Internal Audit Course for Clinical/Medical Laboratories under 15189

Training for internal auditors in clinical/medical laboratories with quality systems conformant to ISO 15189.

Quality managers in clinical laboratories with a quality system cannot do it all on their own. An internal audit program is not a quality-only activity.  It is an operational activity as important as all other quality activities in the laboratory

The Internal audit is the absolute best tool the laboratory can use to determine the health of their quality system – and its ability to support he production of technically valid results for patients and physicians

This course is designed to motivate clinical laboratory staff to participate in an internal audit process and learn how to plan and conduct internal audits within the laboratory.

This 3-day Training Course examines ISO 15189 and the auditing principles and techniques used to meet the internal audit requirements it contains. It also facilitates the practice of required internal audit skills. It is based on internationally-recognized approaches to conducting conformant internal audits. The techniques learned by participants promote the involvement of all types of staff as auditors and auditees. The course includes easy-to-implement methods for risk-based thinking, continual improvement, and closing out findings through the analysis of root causes aimed at their elimination.

WHO SHOULD ATTEND?

Medical Lab Quality System personnel responsible for QMS and Internal Auditing must participate.  Medical Lab Pathologists, Microbiologists, Biochemists and Technicians should also be involved in order to understand 15189 internal audit requirements and to the lab’s quality and accreditation framework.

COURSE OBJECTIVES

Upon successful completion of the course, participants will have gained the following:

  • Knowledge on how to audit a Medical Laboratory that conforms to ISO 15189
  • Identification of documents and records required by ISO 15189
  • Understanding of risk management plans
  • Understanding of auditing principles
  • Understanding of internal auditing process including planning
  • Ability and practice in the performance of an internal audit
  • Writing of audit findings
  • Preparation of audit report, follow-up and closing the loop
  • Characteristics of an effective internal auditor
CERTIFICATES

All participants who take and qualify a written exam will receive a Certificate of Successful Completion.

For all staff who participate in the operation of the a quality system:

• Organizations conducting testing, calibration, inspection, evaluation, or certification
• Organizations using a QMS to support their business activities
• Managing a quality system
• Training staff in quality systems
• Managing the organization

DATE(S) AND LOCATION(S):

Contact training department for more info at admin@americanscouncil.com

EARLY REGISTRATION*

$600.00 USD in North America
$800.00 USD for International Delivery

REGULAR REGISTRATION*

$800.00 USD in North America
$1,000.00 USD for International Delivery

*  Early registration cut-off is normally 21 days prior to the scheduled training event.

5% additional discount for 2nd, 3rd, or more students from the same company attending the same training course. Space is Limited to 20 people for each training session.

Fees are non-refundable for cancellations; however, you may substitute another member of your staff, or attend another class offered by ASC at a later date.  If ASC cancels this class for any reason, the full registration fee paid will be refunded.