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? 
 
Koen: Of course. At Pauwels Consulting, we focus strongly on training, auditing and consulting. Through these types of training sessions, we want to further share our expertise and sharpen the skills of internal employees. Our training sessions are not just for beginners, but also for experienced employees who need a refresher.
 
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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Pauwels Blog

Pauwels Consulting has made the Best Workplaces™ 2022 list

05 Apr 2022

After being recognised as a Great Place to Work® for a second time, we have also made the top 10 of Best Workplaces™ in the category ‘medium companies’ in Belgium. A feat we are very proud of!

Thank you to all of our colleagues and consultants for your enthusiasm and honest feedback. Of course, this doesn’t mean that our work is done. We will always strive to improve our organisation. Let’s continue to shoot for the moon!

What is Great Place to Work®?

Great Place to Work® measures the trust, pride and camaraderie within an organization to determine how well an organisation takes care of their employees. Employees fill out a survey ‘Trust Index’, in which they answer questions about their experiences working for the firm, and a Culture Audit maps the organisational practices. These scores are combined to determine if an organisation deserves the Great Place to Work® label.

Pauwels Consulting received the Great Place to Work® label for the second time in a row in January 2022.

What is Best Workplaces™?

In the category ‘medium companies’, 19 institutions received the Great Place to Work™ label. Of these certified organisations, the very best places to work also feature on the list of Best Workplaces™.

Pauwels Consulting placed 6th on the list of Best Workplaces™! We are very proud of this feat and we hope to do even better next year. Together, we can make Pauwels Consulting the absolute Best Workplace!

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Pauwels Blog

Business case: QMS at Wiese Europe

29 Sep 2021

Wiese Europe is an independent family business that specialises in developing and building custom made loading and transfer systems. These are loading arms used in the chemical and food industries for loading and unloading liquid products into ships and tanker trucks. A couple of years ago, Wiese Europe obtained ISO 9001:2015 certification for their Quality Management System (QMS). But that system must, of course, also be maintained, monitored and improved in order to keep the certification.

Wiese Europe found this a less than straightforward matter, as its internal team did not have the required QMS expertise, nor did they have the manpower to deal with it in depth. So General Manager Ellen Jacobs went in search of an external expert. The company found Pauwels Consulting on Google. Soon Luc Marivoet, one of our QHSE (Quality, Health, Safety and Environment) experts, was working with Wiese Europe.

Ellen Jacobs: “Of course, we considered some alternatives, but Pauwels Consulting stood out. It was clear that they had the right know-how and expertise covering ISO and QMS, as their excellent references also show. And we clicked right from the start with both Luc and account manager Koen De Borle. Their combination of insight, knowledge and the personal touch soon convinced us to choose Pauwels Consulting.”

Koen De Borle: “When a company approaches us with a specific need, they logically expect our knowledge in that domain (in this case, ISO and QMS) to be up to date and to stay that way. Wiese Europe came on board with us because their organisation wanted to keep up with the latest developments without having to invest in burdening its own people with doing the job. This is something we can deal with via our team of QHSE experts. In a team of senior consultants and junior positions, knowledge is constantly shared and tested against current legislation and trends in the sector.”

A real QHSE assignment

Luc was eventually assigned a wide range of tasks. For instance, he not only helped Wiese Europe prepare for the surveillance audit for its ISO 9001 certification, but also gave advice on the implementation of version 2017/6.0 of the VCA** checklist and the practical implementation of the Machinery Directive 2006/42/EC (health and safety requirements for machinery). He also supports the company’s welding engineer with the fusion welding standard ISO 3834-2 and standard EN 1090-1 on the execution of steel structures. Quite a challenge! Fortunately Luc has plenty of experience in QHSE Management, so he knows the best ways to approach this kind of job.

