Strategies for effective corporate participation in standards development and implementation.
There has to be a champion of EC 1992 preparedness within each company or division. For large corporations whose divisions have relatively similar products and operations, more centralized coordination may be useful. The cooperation of companies, organizations, and individuals in standards-setting activities like those of AAMI will help ensure that all suppliers to the European Community are operating on a level playing field. I have described how we are taking advantage of our experience and staff resources in the United States and Europe in order to avoid delays or difficulties in obtaining the CE mark. High-quality assistance is also available to smaller companies. Internal auditors can receive lead assessor training through contract courses as our corporate auditors did. Several medical device, quality control, and quality assurance magazines and newsletters routinely publish information on EC 1992. Finally, there are numerous consultants working actively in this area. The Journal of the American Society of Quality Control periodically publishes a list of consultants in various areas of specialization.
De Risio
R J
RJ
Quality and Environmental Affairs, Pfizer Hospital Products Group, New York, NY.
D004865:Equipment and Supplies, Hospital / Q000592:standards*; D005060:Europe; D005062:European Union; D006801:Humans; D007221:Industry; D011786:Quality Control; D012015:Reference Standards; D014481:United States; D014486:United States Food and Drug Administration