Course information

ISO 15189 Requirements for Quality and Competence Training​ Course Outline

Module 1: Introduction to ISO 15189

  • Scope
  • Terms and Definitions

Module 2: General Requirements

  • Impartiality
  • Confidentiality
  • Requirements Regarding Patients

Module 3: Structural and Governance Requirements

  • Legal Entity
  • Laboratory Director
  • Laboratory Activities
  • Structure and Authority
  • Objectives and Policies
  • Risk Management

Module 4: Resource Requirements

  • General
  • Personnel
  • Facilities and Environmental Conditions
  • Equipment
  • Equipment Calibration and Metrological Traceability
  • Reagents and Consumables
  • Service Agreements
  • Externally Provided Products and Services

Module 5: Process Requirements

  • Pre-Examination Processes
  • Examination Processes
  • Post Examination Processes
  • Nonconforming Work
  • Control of Data and Information Management
  • Complaints
  • Continuity and Emergency Preparedness Planning

Module 6: Management System Requirements

  • General Requirements and Options
  • Management System Documentation
  • Control of Management System Documents
  • Control of Records
  • Action to Address Risks and Opportunities
  • Improvement
  • Corrective Action
  • Evaluations
  • Management Reviews

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Who should attend this ISO 15189 Requirements for Quality and Competence Training Course? 

This ISO 15189 Requirements for Quality and Competence Course is designed for individuals and professionals working in the field of medical laboratories and healthcare facilities. This course is particularly beneficial for professionals such as:

  • Laboratory Managers and Supervisors
  • Medical Professionals
  • Healthcare Administrators
  • Biomedical Scientists
  • Laboratory Accreditation Personnel
  • Quality Improvement Teams
  • Regulatory Compliance Personnel

Prerequisites of this ISO 15189 Requirements for Quality and Competence Training Course

There are no formal prerequisites for this ISO 15189 Requirements for Quality and Competence Training Course.

ISO 15189 Requirements for Quality and Competence Training Course Overview

ISO 15189 outlines requirements for Quality and Competence in medical laboratories, ensuring reliability, accuracy, and proficiency in testing and calibration services. Its relevance lies in bolstering patient care, providing reliable diagnostic results, and maintaining the highest standards of quality and competence in medical testing facilities.

Proficiency in ISO 15189 is critical for Laboratory Managers, Technicians, and Quality Assurance Professionals. Mastery of this standard enables them to establish and maintain quality management systems, enhance laboratory operations, ensure accuracy in test results, and meet regulatory compliance, which is crucial in healthcare settings for providing trustworthy diagnostic services.

The Knowledge Academy's 1-day Training immerses delegates in ISO 15189's requirements, covering quality management, competence, and technical aspects specific to medical laboratories. Delegates gain insights into implementing quality assurance practices, understanding competence requirements, and aligning laboratory operations with ISO standards, enhancing their ability to ensure top-notch quality in medical testing.

Course Objectives:

  • To understand the requirements outlined in ISO 15189 for medical laboratory quality
  • To establish and maintain effective quality management systems in medical laboratories
  • To ensure competence and proficiency in laboratory testing and calibration services
  • To implement quality assurance practices to enhance reliability and accuracy
  • To align laboratory operations with ISO 15189 standards for regulatory compliance
  • To improve patient care by ensuring the reliability of diagnostic testing

Upon course completion, delegates will possess comprehensive expertise in ISO 15189, empowering them to establish and maintain high-quality laboratory practices, ensure accuracy in diagnostic services, meet regulatory standards, and ultimately enhance patient care by providing reliable and accurate testing services in medical laboratories.

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What’s included in this ISO 15189 Requirements for Quality and Competence Training Course?

  • ISO 15189 Requirements for Quality and Competence Examination
  • World-Class Training Sessions from Experienced Instructors  
  • ISO 15189 Requirements for Quality and Competence Training Certificate
  • Digital Delegate Pack   

ISO 15189 Requirements for Quality and Competence Exam Information

To achieve the ISO 15189 Requirements for Quality and Competence Training​, candidates will need to sit for an examination. The exam format is as follows: 

  • Question Type: Multiple Choice  
  • Total Questions: 30 
  • Total Marks: 30 Marks 
  • Pass Mark: 50%, or 15/30 Marks 
  • Duration: 40 Minutes  

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NYC Seminar and Conference Center
71 West 23rd Street
Suite 515
New York
NY 10010

T: +1 7204454674

Ways to take this course

Experience live, interactive learning from home with The Knowledge Academy's Online Instructor-led ISO 15189 Requirements For Quality And Competence Training | ISO Training in New York. Engage directly with expert instructors, mirroring the classroom schedule for a comprehensive learning journey. Enjoy the convenience of virtual learning without compromising on the quality of interaction.

Unlock your potential with The Knowledge Academy's ISO 15189 Requirements For Quality And Competence Training | ISO Training in New York, accessible anytime, anywhere on any device. Enjoy 90 days of online course access, extendable upon request, and benefit from the support of our expert trainers. Elevate your skills at your own pace with our Online Self-paced sessions.

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