Why pursue ISO?
ISO is the International Organization for Standardization. The organization develops and publishes international standards that cover a wide range of industries, including life sciences. Today, ISO is considered the gold standard among international markets, and is therefore highly desirable to both new and established life sciences companies. Because regulators use ISO standards to establish regulations, complying with these standards offers businesses a competitive advantage and a ‘head start’ in the marketplace.
When an "interested party" recognizes an organization as being ISO certified, they appreciate the external objective oversight on that company's quality management system. This gives the interested party a higher level of confidence in the safety, reliability, and quality of the company's product or service.
FDA vs. ISO
The United States Food & Drug Administration is a federal agency responsible for protecting public health. However, many are unclear as to what the similarities and differences are 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.”
Source https://www.fda.gov/media/123488/download
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 then engage with such a third party after implementation for an extensive audit and cascade of audits thereafter. This process, if implemented properly, will result in a certification of conformity and compliance with a specific ISO standard.
For a successful outcome, 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 electronic quality management system (eQMS) can elevate the ability of an organization to manage documents and records, assign and track training, manage nonconformities, 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. These components are key requirements of the ISO 9001:2015 standard.
What is the ultimate purpose?
Standard developers (like ISO), regulators, and governments are all committed to offering 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 to implement ISO standards may have a competitive advantage in growing world markets.