Audited and certified - We have mastered the process for ISO 9001
In spring 2021, we shouldered the "ISO certification rucksack" and set out on our journey. Now, after less than three quarters of a year, we have already reached our goal.
Why ISO certification is important for us, what barriers we had to overcome in the project and what our next steps are going to be, is what we talk about with our Quality Management Officer Ulrich Becker.
Dr. Ulrich Becker
- Why do we even need an ISO certification?
We build up our customers' trust and strengthen the competitiveness, even in the focus areas of regulated industries like pharmaceutical engineering and medical technology.
Our goal is to monitor processes to improve their efficiency and performance with appropriate key performance indicators and to keep track of product and process quality.
By optimizing processes and preventing errors, the QM system helps to put the focus on quality costs. Comprehensive risk management enables us to identify and prevent risks. In addition, employee satisfaction will increase thanks to structured processes and clearly established responsibilities.
The certification of our quality management system improves our product and service quality in the long term. The first step has already been taken. And step after step will follow.
- What were the challenges and highlights of the certification process?
The project started off as a huge ball of wool where we first had to find the beginning. The destination was clear but the pragmatic path was quite misty. We had to answer the following questions: What do we need for the auditing? Who are the right contact persons for the respective departments? What do their processes look like? Which ones have already been documented and which ones still need to be documented? And what are we still missing completely?
Furthermore, our offices had to comply with certain formal requirements from DEKRA. It wasn't always easy to bring the employees concerned together and find free slots in the full schedules.
After we'd managed to break the ice, however, our colleagues demonstrated high willingness to contribute. This was great, as was also shown by the auditor's enthusiasm for us and our company. It was really exciting to get to know proALPHA from completely different perspectives.
- What did the project schedule look like?
Together with a consultant for quality management, we first established a plan with the project milestones and measures which defined the specific to-dos. Then, we had to map the chapters of the ISO management system in our BIC Cloud, the tool in which we model the processes. Missing process descriptions had to be added later, and we gladly assisted the persons responsible in doing so.
Another important step toward compliance with the standard requirements was the development of a format of Word documents for the practical document control with and in the BIC Cloud.
At the same time, we inquired a random choice of persons in order to find out what documents are currently to be controlled and what they should look like ideally.
In July, we finally started our QM blog to establish an internal communication channel.
Approaching the finish line, we organized an internal audit and finally the certification audit.
- What added value does the certification create for us and our customers?
The certification attests to our quality. Our customers finally have written proof of our previously verbal commitments. This creates more trust in the partnership and facilitates our access to the market.
- And now? What are the next steps?
We'll get down to work again. After all, there's still a lot to be done. We're going to implement the proven audit tool of our group company Böhme & Weihs, continuing our QM activities with the help of a tool. Furthermore, we'll initiate the measures that we were able to derive from the internal and external audits.
We're putting a lot of time and effort in the completion of larger projects. For example, we're currently working on a roll-out plan for our international offices and investing a lot of time and effort to complete the business processes in the BIC Cloud. We've also received a number of recommendations from our auditors which we'll start to implement little by little.