are complex adaptive systems, even if we could define the best set of procedures at a moment in time, sooner or later that set would become obsolete due to the changes in the system and in the context.

We will always be guessing what the best set is. What I can give you is a list of topics that should be considered when thinking what procedures are needed or not. Consider that procedure may be useful or needed because of:

• Complexity of tasks – complex tasks are more prone to errors and mistakes;
• Staff rotation – if staff rotation is high, people have not much experience and a procedure that someone can use as guide in case of doubt is very useful;
• Staff training – if staff training is very poor;
• Performance – if performance results show a bad performance perhaps procedures can help people in their work;
• Complaints – a particular case of performance;
• Risk analysis - risk-based thinking is a great way of implementing prevention and control into a quality management. ISO 9001:2015 promotes the process approach and in this free webinar on demand - The Process Approach - What it is, why it is important, and how to do it - https://advisera.com/9001academy/webinar/iso-9001-process-approach-free-webinar-on-demand/ I show how to relate processes, risks, training, documentation and control
• Requirement – if a law, or a standard, or a contract requires a procedure.
   

You can find more information about documents and records below:

• List of mandatory documents required by ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-90012015/
• How to structure quality management system documentation - https://advisera.com/9001academy/knowledgebase/how-to-structure-quality-management-system-documentation/
• New approach to document and record control in ISO 9001:2015 - https://advisera.com/9001academy/blog/2015/06/30/new-approach-to-document-and-record-control-in-iso-90012015/
• Free online training ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
• Book - Managing ISO Documentation: A Plain English Guide - https://advisera.com/books/managing-iso-documentation-plain-english-guide/