Total Medikal Türkiye
Successful ISO 13485 Certification at THI Medikal
Total Medikal Türkiye
Successful ISO 13485 Certification at THI Medikal
„Working with Wolfgang was a great experience for our team. His precise follow-up and structured guidance ensured that we stayed on track throughout our ISO 13485 preparation. He not only helped us build a solid quality management system but also invested time in training our engineers, making sure the knowledge stayed within the team. His clear communication, practical tools, and dedication made a real difference in our journey toward certification.“
Yiğit Dereli
Plant & Quality Manager of THI Medikal
Initial situation
THI Total Healthcare Innovation GmbH’s production plant for surgical gowns in Menderes, Turkey, was certified in accordance with ISO 9001. The customer required certification in accordance with the ISO 13485 standard for quality management systems in medical technology as an important framework condition for product approval. Therefore, a challenging schedule was set for the successful certification.
Project description
A gap analysis was carried out on site to assess the status and maturity of THI Medikal’s quality management system.
The difference between reality and the requirements of this demanding standard was presented to the local team in an understandable way. Concrete measures were jointly derived in an implementation workshop.
With practicable templates for process descriptions and checklists, I was able to lay the foundation for pragmatic, rapid implementation.
The progress of the project was closely monitored through my regular coaching sessions and measure reviews in remote meetings.
Particular challenges were
- the completely new creation of a process development and approval process including suitable milestone planning, the definition of criteria for quality gates and the governance of the process,
- the definition and introduction of a risk management process in accordance with ISO 13485 and the moderation of a process FMEA for the surgical gown manufacturing process.
The effectiveness of the team’s activities was checked in a system audit in accordance with ISO 13485 and, after a further correction loop, the status ‘Fit for Certification’ was awarded.
Key aspects of my work:
- Communicating the importance and benefits of the requirements of the standard to the employees of the production plant in a way that they can understand in order to reduce resistance
- Staying constantly on the ball and motivating employees, as day-to-day business is always in conflict with process and improvement work
Ensuring pragmatic documentation that is as lean as possible. The benefits must always take centre stage!
Results
- Successful certification according to ISO 13485 at the first attempt with minor potential for improvement in February 2025.
- Significantly increased maturity of THI Medikal’s QMS and greatly increased quality awareness of the team.
Duration
- Project duration: 11 months
