ISO 15189 Requirements for Quality and Competence Training Overview

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   

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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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Why choose us

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. 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, 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. 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 sessions.

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Highly experienced trainers

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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State of the art training venues

We only use the highest standard of learning facilities to make sure your experience is as comfortable and distraction-free as possible

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Small class sizes

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

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Great value for money

Achieve certification without breaking the bank. Find a lower price elsewhere? We'll match it to guarantee you the best value

Streamline large-scale training requirements with The Knowledge Academy’s In-house/Onsite ISO 15189 Requirements for Quality and Competence Training at your business premises. Experience expert-led classroom learning from the comfort of your workplace and engage professional development.

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Tailored learning experience

Leverage benefits offered from a certification that fits your unique business or project needs

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Maximise your training budget

Cut unnecessary costs and focus your entire budget on what really matters, the training.

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Team building opportunity

Our ISO 15189 Requirements for Quality and Competence Training offers a unique chance for your team to bond and engage in discussions, enriching the learning experience beyond traditional classroom settings

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Monitor employees progress

The course know-how will help you track and evaluate your employees' progression and performance with relative ease

What our customers are saying

ISO 15189 Requirements for Quality and Competence Training 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 price for ISO 15189 Requirements for Quality and Competence Training certification in the United Kingdom starts from £1495
The Knowledge Academy is the Leading global training provider for ISO 15189 Requirements for Quality and Competence Training.
Please see our ISO Certification courses available in the United Kingdom
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You won't find better value in the marketplace. If you do find a lower price, we will beat it.

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Flexible delivery methods are available depending on your learning style.

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High quality resources

Resources are included for a comprehensive learning experience.

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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"

Joshua Davies, Thames Water

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