ISO 9001: 2000 Quality Management System Design

3.1 Continuous/Continual Improvement Is Inherent

We have established that the QMS should be a blend of business strategy and quality management (an integrated QMS)—in full conformance with the Standard. This section creates the implementation framework for our approach.

3.1.1 Continuous Versus Continual Improvement Concept

First it is necessary to understand the equivalency between continuous and continual improvement so that we can readily use the terms interchangeably.

The normative definition in ISO 9000:2000 for continual improvement states that it is a recurring activity to increase the ability to fulfill requirements (3.1.2) ^[1]. The definition notes that the process (3.4.1) of establishing objectives and finding opportunities for improvement is a continual process through the use of audit findings (3.9.5) and audit conclusions (3.9.6), analysis of data, management reviews (3.8.7), or other means and generally leads to corrective action (3.6.5) or preventive action (3.6.4). This is basically the plan-do-study-act scenario that was originally described in a less explicit manner by the American physicist Walter A. Shewhart in 1931 ^[2].

The equivalency of the two ideas can be readily shown by comparing this activity to a typical continuous improvement scenario used in TQM programs (see Table 3.1) ^[3].

3.1.2 Quality As a Philosophy ^[4].

As a result, the Shewhart cycle can be used as the basic tool for continuous/continual improvement and as the foundation for QMS implementation. However, before we can logically define a method for QMS implementation, we must first define what we mean by a QMS, and, in particular, what we mean by quality. A quality system must be designed to be measurable. In fact, the cost of poor quality can be staggering ^[5].

3.1.3 Quality As a Scientific Measurement

The ISO 9000:2000 vocabulary specifies quality in operational terms. (Alert: the definitions are normative—they are part of the Standard, not just a guideline). The definition begins with the word degree ^[6].

Degree in the definition implies a scale associated with quality. Quality is not absolute but relative to what is acceptable from the receiver's (customer's) standpoint. We also learn from the definition that quality is based upon not only what the customer needs but also what the customer expects. This is what makes the fulfillment of quality so difficult—few of us really fully know what we need. Until we receive the result of the contract, we do not really know what our expectations are, even when there is a specification. Just try meeting someone's expectations in regard to paint and you will find that gloss and aesthetics are one big headache.

As a result, I consider quality an iterative process that depends upon specific measurements but that is always open to improvement. This is the important role of validation (i.e., a test program that includes the customer's participation whenever possible).

Thus, when we begin the quality process we mean that high quality is defined as our ability to meet customer requirements that have been specified quantitatively. For a service organization, it might mean 7-day, 24-hour ready availability or an effective triage to provide health management. For a manufacturing organization, it might mean on-time delivery, or user-friendly instrumentation. All of the requirements must be measurable and addressable in terms of metrics. Otherwise, you have an open-ended relationship, and nobody knows when the job is done and when it is time to get paid—a common problem in contracting for either a new sun deck for your house or a QMS ^[7]. Whatever the metrics are, they must be subject to analysis and continual improvement. Such metrics form the basis for enterprisewide quality objectives ^[8].

3.1.4 Continual Improvement Is Intrinsic Within the Standard

The ability to define a continually improving (C/I) QMS is inherent in the Standard, and the Standard's process orientation provides a method to drive the QMS at whatever rate makes sense for the organization.

3.1.5 Customer-Driven Orientation

The customer orientation of the Standard was introduced when we stated the eight quality management principles, the first of which is customer focus (where customer refers to interactions between both internal and external parties). For example, the requirements for a customer-driven program are fortified in a number of the Standard's clauses, including 5.1 Management commitment, 5.6.2 Review input, 5.6.3 Review output, and 6.1 Provision of resources. The essence of these clauses deal with communication in regard to meeting customer requirements, customer feedback, and the enhancement of customer satisfaction.

In this manner, we can demonstrate that the Standard provides us with the platform for a unified QMS because the Standard's orientation is thematically aimed at an effective customer relationship.

Next, we need to demonstrate how the continuous improvement cycle—desired by both ourselves and the customer—is intrinsic within the Standard.

3.1.6 Shewhart Cycle

We can demonstrate the inherent continuous/continual improvement properties of the Standard if we indicate the relationship between the five operational sections and their corresponding paragraphs of the Standard and the Shewhart cycle of plan-do-check-act as indicated in Figure 3.1.

Figure 3.1: ISO 9001—2000 continuous/ continual improvement cycle by paragraph.

In this diagram, we have placed each of the operational paragraphs in a related category of the Shewhart cycle ^[9]. The exact placement of the elements is subject to conjecture, but what is important here is that there is an approximate 1:1 correspondence with the paradigm ^[10].

