ISO 9000, ISO 15189, CAP 15189, and GHS – that is a lot of acronyms! Whether you are new to the lab environment or new to lab management, this can be a little confusing but its important to understand what these standards are and how they are related.
The International Organization for Standardization (ISO) is a worldwide federation of 165 body members/organizations dedicated to creating international professional standards. ISO often provides the baseline standards for most quality related programs within the United States. For example, ISO 15189 is a comprehensive standard on quality management in medical laboratories (quality and competence).
You may have already made the observation that that there is also CAP 15189. Is this a coincidence? Definitely not! The College of American Pathologists (CAP) has based its CAP 15189 Accreditation Program on this standard. So, when your lab is seeking CAP accreditation you may wish to reference not only the checklist provided by CAP, but also be sure to learn more about the ISO 15189 standard.
In addition to ISO 15189, the ISO 9000 series also addresses quality management and quality assurance, including understanding RCA – or root cause analysis. RCA is a process to analyze nonconforming outputs (or when things go wrong). Conducting RCA is a technical process that requires training and inclusion of multiple stakeholders. To learn more about RCA check out this great session, “Root Cause Analysis in the Histology Laboratory” being offered at the 2021 NSH Convention.
What about GHS? You may find yourself thinking about the GHS (Globally Harmonized System of Classification and Labelling of Chemicals) and how it is related to ISO or CAP. GHS is recognized by ISO and CAP - but it was created by the United Nations in 1992. GHS is referenced in ISO 11014, ISO’s standard on safety data sheets (SDS).
The take away message is that no one organization decides all things, rather they all work together to create standards that are adopted by most regulatory agencies so goods and services, no matter who or where they are produced have the same quality and safety.
To learn more about GHS labels, you can access NSH's health & safety committee infographic (pictured to the left).
By Connie Wildeman, National Society for Histotechnology