You may have heard of ISO standards before, but what exactly are they? ISO stands for the International Organization for Standardization, and it’s the world’s largest developer of voluntary international standards. Over 160 countries have joined the organization, which publishes standards for a plethora of industries, pharmaceutical not excluded. ISO 9000 happens to be the most widely implemented group of standards around the world. Its focus? Quality management.
So how did ISO standards come about, what is the ISO 9000 group, and how is it applicable to the pharmaceutical industry? Keep reading to find out!
1. ISO Standards Stemmed From a Need for Accident Reduction During World War II
The beginnings of the ISO 9000 group date all the way back to World War II. During this time, Britain’s Ministry of Defense wanted to reduce mistakes that were resulting in accidents during the manufacturing of munitions. The newly developed standards to deal with this issue focused on the management of procedures first and then consistency in quality of the products.
Implementing the standards resulted in overall success and it got people thinking that a variety of industries could benefit from similar quality assurance systems. Not too long after, the world’s first management systems quality standard, the BS 5750, was born. It replaced the standards of individual industries and guaranteed quality and consistency across all of them. Eventually, the BS 5750 became the first version of ISO 9000 in 1987. Since then, the standards have been updated a few times, resulting in the series that’s around today.
2. ISO 9000 Today Is a Series of Four Self-Complementing Standards
ISO 9000 consists of four different standards. The basis of the family is formed by the specifics of quality management systems as defined by
ISO 9000:2015, which also provides a terminology roadmap for users to be able to better understand the remaining standards.
ISO 9001:2015 informs users on how to attain quality requirements while meeting regulatory stipulations and simultaneously being able to identify and implement possible improvements to their processes. In other words, it explains how to implement and enhance quality management. Today ISO 9001 is the most common ISO standard implemented worldwide by over a million organizations.
The next standard in the family, the ISO 9004:2009, lays out eight principles that should be followed by organizations in order to achieve improved performance and productivity. These fundamentals include maintaining a customer focus, striving for continual improvement, maintaining mutually beneficial relationships with their suppliers, engaging employees fully in the organization’s operations, and making decisions based on facts.
Finally, ISO 19011:2011 outlines guidelines for internal and external audits of ISO 9001, the only auditable standard. Audits of ISO 9001 are generally used to confirm and improve quality management system effectiveness, including risk management and mitigation. External audits can be done by any interested third party, though the usual case is that a company audits its suppliers. An example relevant to the pharmaceutical industry would be an audit of a packaging or medical dosing equipment supplier. Such and similar scenarios are where individuals with quality assurance training can come in.
3. Quality Control Diploma Holders Can Help Companies Operate According to ISO 9000 Standards
Because pharmaceutical companies supply products that affect health and wellbeing, they always strive for high standards of consistency and quality of their goods. As such, the industry is governed by a large number of regulations and standards, ISO 9000 non-exempt.
As a quality control diploma holder, you just might find yourself assessing the quality standards of a company’s suppliers according to ISO 9001, essentially performing an external audit. You may also be working with companies internally to make sure all of their processes are sufficiently compliant with international standards. This is a very important role that helps eliminate instances of contamination, mix-ups, and errors, ensuring that products are safe and consistent.
Are you looking to enroll in quality assurance courses and make sure pharma products are of top-notch quality?
Explore the options offered by AAPS!
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