Output Matters
It's often said that an organization can have a good quality management system (QMS) that conforms to ISO 9001 and yet still produce "junk." This observation derives from the perfectly valid distinction between third-party registration of a QMS and product certification. Certifying a QMS is no absolute guarantee that the product produced by the certified organization will be in conformance with requirements. Nonetheless, ISO 9001 contains many requirements that, taken together, should provide reasonable assurance that a system's output will meet customer requirements.
ISO 9001 requires that an organization's quality policy include commitments to meeting requirements and continually improving its QMS. The standard requires that product designs be validated to ensure they will meet requirements for given applications. ISO 9001 also requires that a product be verified to ensure it meets requirements. Identifying and meeting customer requirements is a consistent theme throughout ISO 9001. For example, one of the expected outputs of a management review is a decision regarding product that doesn't meet customer requirements.
We need to stop perpetuating the myth that organizations can truly be in conformance with ISO 9001 and still produce product that doesn't meet customer requirements. ISO 9001-registered organizations and auditors alike tend to focus on conforming 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 to the organization's customers that it can consistently provide product that meets customer requirements.
We must make certain our systems deliver conforming product to our customers. The standard requires it, and the credibility of ISO 9001 registration demands it. It's the output of our QMS that matters to our customers.
Note: This article summarizes several important concepts related to ISO 9001:2000 that are explained in more detail in ISO 9001:2000 Explained, Second Edition by Charles A. Cianfrani, Joseph J. Tsiakals and John E. (Jack) West (ASQ Quality Press, 2001).
John E. (Jack) West is a consultant, business advisor and author with more than 30 years of experience in a wide variety of industries.
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