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- Al Khobar Al Shamalia, Al Khobar 34427, Saudi Arabia
- [email protected]
- Sun _ Thrs: 9.00 to 18.00
Lead Auditor Course
Lead Auditor Course
ABOUT COURSE:
Our 5-day ISO/IEC 17025:2017 Lead Assessor Training course is designed to develop and further enhance your understanding of the newly released ISO/IEC 17025:2017. Participants will cover the full range of assessment techniques, good practices, and assessor responsibilities and gain practical experience of planning, running, and reporting on assessments.
COURSE OVERVIEW:
Ashbrooke’s 5-day ISO/IEC 17025:2017 Assessor/Lead Assessor Training Cours is designed to develop the necessary expertise to audit a Laboratory Management System based on the updated ISO/IEC 17025:2017 standard requirements Participants will cover the full range of assessment techniques, good practices, and assessor responsibilities and gain practical experience of planning, running, and reporting on assessments; after which each successful delegate will have earned his/her training qualification for certification as an IRCA Lab QMS Auditor / Lead Auditor.
This new ISO/IEC 17025:2017 aligns and harmonizes the requirements for a Laboratory Management System with ISO 9001:2015. The five-day course incorporates and explains the amendments to clauses where ISO determined that such changes were necessary. The technical requirements for laboratories who provide testing and calibration services are enhanced by the use of management systems Assessor/Lead Assessor Training Cours is designed to develop the necessary expertise to audit a Laboratory Management System based on the updated ISO/IEC 17025:2017 standard requirements Participants will cover the full range of assessment techniques, good practices, and assessor responsibilities and gain practical experience of planning, running, and reporting on assessments; after which each successful delegate will have earned his/her training qualification for certification as an IRCA Lab QMS Auditor / Lead Auditor.
This new ISO/IEC 17025:2017 aligns and harmonizes the requirements for a Laboratory Management System with ISO 9001:2015. The five-day course incorporates and explains the amendments to clauses where ISO determined that such changes were necessary. The technical requirements for laboratories who provide testing and calibration services are enhanced by the use of management systems that incorporate the requirements of ISO 9001:2015.
This is generally followed by understanding: 1. ISO 19011:2015 2. Quality Management principles 3. ISO/IEC 17025:2017 principles Over 90% of the course is dedicated to syndicate activities designed to examine and explore the disciplines of planning and conducting QMS audits. This course contains 4 Questionnaires, 8 Workshops, plus several additional skills development activities. Prior Knowledge Expectation… To ensure detailed and through understanding it is advised to: 1. Fill Pre-course form 2. Have basic understanding of ISO/IEC 17025:2017 before attending this course. 3. Basic knowledge of Management System and in particular Quality Management
COURSE OBJECTIVE:
This intensive 5-day course is certified by the Governing Board of the International Register of Certificated Auditors (Ashbrooke Quality Assurance Ltd. IRCA Certificate No. A17020). On successful completion of this course participants will achieve one of the formal requirements in becoming an IRCA Registered Lead Auditor. This course will allow delegates to develop practical audit skills and apply the newly updated management and technical requirements of ISO/IEC 17025:2017 to the specific processes and needs of the company.
Furthermore delegates will be able to assess compliance of an organization’s testing and calibration laboratory practices to meet the company’s own internal or external (e.g. Accreditation Body) requirements. This course will show attendees on how to plan, develop and implement an internal and external audit process appropriate to the requirements of ISO/IEC 17025:2017 with confidence. Interactive learning techniques are used to teach delegates how to identify risks and opportunities in an organization and take preventative action against risks. On top of that this course will coach delegates on how to save time and cost through more efficient lab testing procedures and calibration processes.
WHO SHOULD ATTEND?
1. This seminar is designed for Lab Management Representatives, ISO/IEC 17025:2017 Implementation Teams, Internal Auditors and others who would like to develop judgment and decision-making in ISO/IEC 17025:2017 and learn the auditing process for first, second, and third party auditors.
2. Anybody that wants to comply with mandatory ISO/IEC 17025:2017, SASO Saudi Arabia, ESMA UAE, DAC Dubai or any other country requirements for training of Quality Managers in laboratories.
3. Professionals that want to know the advantages of operating an effective laboratory management system.
4. Anybody that is looking to expand his / her skills in the area of good laboratory practicesAnybody involved in preparing an organization for
assessment/accreditation by Govt. Agency, any Accreditation Body around the world.
