ISO 15189 Laboratory Quality Control Software
- Keep your Lab Ready for Inspection: proof of ISO 15189 compliance just a click away
- Dramatically reduce document deficiencies on your next inspection
- Reduce time, cost and stress of Laboratory Inspections
- 100% cloud-based: no servers needed
- Fully customizable: only use the modules you need
- We bulk upload of your lab’s documents, as well as all accreditation checklists
- Designed for Fast Learning: less than a couple hours to train your team
Here are just some of the ways we help you achieve this:
Requirement: ISO 15189 – Clause 4.3 (Document Control)
“The laboratory shall control documents required by the quality management system and shall ensure that unintended use of any obsolete document is prevented.”
Solution: SoftTech Health QMS™ Document Control Module
- Keep all your SOPs, policies, and other documents up to date and approved by the right people at the right time, with automated tracking.
- Automated headers are inserted into your documents to ensure they always show the latest information.
- Purpose-built to help you more easily meet all of the Document Control requirements for JCAHO, CAP, ISO and more.
Requirement: ISO 15189 – Clause 4.8 (Resolution of Complaints)
“The laboratory shall have a documented procedure for the management of complaints or other feedback received from clinicians, patients, laboratory staff or other parties. Records shall be maintained of all complaints and their investigation and the action taken …”
Solution: SoftTech Health QMS™ Feedback Manager Module
- Track all feedback reports from patients, vendors or employees.
- Each report is automatically forwarded to the right person in your organization.
- Automatically track internal investigative action for every complaint.
Requirement: ISO 15189 – Clause 4.9 (Identification and control of nonconformities)
“The laboratory shall have a documented procedure to identify and manage nonconformities in any aspect of the quality management system, including pre-examination, examination or post-examination processes.”
Solution: SoftTech Health QMS™ Non-Conforming Events Module
- Track all the incidents that occur in your organization.
- Built-in escalation tools are customizable, so you can ensure all your NCEs are seen by the right staff, automatically and in real time.
- Analysis, follow-up, and record-keeping is made easy and efficient, with automated graphs and reports.
Requirement: ISO 15189 – Clause 5.1.6 (Competence Assessment)
“Following appropriate training, the laboratory shall assess the competence of each person to perform assigned managerial or technical tasks according to established criteria.”
Solution: SoftTech Health QMS™ Competency Manager Module
- Set up, deliver, and track your competency assessments in one user-friendly application.
- Easily create quizzes, automate the marking of responses, and set up automated reminders to make sure that competency assessments are done on time.
- Track competency progress for each team member.
Requirement: ISO 15189 – Clause 5.3.1 (Equipment)
“The laboratory shall have a documented procedure for the selection, purchasing and management of equipment.
The laboratory shall be furnished with all equipment needed for the provision of services (including primary sample collection, sample preparation, sample processing, examination and storage). In those cases where the laboratory needs to use equipment outside its permanent control, laboratory management shall ensure that the requirements of this International Standard are met.
The laboratory shall replace equipment as needed to ensure the quality of examination results.”
Solution: SoftTech Health QMS™ Equipment Manager Module
- Record and track important information and dates for your equipment and inventory.
- Set up automated reminders and evaluation tasks for all your maintenance needs.
- Save time with automatic quality logging of all calibrations and testing.
Requirement: ISO 15189 – Clause 4.10 (Corrective Action) & Clause 4.11 (Preventive Action)
“The laboratory shall take corrective action to eliminate the cause(s) of nonconformities. Corrective actions shall be appropriate to the effects of the nonconformities encountered…”
“The laboratory shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems…”
Solution: SoftTech Health QMS™ CAPA Module
- Streamlined set of reporting, tracking, and management features.
- Easily track and respond to every CAPA report, with customizable tools that work the way you want them to work.