It starts with the quality policy, the most high-level document in a QMS, continues with a quality manual, no longer mandatory with ISO 9001:2015, but still considered useful by most organizations to present a general description of the management system. For example, I recommend designing the quality manual based on the process mapping exercise of clause 4.4.1 b). Then come the procedures where we can describe what is done in the QMS, by whom, and when. When it is needed a more detailed description about how to do something in the QMS we use work instructions. At the base, we have forms that, once filled in, become records. We have also other records not generated by filling a form. For example, an e-mail sent by a customer with a complaint becomes a record.
Procedures and work instructions are not mandatory. Please check clause 4.4.2. Each organization can consider a list of topics when thinking about what procedures are needed or not. Consider that procedure may be useful or needed because of:
The 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 a 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
Requirement – if a law, or a standard, or a contract requires a procedure.
“Also, I liked that a SWOT analysis is carried out. Is a SWOT always carried out?"