Plan. The following Standard paragraphs provide the framework in which top management places its unified quality/business plans, marketing, and sales promotions and strategies, establishes performance metrics, and records progress against goals to measure the effectiveness of the QMS:

• 5.3 Quality policy;

• 5.4.2 Quality management system planning;

• 7.1 Planning of product realization;

• 7.3.1 Design and development planning;

• 7.5.1 Control of production and service provision;

• 8.1 General (measurement, analysis, and improvement).

Do. The following Standard paragraphs establish the implementation protocols within which we design, manufacture, and service products:

• 4.1 General requirements;

• 4.2.1 General (documentation requirements);

• 4.2.2 Quality manual;

• 4.2.3 Control of documents;

• 4.2.4 Control of records;

• 5.1 Management commitment;

• 5.2 Customer focus;

• 5.4.1 Quality objectives;

• 5.5.1 Responsibility and authority;

• 5.5.2 Management representative;

• 5.5.3 Internal communication;

• 6.1 Provision of resources;

• 6.2 Human resources;

• 6.3 Infrastructure;

• 6.4 Work environment;

• 7.2.1 Determination of requirements related to the product;

• 7.2.2 Review of requirements related to the product;

• 7.2.3 Customer communication;

• 7.3.2 Design and development inputs;

• 7.3.3 Design and development outputs;

• 7.4 Purchasing;

• 7.5.3 Identification and traceability;

• 7.5.4 Customer property;

• 7.5.5 Preservation of product;

• 7.6 Control of monitoring and measuring devices;

• 8.2.4 Monitoring and measurement of product;

• 8.5.1 Continual improvement.

Check. The following Standard paragraphs provide the mechanisms whereby we monitor our progress against quality goals so that the entire QMS can be analyzed and corrected to achieve continual improvement:

• 5.6 Management review;

• 7.3.5 Design and development verification;

• 7.3.6 Design and development validation;

• 7.5.2 Validation of processes for production and service provision;

• 8.2.1 Customer satisfaction;

• 8.2.2 Internal audit;

• 8.4 Analysis of data.

Act. The following Standard paragraphs establish the methods required to correct those areas that are out of conformance and to establish long-term preventive action programs:

• 7.3.4 Design and development review;

• 7.3.7 Control of design and development changes;

• 8.2.3 Monitoring and measurement of processes;

• 8.3 Control of nonconforming product;

• 8.5.2 Corrective action (w/response to customer complaints);

• 8.5.3 Preventive action.

There is operational power when all clauses are implemented. Thus, when all paragraphs of the Standard are implemented, the paradigm ensures that the system will be documented; that those documents will be used by the employees; and that there will be adequate measurements made to judge whether or not we have demonstrated effective performance against our business/quality objectives.

^[1]Guidance on the terminology used in ISO 9000:2000: http://www.iso.ch/iso/en/iso9000-14000/iso9000/2000rev8.html.

^[2]The role of the Shewhart Control Chart and the development of the continuous improvement cycle is introduced in both Juran, J. M., Juran on Quality by Design, The Free Press, 1992, and Deming, W. Edwards, Out of the Crisis, Cambridge, MA: MIT Press, 1986. Dr. Deming is very clear on the fact that the Deming cycle is based on the original Shewhart cycle.

^[3]Based on the work of Dr. Anthony F. Costonis, president and founder of Corporate Development Services, Inc., of Lynnfield, MA, at http://www.Corpdevelopment.com.

^[4]See, for example, Hoyer, R.W., and Brooke B. Y. Hoyer, "What is Quality?" Quality Progress, at http://www.asq.org, July 2001, p. 53.

^[5]Joann Muller summarizes the cost of poor quality for Ford in Business Week, June 25, 2001, p. 80. Ms. Muller notes that "Quality problems and related production delays cost the company more than $1 billion in lost profits last year alone." The Firestone tire fiasco "cost Ford about $500 million."

^[6]ISO 9000:2000: Clause 3.1.1 Quality.

^[7]Whenever I do a certification audit, I do not ask what the quality policy is. This would require rote memorization. Instead, I ask what quality means to the employee. The answers are enlightening (e.g., "Looks perfect, nice shape, good condition," "Do it right the first time," "Product that is workable," "The way it is supposed to be," "Get a repeat order," "Make the customer happy," "Something I would buy myself," and "Meet customer specs").

^[8]The pervasiveness of measurement in the Standard has, rightfully, become a popular publication topic. See, for example: Olivier, Daniel P., and Paschal Dwane, "Using Measurement to Improve Quality," Medical Device and Diagnostic Industry, October 2001, p. 84, at http://devicelink.com/mddi.

^[9]The integration of the Shewhart cycle by the ISO/TC 176 committee is discussed in, "Guidance on the Process Approach to Quality Management Systems," ISO/TC 176/SC 2/N544, December 2000, at http://www.iso.ch/9000e/2000rev_9e.htm.

^[10]For a lucid discussion of the various applications of the Shewhart cycle refer to "What Deming Told the Japanese in 1950," QMJ, Fall 94, p. 9.