ISO 15189 is an international standard that defines requirements for the competence, quality and reliability of the work of medical laboratories. This standard enables laboratories to improve the accuracy of results, optimize work processes and ensure compliance with global regulatory requirements, thereby raising the level of healthcare quality.
Simplify helps medical laboratories implement the ISO 15189 standard, enabling them to develop effective quality management system, improve diagnostic procedures and acquire accreditation that confirms their expertise. Through analysis of existing practices, optimization of laboratory procedures and staff training, we ensure that your laboratory operates in accordance with the highest international standards.
ISO 15189 is not just a standard – it is a strategic tool for medical laboratories that want to improve precision, increase the credibility of their results and ensure the trust of patients and healthcare institutions. If you want to improve the quality of your laboratory analyzes and ensure long-term compliance with standard requirements, Simplify is your reliable partner. Contact us and together we will create a strategy to improve your laboratory system.
Simplify provides comprehensive support medical laboratories in implementation and maintenance ISO 15189 standards, enabling them to achieve a high level of accuracy and reliability in diagnostic processes. Our goal is to help laboratories in development of an effective quality management system, improving procedures and increasing the trust of patients and health institutions.
Current state assessment and compliance identification – We analyze existing laboratory procedures and identify areas for improvement in accordance with ISO 15189 requirements.
Development and improvement of quality management systems in laboratories - We assist in the implementation of policies, procedures and controls that ensure the consistency and quality of laboratory analyses.
Training and empowerment of laboratory staff - We organize employee education so that they understand the key principles of the standard and actively participate in its application.
Support during accreditation - We prepare laboratories for the accreditation process through the preparation of documentation, internal verification and support during the audit by the accreditation body.
Continuous improvement and maintenance of the system - After accreditation, we provide constant support for optimization and adaptation of the system to new requirements and regulatory changes.
GAP Analysis: We start with a detailed GAP analysis in order to assess the current state of your medical laboratory in relation to the ISO 15189 standard. This step helps identify key areas that need improvement to ensure full compliance.
Development of the Action Plan: Based on the results of the GAP analysis, we create customized action plan which includes all necessary measures to improve laboratory procedures, increase accuracy and reduce errors in analyses.
Implementation and Training: We help you in implementing the necessary changes through the optimization of existing procedures and the introduction of new control mechanisms. We also organize training for laboratory staff to ensure that everyone understands ISO 15189 requirements and actively participates in improving the quality of laboratory analyses.
Compliance Check: Before the formal accreditation process, we conduct an internal compliance check in order to identify and correct any non-conformities. This step ensures that your laboratory is fully ready for accreditation.
Support During Accreditation and Continuous Improvement: During the accreditation process, we provide professional support and we work with your team to ensure a successful evaluation by the accreditation body. After accreditation, we continue to provide support in continuous improvement laboratory procedures to maintain high standards of precision and reliability.
With Simplify as a partner, your medical laboratory is insured accuracy, credibility and globally recognized standards in diagnostic analyses. Contact us and start your transformation to a superior laboratory system with ISO 15189.
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