2.2 Effective QMS Processes

The impact of ISO 9000 certification on performance is a popular topic for speculation. However, rigorous evidence of performance improvement and cost reduction has begun to appear in the literature ^[2].

The process to produce an effective QMS requires the following:

The analysis of the tandard's requirements—these are stated in terms of SHALLS;
The introduction of an interpretive scheme based on the author's experience and technical background;
The top management decision on the total effort to be expended to produce the QMS (i.e., the degree of responsiveness);
The integration of business strategy with strategic quality management goals;
The clear presentation of the strategic organizational policies documented in a quality manual (manual);
The aggressive implementation of the designed QMS;
The demonstration that the QMS is effective through the analysis of data that tracks QMS performance against quality objectives.

The integration of business objectives with quality and customer satisfaction metrics—as the most effective way to evaluate corporate performance—is exemplified by the work of Robert S. Kaplan and David P. Norton with their publication in 1992 of The Balanced Scorecard—Measures that Drive Performance. Since then, it has been estimated by Bain & Co. that about half of Fortune 1,000 companies in North America use the Balanced Scorecard in their strategic analysis. Most importantly, the authors offer data that indicates that the technique produces positive results ^[3].

Practical Considerations In practice, ISO 9000 systems exist somewhere between the two limits of either a fully responsive QMS based on clearly defined and stated organizational policies or a QMS based on policies formed from just a repetition of the Standard's phrases. In my experience, the primary reason that fully responsive QMS structures are hard to find is that the documentation teams are unaware that there is a systematic design approach upon which to base their efforts. Once the teams are made aware of such an approach, their ability to optimize the flow of information throughout the QMS significantly improves. The response time in resolving organizational issues decreases and the overall gain in productivity improves via an enhanced knowledge by every employee on just what the organization's objectives are ^[4].

As a result, our goal is to present a set of QMS design rules that we believe can produce a fully responsive QMS that is both in compliance with the Standard and an effective strategic declaration of the organization's business objectives.

We firmly believe that the intrinsic value of the Standard is its bottom-line focus on productivity and thus profitability—regardless of how the supplier wishes to state such objectives (e.g., lowered customer complaints, increased return on investment, lowered rejects, increased repeat purchase orders, and lowered product-return rates).

The Standard—through its inherent continuous/continual improvement paradigm, stress on customer satisfaction, heightened awareness of a lowered cost of quality, transparent business/quality objectives, and explicit calls for process/procedural analysis—offers the supplier a unique opportunity to improve its competitive advantage.

Specifically, the Standard has integrated the following eight quality management principles into its requirements ^[5]:

Customer focus;
Leadership;
Involvement of people;
Process approach;
System approach to management;
Continual improvement;
Factual approach to decision making;
Mutually beneficial supplier relationships.

As a result, only a fully responsive QMS will include the totality of the eight principles and offer the organization the maximum return against these principles. However, this potential for enhanced marketability, productivity, and profitability is dependent upon the supplier's desire to fully comply with the Standard, write the documented system in a user-friendly manner for a very wide range of readers, make a total management commitment to this effort, and establish a QMS that can be maintained in a cost effective manner.

The goal is to improve organizational effectiveness, not just get certified. Most importantly, a unified, strategic, business-and-quality policy signals to all employees that the main purpose of the ISO 9000 certification is to improve the effectiveness of the operation, not just achieve certification.

^[2]See, for example, Romano, P., "ISO 9000: What Is Its Impact on Performance?" QMJ, Vol. 7, No. 3, 2000, ASQ.

^[3]"On Balance," CFO, February 2001, p. 73; Lawton, Robin, "Balance Your Balanced Scorecard," Quality Progress, March 2002, p. 66, at http://www.ASQ.org.

^[4]Personal observation: One of the key questions that I ask during surveillance audits is in regard to what has been the most dramatic impact of the QMS on an organization. Invariably the answer has to do with greatly improved overall communication in regard to problem solving. The second highest frequency response is a growing knowledge of organizational progress against goals.

^[5]ISO 9000 Quality Management Principles at http://www.iso.ch/iso/en/iso9000-14000/iso9000/qmp.html.