Course Title: ISO 15189 (Medical Laboratories) Lead Auditor

CEU: 4.0

Prerequisites:  None

Course Time Period:

You can take training at your own pace. You can logon and logout as many times as needed. You can re-take the exam as many times as necessary until you pass the exam and an online certificate is issued.

Key Session Topics:

Course Content

Scope and References
Terms and Definitions
Foundation for Lead Auditor
Audit Management for Lead Auditors
Lead Auditor Qualification and Competency
Company and management responsibility for medical laboratories
Audit/Implementation questions for the company and management responsibility
Quality management system for medical laboratories
Audit/Implementation questions for quality management system
Document control for medical laboratories
Audit/Implementation questions for document control
Service agreements for medical laboratories
Audit/Implementation questions for service agreements
Examination by referral laboratories for medical laboratories
Audit/Implementation questions for examination by referral laboratories
External services and supplies for medical laboratories
Audit/Implementation questions for external services and supplies
Advisory services for medical laboratories
Audit/Implementation questions for advisory services
Resolution of complaints for medical laboratories
Audit/Implementation questions for resolution of complaints
Identification and control of nonconformities for medical laboratories
Audit/Implementation questions for identification and control of nonconformities
Corrective action for medical laboratories
Audit/Implementation questions for corrective action
Preventive action for medical laboratories
Audit/Implementation questions for preventive action
Continual improvement for medical laboratories
Audit/Implementation questions for continual improvement for medical laboratories
Control of records for medical laboratories
Audit/Implementation for control of records for medical laboratories
Evaluation and audits for medical laboratories
Audit/Implementation questions for evaluation and audits for medical laboratories
Management review for medical laboratories
Audit/Implementation questions for management review for medical laboratories     

ISO 15189 Final Exam

Certificate Issuance: Online Certificate is issued upon completion of course and Final Exam

Courses Approval: All courses are approved by Quality University and the certificate issued has Quality University registered mark and certificate number.

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• Select your course. You may take the course and exam at your leisure.

You may retake the exam as many times as needed until a passing score is achieved.

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Once you complete the course with a passing score on the exam you will be issued a certificate. Please print this cerificate for your own records. If you need to reprint a certificate for any reason, visit the "My Courses" link and you will have an option to reprint a certificate for any training you have completed.

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