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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
  • 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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Prerequisites

In this ISO 15189 Requirements for Quality and Competence training course, there are no formal prerequisites.

Audience

This training course is suitable for anyone who wants to expand their expertise in developing the quality management systems used by medical laboratories.

ISO 15189 Requirements for Quality and Competence Training​ Course Overview

ISO 15189 Standard specifies the requirements for medical labs' quality and competence. Medical laboratories can use this international standard to establish their quality management systems and measure their own competence. This training course will provide information about the utilisation of ISO 15189 by laboratory clients, governing agencies, and accreditation bodies to certify or recognise the competence of medical laboratories. By implementing the ISO 15189 standard delegates will ensure the accuracy of medical test findings and at the same time check the validity in a timely way from the laboratory. Holding the ability and knowledge to handle all the medical laboratory systems can lead the delegates to attain numerous job positions like Quality Assurance Managers, Laboratory Assistant Quality Assurance Managers, Senior Executive Assistant Managers, and various highly skilled job roles.

In this 1-day ISO 15189 Requirements for Quality and Competence training course, delegates will get equipped with all the important topics by which they will become fully familiar with the requirements for quality and competence in medical laboratories. Delegates will acquire knowledge about the objectives and policies to promote the welfare of patients through confidence in the quality and competence of medical laboratories. Our expert and highly skilled trainer will conduct this training course to fulfil the requirements for the medical laboratory to plan and implement the ways to identify the actions to address risks and opportunities.

Course Objectives:

  • Learn to assess the present state of a laboratory's operations, equipment, staff, and service quality.
  • Enable professionals to develop the skills needed to drive ISO 15189 implementation in medical laboratories.
  • Become acquainted with robust quality management to improve the credibility of the medical laboratory.
  • Get familiar with all the responsibilities of the organisations and management in the Quality Management System.

After attending this ISO 15189 Training course, delegates will be able to identify the requirements for the of quality and competence of medical laboratories for the better working of the system. They will also be able to confirm or recognise the competence of medical laboratories by laboratory users and regulatory authorities.

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  • Delegate pack consisting of course notes and exercises
  • Courseware
  • Experienced Instructor

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Why choose us

Ways to take this course

Our easy to use Virtual platform allows you to sit the course from home with a live instructor. You will follow the same schedule as the classroom course, and will be able to interact with the trainer and other delegates.

Our fully interactive online training platform is compatible across all devices and can be accessed from anywhere, at any time. All our online courses come with a standard 90 days access that can be extended upon request. Our expert trainers are constantly on hand to help you with any questions which may arise.

This is our most popular style of learning. We run courses in 1200 locations, across 200 countries in one of our hand-picked training venues, providing the all important ‘human touch’ which may be missed in other learning styles.

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Highly experienced trainers

All our trainers are highly qualified, have 10+ years of real-world experience and will provide you with an engaging learning 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

We limit our class sizes to promote better discussion and ensuring everyone has a personalized experience

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Great value for money

Get more bang for your buck! If you find your chosen course cheaper elsewhere, we’ll match it!

This is the same great training as our classroom learning but carried out at your own business premises. This is the perfect option for larger scale training requirements and means less time away from the office.

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Tailored learning experience

Our courses can be adapted to meet your individual project or business requirements regardless of scope.

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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

This gives your team a great opportunity to come together, bond, and discuss, which you may not get in a standard classroom setting.

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Monitor employees progress

Keep track of your employees’ progression and performance in your own workspace.

What our customers are saying

Frequently asked questions

FAQ's

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 Australia starts from AUD1295
The Knowledge Academy is the Leading global training provider in the world for ISO 15189 Requirements for Quality and Competence Training.
Please see our ISO Training courses available in Australia

Why choose us

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Best price in the industry

You won't find better value in the marketplace. If you do find a lower price, we will beat it.

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Many delivery methods

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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