5. Existing ISO 9001:2015 / ISO/TS 16949 auditors who are looking to expand their skills in the area of laboratory practices or who wish to audit laboratory environments.
The below mentioned roles and designation are mostly attending this ISO/IEC 17025:2017 Lead Auditor Courses, but not limited to:
1. Laboratory Directors and Managers
2. Technical Director and Managers
3.Laboratory Operation Manager
4.Govt. Laboratory Officials
5.Quarantine and Regulatory Laboratory Inspectors
6.Laboratory Engineers and Calibration Engineers
7.Laboratory Technicians
Medical Laboratory Technician
8.Calibration Technicians
9.Laboratory Analysts
10.Technical experts wanting to prepare for alaboratory audit function
11.Members of the Laboratories seeking ISO/IEC17025:2017 accreditation
12.Auditors wanting to perform audits underISO/IEC 17025:2017
Laboratory Engineers and Calibration Engineers
13.Laboratory Technicians
Medical Laboratory Technician
14.Calibration Technicians
15.Laboratory Analysts
16.Technical experts wanting to prepare for a laboratory audit function
17.Project managers or consultants wanting to
18.master the Laboratory Management System audit process
Above mentioned are not only group people to attend this course but if you are associated or interested in improvement of Quality Management systems for lab, you are encouraged to attend this course.
COURSE PREREQUISITES:
To ensure detailed and through understanding it is advised to:
- Fill Pre-course form
- Have basic understanding of ISO/IEC 17025:2017 before attending this course.
- Basic knowledge of Management System and in particular Quality Management System
Knowledge of the ISO 9001:2015 and ISO / IEC 17025:2017 requirements may be gained by completing the respective QMS Foundation Training Course or equivalent.
COURSE CERTIFICATION:
Ashbrooke’s course is approved by IRCA (IRCA Certification No. A17020) and Chartered Quality Institute (CQI).It meets the training require ments for individuals seeking registration as a Lead Auditor under the IRCA Auditor Registra tion Scheme.
COURSE OUTLINE:
Day Nr. 01
- Introduction
- Course Requirements
- Pre-Course Questionnaire review
- Normative, regulatory and legal framework related to laboratory management
- Fundamental principles of laboratories management
- Laboratory Management System (LMS)
- Auditor Code of Conduct
- Key Vocabulary – Review
- Principles – Review
- Audit Cycle
- Case Study 1 – Examining Documentation to ISO/IEC 17025:2017
- Audit Trail Challenge
Day Nr. 02
- Open Review
- Questionnaire No. 1
- Auditor‘s Challenge – Incident
- Case Study 2 – Preparing a Checklist
- Audit Trail Challenge
- Case Study 3 – Preparing an Audit Plan
- Audit Trail Challenge
- Case Study 4 – Conducting an Opening Meeting
- Auditor’s Bingo
Day Nr. 03
- Open Review
- Questionnaire No. 2
- Auditor’s Challenge – Incident
- Case Study 5 – Conducting an Interview
- Auditor’s Challenge – Incident
- Auditor’s Bingo
Day Nr. 04
- Open Review
- Questionnaire No. 3
- Auditor’s Challenge – Incident
- Case Study 6 – Preparing an Audit Report
- Audit Trail Challenge
- Case Study 7 – Conducting a Closing Meeting
- Case Study 8 – Follow-up and Review of Corrective Action
- Auditor’s Bingo
Day Nr. 05
- Open Review
- Questionnaire No. 4
- Audit Trail Challenge
- Final Instructions and Questions
- Final Examination
- Course Close
TRAINING METHODOLOGY:
- Interactive training room based sessions
- Presentations including examples
- Accelerated learning techniques
- Participative discussion & workshops
- Roles plays and delegates interaction
- Industry specific and real time operational examples
- All of the course material and the instructions will be in English.
