Next in our series on the Future of GCP QA, we look at how the theories of quality management consultants like Shewhart, Deming, and Juran evolved into systems and standards that were adopted by entire industries. The International Organization for Standardization, which established in 1947 on the pre-war foundations of the International Federation of the National Standardizing Associations, was well-positioned to perform this work.
ISO is a voluntary organization of global member bodies that develops and produces standards, much like the International Council on Harmonization. It published its first standard (or "recommendation") in 1951 on industrial length measurements. ISO's web site includes a helpful timeline, including a photo of the lovely home in Geneva, Switzerland that served as their first headquarters. Its standards cover a range of technical topics, but in 1987, ISO published its
Fun facts about ISO:
- The International Organization for Standardization is known by the pseudo-acronym ISO, chosen as a globally unifying nickname because acronyms for the organization would be different in different languages. A pseudo-acronym is different than an orphan or empty initialism, which is an acronym that has lost its original meaning or has been rebranded to the actual name of the thing it represents.
- If you've ever taken photographs with an analog camera, you may recognize the ISO number as an indicator of a film's sensitivity to light, based on an ISO standard.
- ISO has published standards on a wide variety of topics, including freight containers, information security, video coding, energy management, anti-bribery systems, health and safety management, and social responsibility.
In 1987, ISO published the first of its 9000 series standards on quality management. The two current versions of these standards are ISO 9000:2015, Quality management systems — Fundamentals and vocabulary and ISO 9001:2015, Quality management systems — Requirements. You may have never encountered the text of these ISO standards in your day to day work in clinical research because ISO, unlike ICH, charges users to download its standards - 225 Swiss francs for ISO 9000 and 179 francs for ISO 9001. You can, however, download this brochure on the seven ISO Quality Management Principles for free.
The seven principles — customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making, and relationship management — are described in the brochure at a level of detail reminiscent of your average Reader's Digest article. The ISO standard behind the paywall reveals a bit more. We learn that an ISO organization has a quality policy and quality processes, with defined inputs and outputs for each process. Changes to the quality management system should be planned. Leadership should demonstrate commitment to the quality management system. The organization should define requirements for its products and services and communicate with customers about them. Products and services obtained from external suppliers must conform to requirements. Performance should be measured. The organization should perform internal audits to gauge the effectiveness of its quality management system. Management must review the quality management system at intervals to verify its continued suitability.
Sound familiar? These principles are clearly reflected in ICH's Pharmaceutical Quality System Q10 guideline, as well as pharma, biotech, CMO, and CRO quality policies the world over. Soon we'll get into the details of how GCP, GLP, and GMP quality systems sprang up in slightly different incarnations from this common foundation.
