What does the ISO 15189 course cover?
ISO 15189 is covered here in 8 modules: Introduction to ISO 15189: History and development of the standard, Quality Management System (QMS) Fundamentals: Definition and scope of a QMS, Laboratory Quality Control: Principles of quality control and 5 more. The outline lists 32 specific topics, opening with overview of ISO 15189 and its importance in laboratory quality management and closing with Clause.
How do you approach ISO 15189 step by step?
The work is sequenced in 8 stages. It starts with Introduction to ISO 15189: History and development of the standard, moves through Quality Management System (QMS) Fundamentals: Definition and scope of a QMS and Laboratory Quality Control: Principles of quality control, and ends at ISO 15189 Requirements: Clause 6: Resource management, Clause 7: Product realization.
What is in Module 1 of the ISO 15189 course?
Module 1 is Introduction to ISO 15189: History and development of the standard. It works through overview of ISO 15189 and its importance in laboratory quality management, history and development of the standard and key principles and requirements of ISO 15189. It sets the vocabulary the remaining 7 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: ISO 17025, Laboratory Quality Control, ISO/IEC 17025.
More answers: what you get with every course, refund policy, all help answers.
Mastering ISO 15189: A Step-by-Step Guide to Laboratory Quality Management
Course Overview
This comprehensive course is designed to provide laboratory professionals with a step-by-step guide to implementing and maintaining a quality management system (QMS) in accordance with ISO 15189. Participants will gain a thorough understanding of the standard, its requirements, and how to apply them in a laboratory setting.Course Objectives
- Understand the principles and requirements of ISO 15189
- Learn how to implement and maintain a QMS in a laboratory setting
- Understand the importance of quality control, quality assurance, and continuous improvement
- Develop skills in auditing, risk management, and corrective action
- Apply ISO 15189 requirements to real-world laboratory scenarios
Course Outline
Module 1. Introduction to ISO 15189: History and development of the standard
- Overview of ISO 15189 and its importance in laboratory quality management
- History and development of the standard
- Key principles and requirements of ISO 15189
Module 2. Quality Management System (QMS) Fundamentals: Definition and scope of a QMS
- Definition and scope of a QMS
- Quality policy and objectives
- Quality manual and procedures
- Organizational structure and responsibilities
Module 3. Laboratory Quality Control: Principles of quality control
- Principles of quality control
- Types of quality control (internal, external, and proficiency testing)
- Quality control procedures and records
- Corrective action and preventive action
Module 4. Laboratory Quality Assurance: Principles of quality assurance
- Principles of quality assurance
- Types of quality assurance (audits, assessments, and evaluations)
- Quality assurance procedures and records
- Continuous improvement and quality planning
Module 5. Risk Management: Risk monitoring and review, Risk mitigation and risk control
- Principles of risk management
- Risk assessment and risk analysis
- Risk mitigation and risk control
- Risk monitoring and review
Module 6. Auditing and Corrective Action: Principles of auditing, Audit procedures and records
- Principles of auditing
- Audit types (internal, external, and third-party)
- Audit procedures and records
- Corrective action and preventive action
Module 7. Continuous Improvement: procedures and records, Quality planning and quality policy review
- Principles of continuous improvement
- Types of continuous improvement (incremental, breakthrough, and innovation)
- Continuous improvement procedures and records
- Quality planning and quality policy review
Module 8. ISO 15189 Requirements: Clause 6: Resource management, Clause 7: Product realization
- Clause 4: Quality management system
- Clause 5: Management responsibility
- Clause 6: Resource management
- Clause 7: Product realization
- Clause 8: Measurement, analysis, and improvement
Course Features
- Interactive and engaging: The course includes interactive lessons, quizzes, and exercises to keep participants engaged and motivated.
- Comprehensive and personalized: The course covers all aspects of ISO 15189 and provides personalized feedback and guidance.
- Up-to-date and practical: The course is updated regularly to reflect the latest developments in laboratory quality management and provides practical examples and case studies.
- Real-world applications: The course provides real-world examples and case studies to illustrate the application of ISO 15189 in laboratory settings.
- High-quality content: The course is developed by experts in laboratory quality management and provides high-quality content that is accurate, relevant, and useful.
- Expert instructors: The course is taught by experts in laboratory quality management who have extensive experience in implementing and maintaining QMS in laboratory settings.
- Certification: Participants receive a certificate upon completion of the course, issued by The Art of Service.
- Flexible learning: The course is available online and can be completed at any time and from any location.
- User-friendly: The course is designed to be user-friendly and easy to navigate.
- Mobile-accessible: The course is accessible on mobile devices, allowing participants to learn on-the-go.
- Community-driven: The course provides a community-driven learning environment where participants can interact with each other and with the instructor.
- Actionable insights: The course provides actionable insights and practical advice that participants can apply in their laboratory settings.
- Hands-on projects: The course includes hands-on projects and exercises that allow participants to apply their knowledge and skills in a practical way.
- Bite-sized lessons: The course is divided into bite-sized lessons that are easy to complete and allow participants to learn at their own pace.
- Lifetime access: Participants have lifetime access to the course materials and can review them at any time.
- Gamification: The course includes gamification elements that make learning fun and engaging.
- Progress tracking: The course provides progress tracking and feedback to help participants stay on track and motivated.