ISO 15189

SBS Quality Management Software tools enable efficient compliance to ISO 15189.

ISO 15189:2012 specifies requirements for quality and competence in medical laboratories.

ISO 15189 can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.

SBS Quality Management Software tools:

SBS Product Key Features
T-Med Database · Maintain training records
· Record certification and re-certifications
· Evaluate training effectiveness
· Email delinquency notices
· Manage training compliance
· CFR 21 part 11 compliant
Q-Med Database · Manage corrective actions (CARs)
– Safety and Supplier CARs (SCARs)
· Manage preventive actions (PARs)
· Internal audit management
· Document Quality Management System reviews
· Manage continual improvement projects
· Monitor and measure customer perceptions
· Manage and assess risk (FMEA / SWOT analysis)
· CFR 21 part 11 compliant
Ground Control · Complete document life cycle management
· Track training based on new document releases
· Develop training requirements / training plans
· Document self-paced training
· Record certification and re-certifications
· Evaluate training effectiveness
· Email delinquency notices
· Manage training compliance
Asset Tracking · Control of monitoring and measuring devices
· Calibration recall list
· Manage preventive maintenance on critical equipment
· Time based PMs or counter based PMs
Vendor Management · Develop Vendor qualification plans
· Record qualification results
· Maintain your Approved Vendor List (AVL)
· Establish criteria for selection, evaluation and re-evaluation of suppliers
· Link electronic files (paperless system)

SBS QMS Software is sold as individual products or as a suite of tools with options for concurrent user licensing.  Our software may be install locally or deployed on our cloud server (accessible by any internet enabled device).