Certified Medical Labs Lead Auditor

Overview

  • 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.

Certificate Recognition

  • 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).



Recertification

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.

Exam Contents (Job Task Analysis)

Domain Task Approximate weight %
1. Planning and preparing audit activities 13%
1.1 Managing audit program 3%
1.2 Prepare Audit plan 2%
1.3 Conduct Document review 3%
1.4 Prepare Audit documents 3%
1.5 Assign work to the audit team 2%
2. Conducting onsite audit activities 20%
2.1 Conduct opening meeting 2%
2.2 Communicate during the audit 6%
2.3 Generating audit findings 8%
2.4 Preparing audit conclusions 2%
2.5 Conduct Closing meeting 2%
3. Conducting Post audit and Reporting Activities 8%
3.1 Prepare audit final report 5%
3.2 Completing and follow up the audit 3%
4. Auditing lab competence against ISO/IEC 15189 requirements 30%
4.1 Audit management requirements 15%
4.2 Audit technical requirements 15%
5. Using professional lab audit methods and techniques 29%
5.1 perform audit Sampling 3%
5.2 Conduct witness and Vertical audit 4%
5.3 Implement audit concepts 8%
5.4 Interpret principles of lab accreditation 9%
5.5 Developing auditor Professional Competence 5%

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

  1. According to ISO 15189, When it is required to monitor the environmental conditions in a lab ?
    1. If required by relevant specifications
    2. Where they may influence the health of staff
    3. Where they may influence the quality of the sample
    4. All of the above
  2. Lab witness audit can be used to:
    1. Confirm technical competence of technicians
    2. Confirm effectiveness of corrective actions
    3. Confirm implementation of QC plan
    4. All of the above
  3. Which of ISO 15189 clauses is the most relevant to the following finding:
    1. (5.4.2)
    2. (5.1.9)
    3. (4.15.2)
    4. (4.14.7)
  4. The following document is mandatory to be used by the auditor during the lab audit:
    1. Audit checklist
    2. Audit report
    3. Document review report
    4. All of the above
  5. 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

    1. The lab is implementing effective system for customer satisfaction
    2. The lab is not identifying the retention period for retained samples
    3. The lab is implementing effective system for retention of samples
    4. The lab storage area is not sufficient
  6. The standard explaining the guidelines for auditing management systems is:
    1. ISO 9001
    2. ISO 15189
    3. ISO 19011
    4. ISO 9002
  7. Presentation of the audit findings and conclusions during the closing meeting of the audit should be done in such a manner that they are:
    1. Accepted by the auditee
    2. Approved by the auditee
    3. Acknowledged by the auditee
    4. Accepted by the quality manager
  8. Which requirement specifically states the frequency of laboratory internal audits?
    1. ISO 15189 does not specify a frequency for internal audits
    2. Clause 4.13 of ISO 15189
    3. Clause 8.7 of ISO 19011
    4. Annex A of ISO 15189

All of the above Corrrect Answers Versus JTA Domains

Question Domain Correct Answer
1 4 D
2 5 A
3 2 D
4 1 C
5 3 B
6 5 C
7 2 C
8 4 A

You can download the full Exam handbook from here


Fees

Certification Application and Examination Fees:

    • $300

Retest Fees:

    • $200

Certification Renewal:

  • $300 every three years


References

  • 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

Testing Centers

  • 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

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