From September 1st, 2020, the new framework regulation (EU) 2018/858 is mandatory for the approval of vehicle types and their equipment. Of course, all training courses from Mark Haacke Training & Consulting are based on the new requirements. The fulfilment of all legal requirements during the development, production and use of vehicles is an important factor for companies to minimize costs and risks by finding a reasonable balance between the costs incurred to provide all required evidence and the risks that may arise from a deviation from these requirements. The knowledge imparted in this training goes beyond the knowledge of the basic CoP training and provides the participants (optionally adapted to the specific needs of the company) with knowledge about the subtleties of the legal requirements. The training is primarily aimed at experts from the fields of homologation, quality assurance and CoP. Interested parties from other fields are welcome. The training is almost the same as the "Basic Training Approval Procedures" and "Basic Training CoP", in order to make the start easier. The training comprises the following learning units - summary of CoP basic training - consolidation of CoP- Q and QM system - consolidation of CoP- P / product tests - consolidation of the legal requirements and differentiation from other production securing measures, as well as other legal requirements - evaluation / assessment of CoP tests in detail - measures in case of non-conformity in detail - summary of recalls and market surveillance - practical exercises and quizzes to consolidate the acquired knowledge - learning success control

Are you facing a major restructuring? Are you looking for ways to fundamentally improve yourself and your company?We as external consultants offer a new and fresh perspective directly out of a Start-Up Environment!   Taliox Who are we? We are a successful start-up from Hamburg that offers a variety of services in the field of information technology. Taliox was founded in 2016 by four IT specialists and has since been helping its customers to benefit from innovative and state-of-the-art technologies. As today's digital natives, our team can deliver innovative software solutions by combining an intrinsic technical understanding with the latest research. As an innovative digitizer, we optimize processes, design digital strategies, and carry out feasibility studies. We realize our customers' ideas, whether it is a web or desktop application, an app, or a website. Furthermore, with a platform for advanced digital quality planning and an Audit Assistant, we have a constantly expanding product portfolio.   Industry sectorsIT consulting, automotive, consumer goods, software development Areas of applicationproject management, process management, strategy development, concept development, team management, IT security, digitization, software development, performance optimization ProductWe provide organizational consulting, develop information strategies for your company, carry out feasibility studies and calculate the solution costs.With the aim of solving the actual problems directly! Building up on our consulting methods from Problem-Solving and Consulting I we will build a first solution for your problem in this process and test its suitability for you.  We will concentrate on the first three steps of our methodological consulting, based on our experience, will adapt to your needs in this process.  Methods IDEATE  PROTOTYPE TEST Our way of working is divided into three activities according to our consulting work. In the first step, the information shared with us is used to generate and evaluate different ideas based on your challenges. We then switch to prototyping mode after detailed elaboration to create prototypes that will be used for evaluation.The prototype can be very versatile and depends on your ideas. This can range from a web or desktop application, a website to an app! Finally, the prototype that has now been built is used to generate actual user feedback.Instead of working at the concept level, this format is more of a practical type to generate results that might as well be used in future project phases. Companies with whom we can work can break down stuck thinking patterns with our help and make the best future-oriented decisions in intensive cooperation with us. Our working concept effectively structures our cooperation with the aim of your maximum success

Introduction and further development of your QM system according to IATF 16949 The requirements of IATF 16949 and the applicable customer requirements of the OEMs provide a globally recognized set of rules that must be observed by all companies that want to be involved in the supply chain of the global automotive industry. We can offer you fast and pragmatic support to mirror your existing QM system to the requirements and to develop it further. This can lead to preparation for certification of your QM system according to IATF 16949 or simply prepare for a customer audit.   Goal: A certifiable QM system according to IATF 16949 and the applicable customer requirements from e.g. VW Formula Q, MBST BMW and GM Group supply Content  All tasks and the necessary scope will be agreed and defined with you before the offer is submitted. You will receive a final offer from us on the basis of the target price once we have clarified all the contents with you. Usual steps: -        Review of the existing QM system Description -        Sighting of claims -        Initial measurement of the presentation -        Discussion of possible areas for improvement and possible measures -        Support for the introduction of measures -        Audit of the new/changed QMS -        Support for management evaluation   The provider:   MDQM is a freelance engineering office with Markus Dönni as owner. Markus Dönni has been working in the QM of the automotive industry for 25 years and has been running the engineering office since 2003. 400 audits worldwide have given him the opportunity to gain experience in auditing both within the organization and with its suppliers. As a certified AQMA auditor according to ISO9001, IATF 16949 1st/2nd party auditor, and certified VDA 6.3 3rd party auditor, he covers the entire QM audit spectrum.   As the responsible project manager he introduced a worldwide QM system for a German automotive OEM. Later also for various suppliers worldwide. During the transition to IATF 16949, he accompanied many companies in changing and rebuilding their QM systems.

