Reality and Novel Research on ISO 9001 Standards and Comparison of ISO 9001:2008 Vs ISO 9001:2015

Abstract

Aim: The primary objective of this article is to elucidate the importance of ISO standards in Pharmacy educational Institutions, growing organizations. Secondly, to know the updates and basic difference between ISO 9001: 2008 and ISO 9001: 2015. Over the past 60 years the implementation of ISO became more in the competitive society. There are around more than 40 number pharmacy colleges in Tamil Nadu. Still many more colleges are yet to get approval to begin. It makes pleasure that the circle of the pharmacy is getting unlimited. Method: ISO simply says: "say what do you do” and "do what you say”. The competitions among the educational institutions are becoming more and more. As per basic local market standard, when there is a demand in the market usually there will be more chances for defilement and dishonesty. Methods of accountability in the education system are failure. Yet to refine and get a newer technology and methodology for assessment. Result: Pharmacy is one of the health care profession also, a practical and product oriented course and hence the adulteration may result severe risk to the society and people. The results are duplication/ manipulation of the task, creating new type of formats, cooking up the results during the time of audit, week internal audit and random inspection process, poor understanding of roles and responsibility, double or triple entry of the same values, vague and blurred concept on ISO standards, etc.   Conclusion: The educational institutions must check the quality of the education program provided. Many of the organizations and the institutions are following the ISO standards but, lagging behind Measurement, analysis and improvement. Lack of internal communication, review, follow up, corrective action and tuning and changing the corrective action if not found effective. Quality system will develop by strengthening the internal audit program. This research article may help growing organizations, institutions and other public community shops to lead a quality product by their system.