ISO 9001 demands effectiveness. For a defined management system to be ISO 9001 certified, it must be effectively implemented and it must effectively meet ISO 9001 requirements. Otherwise, conformity to the standard has effectively not been demonstrated. The problem: organizations failing to effectively demonstrate conformity to a basic ISO 9001 requirement nevertheless receive ISO 9001 certification.
This fundamental yet often over-looked requirement of ISO 9001 involves the process approach. The process approach is based upon Plan-Do-Check-Act (PDCA). Roughly, following this approach, management states its plan for processing, operations are conducted accordingly, performance is evaluated, and action is taken to improve processing as appropriate. Repeat.
Management’s stated plan for how to operate is captured in procedures describing management’s planned arrangements for processing (or, describing the organization’s processing requirements). A procedure tells us how management wants it to be done. Procedures resulting from a process approach describe how processes happen, how process work. Process-based procedures are designed to transparently convey how processes operate, from input to output, describing whatever controls are in place to assure proper processing, with the ultimate goal of assuring product or service quality.
On the other hand, a standard-based approach is focused upon conformity to ISO 9001 requirements. Standard-based management systems are structured according to, and largely defined by, ISO 9001. They are designed to respond to ISO 9001 requirements and focused upon ISO 9001 requirements to a fault. They are therefore easy to spot, consisting of manuals and procedures written to uniformly address the clauses or sub-clauses of ISO 9001, often written in terms of the standard itself.
DESIGNED TO FAIL
Here’s a closer look at the problem:
Procedures designed to respond to ISO 9001 requirements by design fail to describe how processes work. Since ISO 9001 requirements do not describe organizational processes, procedures written to address ISO 9001 requirements do not properly address processes. A set of standard-based procedures cannot effectively describe how any single process works, let alone how a system of processes works.
Following standard-based procedures, nothing happens. They do not effectively describe processes, and they are not followable as process documentation. Thus, they obscure processes and their definition in the name of conformity to ISO 9001 requirements, confusing personnel who are told to follow procedures.
In designing systems to respond to ISO 9001 requirements, organizations have procedurally ignored the most important processes of the organization: core processes—the ones which the organization could not perform its essential functions. These are the processes that should be proceduralized in honor of the plan phase of the PDCA cycle, instead of proceduralizing requirements to assert conformity to requirements.
To be certified, a management system first needs to work as defined. Processes must be carried out according to defined planned arrangements while producing acceptable results. Not until we know how a system works, in terms of inputs, outputs and organizational processing requirements, can we tell whether or not it meets ISO 9001 requirements. To effectively assess conformity to ISO 9001, auditors need to understand processes and systems, not merely ISO 9001 requirements.
A standard-based mind-set focuses upon conformity over effectiveness, and in so doing, accomplishes neither. The intent of the standard is defeated every time a standard-based system is certified to ISO 9001. Yet there appear to be more certified standard-based systems than there are certified process-based systems.
THIS. IS. A. BIG. DEAL.
Ironically, organizations have often adopted a poor approach to quality management in the name of “quick, easy” ISO 9001 certification and they are hurting themselves as a result. Some have been for decades. Yet ISO 9001 consultants and book authors still push self-serving, standard-based solutions. While they often meet with financial success, as do CBs accepting these standard-based solutions, organizations—the customers in these arrangements—are not receiving value from ISO 9001 professionals. Instead, they are left struggling with certified-yet-dysfunctional management systems, systems failing to meet the requirements of the standard in the first place.
Standard-based solutions appear to benefit only those ISO 9001 professionals who promote them. A standard-based approach isn’t acceptable by the standard and it isn’t good for quality. Neither is it good for organizations, or, in the long run, for ISO 9001 or the quality business. Where is the customer focus of ISO 9001 consultants who promote standard-based solutions, and that of CB auditors who accept these solutions?
Regardless, CB auditors often still tell organizations using a standard-based approach that they are doing a good job, issuing certificates as proof, thereby validating the standard-based approach and those who promote it. That is why ISO 9001 is failing. Organizations rely on highly paid CB auditors to assess effectiveness and conformity and to identify opportunities for improvement, but auditors often effectively do none of these. Instead, they often seem to thoroughly scrutinize what in reality is clearly a dysfunctional system, only to assert that it complies with ISO 9001.
Contrary to apparent popular belief, CB auditors are not supposed to certify standard-based systems. When they stop certifying standard-based systems, consultants and book authors selling standard-based solutions will need to improve or withdraw from the business. Our quality revolution can then commence based upon a solid foundation for improvement, finally eliminating this bad approach to quality management.
Quality professionals concerned with professionalism or posterity should reject the standard-based approach while promoting the process approach instead. Customer-focused quality professionals should have been doing so for decades. Those who haven’t until now shouldn’t wait until the 2015 standard undeniably requires it. The process approach is simply the right thing to do for quality and for business. It’s already long overdue.
Bio:
T. D. (“Dan”) Nelson is a quality management consultant, author, and trainer
specializing in the process approach, ISO 9001, and related sector schemes.
Dan has roughly 20 years of experience with ISO 9000 and over 15 years’
experience with the process approach. Dan holds an MA in Business
Administration from the University of Iowa. Dan can be reached at:
dan@tdnelson.com
319.210.2642