Luc Marivoet: “For a QMS or QHSE project you need an analytical and structural approach, balancing pragmatism, ambition and customer sense. So you shouldn’t just charge in like a bull in a china shop, but rather follow a step-by-step plan: observe, analyse and improve. It is important to build your suggestions for improvements on solid foundations, because you are trying to change something in an existing structure. That can be sensitive. So you need good reasons to convince a company or organisation. Only then can you put your own accents on it. At the same time, it’s still important to take other people’s expertise into account, because you can often come up with a better solution as a team. You are never too old to learn.

How has the assignment gone?

To ensure a smooth handover, Luc first sat down with his predecessor. That meeting showed that a well-structured quality management system was in place. However, there were also two important points for attention: the 2020 internal audit programme had not yet been implemented and risk-based thinking had not been incorporated into the processes.

As a surveillance audit was scheduled for late March 2021, Luc immediately went to work on those points. In three months, working together with a motivated internal audit team, he evaluated no less than 21 processes. To give future internal auditors more breathing space, Luc subsequently modified the audit programme to spread the internal audits more evenly over a three-year period (the duration of ISO 9001 certification), so that the internal audit team can carry out the audits in a more focused way.

Because Wiese Europe’s prevention advisor also holds another position in the company, the company asked Luc to help their prevention advisor on compliance with the legal requirements under the Code on welfare at work. This assignment focuses primarily on the purchasing procedure for work equipment, personal protective equipment and collective protective equipment (also known as the three green lights procedure), and Luc is involved in drawing up the various risk analyses, the HSE Project Plan, the Global Prevention Plan (GPP) and the Annual Action Plan (AAP).

Great results

This project is a good example of the kind of QMS and QHSE challenges that Pauwels Consulting is happy to take on. So we are pleased with the results of our collaboration with Wiese Europe, not least the fact that Wiese Europe has been awarded VCA** certification in accordance with the new version 2017/6.0.

We are also particularly proud of the training pathway developed and the improvements to the internal audit process:

1. Developing a training pathway

Wiese Europe and Pauwels Consulting have jointly developed a training pathway as part of the Training and Knowledge Management process. This pathway consists of 2 modules: ‘introduction’ and ‘technical’. The ‘introduction’ module is followed by all staff, and deals with general arrangements and information within Wiese Europe. In the technical module, employees can follow specific training courses in their particular field, both in-house and externally. All these training courses have been put into a handy matrix, giving everybody a clear overview of which job profiles require which training.

2. An improved internal audit process

The modified audit programme for the Wiese Europe QMS has also been a success story. Not only are the audits better timed, but thanks to the rearrangement of the audit programme, Wiese Europe can now also demonstrate that they have checked all the requirements of the ISO 9001 standard for the audited processes.

The internal audits now also identify the risks in each process and the extent to which these have been controlled. These improvements provide a more solid basis for internal audits. This was also noticed by the external auditor, who gave it a positive mention in the report for the ISO 9001:2015 surveillance audit. Wiese Europe successfully passed that surveillance audit.

It also covered monitoring of the improvement plan, the management review and the process indicators. Existing processes are now updated on the basis of in-house and audit findings.

A successful collaboration

Both Pauwels Consulting and Wiese Europe are satisfied with their work together so far. This translates into a lasting partnership, and the recent extension of Luc’s assignment.

Luc Marivoet: “In this project, the staff and management of Wiese Europe play an important role in the success of the assignments. An internal team of motivated employees helped steer everything in the right direction. And the clear commitment and leadership from the Wiese Europe management is also a great benefit. Quality, safety and health are clearly integrated into their business processes, and that’s very nice to see.”

Ellen Jacobs is also more than satisfied with working with Pauwels Consulting: “The cooperation is excellent, and the communication and planning are always punctual and correct. And above all, the QMS is being properly monitored, so we can focus on our core business. Given our good relationship and the wide-ranging expertise of Luc and Pauwels Consulting, we can also trust them to handle other matters, such as support for VCA and advice on the AREI and the Machinery Directive. So we are pleased to have found in Pauwels Consulting an expert and reliable partner who we can work with and want to work with in the longer term. We have to give this collaboration a 10/10.”

