At Siemens Healthineers France, ISO 9001 hinges on top management involvement

© Siemens Healthineers

© Siemens Healthineers

Quality and performance are deep-rooted in Siemens Healthineers France, the medical imaging and associated activities specialist. The group has consequently obtained AFAQ ISO 9001 certification based on the 2015 version. Both auditee and auditor tell us more.

Siemens Healthineers France supports health professionals and helps them optimize their clinical, operational and financial performance. Its pledge: to provide patients with the best possible care in the most cost-effective way. Faced with such challenges, it’s clear that the enterprise’s ISO 9001 and quality management strategy had to have been initiated very early on, in fact from the first version of the voluntary standard back in 1994. “In the context of a merger and high demand, at the end of 2015 we asked AFNOR Certification to conduct an external audit intended to certify the conformity of our management system with the requirements of voluntary standard ISO 9001:2015. Siemens Healthineers adopted this approach on a company-wide and workforce-wide scale, aiming to ensure continuity of its message and of its operations. This is essential since interoperability is an omnipresent requirement,” explains Nathalie Ducrocq-Parisot, Director of Quality, Regulatory Affairs and HSE at Siemens Healthineers.

Internal audits and a collaborative approach

Managers working in a medical infrastructure enterprise such as Siemens Healthineers France must face the challenges of a complex and constantly changing environment, such as the constant stream of scientific advances, the drastic cost-cutting policies pursued by healthcare players, the increasing amalgamation of hospital entities, transformation of the patient journey now combining shorter hospital stays with the demand for optimal comfort, and more. One of the assets of the 2015 version of ISO 9001 is that top management is in fact placed at the heart of the process.

“ISO 9001:2015 is very clear and emphasizes involvement by top management as a success factor. Our 80 managers have shown strong commitment from the outset of our certification approach. They were very quick to take on board all the implications of the standard, in particular due to our collaborative internal audit approach which encourages interaction and discussion. The 2015 version of ISO 9001 incorporates meaningful assessment of processes and improvements to be made, based on a time/cost/performance/risks model totally suited to our environment and our quality requirements,” adds Ducrocq-Parisot.

The company implemented training actions concurrently with the certification audit in the course of 2016. Staff therefore quickly got access to concrete operational methods and tools to be deployed in their activities. Another strength of ISO 9001:2015 for Siemens Healthineers is the emphasis on managing risks and leveraging opportunities. “This aspect ensures better determination of priorities and time scales at both corporate and process level. It is also integrated into our audit tools and forms,” explains Ducrocq-Parisot.


© Siemens Healthineers

© Siemens Healthineers

Room for improvement

Certification of course highlights the strengths of an operation, but also its weaknesses so that it can progress. And in this case, relations with suppliers and service providers were among the opportunities for improvement identified during the certification process. “We already assessed and trained our suppliers and service providers, but our procedures were too limited. And this is a key benefit of having an external auditor; it makes you look at a subject from a different perspective. This outside view led us to consider the following question: are we meeting our suppliers’ needs? Our objective is to develop a more in-depth approach focusing on partnership and mutual support, like in the automotive sector for example. We have already made progress since we obtained the certification, but we need to take it even further,” says Ducrocq-Parisot.

As a further step, Siemens Healthineers will shortly commit to a “digital hospital” certification project. At a time when hospital sector players are increasingly trending towards concentration, it is vital to share patient data and facilitate communication flows between colleagues, while complying with safety and confidentiality rules. “This is a new stage in the development of our service offer and our information systems,” concludes Ducrocq-Parisot.



For more information on AFAQ ISO 9001:2015 certification (in French)… For more information on AFNOR Group’s expertise on quality…


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