ISO 15189 Medical/Clinical Laboratory Quality Management System Standard Internal Assessor Virtual Training

ISO 15189 is an international quality management system standard designed specifically for medical laboratories. It outlines the controls required to manage risks that may have an impact on the validity of examination results, and tools to help the laboratory to improve its operations and customer satisfaction.

ISO 15189's requirements are designed to apply to all types of human pathology testing and therefore often need to be interpreted with respect to the type of testing concerned, and the techniques involved.

The requirements in the ISO 15189 standard covers management and technical requirements that will ensure an efficient and efficient laboratory producing reliable results. The requirements also cover staff, management, physical laboratory, quality of samples and analytical methods, customers, process management, equipment quality , competence ,complaint management , error prevention etc.

This training will help you understand the key concepts in ISO 15189 for implementing a quality management system, a prerequisite for clinical laboratory accreditation.

The delegates will be able to understand and interpret the requirements of ISO 15189, including its QMS. Identify required documents and understand a risk management plan.

This course is delivered in such a way that delegates will be able to apply the concepts, methods and principles in their daily professional lines.

WHO SHOULD ATTEND:

Laboratory managers, quality managers and frontline staff responsible for implementing the quality system of Laboratories.

Others include:

• Clinical Microbiologists,
• Clinical Biochemists and Technicians
• Those working in Medical labs with a need to understand ISO 15189
• Consultants
• Pathologists
• Laboratory scientists
• Internal Assessors
• Companies seeking ISO 15189 accreditation
• Certification / Registrar / Accreditation body auditors
• Existing internal auditors who are looking to expand their skills in the area of laboratory practices
• Supplier Quality Auditors who need to evaluate clinical laboratory services

COURSE CONTENT:

• Purposes of the standard, and the history of accreditation requirements.
• How the standard applies to the laboratory process.
• Structure of the standard.

• ISO 15189 Standard Requirements
• Management and technical clauses of ISO 15189 (a facilitated discussion will occur with each clause  
• Internal Audits & Management Reviews
• Clinical Testing Criteria
• Complaint Handling Processes
• Corrective Actions and Preventative Actions
• Training
• Confidence Region for Clinical Results
• Traceability of Measurement

LEARNING OUTCOMES:

• An understanding of the medical testing accreditation requirements.
• Ability to apply the requirements of ISO 15189 standard  
• Identify the purpose and interaction of the management system and technical requirements.
• Implement these requirements to ensure added service to customers and enhanced confidence in the facility's results.

Duration: 2 days