Tools, Technologies and Training for Healthcare Laboratories

ISO 9001:2015 Quality Management Systems Requirements

Contributing editor Dr. Pereira begins Part 1 of a series on the ISO standards applicable to medical laboratories. As this global standard spreads, labs need to take a closer look at what is required to implement them. ISO 9001 had a recent revision in 2015, and Dr. Pereira looks in detail at the new changes.

ISO 15189:2012 Medical laboratories - Requirements for quality and competence

Contributing editor Dr. Pereira continues part 2 of a series on the ISO standards applicable to medical laboratories. The ISO 15189 is widely popular for laboratories, but many aspects are confusing, vague, and misunderstood. Dr. Pereira shows how to interpret the standard's requirements.

Glossary of ISO Terms

A glossary of different ISO terms for metrology that are relevant to Clinical Laboratories.

ISO 15189 QSE 5.6: Assuring the Quality of Examination Procedures

Greg Cooper of Bio-Rad gave a presentation on how ISO 15189 applies to clinical laboratories.

ISO-4: ISO 14001:2004 and Environmental Management

ISO standards do not only govern quality management, but also sustainability. Guest authors Perigo and Rabelo discuss the attraction of an additional ISO certification: the 14001:2004 standard.