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ISO 15189


A large amount of innovations, especially in technology, have vastly enhanced the productivity of medical laboratories in recent years; yet at the same time, commoditization is increasingly affecting the services they provide. To prepare for the future, medical laboratories need to overcome some challenges, investing more in automation and reducing diagnostic errors, hiring and developing human talent, and strengthening business relationships with doctors to enhance process efficiency and effectiveness and to reduce deviations and unnecessary costs.

ISO 15189 is the most widely-recognized international quality standard for medical laboratories. Its goal is to help organizations to develop their quality management systems and to assess their own technical competences, helping laboratories to improve business processes, products and services. This standard is based on the Continuous Improvement Model, which is also used for other standards, such as ISO 9001 or ISO/IEC 17025, making it easier for organizations to meet international patient care requirements and to obtain an accreditation seal.

SoftExpert offers the most advanced and comprehensive software solution for compliance management, meeting the demanding needs of various global regulations. SoftExpert Excellence Suite (SE Suite) helps companies to comply with ISO 15189 while lowering costs, maximizing success, increasing productivity and reducing risks.

SoftExpert's solution enables organizations to easily meet ISO 15189 requirements, providing resources to develop policies, manage complaints and nonconformities, fix targets and objectives, analyze and understand data, and measure results to make decisions regarding patient care, boosting QMS efficiency and reducing rework and waste. With online collaboration capabilities, the organization and managers can communicate and be updated on quality initiatives, involving more users, teams, offices and business units with a systematic and unified approach that ensures the maintenance and effectiveness of the QMS.

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Document control
Business process modeling
Performance appraisal
Equipment management
Problem management
KPI Tracking


  • Laboratory commitment to promoting quality.
  • Automation of quality processes to enhance their effectiveness and efficiency.
  • Regulatory requirements met in an effective way, with reduced efforts.
  • Products and services better aligned with patients’ expectation.
  • Alignment of quality and strategic objectives.
  • Lower operating costs.
  • Mitigation of equipment failures, risks and process deviations.
  • Products and services delivered with better quality.
  • Relationship with patients strengthened, maximizing loyalty.

About SoftExpert

SoftExpert is a market leader in software and services for enterprise-wide business process improvement and compliance management, providing the most comprehensive application suite to empower organizations to increase business performance at all levels and to maximize industry-mandated compliance and corporate governance programs.

Founded in 1995, SoftExpert has a rich history of innovation and growth as a true industry leader. More than 300,000 users from 2,000 organizations worldwide trust SoftExpert applications to ensure the highest standards of efficiency, quality and innovation for their products, services and processes.

By streamlining and integrating all levels and operations, SoftExpert applications also enable organizations to address an ever-increasing variety and number of international standards, laws and regulations that affect business operations by delivering enhanced compliance capabilities based on industry-specific best practices.

SoftExpert solutions are used by leading corporations in all kinds of industries, including consumer products, automotive, food and beverage, mining and metals, high tech and IT, energy and utilities, government and public sector, financial services, transportation and logistics, healthcare, education, medical devices and many others.

Along with its extensive network of resellers spread across all continents, SoftExpert also provides hosting, implementation, post-sales support, and validation services for its solutions to ensure that customers realize the maximum value from their investments.

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