The Quality Blog is a blog about quality assurance, quality management and quality in general. The blog covers topics like TQM, ISO9001,human errors, BPM, Lean, Six Sigma...
In Europe, more and more medical labs pursue ISO 15189 certification. This standard is based on ISO 17025 (thus also on ISO 9001) but with more specific demands and guidelines specific to medical labs. In 2007, an updated/revised version was published for a standard dating from 2003. Despite the fact that it is not an obligation in Europe yet, the European medical world invests more and more to get certified. In the United States where FDA rules the medical world, it is a requirement. Therefore, companies that want to be active on both continents will be facing a double certification for a while.