Qualitas-Consulting
Quality management
Why a QMS?
A quality management system (QMS) helps your company to deliver high-quality products and services. Improvements are approached in a structured manner and you can deliver verifiable product quality that fulfils all requirements. With a quality management system, you have the quality of your processes and products under control and also demonstrate that you are continuously improving them.
We offer support with:
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The establishment of a QMS
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Creating an overview and clarity in strategic objectives
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Measuring quality and objectives
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Analysing causes and sustainable problem solving
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Ensuring continuous improvements
Our team of quality consultants has experience in setting up and implementing quality management systems and is a sparring partner for your management.
Book a quickscan now or give us a call if you:
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Want to gain insight into your current situation and the quality goals you want to achieve.
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Want to increase your turnover and increase your profit - with lower error costs at the same time.
With our quality quickscan, you will receive a clear assessment of your quality level and immediately implementable measures to optimise your company.
Information security
Information Security Management System (ISMS)
Information security can no longer be excluded from your business processes. With the increasing digitalisation of business processes, information security is becoming more and more necessary. With an information security management system (ISMS), you have your processes under control, ensure the continuity of your business processes and prevent security and data protection incidents.
We offer support with:
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The immediate resolution of information security incidents.
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The elimination of security gaps in IT.
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Setting up and maintaining an ISMS.
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The certification of your organisation.
Our team of information security consultants has experience in setting up and implementing information security management systems and acting as information security officers in a variety of industries.
Book a quickscan now or call us if you:
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Wonder if your cyber security is adequately assured.
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Know that improvements are needed but aren't sure where to start.
Conformity of medical devices and CE registration:
Medical software
Medical software has become much more important in the context of the MDR. The testing and validation of software is now an essential part of the authorisation process. Our experts have experience with the hardware, software and information security requirements that your device must fulfil.
CE registration of medical devices
Our team of medical device consultants is experienced in setting up and implementing quality management systems for medical devices as well as setting up and managing a technical dossier. We can assist you with all CE registrations, from simple Class I devices and Class IIa software to complex Class IIb and III devices.
We offer support with:
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The translation of conformity requirements into practical solutions.
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The technical validation of the device and associated software.
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The creation and management of technical documentation.
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The organisation of the CE registration process.
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Planning and carrying out post-market surveillance.
Book a quickscan now or give us a call if you:
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Gain insight into your current compliance requirements and achieve CE registration.
Our quickscan provides you with a clear overview of the requirements that apply to your organisation and your medical device. You will receive an immediately applicable step-by-step plan to successfully achieve CE registration.
Certification
Which certification?
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ISO 27001, Information security
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NIS 2, Information security
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IEC 62443, Information security
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ISO 9001, Quality management
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ISO 14001, Environmental management
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ISO 13485, Medical devices
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ISO 14971, Risk management for medical devices
We offer support with:
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Setting up a management system.
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Conducting internal audits.
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Accompanying external audits.
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Creating an overview and clarity in strategic objectives.
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Making quality and objectives measurable.
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Analysing and resolving deviations and non-conformities.
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Ensuring continuous improvement.
Our team of consultants is experienced in setting up and implementing quality management systems and in supervising various certifications.
Book a quickscan now or give us a call.
Arrange a quick scan or an initial consultation now
Call us on +43 681 20235856 or send us a message!