ISO 9001 has had no effect on quality in the in vitro medical diagnostics industry

Abstract

ISO 9001 certification (currently ISO 9000:2000) implies that an organization is managed in a quality manner. ISO certification is primarily achieved by audits that show that a company follows its own procedures. These procedures are prepared by the company with few ISO requirements. ISO procedures are flawed in two ways: they can represent only part of what an organization does within a process, and they often lack sufficient detail. The latter limitation allows both adequate and inadequate tasks. Often, people pay attention to ISO only when audits are imminent, which contrasts with other quality initiatives that have goals directly related to quality with frequent measurements and continual involvement by staff. There does not appear to be any connection between company successes or failures and ISO certification, and failing an ISO audit is a rare event. All of this leads one to conclude that ISO 9001 has had no effect on quality. In addition, there is a danger that “flexible” or so-called horizontal ISO standards that lack detail will supplant more traditional standards, which prescribe a procedure that has been agreed to by a consensus of experts. Improving ISO 9001 starts with recognizing its limitations. Recommendations regarding ISO certification include: dropping it, minimizing resource allocation to it, and trying to change it.