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

Lead Auditor - ISO 15189:2012

• In today’s hyper competitive landscape, it is imperative for Medical Laboratories to function effectively; and deliver the most reliable results that guarantee the accurate diagnosis & treatment of patients. This course is designed to help professionals build the capability to initiate & spearhead an audit for ISO 15189, to assist medical laboratories in maintaining the highest level of quality & integrity through all their processes.
• You will grasp the key concepts, techniques & procedures for successfully executing an ISO 15189 audit in the capacity of a Lead Auditor. Build the competence to plan for an ISO 15189 audit, propel team towards goal fulfillment, monitor, evaluate, interpret key audit findings, communicate results to clients & maintain compliance to the ISO 15189 standard, while constantly improving the medical laboratory’s management system.
• Empirical approach to coaching will include detailed training material, assignments, case studies and presentations to assist students in analysis and synthesis of body of knowledge and to develop required skills.
• On course completion, appear for the exam and qualify for Credentials Global’s ISO 15189 Lead Auditor certification.
• This course is open to all professionals, health specialists, quality managers, compliance executives, experts, who intend to lead audits conforming to the ISO 15189 standard.

Key Outcomes:

• Acknowledge the objective and value of an ISO 15189 audit
• Understand how ISO 15189 correlates to other international regulatory frameworks
• Appreciate how conforming to ISO 15189 can improve the reliability, validity & accuracy of test results & positively impact patient health & safety
• Interpret the requirements of ISO 15189 that need to be fulfilled for successful accreditation
• Develop confidence to lead & manage an ISO 15189 audit successfully
• Gain the skill set to initiate, execute, monitor, evaluate, draft audit reports & carry out improvements to achieve excellence in operation & management of Medical Laboratories
• Assist the medical laboratory to maintain compliance to ISO 15189

Course Chapters:

Chapter 1 Introduction to Course
Chapter 2 Introduction to Standard & Terms and Definition
Chapter 3 Quality Related Concepts
Chapter 4 Process Mapping
Chapter 5 Conformity Assessment
Chapter 6 Organization & Management Responsibility
Chapter 7 Quality Management system and Document Control
Chapter 8 Service Agreements & Examination by referral laboratories
Chapter 9 External Services & Suppliers
Chapter 10 Advisory Services & Resolution of Complaint
Chapter 11 Non conformities & CAPA
Chapter 12 Continual Improvement and Control of Records
Chapter 13 Evaluation & Audits
Chapter 14 Management Review
Chapter 15 Personnel
Chapter 16 Accommodation & Environment
Chapter 17 Equipments, Reagents & Consumables
Chapter 18 Process Control
Chapter 19 Quality Control
Chapter 20 EQA
Chapter 21 Laboratory Information Management System
Chapter 22 Guidelines For Auditing Management Systems
Chapter 23 Audit Excellence

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

What is the course attendance criteria?

• A minimum attendance of 80 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 80 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, 40 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.