- context of the organization
- risk and opportunities management
- organizational knowledge
Quality procedures or SOPs can have different formats and structures. They can be narrative, i.e., described through text; they can be more structured by using tables; they can be more illustrative, i.e., flow charts; or they can be any combination of the above.
SOPs should include the following elements:
- Title – for identification of the procedure;
- Purpose – describing the rationale behind the procedure;
- Scope – to explain what aspects will be covered in the procedure, and which aspects will not be covered;
- Responsibilities and authorities of all people/functions included in any part the procedure;
- Records that result from the activities described in the procedure should be defined and listed;
- Document control – identification of changes, date of review, approval and version of the document should be included in accordance with the established practice for doc ument control;
- Description of activities – this is the main section of the procedure; it relates all the other elements of the procedure and describes what should be done, by whom and how, when and where. In some cases, “why” should be clarified as well. Additionally, the inputs and the outputs of the activities should be explained, including the needed resources.
Appendices may be included, if needed.