This program is a worldwide accredited program from the American Accreditation Association (AAA) according to ISO/IEC 17024 to provides certification for medical Lab Lead auditors as evidence for their competence to perform auditing of medical laboratories.
You can get your exam in one of 672 testing centers available in 85 countries all over the world.
The aim of the certification program is to evaluate that the candidate possesses necessary competence (knowledge and skills) to plan and perform internal and external audits of labs according to ISO 15189: 2012 Medical laboratories — Requirements for quality and competence.
The examination is (open book) consists of 100 multiple choice questions by computer-based test (CBT) and 2 hours to complete the test.
the Candidates whom pass the exam and get at least score 70%, will be certified.
The certificate is accredited by the American Accreditation Association (AAA) according to ISO/IEC 17024 which is well-recognized Standard worldwide as the highest standard in personnel certification accreditation.
American directory of competent persons (ADCP) will recognize all the Certified Lead auditors, which is widely used by employers to find auditors worldwide and to proof the auditor competency.
The certification program is provided in partnership with SMT Prometric, the No. 1 organization worldwide which provide testing centers and solutions in most of the countries all over the world.
Benifits of Certification
Be recognised as a competent auditor
IG certified Lead auditors are highly recognized worldwide, The program is accredited by the American Accreditation Association according to ISO/IEC 17024 and the certified Lead auditors will be added to the list of American directory of competent persons (ADCP) which is widely used by employers to find auditors worldwide.
Get Continuing education and professional development credits The program provides continuing education and professional development credits for the personnel working in the health sector field, it is evidence of competency as medical labs lead auditor.
Improve your career prospects
IG certificated auditors are highly valued by employers worldwide and have the highest standards of training and work experience. On average, our certified auditors have higher salaries than non-certified auditors, You’ll become a worldwide recognized certified Lead auditor and use the logo in your email signature and business documents.
Become part of our network
Gain access to a range of networking opportunities where you can communicate with professional peers to share challenges, prospects, opinions and solutions. You can also connect with other members online through our LinkedIn group.
Get the latest reports, news and insights We offer leading information and insights on the development of the different Accreditation and ISO standards. IG certified Lead auditors get free access to our latest reports, information updates on the accreditation standards and guidelines worldwide, as well as the Networks e-newsletter on how we are influencing the profession.
Who Can Be Certified?
Medical labs Laboratories auditors, such as those employed by hospitals, clinics, health care centers and stand-alone laboratories or Accreditation Bodies.
Laboratory management practitioners, such as Laboratories directors, quality managers and Lab pathologists.
Employees conducting Laboratories audits within their own organisations (internal audits).
The policy for awarding recertification is to allow certificants three years from the date of certification to meet recertification requirements.
At the end of each three-year certification period, we ask that you update us on your experience and confirm that you’re still active in the auditing profession.
You can recertify at any time up to three months before your recertification due date. To recertify, you need to submit evidence of your continuing professional development (CPD) and audit experience . In due course recertification will be a fully online process.
4. Auditing lab competence against ISO/IEC 15189 requirements
4.1 Audit management requirements
4.2 Audit technical requirements
5. Using professional lab audit methods and techniques
5.1 perform audit Sampling
5.2 Conduct witness and Vertical audit
5.3 Implement audit concepts
5.4 Interpret principles of lab accreditation
5.5 Developing auditor Professional Competence
Samples of Test Questions
The following sample test questions were developed by subject matter experts. The correct answer key at the end of this list of questions provides the correct answers to each question and represented domain.
Select the best answer of the following
According to ISO 15189, When it is required to monitor the environmental conditions in a lab ?
If required by relevant specifications
Where they may influence the health of staff
Where they may influence the quality of the sample
All of the above
Lab witness audit can be used to:
Confirm technical competence of technicians
Confirm effectiveness of corrective actions
Confirm implementation of QC plan
All of the above
Which of ISO 15189 clauses is the most relevant to the following finding:
The following document is mandatory to be used by the auditor during the lab audit:
Document review report
All of the above
What should be reported by the auditor in the following case :
When asked about what happens to test items after testing is complete, the laboratory manager explained that it all depends on the circumstances. in most cases the items were kept for a few months and then discarded as the storage areas filled up
The lab is implementing effective system for customer satisfaction
The lab is not identifying the retention period for retained samples
The lab is implementing effective system for retention of samples
The lab storage area is not sufficient
The standard explaining the guidelines for auditing management systems is:
Presentation of the audit findings and conclusions during the closing meeting of the audit should be done in such a manner that they are:
Accepted by the auditee
Approved by the auditee
Acknowledged by the auditee
Accepted by the quality manager
Which requirement specifically states the frequency of laboratory internal audits?
ISO 15189 does not specify a frequency for internal audits
Clause 4.13 of ISO 15189
Clause 8.7 of ISO 19011
Annex A of ISO 15189
All of the above Corrrect Answers Versus JTA Domains
ISO 19011:2018, Guidelines for auditing management systems
ISO 15189: 2012 Medical laboratories — Requirements for quality and competence
World Health Organization, WHO lab quality management system handbok
ILAC-G20:2002 , Guidelines on Grading of Non-conformities
ILAC-G11:07/2006, ILAC Guidelines on Qualifications and Competence of Assessors and Technical Experts
IAF& ISO/TC 176/SC 2: 2011, Criteria for Competence of AB Assessors and Assessment Teams
IAF Assessor Working Group ,Validation Report Job Task Analysis (JTA) for Accreditation Body Assessor
SWEDAC DOC 05:6 Version 2, Internal audits and management reviews – guidance for laboratories and inspection bodies
NABL 161 , Guide for Internal Audit and Management Review for Conformity Assessment Bodies
NABET Criteria for accreditation of ISO/IEC 17025 Internal Auditing Training Course
ISO/IEC 17021-1 :2015, Conformity assessment — Requirements for bodies providing audit and certification of management systems — Part 1: Requirements
IG has a Partnership with Prometric Testing Centers for computer-based testing
You can find the nearest testing center to you from from 8,000 secure test centers across more than 160 countries around the world
Prometric is a leading provider of technology-enabled testing and assessment solutions to many of the world’s most recognized licensing and certification organizations, academic institutions, and government agencies. Prometric supports more than 7 million test takers annually at testing locations in more than 160 countries around the world.
With Prometric’s reputation for reliability and professionalism, we are confident that IG candidates will have a great testing experience- from the time you schedule an examination appointment right through the completion of your computer- based examinations.
Prometric recently allowed remote testing. Check Prometric website for more details
Search for the nearest testing center to you from here
Certification Review Committee
Mrs. Katherine Williams American Accreditation Association – AAA (USA)
Dr. John Pitts United Kingdom Accreditation Service (UKAS)
Dr. Thuppil Venkatesh NABL (India)
Ms. Marianne Edman Falkensson Swedish Board for Accreditation and Conformity Assessment- SWEDAC
Dr. Mohamed Saad United Nations Industrial Development Organization (UNIDO)
Dr. Nagib Ibrahim Emirates International Accreditation Centre