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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Montreal is the largest city in the province of Quebec and is the 9th largest city in the whole of the continent of North America. The city is named after the hill in the heart on the city called Mount Royal. It has and estimated population of roughly 1.65 million people. Education in Canada is mostly free and publicly funded. It is overseen by the federal, provincial and local governments, with the education within provincial jurisdiction and the curriculum overseen by the province. Education is compulsory in most provinces up to the age of 16. Parents can choose between sending their children to one of the public schools or they can sent them to a fee paying private school. Those who live in Montreal and find that picking a secondary school is a fraught decision involving school zones and ratings. Royal West Academy is one of the most prestigious schools in Montreal. It is a public Anglophone secondary school that performs excellently academically. Royal West Academy is part of the English Montreal School Board. The schools mission is to provide a structured environment for those who are committed to academic study. They offer top computer training courses and have an appreciation for the arts, social issues and community responsibilities. To enter this school students must pass an entrance exam due to the limit places that are available. Canada’s higher has a very good reputation. However there is no formal ranking system and students will often choose colleges and universities bases on geographic convenience and the reputation of a particular course. Montreal has the highest concentration of post-secondary students of all major cities in North America. There are 4 universities, seven degree awarding institutions and 12 CEGEPS (publicly funded pre‑university college in the province of Quebec) in a 5 mile radius. The University of Montreal is the second largest research university in the country. It is ranked 115th in the world and is the 5th highest ranked Canadian university in the world rankings. The university is affiliated with two other higher education institutions in the area; the École Polytechnique de Montréal (School of Engineering) and HEC Montréal (School of Business). The school of business is widely regarded as being one of the best business schools in Canada. The University of Montreal is a Francophone institute which means the lessons are taught predominantly in French.

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Address

Regus,
2001 University Street, Suite 1700
Montreal
Quebec
H3A 2A6

T: +1 6474932992

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 Montreal. 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 Montreal, 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.

Streamline large-scale training requirements with The Knowledge Academy's In-house/Onsite at your business premises. Experience expert-led classroom learning from the comfort of your workplace and engage professional development.

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What our customers are saying

ISO 15189 Requirements For Quality And Competence Training | ISO Training in Montreal 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 Montreal starts from CAD2595
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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