The Missing Key
Clearing up misunderstandings about ISO 9001 conformance
by John E. "Jack" West
Past perceptions about conformity to ISO 9001 suggest an organization may have a good quality management system (QMS) that conforms to ISO 9001, but it can still produce junk. In fact, ISO 9001 contains many requirements that, taken together, should provide reasonable assurance that the output of the system—the organization’s products and services—will indeed meet customer requirements.
There is also the myth that the design and development clauses of ISO 9001 cannot be applied to highly innovative product developments because they are too restrictive. Yet, we continue to see product and service disasters in the marketplace that could readily have been prevented by judicious application of these same design and development requirements.
First, the scope of ISO 9001:2008 clearly states the intent of the document to meet customer requirements (see Table 1). ISO 9001, clause 5.3, also requires that the quality policy include commitments to meeting requirements and continual improvement of the QMS.
Clause 7 on product realization requires identification of customer requirements. Clause 7.3 requires that product designs be validated to ensure they will meet requirements for given applications, and it requires the product be verified to ensure those requirements are met. The overall requirements of clause 7.3 are summarized in Table 2.
Pinpointing the problems
What, then, is the issue? There are several:
Innovation and product definition. Some experts express the opinion that clause 7 does not adequately address situations in which the customer does not know he even needs the product, much less its detailed functional requirements. For example, many products available today were not even a gleam in the user’s eye a few years ago. It is argued that the formal design process of ISO 9001 is too narrow to include such innovative designs, so it is often ignored.
A careful reading of ISO 9001 reveals this concern is not valid. What can stuffy old ISO 9001 do to control such a situation? A lot, actually. Note the need to identify product requirements that are necessary but not stated by the customer. Also note that the product design must include as inputs the organization’s own requirements for the product, and that the product design must be verified and validated to ensure that the product meets specified requirements and will be suitable for a given application.
No product development should go forward in the absence of a robust process to define the design inputs and outputs, and to verify and validate product functionality.
Design review. After requirements are documented and a product development plan has been created, the actual work of developing a product can proceed. One activity of the process that is often ignored or treated in an extremely superficial manner is design review (subclause 7.3.4).
The purpose of this requirement is to ensure timely release of a new product that fully meets the needs of the customers. It also can contribute significantly to reduced cost. The intent of the standard is to involve all appropriate individuals as soon as it is feasible so they can understand and address life-cycle issues early in the process.
Design and development review is intended to address more than just the question of whether the product will meet specified requirements. An effective design review should address all the abilities associated with a new product—manufacturability, deliverability, testability, inspectability, capability, serviceability, repairability, availability and reliability—as well as issues related to inventory and production planning.
Design reviews are intended to identify issues, discuss possible resolutions and determine appropriate follow-up early enough to minimize cost and schedule impact.
Verification is simply a comparison of design output to input requirements to ensure the development project is on track. Often this step is just ignored but, if done properly, it determines objectively whether the requirements will be met by the ultimate product design. It is often an incremental process and, for complex innovative products and services, can require years of work. In fact, for entrepreneurial start-ups, this step develops confidence in the start-up company’s business case—its very reason for being.
When verification is complete, the organization should have high confidence its product will work as intended. Verification is not complete until you can answer the question: Will the product do what I claim it will do?
Validation is a confirmation the product will meet actual application needs. This is best conducted directly with users and may involve having them use product prototypes or development models.
For services, it may involve test sites where the service is piloted with actual clients. User feedback can be critical in making the best final product design decisions. When users provide negative feedback, you have a golden opportunity for designers to use their innovative talents to develop customer-friendly solutions.
It is especially important to rigorously address verification and validation for the design and development of innovative new products or extensions of existing product lines in which customer requirements are vague or nonexistent.
Customer dissatisfaction with newly released products can be harmful—even devastating—to a new product launch and can even negatively influence the marketing of unrelated products. Control of the design and development process (see Figure 1) can at least minimize the occurrence of widespread "infant mortality" (for example, new batteries in a new airplane).
Design validation is not complete until you can face your investors and tell them how the product will meet your potential customer’s needs for specific applications. Will the customer be willing to pay enough for the new product to cover all our front-end costs with a reasonable return on investment?
Process capability and capacity. There is a note in clause 7.1 of ISO 9001:2008 that says: "The organization may also apply the requirements given in 7.3 to the development of product realization processes."
Perhaps the most significant difficulty with ISO 9001:2008 is that this note does not make the use of the design process mandatory for production and service delivery processes. Often, this notion is completely ignored until the organization discovers it cannot produce enough conforming product to meet customer demand, or worse, cannot deliver in sufficient volume to achieve enough positive cash flow to survive.
Prototypes get tested and work as intended. Pilot runs are successful and delight test customers. But what happens when the demand for volume delivery hits the organization? In my experience, scale-up of a new product is often the Achilles’ heel of the organization. At the point when solid process capability and capacity are needed, it is too late to think about these subjects. They must be addressed during product design.
I have even seen situations in which high-tech products could be produced easily in low volume, but the entrepreneurs involved never realized that scale-up of their great idea was technologically impossible or required capital equipment expenditures that had been grossly underestimated.
An organization is not ready for product or service rollout until the product realization and delivery processes are capable of delivering conforming product at the needed volume. Note there are not two things here. There is only one: ability to deliver the required volume of product that meets customer needs.
Keep the product in mind
We need to stop perpetuating the myth that organizations can truly be in conformance with ISO 9001 and still produce product that does not meet customer requirements. Why does the myth persist? Because standards implementers and auditors tend to focus on conformance to the details of ISO 9001 and often lose sight of the basic requirements. Never lose sight of the product.
A claim that an organization conforms to ISO 9001 should mean the organization’s customers will consistently receive a product or service that meets its requirements. An organization that consistently produces nonconforming product and is unable or unwilling to take corrective action to eliminate the causes of these problems should not make claims of conformity to ISO 9001
We must ensure our systems deliver conforming product to our customers. The standard requires it, and the credibility of ISO 9001 certification demands it. It is the output of our QMS that matters to our customers.
Unfortunately, these messages have not adequately penetrated the world of the quality professional. There is considerable hope, especially for new small businesses. Venture capitalists and other investors are asking new entrepreneurs questions related to these subjects before committing to investments. Due diligence—and perhaps more importantly, common sense—demand it.
John E. "Jack" West is a member of Silver Fox Advisors in Houston. He is past chair of the U.S. Technical Advisory Group to the International Organization for Standardization Technical Committee 176 and lead delegate of the committee responsible for the ISO 9000 family of quality management system standards. He is an ASQ fellow and has co-authored several ASQ Quality Press books.