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In this seminar, you will learn about the requirements of the new ISO 15189 standard for quality and competence in your health institution or laboratory and how to implement them. You will then have everything you need to set up your management system in accordance with the standard and have it accredited.
Our expert will help you understand the current normative requirements in detail and derive the necessary steps. Through appropriate exercises, you will learn how to set up your management system in accordance with ISO 15189. You will also know when accreditation is necessary and how it works.
The discussion and contributions from other participants are always useful. I liked the clarity with which the seminar instructor highlighted in-house IVD medical devices, the clarity regarding DAkkS, and the necessity of accreditation. It is refreshing and helpful when clear opinions are expressed, and it is equally refreshing when it is pointed out when something is not completely certain.
As a certified QMR, our instructor has not only supported numerous IVD users and manufacturers in setting up and maintaining their QM systems. He is also our specialist for the regulatory requirements for medical labs. He will provide valuable information and tips for working with the IVDR and other relevant standards and guidelines.
At the end of the seminar, you will receive a certificate of your newly acquired knowledge and skills, including a performance record, if desired, about implementing the requirements of ISO 15189. This certificate serves as proof of training and can be presented to the relevant authorities, for example, in the context of (re) accreditation.
There is a voluntary online exam at the end of the seminar (duration: approx. 20 min). By passing this exam, you will receive a certificate proving your newly acquired knowledge and skills in addition to your attendance confirmation.
Phone
+49 7531 94500 20
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The seminar covers the following topics:
After the seminar, you will:
This seminar is designed for:
In order to fully participate in the seminar, you will need the latest version of the ISO 15189:2022 standard (e.g., DIN EN ISO 15189:2024-08 or ÖNORM EN ISO 15189:2023-08). Please get in touch with us if we can assist you in this regard or provide you with tips.
After registering, you will receive a confirmation email containing the meeting link, the time, and information about the participants.
An invoice will be sent to you within the next 48 hours, with a payment term of 14 days. If this payment term is not feasible for your company, please send a short e-mail to [email protected] to find a solution.
Three days before our online seminars and workshops, you will receive two e-mails: The first contains the final link to the seminar and the second contains the access data to a cloud folder in which you will find documents for preparation, exercises, and presentations.
If the seminar or workshop takes place in person, you will also receive the access link to your seminar documents three days before the date of the event. We will also provide documents in digital form for in-person events.
The seminar takes place either in person or online.
Our online/remote seminars and workshops are conducted via the video conferencing tool MS Teams. We recommend dialing in 20 minutes before the seminar begins so that any technical problems can be resolved in good time. If you have any questions or encounter any issues, our team is always available to help.
We also recommend that you arrive at the seminar room approximately 20 minutes before the start of the face-to-face events.
At the end of the seminar, you will receive a feedback link for evaluation. The following day, we will send you your certificate of attendance.
If you experience technical problems while participating or have any other questions, you can contact our support team anytime, even at short notice. The documents provided also include an emergency number to help you in urgent cases.
Our general FAQ section answers further technical and organizational questions.
Ulrich Hafen is our specialist for regulatory requirements for medical laboratories. He assists manufacturers of in-house IVD medical devices in meeting IVDR requirements and provides support with strategic issues. He also helps with placing sampling sets on the market. He advises IVD users and manufacturers on setting up and maintaining QM systems in accordance with ISO 15189, Rili-BÄK Part A, and ISO 13485. Ulrich is also a certified QMR and supplier auditor and is the QMR of the Johner Institute.
We are also happy to offer our seminars, courses, and workshops in-house. Depending on your needs, these can be held online or at your premises.
Please feel free to contact us.
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