ISO 15189 Online Internal Auditor Course
Medical Laboratories | Medical laboratories
Aim of the course
ISO 15189 is the internationally recognized standard relating to the competence of medical laboratories. It specifies criteria for the development and assessment of management systems and laboratory technical controls that provide confidence in the results obtained. The standard covers the medical laboratory services including examination requests, patient preparation, sample collection, transport and storage, processing, examination of clinical samples, interpretation and advice in addition to consideration of safety and ethics relating to clinical work.
This online training course will equip delegates with effective auditing techniques and increase their understanding of audit methodologies to assess against ISO 15189 in order to ensure continued compliance, determine improvements, professionally report findings and implement corrective action programmes.
This online internal auditor training has been designed to give you the necessary skills to perform internal audits in a medical laboratory in accordance to the requirements of ISO 15189.
Who can attend this course?
• Quality Managers
• Companies seeking ISO 15189 accreditation
• Certification / Registrar / Accreditation body auditors
• Existing internal auditors who are looking to expand their skills in the area of laboratory practices
• Supplier Quality Auditors who need to evaluate clinical laboratory services
What are the benefits of attending this course?
• Prepare, conduct and follow-up on ISO 15189 audit activities
• Identify the benefits and requirements of an ISO 15189 audit
• Gain the skills to assess an organization's capability to manage its QMS
• Be able to write factual audit reports and suggest corrective actions
What is covered?
• Terminologies & vocabularies in standards.
• Slides carries structure & Overview of 15189 with explanations and examples.
• Planning & Conducting of Internal Audit.
• Writing, reporting and follow up of non-conformities.
• Real time audit non conformity scenario
• Standard copies
• Delegate course reference materials
• Online/Email support to clarify quires.
• Quizzes at the end of module
What prior knowledge should I have?
It is highly recommended that you have prior knowledge of the following concepts:
• The Plan-Do-Check-Act (PDCA) Cycle
• Basic knowledge of the requirements of ISO 15189 standard.
• Commonly used terms and definitions
ISO 15189 internal auditor training online course can be completed within thirty days from the date of registration. All successful candidates will be awarded on ISO 15189 Internal Auditor certificate.
Criteria for successful completion
The evaluation of this course will be based on the scores obtained on the minimum of 70% in final exam.
The final exam will have 3 sections:
Section A: will contain 10 objective questions carrying one mark each.
Section B: will have 4 short answer questions, each carrying five marks.
Section C: Two audit scenario case studies carrying ten marks each.