ISO 15189 Lead Auditor - Online Course

Description

This ISO 15189 lead auditor training course, which comprises audio-visual presentations, handouts, videos, audit checklist and exams, is designed to provide you training and certification to become ISO 15189 lead auditor for Medical Laboratory Management System.  

By enrolling in this e-learning course, you will learn everything you need to know as an ISO15189:2022 lead auditor. Completing this course and getting ISO15189:2022 lead auditor certificate is much easier than any other similar courses available in global market. You can receive this training from your office or home or anywhere through your computer/mobile devices internet at your convenient time with multiple login options. This ISO15189:2022 lead auditor training is immensely useful for busy technical personnel and auditors of medical laboratories and accreditation bodies as well. They can attend this e-learning course from their home or workplace at their own convenient time.

Upon successful completion of this ISO15189:2022 lead auditor training course, the participants will get a certificate for trained ISO15189:2022 Lead Auditor.

TOPICS COVERED UNDER ISO15189:2022 LEAD AUDITOR TRAINING

This ISO 15189:2022 lead auditor training online course comprises three sections, as given below:

Punyam Academy’s ISO 15189:2022 lead auditor training online course has comprises in total 9 Sessions, as given below:

• Session 1: Overview of ISO 15189:2022
• Session 2: Requirements of ISO 15189:2022
• Session 3: ISO 15189:2022 Management System Documentation
• Session 4: ISO 15189:2022 Accreditation Process
• Session 5: Risk Management
• Session 6: Audit Process
• Session 7: Audit Terms and Definitions & Roles and Responsibilities
• Session 8: Performing an Audit based on ISO 15189:2022
• Session 9: Nonconformity and Corrective Action.

1. Handouts
   For all the above nine sessions, participants will get handouts in more than a total of 100 pages in pdf format. The participants of this ISO15189 lead auditor training can download and save the handouts in their computer and print them or read them offline to get detailed knowledge of all the nine topics mentioned above.
   • Manaul - In Session 8, a practical example of real-life medical laboratory management system manual is given for performing document review and understanding adequacy audit findings. Such real-life case study of a ISO 15189 manual will help participants to gain better knowledge and skill of auditing.
   • Audit Checklist - A complete set of more than 500 audit questions (ISO15189:2022 requirement-wise) are given as a ready tool to perform/lead the audit of medical laboratories. The ISO15189:2022 audit checklist also helps laboratory personnel to prepare for the final audit by accreditation body assessors. The participants can download it for future reference and use it during the audit process of the organization.
2. Videos
   This part of the training provides online training video tutorials on management system documentation, audit process, etc.
3. Exams
   In this course, the participant will be required to clear all nine session exams and one final exam as given in a separate section of the course. After successfully passing the final exam, their auto-generated ISO15189:2022 Lead Auditor Certificate will be issued and can be downloaded and printed from the dashboard.

COURSE OBJECTIVES

After completion of this ISO15189 auditor training e-learning course, you will be able to:

• Familiarize yourself with the new structure and clause-wise requirements of ISO15189:2022.
• Know about requirements for pre-examination, examination and post-examination processes
• Know the structural, governance and resource requirements for medical laboratories.
• Know the management system requirements for medical laboratories.
• Understand the new concepts of risk management and risk evaluation techniques
• Know which documents and records have to be maintained/retained by laboratories as per new requirements of ISO15189:2022.
• Learn how to perform/ lead audit of a medical laboratory.
• Use ISO15189:2022 clause wise audit checklist.
• Understand the processes involved in auditing, including opening meeting and closing meeting as per ISO 19011 standard for auditing of management system.
• Know about the types of auditing and questioning techniques.
• Know key terms and definitions useful for ISO15189:2022 lead auditors and their roles and responsibilities
• Familiarize yourself with ISO15189:2022 Laboratory Accreditation process.

WHO SHOULD ATTEND THIS COURSE?

