Costs for Achieving ISO Certification Process

June 16, 2012 by  Filed under: Branding 

The International Standards Organization (ISO) develops standards that can be applied to the conduct of corporate business. These standards are developed by Technical Committees serving under the ISO’s governance. Once voted upon, and approved by enough countries in the international community, companies may request an audit of their firms in order to establish if they are compliant to the standard. Understanding some of the history behind the ISO Standards applicable to medical device firms will also be helpful in appreciating the need for this study. This research study will evaluate the perceived benefits of ISO Certification for small to medium sized, privately held, for profit, United States based medical device firms.

The past decade has brought about a dramatic increase in the number of ISO certified corporations. This trend seems to have started in Europe and has been slowly spreading to the United States.

A study completed by Guler, Guillen, and Macpherson (2002) indicates that between 1993 and 1998 the number of ISO 9000 increased from 46,511 to 271,847 in the thirty-four countries researched. For this same period, in the United States, they concluded that the growth rate was even more dramatic, with an increase from 2,059 to nearly 25,000 Certification. Initially, very large global corporations in the United States began to seek ISO certification; however, just prior to the start of the twenty first century, a movement began in earnest among small and medium sized firms to gain ISO Certification, as well. This process has continued to gain momentum over the course of the first few years of this century.

Few are the companies that will spend funds that are not essential to the business or its future; therefore, there must be some significant benefits perceived by firms going through the ISO certification process. In order to understand this issue, one needs to first recognize that a company encounters a substantial cost to go through the ISO Certification process. A recent study found that costs for achieving ISO certification average $187,000 in 1996 with the costs for small firms decreasing to $50,000.

Normally, small and medium sized privately held firms are even more sensitive to these costs and would not undertake this type of project without believing it was a key factor for the success of their businesses. One of the significant initial results was that 80% of all firms surveyed were either already ISO registered or planning to be. Therefore, if these firms are beginning to embrace ISO, there must be some perceived benefits. What are these benefits? This research study will explore this topic and reveal more facts in order to ascertain if this trend will continue.

OSS Certification is a leading firm who provide ISO 9001 Certification and ISO 14001 Certification Services.

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