About: You have developed an innovative product and would like to have it approved so that it can be installed in vehicles? Your company is growing and the required skilled workers have not yet been hired or are temporarily absent? You are about to be audited by the authorities and want to start the audit with minimal risk? As a supplier, you have identified a risk for a deviation, but you are not able to evaluate it reliably? Your supplier delivers parts within specification, but you suspect a risk for the approval of your products? You have received a problem reported from the field and cannot classify it?   Target: The "Consulting" department of Mark Haacke Training & Consulting, supports you in finding a solution. Here we focus on your needs. Do you need assistance with the tasks to be mastered or would you like to hand over the tasks completely? It is your decision!   About the trainer: Mark Haacke has been working in the automotive industry for more than 20 years. In his curriculum vitae there are stations such as that of an officially recognized expert at an officially recognized monitoring organization, as a project engineer homologation at a supplier or as head of CoP (conformity of production) at a German vehicle manufacturer. In addition to his theoretical knowledge, Mark Haacke can therefore also draw on a very wide range of practical experience. Benefit from this through short processing times and a very goal- and result-oriented way of working.  

Introduction: Acquire competence in quality management in aerospace and defence and knowledge of the requirements of this standard. Special focal points of this standard on the topics of configuration and risk management are clearly conveyed. Trainer competence: Several years of experience in aerospace and defence projects as well as the implementation of DIN EN 9100 are the hallmarks of our trainers for this seminar. Aim: Participants understand the specific requirements of DIN EN 9100 and are able to implement them successfully in their company. Content: o   Basic knowledge of development and manufacturing processes in aerospace o   Official and legal requirements o   Overview of further requirements from Aerospace Material Standard (AMS) or American Society for Testing and Materials (ASTM) o   Supplier database OASIS (Online Aerospace Supplier Information System) of the International Aerospace Quality Group (IAQG) o   The management approaches and requirements of DIN EN 9100 o   Process of certification according to DIN EN 9100 o   Audit management according to DIN EN 9100 o   Competence Check      Requirements: none Target group: Persons from the aerospace industry and the defence sector who are to introduce a QM system or carry out internal audits in accordance with DIN EN 9100 Duration: 3 days Literature: Seminar documents Price per participant open training:               1.500,00 EUR Price per company internal event:                 9.500,00 EUR

Introduction: Acquire competence in quality management in aerospace and defence and knowledge of the requirements of this standard. Special focal points of this standard on the topics of configuration and risk management are clearly conveyed. Trainer competence: Several years of experience in aerospace and defence projects as well as the implementation of DIN EN 9100 are the hallmarks of our trainers for this seminar. Aim: Participants understand the specific requirements of DIN EN 9100 and are able to implement them successfully in their company. Content: o   Basic knowledge of development and manufacturing processes in aerospace o   Official and legal requirements o   Overview of further requirements from Aerospace Material Standard (AMS) or American Society for Testing and Materials (ASTM) o   Supplier database OASIS (Online Aerospace Supplier Information System) of the International Aerospace Quality Group (IAQG) o   The management approaches and requirements of DIN EN 9100 o   Process of certification according to DIN EN 9100 o   Audit management according to DIN EN 9100 o   Competence Check      Requirements: none Target group: Persons from the aerospace industry and the defence sector who are to introduce a QM system or carry out internal audits in accordance with DIN EN 9100 Duration: 3 days Literature: Seminar documents   The price includes the seminar documents, lunch and coffee breaks during the 2-day seminar.

The objective of the standard is the sustainable improvement of start-up, delivery and field quality of all supplier parts, components and systems through process-accompanying assurance of product maturity at the start of production. By applying a standardized method,projects are segmented, assessed early on and corrected.This system for maturity level assurance describes a standard concept for cooperation and communication in complex product development projects with many parties involved in the supply chain. Therefore, it provides a standard set of measured values and criteria with the corresponding methodology. Since planned comprehensive use of the standard in the automotive and supplier industries requires knowledge and competence in different functions of the organization, a correspondingly broad scope and two-day course was designed.   Content The course imparts knowledge about maturity level methods (assessment, content, control and report systematics) that are necessary in maturity level regulatory processes in the product development process.Furthermore, the measurement criteria are worked out in detail in workshop mode. Finally, the content is applied in practice during a group exercise at an “interdisciplinary round table”. Initial situation and history Methods and basic principles of maturity level assurance Positive and negative examples from organizations Typical conflict of interests Role of the participants at the round table Opportunities for cooperation Group work Prerequisites for participation Experience in project work / product engineering process and / or parts/components qualification Target audience QA personnel, product managers, project managers in product development, product planners, leaders/spokespersons of cross-functional and cross-organizational development teams, persons responsible for components, the supplier’s customer team and project leaders, key account managers. Qualification Certificate At the end, you will receive a VDA certificate of qualification. Duration 2 days Literature VDA volume Maturity Level Assurance for New Parts