Any professionals working with medical laboratories or those with ISO15189:2022 accreditation bodies should attend this ISO 15189:2022 lead auditor training. This online training can be beneficial for the following:

• Personnel of medical laboratories.
• Quality managers of laboratories
• Laboratory managers
• Director/ management of laboratories and their representatives
• ISO 15189 consultants, compliance executives, experts
• Anyone who intend to perform audits conforming to the ISO 15189:2022 standard.

This course is developed and brought to you by Punyam Academy, an Exemplar Global (USA) recognized training provider company. Now we are offering this ISO15189:2022 Lead Auditor training for working professionals, medical laboratory personnel, QA Assessors, Quality Managers, and other individuals for enhancing their career to new heights by becoming ISO15189:2022 Lead Auditor. Our e-learning courses help them to succeed in today's competitive environment, to renew licenses, and to update, strengthen and add quality to their existing knowledge and skills. Our courses are also useful for those who want to get a certification or start a new profession as a lead auditor.

This course has been created by a team of our consultants having rich experience in ISO15189 management system consultancy in more than 35 countries, ISO 15189 accreditation for laboratories across the world, as well as vast experience of designing and conducting various ISO e-learning courses and training programs in convenient and cost-effective ways.

If you are a working professional, a student, an entrepreneur, or an individual looking for ISO15189:2022 lead auditor certification online, Enrol Now!

PREREQUISITES

Following are considered as an added advantage for participants of this ISO15189:2022 Lead Auditor Training course:

• Knowledge of Quality management systems.
• Knowledge of medical laboratory activities
• Experience of working in a medical laboratory
• Ability to understand instructions in simple English
• People having a Diploma or Bachelor's degree definitely have an edge over the less qualified participants.

More Information

ISO has published the fourth edition of ISO 15189 standard in December 2022. Now accreditation of medical laboratories will be given by recognized accreditation bodies based on the requirements of the new edition of ISO 15189 standard. The new edition has been completely revised and aligned with ISO/IEC 17025 standard. Among other major changes like increased emphasis on risk throughout the standard, the latest standard includes the requirements for point of care testing (POCT), which were earlier specified in ISO 22870 standard.

Our ISO15189:2022 lead auditor training addresses all the elements of the latest technically revised edition of ISO 15189 standard for quality and competence of medical laboratories. Participants of this course will get a complete overview of the new standard, including its features, benefits and what is new in the revised edition. This online ISO15189:2022 lead auditor training gives a detailed knowledge of all the requirements and process for ISO15189:2022 accreditation of any medical laboratories. In addition, this online ISO 15189 lead auditor training course participants will gain knowledge and understanding of various activities involved in the audit. They will know Audit Techniques, Audit Process, and Audit Requirements as per ISO 19011:2018 guidelines for management system audit. This course provides knowledge of how to conduct an opening meeting, perform an external audit as well as to conduct a closing meeting in any organization. This comprehensive e-learning course will help the medical laboratory mangers, personnel as well as accreditation body auditors to qualify as 'Lead Auditor' for Laboratory Management System based on ISO15189:2022 and get lead auditor certification.

AUTHORS & INSTRUCTORS

For details of the authors, trainers and instructors experience and background, please visit our trainers page. They have very rich experience on the subject.

STUDY MATERIALS

This e-Learning course is provided with study materials and you can read it after your log in or download (PDF format). Use the study materials to reinforce key points and to keep a reminder of what you already learned as well as you can save it in your computer for future reference. The access of this study material is removed after exam is cleared and on line certificate is prepared for the student.

EXAMINATION AND COURSE CERTIFICATE

All paid E-learning course includes the Course Certificate that is issued upon course completion and passing the session exams as well as a final exam given in the course with minimum 60% marks. The option to reappear in the exam is also given to student, if failed in any exam.

END OF COURSE INSTRUCTION

After completing the session and passing each session examination the student can appear for final exam. Once the final exam is cleared then it is considered a end of course. The training certificate is ready on our LMS and student can print it or save the training certificate. It is also available for verification by entering the name and certificate number.