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ISO 15189 Quality Management System for Labs

Document control software to meet your quality management system (QMS) requirements.

PolicyStat’s web-based document control software helps your lab meet ISO 15189 standards for
document control and achieve three of the 12 Quality System Essentials set forth by the Clinical &
Laboratory Standards Institute (CLSI) – process control, documents and records and information
management. Our lean software-as-a-service solution also fulfills document control and quality
requirements set forth by CAP and CLIA.

Meeting quality requirements with PolicyStat

A featured solution in CAP’s document control course, PolicyStat document control software helps your lab meet quality requirements of IS015189 by helping you standardize and keep your content consistent. It also automates workflows to reduce the likelihood of human error.


  • Streamlined process for committee reviews
  • Visualized flowcharts of approvals
  • Control of document creation and templates
  • Automatic notifications of new/revised documents
  • Advanced search capability
  • Record of user review
  • Administrator dashboard with upcoming reviews
  • Automatic versioning and archival
  • Regulatory alerts
  • More

PolicyStat offers quick implementation of its web-based document control software. We also provide the data cleansing services necessary for labs that must adhere to the highest standards of quality to achieve ISO 15189 accreditation.

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