ISO 20387 Internal Auditor Course

Course Objectives

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

1. Understand the principles, structure, and requirements of ISO 20387 and its application within biobanking operations.
2. Interpret the clauses and requirements of ISO 20387 in the context of biobanking competence, impartiality, and consistent operation.
3. Understand the roles and responsibilities of internal auditors in maintaining compliance with ISO 20387 requirements.
4. Plan, conduct, report, and follow up internal audits in accordance with auditing principles and guidelines.
5. Identify nonconformities, risks, and opportunities for improvement within a biobank management system.
6. Evaluate the effectiveness of operational controls, quality systems, and competence requirements in biobanking activities.
7. Apply risk-based thinking and evidence-based auditing techniques during internal audits.
8. Prepare internal audit reports and corrective action requests effectively.
9. Support continual improvement and readiness for accreditation or certification audits.
10. Enhance organizational confidence in the reliability, traceability, and quality of biological materials and associated data.

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Target Audience

This course is designed for:

• Internal auditors involved in biobanking quality management systems.
• Quality managers and quality assurance personnel in biobanks.
• Laboratory managers and technical personnel responsible for biobanking activities.
• Compliance officers and risk management personnel.
• Personnel involved in specimen collection, storage, processing, transportation, and distribution.
• Consultants and professionals supporting biobank accreditation initiatives.
• Researchers and scientific staff involved in biological resource management.
• Individuals seeking knowledge of ISO 20387 internal auditing practices.
• Organizations preparing for accreditation against ISO 20387 requirements.

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Course Content

Module 1: Introduction to ISO 20387

• Overview of biobanking concepts and terminology
• Importance of biobanking quality and competence
• Scope and purpose of ISO 20387
• Relationship with other management system standards
• Benefits of implementing ISO 20387

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Module 2: Fundamentals of Internal Auditing

• Principles of auditing
• Types of audits
• Auditor responsibilities and ethics
• Risk-based auditing approach
• Audit lifecycle and audit program management

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Module 3: Overview of ISO 20387 Requirements

• General requirements
• Structural requirements
• Resource requirements
• Process requirements
• Management system requirements

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Module 4: Context of the Organization

• Understanding organizational context
• Needs and expectations of interested parties
• Scope determination
• Biobank processes and interactions

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Module 5: Leadership and Governance

• Leadership commitment
• Quality policy and objectives
• Roles, responsibilities, and authorities
• Organizational governance in biobanking

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Module 6: Resource Management

• Personnel competence and training
• Infrastructure and environmental conditions
• Equipment calibration and maintenance
• Information management systems
• Outsourced services and suppliers

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Module 7: Operational Processes in Biobanking

• Sample acquisition and collection
• Sample processing and preservation
• Storage and inventory management
• Traceability and chain of custody
• Transportation and distribution
• Data protection and confidentiality

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Module 8: Risk Management and Control

• Identification of risks and opportunities
• Preventive controls
• Risk assessment techniques
• Handling deviations and incidents

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Module 9: Audit Planning and Preparation

• Establishing audit objectives, scope, and criteria
• Audit planning and scheduling
• Preparation of audit checklists
• Document review techniques

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Module 10: Conducting Internal Audits

• Opening meetings
• Interviewing techniques
• Collecting objective evidence
• Sampling methods
• Identifying conformity and nonconformity

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Module 11: Reporting Audit Findings

• Classification of audit findings
• Writing nonconformity statements
• Audit report preparation
• Conducting closing meetings

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Module 12: Corrective Actions and Follow-Up

• Root cause analysis
• Corrective action planning
• Verification of effectiveness
• Continual improvement processes

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Module 13: Practical Workshops and Case Studies

• Audit simulations
• Real-life audit scenarios
• Writing audit reports
• Group exercises and discussions

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Module 14: Final Assessment and Course Review

• Written examination
• Practical evaluation
• Review of key learning points
• Feedback and course conclusion

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Expected Learning Outcomes

Upon successful completion of the course, participants will be able to:

• Conduct effective internal audits against ISO 20387 requirements.
• Identify weaknesses and improvement opportunities in biobank operations.
• Contribute to maintaining biobank competence and quality assurance.
• Support compliance and continual improvement initiatives within their organization.
• Prepare organizations for external accreditation assessments.

Duration: 3 Days

Delivery Methods:

Online Fee: £1,200 per participants

£4000 for a group of 4 -8 participants

Self Study: £500 per participants

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