What does the ISO 15189 course cover?
ISO 15189 is covered here in 12 modules: Introduction to ISO 15189: History and development of ISO 15189, Quality Management System (QMS) Fundamentals: Key components of a QMS, ISO 15189 Requirements: Requirements for the QMS, Requirements for laboratory processes and 9 more.
How do you approach ISO 15189 step by step?
The work is sequenced in 12 stages. It starts with Introduction to ISO 15189: History and development of ISO 15189, moves through Quality Management System (QMS) Fundamentals: Key components of a QMS and ISO 15189 Requirements: Requirements for the QMS, Requirements for laboratory processes, and ends at Quality Management System (QMS) Metrics and Performance Indicators.
What is in Module 1 of the ISO 15189 course?
Module 1 is Introduction to ISO 15189: History and development of ISO 15189. It works through overview of ISO 15189 and its importance in medical laboratories, history and development of ISO 15189, key principles and concepts of ISO 15189 and 1 more. It sets the vocabulary the remaining 11 modules build on.
How is the ISO 15189 course delivered?
The ISO 15189 course is fully self-paced with immediate online access after enrolment. Access does not expire and future updates are included at no cost. It can be taken on any device, and a certificate of completion is issued by The Art of Service when you finish.
How much does the ISO 15189 course cost?
The ISO 15189 course is $199 as a one time payment. There is no subscription, no per seat licence and no hidden fee. Enrolment carries a 30 day satisfied or refunded guarantee, so it can be assessed in full before you commit.
Closely related courses: Medical Laboratory Leadership, ISO 15189 Implementation for Medical Laboratories, AI-Driven Quality Management for Medical Laboratories, ISO 15189 Accreditation for Medical Laboratories.
More answers: what you get with every course, refund policy, all help answers.
Mastering ISO 15189: A Step-by-Step Guide to Implementing a Quality Management System for Medical Laboratories
Course Overview
This comprehensive course is designed to provide medical laboratory professionals with a step-by-step guide to implementing a quality management system (QMS) that meets the requirements of ISO 15189. Participants will gain the knowledge and skills necessary to establish, maintain, and continuously improve a QMS that ensures the accuracy, reliability, and timeliness of laboratory results.Course Objectives
- Understand the requirements of ISO 15189 and its application in medical laboratories
- Develop a quality management system that meets the requirements of ISO 15189
- Implement a QMS that ensures the accuracy, reliability, and timeliness of laboratory results
- Continuously improve the QMS through monitoring, evaluation, and corrective action
- Prepare for ISO 15189 certification and audits
Course Outline
Module 1. Introduction to ISO 15189: History and development of ISO 15189
- Overview of ISO 15189 and its importance in medical laboratories
- History and development of ISO 15189
- Key principles and concepts of ISO 15189
- Benefits of implementing ISO 15189 in medical laboratories
Module 2. Quality Management System (QMS) Fundamentals: Key components of a QMS
- Definition and principles of a QMS
- Key components of a QMS
- Quality policy and objectives
- Quality manual and procedures
Module 3. ISO 15189 Requirements: Requirements for the QMS, Requirements for laboratory processes
- Overview of ISO 15189 requirements
- Requirements for the QMS
- Requirements for laboratory processes
- Requirements for quality control and quality assurance
- Requirements for documentation and records
Module 4. Establishing a QMS: Defining the scope of the QMS, Defining roles and responsibilities
- Defining the scope of the QMS
- Establishing quality objectives and policies
- Developing a quality manual and procedures
- Defining roles and responsibilities
- Establishing a quality management structure
Module 5. Implementing a QMS: Training and awareness programs, Continuous monitoring and evaluation
- Implementing quality policies and procedures
- Training and awareness programs
- Quality control and quality assurance activities
- Continuous monitoring and evaluation
- Corrective action and preventive action
Module 6. Maintaining and Continuously Improving a QMS: Monitoring and evaluation
- Maintaining the QMS
- Continuously improving the QMS
- Monitoring and evaluation
- Corrective action and preventive action
- Quality management review
Module 7. Preparing for ISO 15189 Certification and Audits: Developing a certification plan
- Understanding the certification process
- Preparing for audits
- Developing a certification plan
- Implementing a certification plan
- Maintaining certification
Module 8. Risk Management and Quality Control: Understanding risk management
- Understanding risk management
- Identifying and assessing risks
- Implementing risk mitigation strategies
- Monitoring and reviewing risk management
- Quality control and quality assurance activities
Module 9. Document Control and Records Management: Understanding document control
- Understanding document control
- Developing a document control system
- Implementing document control procedures
- Maintaining and updating documents
- Records management
Module 10. Internal Audits and Management Review: Quality management review
- Understanding internal audits
- Planning and conducting internal audits
- Reporting and following up on internal audits
- Management review
- Quality management review
Module 11. Continuous Improvement and Corrective Action: Implementing corrective action
- Understanding continuous improvement
- Identifying opportunities for improvement
- Implementing corrective action
- Monitoring and reviewing corrective action
- Continuous improvement and quality management
Module 12: Quality Management System (QMS) Metrics and Performance Indicators
- Understanding QMS metrics and performance indicators
- Developing QMS metrics and performance indicators
- Monitoring and reviewing QMS metrics and performance indicators
- Using QMS metrics and performance indicators for continuous improvement
Certification
Upon completion of this course, participants will receive a certificate issued by The Art of Service.Course Features
- Interactive and engaging content
- Comprehensive and up-to-date course materials
- Personalized learning experience
- Practical and real-world applications
- High-quality content and expert instructors
- Flexible learning options
- User-friendly and mobile-accessible platform
- Community-driven and interactive discussions
- Actionable insights and hands-on projects
- Bite-sized lessons and lifetime access
- Gamification and progress tracking
Who Should Take This Course
- Medical laboratory professionals
- Quality managers and quality assurance specialists
- Laboratory managers and supervisors
- Regulatory affairs specialists
- Auditors and inspectors
- Anyone involved in the implementation and maintenance of a QMS in medical laboratories
Course Format
This course is delivered online and includes interactive lessons, quizzes, and hands-on projects.Course Duration
This course is self-paced and can be completed in 12 weeks or less.Technical Requirements
- Computer or mobile device with internet access
- Web browser and email account
- Audio and video playback capabilities