iso 15189 ppt


What is the ISO 15189 standard?

  • International standard ISO15189, based upon ISO17025 and ISO9001 standards, provides the basic requirements for establishing competence and serves as the bible for quality in medical laboratories.

Is ISO 15189 a list/bullet point document?

  • Rather than breaking up sections with sub-sections, the older ISO 15189 document is broader and is in list/bullet point format in its management sections.

What is Quality Management in ISO 15189?

  • Quality management decisions in an ISO 15189 system are based on facts and data. This prevents personal preferences or a top-down management style from inhibiting process and quality improvement. Continual improvement is a permanent objective of ISO 15189 quality management.

Is ISO 15189 the QMS of a CLIA laboratory?

  • ISO 15189 could be chosen as the QMS of a CLIA laboratory, but it needs to be supplemented with the specific CLIA requirements. Because elements of CLIA were incorporated into the ISO 15189 standard, many laboratories considering implementing ISO 15189 can readily meet many of the technical requirements.
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