Understanding ISO 15189:2022 for Medical and Point of Care Testing Labs

The primary purpose of this course is to help leadership and laboratory technicians improve the confidence of laboratory users by providing a structure that promotes consistency of service, valid results, and patient confidentiality. This course is designed to help the participant understand its roles and responsibilities in concert with the requirements of ISO 15189 to ensure the goals of patient welfare and laboratory satisfaction are achieved. Participants will be introduced to risk-based thinking concepts and principles from ISO 22367 for improving its processes; laboratory safety from ISO 15190, and sample management from ISO 20658. Instructors will lecture to establish fundamental concepts and requirements, lead exercises and discussions to illustrate and affirm concepts, and provide opportunities for learning best practices through peer-to-peer discussions.

Price: $1,450.00*

Prerequisites

Fundamental quality concepts are strongly recommended.

Target Attendees

Target learners include Clinical and Point of Care Testing management, i.e., directors, managers, and supervisors.

Learning Outcomes

After successful completion of this course, the participant will be able to:

1. Describe how ISO 15189 achieves the goals of improving patient wellness and the satisfaction of laboratory users.
2. Illustrate how the standard uses risk-based thinking and risk management techniques from ISO 22367 to drive consistency in the application of the standard and how it improves patient and user confidence.
3. Implement the standard through effective application of documents and records
4. Describe the techniques used to monitor and improve laboratory effectiveness.
5. Discuss how and why the implementation of ISO 15189 parallels the implementation of ISO/IEC 17025 and the importance thereof.

CEUs Awarded

1.4 CEUs*, 14 Training Hours

Presentation Style

This course will use lecture, discussion, and interactive exercises.

Reference

Students are required to bring a copy of the ISO 15189 standard with them furnished by their company or purchase them directly from ISO or other approved document provider prior to the class.

*A2LA WorkPlace Training is accredited by the International Association for Continuing Education and Training (IACET) and is authorized to issue the IACET CEU.

Course Content

• Course Introduction
• Mutual Recognition Agreements
• The A2LA Accreditation Process
• ISO 15189-What the Standard Requires
  • Management requirements and responsibility
  • Quality management system
  • Document control
  • Service agreements
  • Examination by referral laboratories
  • External services and supplies
  • Advisory services
  • Resolution of complaints
  • Identification and control of nonconformities
  • Corrective and preventive action
  • Continual improvement
  • Control of records
  • Evaluation and audits
  • Management review
  • Technical requirements
  • Personnel
  • Accommodation and environmental conditions
  • Laboratory equipment, reagents, and consumables
  • Pre-examination, examination, and post-examination processes
  • Ensuring quality of examination results
  • Reporting and release of results
  • Laboratory information management
• A2LA Specific Requirements
  • Advertising accreditation and reporting accredited results
  • Traceability requirements for measurement equipment
  • Participation in proficiency testing
• Implementing IQCP
  • Risk and risk management
  • Risk estimation and evaluation
  • Failure Mode and Effects Analysis (FMEA)

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