CTU Bern (Clinical Trials Unit)

CTU Bern is now ISO 9001:2015 certified

In the first quarter of 2019, the CTU Bern had its QMS externally evaluated, assessed and certified with regards to the services offered. As such, the CTU Bern is successfully ISO certified since April 2019. The certification to the ISO 9001:2015 Standard on Quality Management System includes the CTU services Project Management, Consulting, Data Management, Statistics, Monitoring and
Regulatory Affairs.

As the CTU Bern has grown over the years, our institute has set up and redefined the Quality Management System (QMS) for its services. The processes of our five divisions have been continuously developed, extended and structured in order to have a QMS in place that meets a high quality standard. The ISO 9001:2015 certification completed this work so far.

Although the ISO certification is not a regulatory necessity, it is a good method for an established QMS to be assessed by a neutral body. Since the ISO certification requires to be refreshed in a three year cycle, the CTU receives regular independent feedback about its QMS status and compliance. Furthermore, the preparation for the certification audits offers a good opportunity to continually question and adapt the existing structures. In this way,
the QMS and the individual process areas can be improved and further developed, which, in consequence, rises customer satisfaction.

The certification itself bases on the evaluation of the QMS regarding the ISO set of quality management principles. The main focus is on customer orientation, motivation and implication of top management, process approach and the continuous improvement of practices established at the CTU Bern. The assessment took place within the scope of
two audits (stage 1 and 2) conducted by an independent and accredited certification body.

Audit Execution

The first phase (stage 1) in February consisted of a half-day audit conducted by an external auditor. The auditor started with making herself familiar with the existing QMS and the CTU specific processes. The focus was hereby on the presence of the relevant documents of all CTU divisions, such as policies, SOPs, instructions, checklists, etc.

The requirements of the ISO 9001:2015 certification were authoritative and considered during the auditor’s examination. It was assessed whether the QMS and the processes were sufficiently covered and thus did not stand in the way of the second certification phase.
The stage 1 review gave the go-ahead for the second part, so that the two-day certification audit (stage 2) followed beginning of April. This time, the emphasis was on reviewing
the CTU documents relevant to all services and conducting interviews with employees. The purpose was to verify whether the respective areas complied with the requirements of
the ISO norm and as such satisfactorily fulfilled the standard.

The evaluation itself was very positive. Apart from one major finding, which has since been fixed, there were only two minor observations, for which corrective actions are still ongoing. All in all, it was a very good audit, which resulted in the successful ISO 9001:2015 certification of the CTU Bern.

Many thanks to all who collaborated during the preparation and the audits itself!