ISO 15189 Internal Auditor Course

Course Objectives

At the end of this course, participants will be able to:

1. Understand the purpose, structure, and requirements of ISO 15189 for medical laboratories.
2. Interpret the clauses and principles of ISO 15189 and their application within laboratory operations.
3. Understand the roles and responsibilities of internal auditors in maintaining laboratory quality management systems.
4. Plan, conduct, report, and follow up internal audits in accordance with ISO 19011 auditing guidelines.
5. Identify nonconformities, risks, opportunities for improvement, and corrective actions within laboratory processes.
6. Evaluate laboratory compliance with quality and competence requirements.
7. Develop effective audit checklists and audit reports.
8. Improve continual improvement processes and support accreditation readiness.

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Target Audience

This course is designed for:

• Medical laboratory managers and supervisors
• Quality managers and quality officers
• Laboratory analysts and technicians
• Internal auditors and compliance officers
• Healthcare quality professionals
• Laboratory consultants
• Personnel involved in ISO 15189 implementation and maintenance
• Individuals preparing laboratories for accreditation

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Course Content

Module 1: Introduction to ISO 15189

• Overview of laboratory quality management systems
• Purpose and benefits of ISO 15189
• Structure and key concepts of ISO 15189
• Relationship with ISO/IEC 17025 and healthcare regulations

Module 2: Requirements of ISO 15189

Management Requirements

• Organization and management responsibility
• Document control
• Review of requests and contracts
• Corrective and preventive actions
• Internal audits
• Management review
• Continual improvement

Technical Requirements

• Personnel competence
• Accommodation and environmental conditions
• Equipment management
• Pre-examination processes
• Examination procedures
• Quality assurance of examination results
• Post-examination processes
• Laboratory information management

Module 3: Principles of Auditing

• Audit concepts and terminology
• Types of audits
• Auditor competence and ethics
• Risk-based auditing approach
• Audit lifecycle

Module 4: Audit Planning and Preparation

• Developing audit plans
• Preparing audit checklists
• Reviewing documented information
• Audit scope, objectives, and criteria

Module 5: Conducting Internal Audits

• Opening meetings
• Interview techniques
• Collecting and verifying evidence
• Process auditing
• Identifying conformity and nonconformity
• Communication during audits

Module 6: Reporting Audit Findings

• Writing nonconformity statements
• Audit reporting techniques
• Classification of findings
• Corrective action requests
• Audit follow-up and verification

Module 7: Corrective Actions and Continual Improvement

• Root cause analysis
• Corrective action effectiveness
• Monitoring improvements
• Risk and opportunity management

Module 8: Practical Exercises and Case Studies

• Audit simulations
• Checklist development workshop
• Nonconformity identification exercises
• Mock audit activities
• Group presentations and discussions

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Training Methodology

The course will be delivered using interactive and practical learning approaches, including:

• Instructor-led presentations
• Interactive discussions
• Real-life laboratory case studies
• Group exercises and workshops
• Mock audits and role plays
• Audit checklist preparation
• Practical audit reporting exercises
• Question and answer sessions
• Continuous assessment and feedback

Participants will receive training materials, audit templates, sample checklists, and practical exercises to enhance understanding and implementation skills.

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Course Duration

2 – 3 Days

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Expected Learning OutcomeUpon successful completion of the course, participants will gain the competence to effectively conduct internal audits of medical laboratory management systems in accordance with ISO 15189 requirements and ISO 19011 auditing guidelines.

Fees

Online- £900 per

£2,500 for 3-5 Participants

£3000 for a group of 6- 10 participants

Registration: Send name, email address and course title to info@iscbonline.com