Certified ISO 17025 Lead Auditor

Certified ISO 17025 Lead Auditor

What is ISO lead auditor?

ISO/IEC 17025 is an international standard for testing and calibration laboratories. The main objective for this standard is to ensure the quality and conformity of testing labs and their results. This is very essential to avoid errors that can cause anything from repeating the job to fatal mistakes that might lead to severe casualties.

ISO/IEC 17025 deals with three main pillars:

  • The quality management system of the lab itself
  • The competency of the staff working at the lab
  • The equipment

How do I become an ISO Lead Auditor?

To be come an ISO 17025 Lead Auditor, you must first undertsand the guidelines for this standard. You can do this either on your own by research online, or you can buy material regarding this ISO standard. Then you need to traing yourself on this standrd by memorizing and understanding the international guidelines. You can also get training from special training providers or train yourself on your own.

Then you must take the ISO 17025 Lead Auditor TEST through an accredited Personnel Certification Body that has this test within its scope.

The Test is either done online or in person through testing centers like Prometric

Upon successful completion of the test, you will be granted the ISO 17025 Lead Auditor certification which can be very helpful for recognizing your competencies in this field. Whether you are an internal lead auditor at your company or an external lead auditor who conducts regular audits to clients, this certification is very important for your competitive edge, competency building and credibility.

 

What do testing labs usually get accredited for?

Testing Labs seek ISO/IEC 17025 accreditation for:

  • Their quality management systems
  • Their calibration artifacts
  • Their PT Programs (Conformity Assessment)

Staff however do not get direct accreditation/certification from the ISO/IEC 17043 accreditation body. This is where a Personnel certification is an added value for the lab, the working staff and the industry.

 

What does it mean to have ISO 17025 certified lead auditors at your lab?

To have staff with ISO 17025 Lead Auditor certification means your lab is better equipped with competent staff to ensure the sustainability of the ISO/IEC 17025 Standards. Accredited Labs with certified lead auditors define a high competent lab.

 

Should I only pursue ISO 17025 Lead Auditor certification if I work at a lab?

As a matter of fact, having a personnel ISO 17025 Lead Auditor certification means you are more competent than others in your field. This will help you in advancing in your career or successfully landing at new labs who appreciate this specific competency in Lead auditors.

 

Overview

  • This program is a worldwide accredited program from the American Accreditation
    Association (AAA) according to ISO/IEC 17024 to provides certification for Lab Lead
    auditors as evidence for their competence to perform auditing of testing/ Calibration
    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/IEC 17025:2017 requirements for Testing and Calibration
    Laboratories.
  • 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

Benefits of Certification

  • Be recognized 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.

  • 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?

  • Testing/ Calibration Laboratories auditors, such as those employed by laboratories or
    Accreditation Bodies
  • Laboratory management practitioners, such as Laboratories management consultants,
    quality managers and Lab managers managers
  • 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 17025 requirements 30%
4.1 Audit General requirements 3%
4.2 Audit Structural requirements 2%
4.3 Audit Resource requirements 9%
4.4 Audit Process requirements 10%
4.5 Audit Management System requirements 6%
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. The laboratory shall have a system for the unambiguous identification of test or calibration
    items. The identification shall be retained:

    1. While the lab is testing the item
    2. While the item is under the lab responsibility
    3. Till return of the item to the customer
    4. Till release of the test report
  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/IEC 17025:2017 clauses is the most relevant to the following finding?
    Although statement of conformity to relevant regulations are provided in test reports but the
    decision rule employed found not established/documented

    1. (7.8.7)
    2. (7.8.6)
    3. (6.4.6)
    4. (6.2.1)
  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. Some customers usually wanted their test
    items returned, but 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/IEC 17025
    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. Traceability includes three components for each step in the traceability chain:
    1. Uncertainty, calculation, documentation
    2. Competence in calibration, uncertainty, traceability
    3. Documentation, registration, reference to the SI
    4. Competence in calibration, uncertainty, reference to the SI

All of the above Corrrect Answers Versus JTA Domains

65C72C846

Question Domain Correct Answer
1 3 B
2 5 A
3 2 B
4 1 C
5 3 B

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/IEC 17025: 2017, General requirements for the competence of testing and calibration
    laboratories
  • ILAC-G20:2002 , Guidelines on Grading of Non-conformities
  • ILAC-G11:07/2006, ILAC Guidelines on Qualifications and Competence of Assessors and
    Technical Experts
  • ILAC-G11:07/2006, ILAC Guidelines on Qualifications and Competence of Assessors and
    Technical Experts
  • 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 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

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