How can Pauwels Consulting help you?

Can you too use some help with your QMS or QHSE projects? Do you lack the expertise needed to conduct your internal audits thoroughly? Or do you have any other questions or needs concerning QMS and QHSE? Pauwels Consulting will be happy to help you. Contact us on +32 9 324 70 80 or at contact@pauwelsconsulting.com. See you soon!

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Projects

Continuous Integration Continuous Delivery

20 Dec 2019

Digipolis faced the challenge of designating tasks that require very specific knowledge on CI/CD internally. As CI/CD is not an isolated project but a company wide implementation, they were looking for a partner to support them at peak moments.

Digipolis Service Factory is developing and offering various microservices for most common business requests. Pauwels Consulting is supporting Digipolis in the implementation of good continuous integration and continuous development practices in the Service Factory.

About

To put the microservices into production, Digipolis does Continuous Integration / Continuous Delivery (CI / CD) within the Service Factory. For this Digipolis uses a set of tools that support this process. The team uses Red Hat Openshift as an application platform. Openshift is a Kubernetes platform on which one can implement Docker images containing many additional functionalities that have been built. Almost all tools that have been built run on the Openshift platform, installed in two separate clusters. One cluster for dev & test and one production cluster, each with their own image repository, security polices and high availability rules.

All the tools required for CI / CD run on Openshift. The most important are Jenkins and Nexus Repository Manager. Jenkins is used to defining and executing the CI / CD pipeline. Digipolis had to start their pipeline manually and manual approval was also required to move from acceptance to production.

The pipeline stated which automatic tests were needed to perform, which builds are ready to make and where they will be rolled out. The pipeline is written in Groovy and has a declarative syntax. They use the Nexus Repository Manager as a cache of Maven and Red Hat repositories. They are also used for their own libraries and packages.

All source code of our microservices is shared via Github. Developers, employees of the Service Factory and system users of the different tools have access to the source code. This allows everyone to make and share adjustments quickly and easily where necessary. All CI / CD configuration is also merged with the source code of the microservices.

Digipolis faced the challenge of designating tasks that require very specific knowledge of CI/CD internally.

As CI/CD is not an isolated project but a company-wide implementation, they were looking for a partner to support them at peak moments.

Solution

The IT Department of Pauwels Consulting has a DevOps and infra competence center with expertise in both the Red Hat stack and Openshift stack and expertise in all the aspects of CI/CD.

We are helping Digipolis with various tasks:

  • Writing tests for existing and new microservices.
  • Setup of automated static code analysis in order to check for security issues, measure technical debt and report on test coverage.
  • Streamlining pipelines so all jobs use the same stages.
  • Reducing the size of the Jenkinsfiles by using shared pipelines.
  • Setup of GitHub webhooks in order to start all jobs automatically.
  • Implementing Open Shift’s new Jenkins client plugin.

 

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Projects

ESA obtains ISO 9001 certificate with the help of Pauwels Consulting

15 Oct 2019
Pauwels Consulting started an ISO 9001 quality management project at ESA, the European Society of Anaesthesiology. During the project Luc Marivoet, Senior Quality consultant, advised and supported them with the implementation of a quality management system in order to obtain the ISO 9001 certification.

ESA, The European Society of Anaesthesiology, based in Brussels, is a not-for-profit organisation that brings together all knowledge, training & certifications related to anesthesia, intensive care and pain management. It is a large organisation with a network of more than 400 volunteer doctors and around 30,000 members worldwide, of which around 10,000 are truly active within the organisation.

ESA supports members and fellow organisations with organising conferences, workshops, clinical research, exchange of ideas and new concepts. In addition, ESA takes on a major educational role by providing training and refresher courses through masterclasses, webinars, e-learning modules and simulation classes. This can be done online, but also through the training centers that are spread worldwide.

