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
- implementation process
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.
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.
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.
Read how life science businesses, including laboratories, use Qualsys’s quality management software for compliance with ISO 15189.
Try our free ISO 15189 gap analysis tool to understand the difference between CPA and UKAS.