This course is intended particularly for laboratories or organizations that work closely with laboratories to develop effective management systems that conform to ISO/IEC 17025.
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16 hours
Combination lecture and classroom exercises
Available at QSG’s training facilities, on-site at your organization, and virtually
ISO/IEC 17025 specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing and calibration quality systems using standard methods, non-standard methods, and laboratory-developed methods.
ISO/IEC 17025:2017 consists of five elements: Scope, Normative References, Terms and Definitions, Management Requirements, and Technical Requirements. The two main sections are Management Requirements and Technical Requirements. Management Requirements are primarily related to the operation and effectiveness of the laboratory’s quality management system. Technical Requirements includes factors that determine the correctness and reliability of the tests and calibrations performed by the laboratory.
An integral part of a successful management system is an effective audit program. An audit program is also essential and required to achieve and maintain accreditation. This ISO/IEC 17025 training course provides a detailed review of ISO/IEC 17025:2017 as well as a review of ISO 19011, Guidelines for Auditing Management Systems.
In this course participants will be introduced to the principles of auditing, will be provided with an approach for developing, implementing, and managing an audit program, will learn the audit process and several audit methods for collecting, verifying, and recording objective evidence, and will discuss audit risks. Numerous hands-on audit activities, including developing and using checklists, are incorporated throughout the course to allow participants to begin to leverage their knowledge gained during the course.
This course is intended particularly for laboratories or organizations that work closely with laboratories to develop effective management systems that conform to ISO/IEC 17025. Participants may include:
Professionals working in or with a Laboratory
ISO Managers/Management Representatives
Auditors (Internal, 3rd Party, and Supplier)
Process Owners
Through training, participants will:
Become familiar with ISO 17025:2017 laboratory management system requirements clauses and sub clauses
Get an overview of ISO/IEC 17025:2017 laboratory management system (LMS) and the benefits to implement it
Understand general and structural requirements of the ISO/IEC 17025:2017 standard
Understand the required documentation, list of procedures and records required and how to audit them
Gain knowledge of internal auditing and use of audit checklists
Understand process-based audits
Get ready-to-use internal audit checklists with clause-wise questions to perform an effective audit
Understand the new concepts of impartiality, risk management and risk evaluation techniques, decision rule, and process approach
This ISO 17025 auditor training online course is specifically designed for those who want to learn auditing techniques based on ISO 17025:2017 as well as ISO 17025:2017 requirements in detail. This class consists of 8 sessions:
Day 1
Session 1: ISO 17025:2017 Laboratory Management system overview
Session 2: Requirements of ISO 17025:2017 Laboratory Management System
Session 3: ISO 17025:2017 Documentation
Session 4: ISO 17025:2017 Internal Audit process
Day 2
Session 5: ISO 17025:2017 Audit Records and Audit Checklist.
Session 6: Impartiality, Risk Management, Decision Rule and Process Approach, Key changes in ISO 17025-2017
Session 7: Basic concept and evaluation of Measurement Uncertainty
Session 8: Measurement Uncertainty – Practical examples
Bob,
Thank you for all of your time and assistance with both; the Internal Audits and the Gap Analysis. I strongly feel that our QMS will have great improvements from these events.
Hi Bob,
Not sure if I ever told you, but the quality manual spreadsheets you provided have impressed every external auditor that’s come in.
We are grateful to you for sharing the template with us. We were certified to the 2015 version of the standard in December and the auditor said we saved him hours of auditing because we had all the information in one place.
More recently a customer asked if we might share the template with them. But I wanted to ask you if that would be alright before doing so.
Please let me know as soon as you can. Take care.
Hi Al,
I want to tell you how pleased everyone was with how far we have come. That is due in no small part to your efforts and coaching. Scott and I appreciate what you have done.
We had our ISO 9001:2015 certification audit this week and we passed with flying colors! No findings and only 3 OFI’s. We should be receiving our certificate in 4-6 weeks.
I wanted to say Thank You, to you and the QSG team for helping us with this transition. Your assistance certainly made it a much less daunting of a task for us to achieve. I’ll be sure to contact you when it’s time for our internal audit.
Thanks again for all your help!
Angelo,
It feels nice to put the successful audit behind us! We filed our corrective action report and sent it over last Friday. We should get our official re-certification in the coming days.
Al was a great resource in pulling us through this project. He fit well with the team. With Al and Don, you have some quality people working for your organization.
We’ll be getting back in touch with Al next month to begin scheduling out the training for ISO 9001:2015.
To Bob, Angelo, and Al,
As you have heard we successfully completed our ISO 9001, 2015 audit this past week with no findings and only 2 observations for improvements. I would like to thank you all for your efforts in helping us complete our journey. I’m confident this will make Vacuum Barrier a stronger organization going further. We will keep you in mind as additional demands surface that we may require your services again.
Thanks for letting us know!
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