ISO 15189 software

ISO 15189 is the quality management system standard for medical laboratories. Qualsys’s quality management software provides a single system for all the ISO 15189 documentation, planning, management, reporting and improvement initiatives.

Qualsys also helps with:

  • staff training
  • validation
  • implementation process


Complex circle

How our software helps with ISO 15189 certification

Laboratory Director roles

Our software incorporates workflow processes and permissions that enable the Laboratory Director to sign-off documentation and processes to evidence their involvement and the completion of their responsibilities.

CAPA management

Qualsys's software provides real-time access to a comprehensive database of accurate and consistent data and manages CAPA activity to conclusion. Reporting and dashboards help you monitor effectiveness.

Risk management

Qualsys's software enables the laboratory to evaluate the impact of work processes and potential failures on examination results as they affect patient safety, and modify processes to reduce or eliminate the identified.

Calibration of critical equipment

Equipment Manager maintains comprehensive records for any type of laboratory equipment. The system guarantees you don’t lose track of who is using equipment or where it is located. It prompts essential maintenance and checks, minimising costs and ensuring you don’t put patients and employees at risk.

Equipment acceptance testing

Audit Manager provides evidence of compliance with processes and equips you with foolproof mechanisms to eliminate process issues. You manage any type of audit or inspection activity, creating and storing checklists of questions ongoing use and analysis.

Reagents and consumable adverse incident reporting

Accident and Incident Manager drives activity to reduce accidents and incidents and comply with the legal requirement to record, report and investigate incidents, accidents and near misses in your workplace.
It provides real-time access to a comprehensive database of accurate and consistent data and manages investigations to conclusion.

Life science businesses across the globe rely on our software and services

pharmaceutical qms software
Pharma compliance management software
pharmaceutical quality management software
pharma qms software
York instruments medical devices quality management software solution
Medical device manufacturers ISO 13485 DYSIS
Biocair logistics medical supply business
Cardiome quality and training record management software

All 7 modules work well on their own or together

The Qualsys team help you to configure the system to meet the requirements of ISO 15189 and your internal requirements.
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See a live ISO 15189 management system in action. Request a demonstration of our software here:

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ISO 15189 case studies

Read how life science businesses, including laboratories, use Qualsys’s quality management software for compliance with ISO 15189.

ISO 15189 gap analysis tool

Try our free ISO 15189 gap analysis tool to understand the difference between CPA and UKAS.