SAP ADDON MIC/3:DIRECT CONNECTION OF MEASUREMENT EQUIPMENT TO SAP QMThe measurement equipment interface connector MIC/3 is a cost-effective add-on for direct online measurement value recording via the SAP interface and transaction. MIC/3 allows direct connection of measurement equipment via diff erent interface systems to the SAP QM application and is also incorporated directly into SAP results recording.MIC/3 supports all common interface systems for interface boxes, e.g. Steinwald, Bobe, Mitutoyo, Ibrit, Elias, Brecht, etc.. Alternatively, measurement equipment can be connected directly to the PC easily via the COM/USB interface – in this case, no interface box is required.A free demo version is available.

Introduction: The purpose of quality management is to create trust for the customer in the performance of a company. This trust is of particular importance when medical products are involved and consumers rely on the effectiveness of the medical products. Acquire competence in the implementation of quality management for medical devices and comprehensive knowledge of the requirements of the standard DIN EN ISO 13485:2016. Through clear practical examples and exercises, you will learn about the special focuses, legal and regulatory requirements and advantages that this standard offers your company. Trainer competence: Several years of experience in the production of medical devices and projects for the implementation of DIN EN ISO 13485 in companies distinguish our trainers for this seminar. Goal: Participants understand the specific requirements of DIN EN ISO 13485:2016 and are able to implement them successfully in their company. Content: o   Sense, purpose and advantages of quality management for medical devices -       Requirements of interested parties o   Identification of legal and regulatory framework conditions -       European directives and medical devices law -       Risk management according to DIN EN ISO 14971 ·   Requirements for risk management and market monitoring ·   Required documented information -       Placing medical devices on the market -       Medical Device Safety Plan Ordinance o   Requirements and implementation of a quality management for medical devices according to DIN EN ISO 13485:2016 and DIN EN ISO 9001:2015 o   Conformity assessment and declaration o   Duties, rights and cooperation with consultants and security officers o   Market monitoring and reporting system o   Control of the processes by means of key figures o   Organization of audit activities in the quality management system for medical devices o   Evaluation of the effectiveness of the quality management system o   Competence check or final examination Requirements: none Target group: Persons and managers who are involved in the production of medical devices and who want to introduce and implement a quality management system. Duration: 5 days Literature: Seminar documents and relevant legal texts Price per participant open training:               2.600,00 EUR Price per company internal event:                 16.500,00 EUR

Introduction: The purpose of quality management is to create trust for the customer in the performance of a company. This trust is of particular importance when medical products are involved and consumers rely on the effectiveness of the medical products. Acquire competence in the implementation of quality management for medical devices and comprehensive knowledge of the requirements of the standard DIN EN ISO 13485:2016. Through clear practical examples and exercises, you will learn about the special focuses, legal and regulatory requirements and advantages that this standard offers your company. Trainer competence: Several years of experience in the production of medical devices and projects for the implementation of DIN EN ISO 13485 in companies distinguish our trainers for this seminar. Goal: Participants understand the specific requirements of DIN EN ISO 13485:2016 and are able to implement them successfully in their company. Content: o   Sense, purpose and advantages of quality management for medical devices -       Requirements of interested parties o   Identification of legal and regulatory framework conditions -       European directives and medical devices law -       Risk management according to DIN EN ISO 14971 ·   Requirements for risk management and market monitoring ·   Required documented information -       Placing medical devices on the market -       Medical Device Safety Plan Ordinance o   Requirements and implementation of a quality management for medical devices according to DIN EN ISO 13485:2016 and DIN EN ISO 9001:2015 o   Conformity assessment and declaration o   Duties, rights and cooperation with consultants and security officers o   Market monitoring and reporting system o   Control of the processes by means of key figures o   Organization of audit activities in the quality management system for medical devices o   Evaluation of the effectiveness of the quality management system o   Competence check or final examination Requirements: none Target group: Persons and managers who are involved in the production of medical devices and who want to introduce and implement a quality management system. Duration: 5 days Literature: Seminar documents and relevant legal texts   The price includes the seminar documents, lunch and coffee breaks during the 5-day seminar.