Via ESA, doctors can obtain the European Diploma of Anaesthesiology & Intensive Care. This can be done almost anywhere in the world, except in North America and Australia. In addition, ESA has a clinical trial network that conducts observation studies on some 1,000 to 50,000 patients. Through the Academic Contract Research Organization (part of ESA), they provide financial support for clinical trials by means of scholarships and collaborate with the European Medical Agency (monitoring body Europe).

“If we want to work with major partners, ISO certification is a necessity anyway. In that respect, having an ISO certificate can create a certain level of trust with potential customers, sponsors or suppliers.”

esa training centers

Amaury van Kesteren – Quality Manager, and Marc Gheeraert – CEO, have major plans for the further expansion of the organisation. Firstly, they want to provide more continuous training, this through a larger network of doctors but also by setting up more local training centers. Currently, there are about 50 of them worldwide but they want to increase that number even more. This would improve the skills of anaesthesiologists around the world.

“ESA is also represented in the World Health Organisation”, says Marc Gheeraert – CEO “which ensures that the quality standards and guidelines are disseminated worldwide. In addition, we also want to guarantee absolute patient safety. To this end, we participate in a Policy Summit and, above all, we have to inform institutional stakeholders about what improvements still need to be made to guarantee this safety”.

Would you like some help in obtaining the ISO 9001 certification?

We organize ISO courses for companies.

Why did you want to implement the ISO quality management system?

Marc: Initially, we started out on our own to work out Standard Operating Procedures, or ‘SOPs’. But when we received a disappointing audit report from a sponsor that revealed a number of things, we decided to seek external help. We found this help through a positive recommendation, from Pauwels Consulting and Luc Marivoet.

How was the guidance of our ISO 9001 QMS Consultant Luc?

Marc: Luc Marivoet guided us very well in setting up, implementing and monitoring the ISO 9001: 2015 quality management system. He has implemented a process approach in developing and improving our quality management system. He has also focused on risk-based thinking so that risks and opportunities were addressed in our organisation. The collaboration was very professional. Because the organization continued to grow strongly, we decided to hire an internal Quality Manager, Amaury. The cooperation between experience & young creativity was a perfect combination for us during the guidance of our ISO certification.

ESA obtains iso certification

Amaury: The focus of the guidance was above all on obtaining the certificate but we are glad that the guidance post-certificate was not forgotten. Of course, the work doesn’t stop when you have the certificate. So, we contacted Luc a few more times to discuss action points for our work, to prepare follow-up audits and to further assist me.

Has the ISO certification had a positive influence on your organization?

Amaury: Yes, it’s nice to know that everything is now neatly documented according to the requirements of ISO 9001 and that we ourselves consider it necessary for the effectiveness of the quality management system. Things are much more structured and there is a system you can rely on to guarantee the quality of your training, certifications and other services each time.

Marc: If we want to work with major partners, ISO certification is a necessity anyway. In that respect, having an ISO certificate can create a certain level of trust with potential customers, sponsors or suppliers. Moreover, the management was pleasantly surprised and impressed that we obtained the certificate.

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Projects

Pauwels Consulting helped obtain the ISO 9001 certificate at Lariplast

08 Oct 2019
Pauwels Consulting started an ISO 9001 quality management project at Lariplast France in Marle, Aisne. The goal of the project was to advise and support Lariplast during the implementation of the ISO 9001 standard and to obtain the renowned ISO 9001 certification.

To jump-start this project, Junior Consultant Engineering Services Elodie Ancion and Senior Consultant Luc Marivoet performed a diagnostic analysis of the company. Then they gave an introductory presentation at Lariplast to increase the overall quality and ISO 9001 awareness within the company.

We had an interesting talk with Karima Aoucha – the Pauwels Consulting Account Manager for Lariplast –  about this quality management project in France and the role of our consultants during the implementation of ISO 9001.

Can you please introduce Lariplast?

