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Implementing a quality management system ensures you have standardized processes.

Key benefits

• Reliability and accuracy of test results
• Eliminate waste and inefficiency

ISO 15189 accreditation (ISO15189:2012) will provide you with official international recognition. It provides proof that you have undergone a rigorous process of quality assurance in your medical laboratory.

Key benefits

• A quality benchmark, world-class recognition
• Client confidence (patients, clinicians, public health system)
• Accreditation provides you with the tools to continually improve your processes

Lab15189^® is a powerful tool for automatically and systematically guiding your medical laboratory to prepare for an ISO-based accreditation system. It also makes it easy to renew your accreditation once obtained.

Lab15189^{® is}

• Centered on ISO 15189 requirements with 12 complementary modules
• Based on the WHO handbook “Laboratory Quality Management System”
• Simple, easy to use, extremely powerful
• Highly intuitive and easy to navigate screens
• Network integration capacity or used as a standalone application

• Ability to record information required by the ISO standard (ISO15189:2012)
• Compatible with attachments of all file types (MS Excel, MS Word, Adobe PDF…)
• Quick search using filter lists and keywords
• Schedule tasks, training, assessments, and reviews
• Task reminders
• Backup/Restore

Document control

The Document Module is used to manage templates, different versions, reviews, validation and authorization of the documents and distribution list.
Lab15189® Document Module allows you to:

• Design your own master list
• Develop and store your own templates
• Define your own version rules (major/minor changes)
• Create list of documents in use
• Access published documents and distribution list quickly
• Generate new documents
• Assign roles for the documents to be reviewed/validated/authorized
• Set reminders and tasks for individual staff
• Send new approved document to specific staff
• Plan next reviews and other tasks to be performed

Lab15189® ensures that in your laboratory only the most current version of the document is available. All previous versions are archived.

Manage laboratory & suppliers information

The Laboratory Module is used to manage all laboratory information, including service providers, suppliers, referral laboratories and test master list.
Lab15189® Laboratory Module allows you to record:

• Laboratory contact details, organizational chart, facilities
• Required environmental conditions
• List of tests performed, sample requirements (pre-analytical, post analytical)
• Referral laboratories, along with tests performed
• Client contracts
• Suppliers, contacts, description form

Key benefits:

• Save and/or attach all information regarding the method chosen to select providers and referral labs
• Set reminder task for the reviews as needed
• Perform easy contract reviews

Manage staff documentation, training & meeting

These modules assist you in managing all information about your staff.

• Staff position
• Staff job description
• Skills, qualifications, experience, Résumé
• Training programs and training plan
• Competency assessment
• Staff suggestions

Key benefits:

• Ensures good human resource management
• Users are notified when competency assessment or training is due
• Easy HR management review & update
• Organize meetings and record attendees name and minutes

Manage Equipment – Consumables & Reagents

With Lab15189®, you can:

• Record all equipment items, reagents & consumables, including manufacturer, supplier information, location, acceptance criteria, lot/batch number, instruction on use, safety, etc.
• Create, schedule tasks and/or task schemes
• Assign responsibilities
• Record all tasks performed in a logbook (calibration, maintenance, repair, verification, corrective action, and more)

Manage IQC, EQA, audits, reviews

Lab15189® allows you to record all information about:

• Internal & external audits, planning, results, etc.
• Reviews(management, sample requirement, contracts, etc.)
• EQA
• IQC
• Customer satisfaction survey
• Preventive action

Lab15189® allows you to define your own quality indicators, and to analyze and monitor them.

Key benefits:

• Planning, follow up, traceability
• Evaluation and continual improvement
• Single store-place of all quality-related documents

Manage nonconformities

Record information about:

• Complaints
• Feedback
• Incidents
• Nonconformities

Key benefits:

• Set up remedial, corrective actions, evaluation, validation, closure
• Full control of nonconformities

Tasks & reminders

Lab15189®

• Suggests creation of corrective actions when appropriate
• Allows you to create as many tasks as needed, attributed to any person
• For each task, substitute staff can be chosen; tasks are automatically transferred to substitutes

The Admin Module allows you to:

• Manage users’ access rights according to the name or job positions
• Set up reminders at regular intervals for audits, reviews and training
• Select the language
• Backup information
• Restore information
• …

Set-up training

The training will focus on how to use of the software. IQLS qualified experts will also provide advice and help you to set up the parameters for your own specific needs.

Complete training

Training on ISO 15189 requirements (ISO15189:2012) and use of the software.