Publications

Abstract : ISO 9001 is the most popular and widely adopted meta-standard for quality and operational improvements in business organisations. As in the case with all types of organisations, pharmaceutical companies too are more and more inclined towards ISO certification. The ISO 9001 belongs to ISO 9000 family of standards and is aimed to help organizations to make sure that they fulfil the needs of the customers through an efficient quality management system. Although the majority of the certified companies are having benefit from it, there are a few companies which find it to be wastage of their resources. It is actually the failure from the company and not from the part of ISO set of standards. This study was actually to find out the reasons for the failure of ISO certification for fulfilling the preset objectives in the case of pharmaceutical companies. This study was conducted on a number of Indian pharmaceutical companies which are certified with ISO 9001 standards. A primary survey was conducted to find out whether the company sees the certification to be beneficial or not. A secondary survey done on the companies which find the certification to be less effective, to find out the reasons for failures. This study is fully based on the above survey results.