Is a Controlled QMS Possible?
 Last month’s column (“Achieve Control for Extraordinary Results”) was the first in a series about the control requirements of ISO 9001. This month we’ll look at the overall quality management system (QMS). The word “control” appears first in the standard’s introduction, under subclause 0.2, which says that one advantage of the process approach is the “ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction.” The next occurrence of the word is in subclause 4.1, which requires organizations to use the process approach, as seen in the figure below.
Controlling a process or system implies that an organization has developed mechanisms to regulate process or system performance. Control implies a certain sense of stability and ongoing good performance. Perhaps the ideal state of control is a stable system with continual improvement built in. This, I believe, is what the best ISO 9001 systems reflect.
Achieving and maintaining this state of control is a significant ongoing task. It involves several key steps, all of which are discussed in subclause 4.1. Some of the most important are:
• Identifying the QMS processes . You can’t control that which you don’t know, so clearly identifying the processes of the QMS is the basic step in achieving control.
• Determining the sequence and interactions among the QMS processes . When individual processes work together effectively in a controlled manner, the overall QMS can best help an organization meet customer requirements and other organizational objectives.
• Deciding the criteria and methods for controlling and operating processes . It takes a bit of work to determine how to establish a state of control for each process and the system as a whole. The effort pays off with improved performance as well as an identifiable baseline for continual improvement.
• Determining how to monitor and measure processes. In many organizations, measurement is a continual subject of debate. The important factor in these decisions is to keep the purposes of measurement in mind: We measure to control and improve performance.
• Acting on the information derived from the measurement data . Data about the processes must be analyzed to determine if a state of control is being maintained, to decide on what improvements are necessary, and to determine if planned results, such as improvements, are being realized.
• Providing the necessary resources to operate, control, and improve processes. Management is often reluctant to provide even minimal resources needed for process operations. In any event, the first step in getting needed resources is to establish a clear understanding of the processes and related resource needs.
• Specifying controls for outsourced processes. Controlling outsourced processes is required, but ISO 9001 doesn’t specify what controls are to be applied. Whatever controls are applied must be defined as part of the QMS. Often the purchasing controls outlined in subclause 7.4 can be used effectively in cases where processes are outsourced.
We should always ask the question: What effects will this new process, or process change, have on other processes, other parts of the organization, the suppliers, and our customers?
When all of the controls discussed in subclause 4.1 are carefully developed, an organization is well on its way to creating an outstanding QMS.
John E. (Jack) West is a consultant, business advisor, and author with more than 30 years of experience in a wide variety of industries. From 1997 through 2005 he was chair of the U.S. TAG to ISO/TC 176 and lead delegate for the United States to the International Organization for Standardization committee responsible for the ISO 9000 series of quality management standards. He remains active in TC 176 and is chair of the ASQ Standards Group.
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