About ISO 15189:2022 for Medical and Point of Care Testing Labs
Price: $995.00
Prerequisites
Fundamental quality concepts are strongly recommended.
Target Attendees
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:
- Describe how ISO 15189 achieves the goals of improving patient wellness and the satisfaction of laboratory users.
- 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.
- Implement the standard through effective application of documents and records
- Describe the techniques used to monitor and improve laboratory effectiveness.
- 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)
Training Dates
November 19 – 20, 2024
Instructor: Carlyn Mathews
Virtual Class
8am - 5pm EST
May 6 – 9, 2025
Virtual Class
1pm - 5pm EST
December 16 – 19, 2025
Virtual Class
1pm - 5pm EST