Pauwels Blog

Case: ISO 9001 training and audits for the Binding Site

26 Sep 2022

The essentials

  • The course: Practical training ISO 9001 and audit techniques
  • The participants: Internal employees of the Binding Site
  • The instructor: Luc Marivoet, QHSE Manager at Pauwels Consulting
  • The client: Amélia Bouzar, responsible for quality and regulatory affairs
  • The account manager: Koen De Borle, Training Program Manager at Pauwels Consulting
  • Format: Two-day workshop with theory and practice
  • Added value: Practical tips from the field
  • Added value: Coaching for the participants, even after the training
  • The result: The Binding Site can now evaluate its QMS itself.

What is the Binding Site?

The Binding Site researches, develops, manufactures and distributes specialist immunodiagnostic assays and instrumentation for clinicians and laboratory professionals around the world. The company has a strong focus on education, collaboration and innovation to improve the lives of patients.

Demand for ISO 9001 expertise

The Binding Site wants to be able to continuously evaluate whether their quality management system meets ISO 9001 requirements. Therefore, the company sought an experienced training partner to train internal staff on ISO 9001 and auditing quality management systems.

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ISO 9001 training and audits

Amélia, you are responsible for quality management at the Binding Site. How did you find Pauwels Consulting?

Amélia Bouzar: A few years ago, we were looking for an expert in ISO standards to train our people. Because we immediately felt that Luc truly understood our needs and wishes, we chose Pauwels Consulting as our external training partner.

Luc, you recently provided another ISO 9001 training course at the Binding Site. What exactly was that about and who was this course intended for?

Luc Marivoet: That’s right. I conducted a two-day workshop for the internal staff of the Binding Site. The purpose of the course was to educate the participants on the basics of ISO 9001:2015, the standard for quality management systems, and how to audit this standard according to ISO 19011:2018, the standard for auditing management systems.

Amélia: For us, it is very important that quality assurance is not the specialty of just a few people. We want to create multidisciplinary teams that can all talk about quality management. That’s why we opted for in-house training sessions with several participants.

What was the training like?

Luc: The training lasted 2 days. The first day we saw the most important theory behind the ISO 9001:2015 standard and solved practical exercises. Here the focus was mainly on the process approach and risk-based thinking.

On the second day, we introduced auditing. We shared tips on what to look for when planning audits and explained how to develop an audit program. We used case studies to teach how ISO 9001 audits should be conducted, what skills you need to do so, and the best way to report and follow up on audit results in an understandable way.

After the course, we will also guide and support the participants in conducting their internal audits.

What are participants capable of after this ISO 9001 training?
Luc: Participants will now be able to test whether their own (or an external) quality management system meets the ISO 9001:2015 standard. They now have the correct basic knowledge and skills to prepare, conduct, report and follow up on an internal audit.
Thank you for this explanation, Amélia and Luc! Koen, you brought the Binding Site in contact with Luc. What is the added value of this training?
Koen De Borle: This training is a good solution for companies and organisations that want to familiarise internal auditors quickly and properly with the theory and practice of ISO 9001 and audit techniques, or who want to refresh the expertise of their existing auditors.
The fact that the Binding Site can now evaluate their own quality management system strengthens their quality management. With the Pauwels Consulting certificate after the training, the participants can also demonstrate their suitability as internal auditors.
Luc is the ideal trainer for this, as he has obtained the additional certificate of QMS ISO 9001:2015 Lead Auditor. Just like all our other QMS consultants, he is therefore engaged daily in implementing and auditing quality management systems. We share these years of experience in the form of tips, cases and interactive exercises. We also guide and support the auditors during a ‘real’ internal audit. Thanks to this practice-oriented approach, the theory becomes much easier to remember.
Finally, an in-company or in-house training at the client’s is also cheaper and more practical than several people participating in courses with open registration. We can also tailor our in-company training more closely to our clients.
Can companies also count on Pauwels Consulting for other training courses? 
We offer various in-house training courses that are guided by experienced experts from various fields within Life Sciences, Engineering and IT. We respond to current trends and needs, such as Lean IPD, (Site) Safety or MES. So don’t worry, there’s something for everyone!
That’s clear! Amélia, Luc and Koen, thank you for your answers, and good luck with your courses.   

ISO 9001 course

Would you like to give your quality management a boost, and follow an ISO 9001 course? Or would you like to organise an interactive training for a larger team in your company? Contact us below. We are happy to help!

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