By Karin Ashkenazi on February 10, 2020

An ISO Primer for Life Sciences Quality & Regulatory Leaders


Why pursue ISO? 

ISO is the International Organization for Standardization. The organization itself develops and publishes international standards that cover a wide range of industries, including life sciences. Today, ISO is considered the gold standard in international markets and, therefore, it is highly desirable to both new and established life sciences companies. Because regulators use ISO standards to establish regulations, complying with those standards offers businesses a competitive advantage and a ‘head start’ in the marketplace. 

When an "interested party" realizes an organization is ISO certified, they appreciate that there is an external objective oversight on the quality management system of the organization, and that gives the interested party higher confidence in the safety, reliability, and quality of the product/service. 


The United States Food & Drug Administration is a federal agency and many are unclear as to what the relationship and/or differences between their regulatory policies and ISO standards. One example of that connection is the FDAs intent in a publication from December 2018: 

“FDA intends to harmonize and modernize the Quality System regulation for medical devices. The revisions will supplant the existing requirements with the specifications of an international consensus standard for medical device manufacture, ISO 13485:2016. The revisions are intended to reduce compliance and recordkeeping burdens on device manufacturers  by harmonizing domestic and international requirements. The revisions will also modernize the regulation.”


Getting started with ISO

ISO doesn’t provide certification or conformity assessment. The process of certification against ISO standards is carried out by external certification bodies. In other words, an organization that pursues certification must understand and implement the standards first, and engage with such a third party after implementation, for an extensive audit and cascade of audits thereafter that, if implemented properly, will result in a certification of conformity and compliance with a specific ISO standard. 

For a successful outcome, the project of implementing ISO standards, should, like any other quality related project, be endorsed by top management and be a top priority for an organization. As such, quality leaders should request resources to support the efforts of implementing and maintaining compliance. For example, implementation of an eQMS can elevate the ability of the organization to manage documents and records, assign and track training, manage non conformities, assign Corrective and Preventive Actions (CAPAs) and assess their effectiveness, support the internal audit program, manage changes related to products and manage externally provided products or services. If you look at ISO 9001:2015 standard alone, those listed components are key requirements of the standard. 

What is the ultimate purpose?

At the end of the day, standard developers like ISO, regulators and governments are all committed to provide guidance to manufacturers, suppliers, and service providers on how to do the right thing in order to achieve the utmost safety, reliability, quality and customer satisfaction. Governments and regulators seek ways to harmonize regulations with international standards to alleviate challenges of compliance. As a result, companies who are already taking steps for implementation of ISO standards may have a competitive advantage in the growing world markets.


Published by Karin Ashkenazi February 10, 2020