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.
ISO 15189 Solution
SoftExpert offers the most advanced and comprehensive software solution for compliance management, meeting the demanding needs of various global regulations. SoftExpert Excellence 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.
Principaux bénéfices de la solution
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.
ISO 13485:2016 – Ce que vous devez savoir
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