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ISO 15189 Internal Quality Auditing of Medical Laboratory Quality Management Systems

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Introduction

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Internal auditing is fundamental to any quality improvement initiative. Many hospital laboratories have adopted the ISO 15189 Quality Management System standard. A fundamental element of all Quality Management System standards is the measurement of s... Read More

Internal auditing is fundamental to any quality improvement initiative. Many hospital laboratories have adopted the ISO 15189 Quality Management System standard. A fundamental element of all Quality Management System standards is the measurement of system & process performance using a process based approach. The method for determining this is to conduct internal audits. Trained auditors must carry out these audits.

This two day course focuses on auditing for real quality improvement as well as compliance. The course provides detailed training in developing the skills necessary to be an effective internal auditor using many fun exercises including preparing for, performing and reporting of a real audit.

Attending delegates should have a good working knowledge of ISO 15189.

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What's covered?

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Please Note: A practical audit within the company forms the basis of day 2. Audit areas within the company must be organised prior to the training so that effective preparation can commence on day 1.  For this reason the numbers on this course are restricted to max 12 (4 audit groups of 3) to ensure all delegates get the attention needed to ensure they become effective Auditors.

 

Day 1:

  • Introduction to Quality Systems (ISO 15189)
  • Purpose of Internal Audits
  • The Audit Process
  • Selecting the Audit Team & Audit Behaviour
  • Auditor Behaviours: Assumptions, Effective Listening, Dealing with Conflict
  • Tools Available to Auditors
  • Audit Preparation

 

Day 2:

  • Audit Preparation
  • Practical onsite audit
  • Evaluating & Reporting the Audit

Delegates must attend both days to receive a Certificate of Attendance.

Who should participate?

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All medical laboratory professionals.

What will I learn?

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Participants achieve the following learning outcomes from the programme;

  • Understand the importance of internal auditing within a quality management system
  • Understand the responsibilities of Internal Auditors
  • Conduct an effective internal audit e.g. plan and organise an internal audit against the organisation’s documented procedures & compliance standards
  • Collect and analyse evidence objectively
  • Evaluate and report the results of an internal audit

Who are the tutors?

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How do we train and support you?

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In-House Courses
For In-House courses, the Tutor will contact the Course Organiser in advance to discuss the programme in more detail in order to tailor it specifically to the organisation.

Course Manual
Delegates will receive a very comprehensive course manual.

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SnapshotSnapshot

Course Code
L003
Duration
2 training days
Delivery Mode
This programme is delivered by or In-Company training 
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ISO 15189 Internal Quality Auditing of Medical Laboratory Quality Management Systems

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ISO 15189 Internal Quality Auditing of Medical Laboratory Quality Management Systems

Duration: 2 days
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