ISO 15189 Gap Analysis in Medical Laboratories

What is it?

Gap Analysis is a fundamental tool for medical laboratories intending to undertake or consolidate the accreditation process according to the ISO 15189 standard – Quality and competence requirements for medical laboratories.

Through a systematic analysis , the laboratory's processes, procedures and documentation are compared with regulatory requirements, in order to identify any gaps and define the actions necessary to fill them.

In practice, it is a snapshot of the current state of the laboratory, useful for defining precisely where it is and what it needs to do to achieve full compliance.

Key points

• Identify gaps between current practices and the requirements of the standard.
• Assess the maturity of the management system , highlighting strengths and critical areas.
• Provide a structured starting point for planning the path to accreditation.
• Prioritize interventions based on their impact on regulatory requirements and clinical processes.
• Promote internal awareness by facilitating staff involvement in quality management.

Gap Analysis, therefore, constitutes a highly valuable preliminary phase , capable of supporting the laboratory on the path to technical and managerial excellence.

Why choose CSQA?

CSQA , as a leading publicly controlled Certification Body with many years of experience, offers a complete path for laboratories towards accreditation:

• an analysis calibrated to the real needs of the laboratory , taking into account its structure, internal processes and the level of maturity of the quality system;
• evaluators with specific technical skills in the ISO 15189 standard and a deep knowledge of laboratory dynamics, ensuring a constructive and professional discussion;
• objective and sector-specific assessments that contribute to organizational growth and the solidity of the management system.

In this way, the laboratory that undertakes this process will be able to transform regulatory compliance into a real competitive advantage and a distinctive sign of quality and reliability.