A notified-body audit was recently conducted at Roth. The successful recertification confirms the effectiveness of the quality management system. Customers can count on a reliable partner with high-quality processes and products.
Our quality management system received initial certification in line with ISO 9001 back in the 1990s. This was followed by initial certification under ISO 13485 for the quality management system for medical products and under ISO 14001 for the environmental management system. For these three ISO standards, a comprehensive recertification audit is conducted every three years. This is our most important audit at system level.
A watchful eye
Within the quality management system, internal and external factors that could affect product quality are constantly monitored. Accordingly, keeping an eye on in-house processes and continuously improving them is not enough. The processes must be constantly adapted to changing situations. And there has been no shortage of these recently: international conflicts, uncertain energy supply and a shortage of skilled workers, to name but a few. By monitoring developments closely and making an early yet considered response at process level, we have always met the rising quality requirements despite challenging conditions.
Conscientious planning
Ahead of the comprehensive ISO recertification audit by the Swiss Association for Quality and Management Systems (SQS), we conducted an internal audit. This involved checking once again that all relevant documents were up to date, and assigning them to the standard elements before sending them to the SQS. The SQS put together the four-day audit programme on this basis. They focused on aspects such as risk analyses and new initiatives relating to climate change. Our relevance analysis and contingency planning impressed the auditors.
Strong customer focus
The auditor also praised the clear processes in production as well as the efficiently organised and productive morning shop-floor meeting. Furthermore, our employees were found to have a high level of specialist expertise, and the auditor was pleased with the good blend of experienced and motivated young employees. In particular, the auditor described the good collaboration within the management team and its customer focus as unique.
We are delighted with the successful recertification, which proves to us and our customers that we deliver what we promise: outstanding quality.