Certified Internal Auditor - ISO 15189 Medical Laboratories - Quality Management System

Internal Auditor - ISO 15189:2012

• This course is designed to help professionals build the confidence to participate in & contribute to an ISO 15189 complaint internal audit. As an Internal auditor for ISO 15189 you will engage in initiating and maintaining an efficient quality management system for your medical laboratory. By attaining compliance with ISO 15189, your laboratory will have a structured framework to streamline its processes, personnel, equipment, operations & service offerings. You can ensure that patient safety and ethical practices are prioritized.
• Gain the skills to plan for and initiate an ISO 15189 audit internally, assess audit findings, draft audit reports, propose corrective measures & evaluate effectiveness of the audit. As an Internal Auditor, you will work towards maintaining conformity to ISO 15189 & updating the laboratory’s quality management system.
• Build a strong foundation for auditing for ISO 15189 though lectures, workshops, discussions, group activities, role plays and case study analysis.
• On completion of training, appear for the exam and qualify for Credentials Global’s ISO 15189 Internal Auditor certificate.
• This course is open to professionals engaging in or monitoring internal audits for ISO 15189.

Key Outcomes:

• Gain understanding of the ISO 15189 standard
• Acknowledge the objective & significance of an ISO 15189 audit
• Appreciate the role and accountability of an ISO 15189 Internal Auditor
• Interpret the requirements to establish conformity to ISO 15189
• Plan for and engage in an internal audit for ISO 15189, review audit data, communicate results, propose recommendations and initiate follow up audits
• Formulate strategy to boost the effectiveness of laboratory procedures, equipment & personnel
• Assist the laboratory to achieve conformity with ISO 15189

Course Chapters:

Chapter 1 Introduction to Course
Chapter 2 Introduction to standard & Terms & Definition
Chapter 3 Quality related concepts
Chapter 4 Process Mapping
Chapter 5 Conformity Assessment
Chapter 6 Management Requirements
Chapter 7 Technical Requirements I
Chapter 8 Technical Requirements II
Chapter 9 Understanding the terms and Definition of Auditing
Chapter 10 Guidelines for auditing management system

Certified Internal Auditor - ISO 15189 Medical Laboratories - Quality Management System etraining online Course

What is the course attendance criteria?

• A minimum attendance of 32 hrs on Learning Management System (LMS) activity for the duration of course is required.
• However, we encourage students to log in maximum number of hrs within a given course duration to take maximum benefit of learning material.

How assignments will be evaluated/graded?

• Assignments will not be graded.
• Assignments will consist of Descriptive Type Questions and Case Studies.

What is the nature of qualifying examination?

• Qualifying examination consist of Multiple Choice Questions.

What is the examination eligibility criteria?

• An open book test can be scheduled once student completes minimum 32 hrs on LMS and completes all given Assignments.

How assignments will be evaluated/graded?

• Assignments will not be graded.
• Assignments will consist of Multiple Choice Questions, True or False, Match the Pairs, Descriptive Types and Case Studies.
• Only Multiple Choice Questions- Auto Diagnostics Feedback is given.

How examination results are presented?

• The designations P (Pass) and NP (Not Pass) are used. No grades are reported.

What are the examination pass norm?

• It is expected that at least 80% of students attending this course should pass at first attempt.

What are the documents permitted during the open book examination?

• Course material
• Copy of ISO 15189 standard
• Copy of ISO 19011 standard

What is the certification policy?

• Certification will be given to student who completes all assignments satisfactorily and clears the examination with the designation P.
• Certification of successful completion are endorsed with the Credentials Global logo and ACCAB’s “Responsible Education Provider”™ Logo
• Student who does not qualify for certificate of successful completion may be awarded a letter of attendance.

What is the re-examination policy?

• A student who gets a letter of attendance after the initial course may apply to be allowed to sit for a re-examination within 1 month from the issuing of the results. A candidate who fails re-examination is required to take the course again paying full fees.

What is complaints and appeals policy?

• Student May raise any complaint in writing or orally, both during the course and afterward. Student is also given the opportunity to raise any issues of the concern during the formal evaluation at the end of the course.
• Contact information: Info@credentialsglobal.com

Do I receive Professional Development Units (PDUs) for the course?

• Yes, 16 PDUs

Is this course accredited?

The Credentials Global education provider accredited with the Accreditation Commission of Conformity Assessment Bodies (ACCAB) www.accab.org

ACCAB’s "Responsible Education Provider"™ Accreditation is a voluntary quality assurance scheme for independent private sector Further Education & Training Institutions(FETIs) including Independent Higher Education Providers, Distance Learning Institutions, Professional Short Course Providers and Specialty Tutorial Schools & Colleges.

The objectives of ACCAB’s “Responsible Education Provider”™ Accreditation Scheme are:

• FETIs have appropriate management systems in place and control over their processes;
• Personnel that are employed by FETIs have required competencies to perform their duties;
• FETIs follow rigorous and consistent processes to educate, train and evaluate students;
• To enable FETIs to state publicly that they have voluntary accepted ACCAB’s “Responsible Education Provider”™ Accreditation Scheme for maintenance and continual improvement of their services delivery.