Any organization that follows this academic minutia is bound for failure. Why would I state that so definitively? As an auditor with over 30 years experience, I have witnessed the failures of ISO implementations countless times. First, the concept of ISO 9001 was specifically relative to managing suppliers. Most of its initial language coming from manuals used for both Briton and USA defense contractors. Second TC176 assumed PDSA (Deming) and PDCA (Toyota) to be one and the same, quite obviously they are not. Third TC176 defined "risk based thinking" devoid of the basic foundation of Risk (Variation + Severity). I can't count the organizations who get this bit wrong, because they leave out the Severity of Variation, thereby treating all variation as having equal severity. Finally, is the plethora of documents not required, but required. Monkeying around with the texts, the standard indicates TC176 only requires 6 documents .... however 4.42 and 7.5.1b interjects the old requirement (basically) that everything should be documented, a paradigm which supports academic only thinking. ....... So what will be the result of an Academic implementation of ISO 9001 by middle management? 1- The organizations Executives will not buy into the system 2- Most of the organizations managers will not learn the specific clauses (language) of the standard, and the relative intent. Leaving such understanding to internal subject mater experts (SMEs), who act like lawyers within the organization. These SMEs will make the standard appear complicated and vague, a cryptic anomaly, to which only they understand. 3- After decades, the initial documented system will become stale, as the organization changes, its documents will not be updated, and soon the documented system will not match current operations. This is a very common discovery by auditors such as myself. Its due in part to the extreme complexity with which organizations choose to document procedures and instructions, especially those departments who wish to ride herd over others. Many organizations I audit who have been registered for decades, have this inherent issue. 4- Management of change is perhaps the least understood as well as the least adhered to requirement of ISO 9001:2015. Most organizations will change, especially if business conditions warrant immediate change, and most will never document such changes. Organizational changes as reaction to the SARs-CoV-2 pandemic is a prime example. Most organizations changed relative to the challenges required by SARs-CoV-2, but few ever documented such changes or later revisions to such changes. ....... Therefore, as a result, the organization will be left with a documented management system and the actual operational system used on a daily basis, the two being very diverse.
The company I work for, hired an ISO consultant company just to be certified as an ISO company. Meanwhile nobody cares about implementing ISO, including top management.