COURSE ASSESSMENT:
The delegate is assessed based on participation and performance throughout the duration of the course. This includes all exercises, role plays, case studies and all other activities during the course. Please note, full attendance is required during the training course. There is a 2 hour written examination at the end of the course. The exam is closed book, however delegate is entitled to use only their copy of the International Standard (s) and/or dictionary if delivery language is not their native language. The minimum pass rate for the examination is 70%. The “Certified ISO/IEC 17025:2017 Lead Auditor” exam fully meets the requirements of the IRCA United Kingdom Examination and Certification Program. The exam covers the following Competence domains:
- Fundamental concepts and requirements of ISO/IEC 17025:2017
- Laboratory Management System
- Fundamental Audit Concepts and Principles
- Preparation of an ISO/IEC 17025:2017 audit
- Conducting of an ISO/IEC 17025:2017 audit
- Closing an ISO/IEC 17025:2017 audit
- Managing an ISO/IEC 17025:2017 audit program
The “Certified ISO/IEC 17025:2017 Lead Auditor” exam is available in English languages and the duration of the exam is 2 hours. After successfully completing the exam, participants can apply for the credential of certified ISO/IEC 17025:2017 Provisional Auditor, Certified ISO/IEC 17025:2017 Auditor or Certified ISO/IEC 17025:2017 Lead Auditor depending on their level of experience. Those credentials are available for internal and external auditors. A certificate will be issued to participants who successfully passed the exam and comply with all the other requirements related to the selected credential. For more information about ISO/IEC 17025:2017 certifications and IRCA certification process, refer to IRCA Website on ISO/IEC 17025:2017 Lead Auditor Certification. In case of failure of the exam, participants are allowed to retake the exam (Kindly contact BEMCON team for more details).
SESSION INFO:
Teaching Hours
40
Total Hours
50
Number Of Days
5 Full Days
Case Studies
10
Number Of Attendees
10-12
Number Of Exercises
10
Course Assessment
02:00 Hours Writing Exam
Question Type
Descriptive and scenario based
Qualification Criteria
70% Exam Score
Certificate Type
Digital Certificate
COURSE FEE:
Course Fee is US $2000/- for each candidate.
This fee covers the cost of enrollment, delegate manual, examination fee and fee for the certificate.
The discount policy is below:
Note:
For students, Govt. Official and NGOs staff, it is required to present official ID to avail the discount.
For already accredited Lab, the Lab Accreditation Certificate copy shall be required.
What is included in the package?
| 1 | Student | = | 15% |
| 2 | Govt. Official and Staff from Govt. Labs | = | 10 % Discount |
| 3 | NGO’s Staff | = | 10 % Discount |
| 4 | Multiple participation from same organization | = | 10 % Discount |
| 5 | BEMCONIANS (Existing BEMCON Customers) | = | 15% Discount |
- Comprehensive Course Manual
- Course Workshops and Interactive Exercises
- Additional Handouts
- 5 days Lunch and teas
- Certification of successful candidates
VENUE:
Our training course will be arranged considering your ease as well as health and safety. A BEMCON representative will email you the details of the venue prior to the scheduled training date.
DAMMAM
JANUARY 26-30, 2025 SUNDAY - THURSDAY
RIYADH
FEBRUARY 02-06, 2025 SUNDAY - THURSDAY
JEDDAH
FEBRUARY 09-13, 2025 SUNDAY - THURSDAY
EASY STEPS
4 EASY STEPS REGISTER
The registration will be purely based on “FIRST COME - FIRST SERVE”
Visit www.ISO17025.Training to register online for the course
Upon receiving your registration details, BEMCON will begin your registration process.
Once you receive your registration number that means your enrolment is confirmed.
ATTENDANCE CERTIFICATE:
Candidates not successful in passing the exam, may:
- Get a Certificate of Attendance from BEMCON.
- Re-sit the exam in future sessions conducted at least after 6 months of first appearance in exam.
CHANGE / CANCELLATION POLICY:
If for some official commitment or unforeseen situation, a participant is unable to attend the course on the specified date; they may:
- Attend training session in other cities/countries*1 where BEMCON courses are scheduled in later dates.
- Utilize same amount of invoice for any other courses offered by BEMCON within 6 months of invoice issue date.
- Adjust this invoice for in-house/on-site*2 training session.
Visa arrangements for attending session in other countries and boarding/lodging will be responsibility of participant solely. – In-house sessions are conditional to availability of number of participants for course and is considered confirmed only after written confirmation from BEMCON team member. Trainer’s traveling and lodging expense will be responsibility of company.
CERTIFICATE DELIVERY:
The certificate delivery time is 50 days after the course exam.
The certificates will be delivered to the participants by hand or by post.
In the case of in-house training, the certificate will be handed over to client contact person within the defined timeline.