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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Hamburg, officially known as ‘Freie und Hansestadt Hamburg’ (Free and Hanseatic City of Hamburg), is the second largest city is Germany. The city is populated with approximately over 1.7 million residents. Like other cities across Germany, education in Hamburg is compulsory for children; it follows the German educational system and is divided into four levels: Kindergarten Education, Primary Education, Secondary Education, and Higher Education. Kindergarten is for children aged from three to 6. Elementary School (Grundschule) is from Grade 1 to Grade 4. After Elementary School, children can go onto one of the three types of schools, Hauptschule, Realschule or Gymnasium, depending on their academic ability from Grades 5 to 9 or 10 and is compulsory up to the age of 18.

The school system in Hamburg is managed by the Ministry of Schools and Vocational Training (Behörde für Schule und Berufsbildung). There is over 240 Primary School and nearly 200 Secondary Schools with over 160,000 students attending every year. The city also has many private colleges as well as religious and special-purpose institutions including the Helmut Schmidt University (formerly known as the University of the Federal Armed Forces Hamburg). Hamburg is home to the International School of Hamburg, which is one of the oldest international schools in Germany.

Hamburg also provides Higher Educations for students who wish to further their education with over 15 universities. There is over 70,000 students attending these universities including over 9,000 foreign students. Hamburg universities are both public and private for students. The public universities are: the University Medical Centre of Hamburg-Eppendorf, the University of Music and Theatre, the Hamburg University of Applied Sciences, the Hamburg University of Technology, and finally the University of Hamburg (Universität Hamburg) which is the largest university in Hamburg; Hamburg also offers private universities including the Bucerius Law School. 

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Address

HafenCity,

Am Kaiserkai 1,

Hamburg, Germany

T: +49 8000101090

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 Hamburg. 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 Hamburg, 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.

Experience the most sought-after learning style with The Knowledge Academy's ISO 15189 Requirements For Quality And Competence Training | ISO Training in Hamburg. Available in 490+ locations across 190+ countries, our hand-picked Classroom venues offer an invaluable human touch. Immerse yourself in a comprehensive, interactive experience with our expert-led ISO 15189 Requirements For Quality And Competence Training | ISO Training in Hamburg sessions.

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Boost your skills with our expert trainers, boasting 10+ years of real-world experience, ensuring an engaging and informative training experience

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Our Classroom courses with limited class sizes foster discussions and provide a personalised, interactive learning environment

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What our customers are saying

ISO 15189 Requirements For Quality And Competence Training | ISO Training in Hamburg FAQs

The International Standards Organisation, or ISO, is a non-profit organisation that develops and publishes organisational standards. 
In this ISO 15189 Requirements for Quality and Competence training course, there are no formal prerequisites.
This training course is suitable for anyone who wants to expand their expertise in developing the quality management systems used by medical laboratories.
Medical laboratories can use this international standard to establish their quality management systems and measure their own competence.
A Quality Management System (QMS) organises, monitors, and improves the factors that influence the laboratory's ability to produce the required outcomes and the users' satisfaction.
ISO 15189 provides certain standards for competence and quality for medical laboratories.
During this training course, delegates will furnish their memories about the laboratory activities, facilities and environmental conditions, reagents and consumables, laboratory equipment, actions to address risks and opportunities, and other knowledgeable concepts regarding the understanding of medical laboratories in a quality management system.
The training fees for ISO 15189 Requirements for Quality and Competence Training certification in Hamburg starts from €1695
The Knowledge Academy is the Leading global training provider for ISO 15189 Requirements for Quality and Competence Training.
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"Really good course and well organised. Trainer was great with a sense of humour - his experience allowed a free flowing course, structured to help you gain as much information & relevant experience whilst helping prepare you for the exam"

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