We support our customers to introduce, establish and operate their first digital QMH, either based on the company's existing Quality Management System (QMS) or based on our blueprint digital and paper-based QMH, which will be tailored to our clients' internal business processes. The digital QMH is also a useful tool to facilitate the partial or complete harmonization of the QM systems of associations of companies. It is an enabler to analyze hurdles that delay time to market, optimize processes and integrate improvements.Goals that are pursued by modelling the business processes are:

The application of the digital QMH provides a standard conformant architecture with a lot of benefits:

Work and information flow

Deloitte’s digital QMH is an end-to-end traceable model that provides a holistic and systematic overview of business processes and their interactions in the product lifecycle. It helps to streamline projects and routine work by showing the relationship between the tasks (SOPs), the artifacts (templates) and the information flow. The digital QMH reveals which processes and tasks need to be performed sequentially and which can be performed in parallel to achieve the project goal as fast as possible. Moreover, it identifies gaps and redundancies in the workstream of the QMS that can be resolved immediately during the implementation of the digital QMH, to avoid unnecessary work or project delays.

Deloitte’s digital QMH can be published on the intranet and project managers and stakeholders can interactively navigate through single processes. Suggestions for improvement can be communicated directly via the discussion threads. This facilitates continuous improvement of the QMS and the digital QMH. The digital QMH enables consistency in the implementation of development projects and routine processes and is a great support for project managers, stakeholders, and auditors.

Full traceability to laws and standards

Deloitte’s digital QMH enables traceability to the laws and standards relevant to your company. Each applicable paragraph of the laws and standards is linked to the business processes, work instructions, SOPs, and templates of your QMS leading to full traceability during daily work and audits. The full transparency of the digital QMH and the automatic roll-out of training plans enable efficient implementation and adaptation of your QMS in the event of an update to legal requirements or the improvement of internal business processes.

Digital QMH as basis for eQMS implementation

The digital QMH forms a good basis for the introduction of an eQMS, as processes can be optimized in advance using the digital QMH. Any existing gaps can be closed, and redundancies removed. In addition, the holistic presentation of business processes, tasks, and artefacts with the associated responsibilities simplifies the introduction of an eQMS.

Process analytics and process mining

Based on the digital QMH you can simulate effort, throughput time and cost and analyze process enhancements for standardized, highly repetitive processes prior establishing changes. Deloitte provides GenAI integration to answer questions based on the process model as well as the QMH documents.

Expertise in establishing a state-of-the-art digital QMH

Our digital QMH is useful for MedTech companies with an established QMS, start-ups introducing a new QMS, or associations of companies wishing to harmonize part or all of their QM systems. After identifying the customer's needs, we offer three key steps to implement the digital QMH:

The digital QMH solution by Deloitte is already in use in the automotive, aerospace, and pharmaceutical industries and has been proven to deliver cost savings. It is an advanced tool that enables MedTech companies to strategically plan, manage, and execute QMS processes and activities. As a result, companies can develop and maintain high-quality products, achieve regulatory compliance cost-effectively, reduce time to market, and keep pace with the evolving challenges in the MedTech industry. 

For more information, please visit our Clinical Research overview website. Please feel free to contact us to discuss your specific needs.