Lariplast France is a company founded in 2013 specializing in the production of plastic cups. Lariplast delivers its cups throughout France to clients from various industries: supermarkets, water cooler and spring suppliers, catering companies, etc. The company has two production lines and ingenious packaging technology.

When and why did Lariplast approach Pauwels Consulting?

Lariplast strives to offer high-quality products that meet international safety standards, from the production, packaging and storage stages to delivery. At the same time, Lariplast is an ecologically responsible company. They are very concerned about reducing their environmental impact. Lariplast decided to take measures to implement the ISO 9001 standard and obtain the required quality and safety certifications. The CEO of Lariplast France started looking for a reliable partner to consult him – and Lariplast as a whole – about ISO 9001.

Eventually, he contacted Pauwels Consulting in March, asking about our ability to help Lariplast with the implementation of ISO 9001. Based on our expertise in the field of ISO 9001, the know-how of our consultants and after an exploratory diagnostic analysis, he decided to partner up with Pauwels Consulting.

Why was Lariplast specifically interested in ISO 9001?

The ISO 9001 standard is a renowned quality management certification, a testimony to quality if you will. ISO 9001 provides guarantees in terms of organizational quality within a company. As a result, Lariplast decided to obtain the certification for its French site.

How did Pauwels Consulting help Lariplast with ISO 9001?

Lariplast was concerned about the quality, hygiene and safety of its products and services and about maintaining its performance and satisfying its customers. Our quality management consultants supported and guided Lariplast during the set-up, implementation and maintenance of certified ISO 9001 quality management systems without compromising quality, hygiene and safety. On the contrary! (Smiles)

lariplast iso9001 luc marivoe

What were the first steps of Pauwels Consulting in this project?

In July 2017, our consultants went on-site to perform a diagnostic audit. They identified possible deviations and considered necessary actions and measures. After that, they drew-up a diagnostic report. After having read the report, the CEO of Lariplast decided to partner up with Pauwels Consulting to obtain the ISO 9001 certification.

After that, we agreed on an intervention plan to map the necessary adjustments and to provide Lariplast with a detailed overview of the measures that needed to be taken. Our colleagues Luc and Elodie also gave an interesting presentation at Lariplast about the importance of the ISO 9001 certification to increase overall quality and ISO 9001 awareness within the company.

How was Luc and Elodie’s presentation received?

The presentation was well received. It was aimed at informing the various stakeholders of Lariplast: from the definition of quality and the key stages of the ISO 9001 certification, to the process of obtaining the actual certification. This presentation made it possible to explain the importance of quality and its implementation within the company in a clear and detailed way. A company-wide presentation like this is a valuable and rewarding step during the implementation process.

What were the next steps in the project?

The project started in July 2017 and took about a year. Luc and Elodie didn’t work on the project full-time though. They visited and cooperated with Lariplast on several occasions for short interventions. Based on those interventions, Lariplast was able to take the appropriate actions to prepare for the next meetings.

What were those key steps?

  • further stimulating company-wide awareness
  • defining the processes that are essential to the company
  • providing the necessary tools and processes
  • testing these processes
  • verifying and validating the implemented processes
  • carrying out internal audits according to ISO 9001
  • accompanying the actual ISO 9001 certification process

Lariplast successfully implemented the ISO9001 quality management system, together with our consultants and obtained the quality certificate.

Are you looking for help in obtaining your ISO 9001 certificate?

Our Quality Managers are happy to help!

Luc Marivoet, our quality expert

Luc Marivoet is Prevention Counselor & Quality Officer at Pauwels Consulting. He has over 25 years of experience in quality management positions. In these positions, he provided support and supervision in an international context (Europe and Asia). Luc now uses his experience to set up, implement, monitor and follow up certified ISO 9001 quality management systems and Supplier Quality Assurance activities. Luc is currently working at a Belgian engineering office specialized in rail infrastructure and technology for the implementation of an integrated management system (ISO 9001 & ISO 45001). He also teaches QHS Management Systems (ISO 9001 and ISO 45001).

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