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Sharkmed Oy specialises in the management of sudden health risks. The company’s extensive product range covers tactical first aid products and emergency care equipment. Sharkmed engages in cooperation with the world’s leading equipment and product manufacturers and imports high-quality PAX first aid kits and emergency backpacks. In addition, Sharkmed has a selection of its own products manufactured.
Sharkmed’s mission is to secure the efficient and safe performance of its customers’ vitally important duties through the provision of high-quality products and services. The values that guide the company’s operation include customer satisfaction, profession-
alism, reliability and responsibility.
In 2018, Sharkmed Oy made the decision to develop its own medical device and introduce it to the market. The company management estimated that in future, health care customers will not only require their suppliers to take care of their legal obligations but also to comply with the requirements set by other regulations and recommendations. Therefore, the design of an applicable quality system was commenced with a partner in connection with product development. The quality system design was based on the ISO 13485 standard, and it took account of the EU’s Medical Devices Regulation (MDR).
Soon after starting to plan product development and the quality system, it was noted that an applicable quality management system was required to the support quality management. The system was to be capable of guiding and automating quality management routines to help ensure operation that complies with the requirements. The system that supports compliance helps Sharkmed standardise its operation, contributing to the introduction of the company’s own medical device and further advancing the company’s objective of internationalisation.
Quality management system to support business operations and quality management
The design of a suitable quality management system was started by acquiring a thorough understanding of the customer’s needs and the standards it complies with. The regulation and standards on medical devices highlight life cycle management to an increasing degree. Thus, the design emphasised product documentation management, post-market-introduction monitoring and risk management. The solution is based on the customer’s quality system documentation.
Main and support processes were created for the quality management system in accordance with the quality system and responsible persons were designated for the processes. A workflow that ensures compliance with the general codes of conduct guiding the processes was built to enable updating documents in a controlled manner: the author of a document prepares or updates the document, after which it is reviewed and approved for publication by the person responsible for the appropriate process. Before a new guideline is applied, the personnel can be provided with related training in a controlled manner, and they can be requested to confirm having read the guideline.
When the guideline enters into force, the system automatically transfers the previous version to the archive, disables the personnel’s access to it and marks the expiry on the document. All currently valid guidelines can be easily accessed by the personnel, the guidelines are appropriately labelled, and the risk of using an expired guideline is eliminated.
A separate workflow was created for document templates to enable updating the templates or marking their expiry in a controlled manner. The document template records are directed to their respective workflows based on the record type, ensuring that the documents remain uniform and unchanged. Applicable infrastructure was implemented for the management of operation-related observations, such as complaints and quality deviations. This enables recording and processing deviations and assigning responsibility for the consequential corrective actions and for managing the actions in a guided manner and in compliance with a standardised process using the system. In addition, the system helps take care of effectiveness assessment by reminding the quality manager about the matter in accordance with the intervals specified in the relevant directive. The system also enables planning and scheduling auditing tasks and assigning the related responsibilities. Workflows related to auditing help ensure that the required tasks are performed on time and in compliance with the requirements.
The deployment project was performed as planned by creating functionalities divided into smaller subsystems and testing them in close cooperation with Sharkmed Oy. This approach not only enabled building the system but also adapting Sharkmed’s own processes so that the complete system serves its purpose in the best possible manner. At the same time, the administrator was provided with thorough understanding of the system’s functionalities, enabling them to support the personnel when deploying the system. The solution was implemented on Konica Minolta’s KMContent cloud service, and it is based on the M-Files information management platform.
Right from the start, Konica Minolta showed genuine interest in Sharkmed’s challenges and a will to find suitable solutions tailored to meet the company’s needs. This laid the foundation for solid trust between the customer and the solution provider. The interaction was honest, and promises were kept throughout the companies’ cooperation.
Konica Minolta presented a clear deployment plan in which the system was divided into smaller subsystems, i.e. sprints. Implementation through sprints made the project more approachable and the deployment feel easy.
“I was very impressed by the fact that when faced with a challenge, Konica Minolta’s expert could provide an alternative solution based on systems implemented for other customers,” states Sanna Nordman, Quality and Marketing Manager at Sharkmed Oy.
The quality system provided the customer with various benefits:
With the new quality management system, Sharkmed Oy will be able to implement daily quality management even if the company expands its business operations.
Sharkmed Oy from Finland specialises in the management of sudden health risks. The company’s extensive product range covers tactical first aid products and emergency care equipment. As Sharkmed Oy needed a solution to automate and streamline their processes, Konica Minolta introduced Sharkmed Oy a tailored solution based on the M-Files information management platform, which met the company’s needs. Sharkmed Oy now benefits from a quality system with different workflows that supports compliance with the requirements in their daily routine – even if the company expands its business operations.