ISO Documentation

One example of documenting everything was a procedure for delivering the mail.  This was justified by saying it was needed when the receptionist was out.

Elaborate Quality Manuals were written. Many replicated the standard and were useless, non-value added. Some were long (90 pages) and most could not be used for a Stage 1 document review.

People in the organization blamed all this nonsense on ISO 9001. (“The standard makes us do that.” When questioned, these folks had not read the standard.). There was a note in the standard that was both illuminating and ignored (after all, it was just a note): This note gives a framework for the extent of documentation – The size of the organization and the type of its activities, processes, products, and services; – The complexity of the organization’s processes and their interaction; and, – The competence of the people in the organization. This framework is still of value!

Document and record control was also an easy nonconformance for auditors.  Somewhere there was an uncontrolled document. It could be a note on a machine, a record used with the wrong revision, or an outdated print.

Then came the 2000 revision. That specific revision threw a curve in document control. The standard called for only 6 required documented procedures.  Since all organizations had these, they were free to cut out what was unnecessary. The 2000 standard was also process-based and following the Plan-Do-Check-Act format. The silos were flipped on their sides. Now an organization had to identify in-puts, through-puts, and outputs. Many organizations asked their people to flow chart their processes and they discovered that this was more than adequate for documentation.  However, an in-depth examination of the process approach showed that many organizations (or, managers) did not really understand this approach.  Therefore, in 2008, an ISO 9001 standard was published, not as a revision but, as a clarification for 2000. Edition.