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 environment in which we all live is shaped not least by industrial companies and is becoming increasingly important in our society. Acquire competence in the implementation of environmental management and comprehensive knowledge of the requirements of the DIN EN ISO 14001:2015 standard. Through clear practical examples and exercises, you will become familiar with the special focuses, legal and official requirements and advantages that this standard offers your company. Trainer competence: Several years of experience in industry and projects for the implementation of DIN EN ISO 14001 in companies distinguish our trainers for this seminar. Goal: Participants understand the specific requirements of DIN EN ISO 14001:2015 and are able to implement them successfully in their company. Content: o   Sense, purpose and advantages of an environmental management system -       Requirements of interested parties o   Identification of legal and regulatory framework conditions -       Structure of environmental law -       Waste/cycle management, water law, emission control -       Law on hazardous substances and chemicals -       Environmental liability and criminal consequences o   Requirements and implementation of an environmental management system according to DIN EN ISO 14001 o   Communication on the project for the introduction and maintenance of the environmental management system o   Planning of emergency preparedness and hazard prevention o   Evaluation of relevant environmental topics on the basis of key figures o   Organization of audit activities in the environmental management system o   Evaluation of the effectiveness of the environmental management system o   Competence Check      Requirements: none Target group: Persons from environmental management and executives who want to introduce an environmental management system or integrate it into the existing quality management. Duration: 4 days Literature: Seminar documents and relevant legal texts Price per participant open training:               1.800,00 EUR Price per company internal event:                 11.500,00 EUR

Introduction: Sustainable action, including the use of energy, is becoming increasingly important in our society. Acquire competence in implementing energy management and comprehensive knowledge of the requirements of this standard. Particular focal points of this standard on energy efficiency are clearly explained. Trainer competence: Several years of experience in the energy industry and projects for the implementation of DIN EN ISO 50001 in companies distinguish our trainers for this seminar. Aim: Participants understand the specific requirements of DIN EN ISO 50001 and are able to implement them successfully in their company. Content: o   Legal and political background to energy management -       Renewable Energy Sources Act (EEG) -       Renewable Energies Heat Act (EEWärmeG) -       Energy Saving Act (EnEG) -       Energy Saving Ordinance (EnEV) o   Recording energy data and consumers o   Development of key figures for the evaluation of energy consumption and calculation of profitability o   Possible improvement approaches to reduce energy consumption o   Possibilities for energy recycling o   Development of an energy program taking into account the changes in the processes of the company and the behavior of the employees o   Purchasing strategies for energy procurement o   Audit of the energy management o   Applying for subsidies o   Competence Check      Requirements: none Target group: Persons from quality or energy cost management and executives who want to introduce an energy management system or integrate it into the existing quality management. Duration: 3 days Literature: Seminar documents Price per participant open training:               1.550,00 EUR Price per company internal event:                 9.500,00 EUR  

Introduction: In May 2019 the new edition of FSSC 22000 (Food Safety System Certification) was published and has been in force since 1 January 2020. From 30 June 2020, all certificates issued in accordance with the previous version of FSSC 22000 will lose their validity. Acquire the competence to implement the current requirements for certification according to FSSC 22000 and comprehensive knowledge of the requirements of the standard DIN EN ISO 13485:2016. Trainer competence: Several years of experience in the food industry and in projects for certification according to FSSC 22000 for companies distinguish our trainers for this seminar. Goal: Participants understand the specific requirements of FSSC 22000 and are able to implement them successfully in their company. Content: o   Sense, purpose and development of the FSSC 22000 o   External and legal requirements o   Requirements of FSSC 22000 and examples of implementation in the company o   Prevention Program -       PRP - Prerequisite Program Requirements) -       oPRP - Operational Prerequisite Program) o   Description of raw materials and products o   Rights and duties of a HACCP representative (Hazard Analysis Critical Control Points) -       Food Law -       Raw materials incl. packaging material -       Products, processes and procedures -       Dangers (physical, chemical and biological) -       Operational and personnel requirements o   Hazard analysis and "critical control points o   Recall of products o   Hygiene requirements o   5 preventive steps o   7 Implementation principles o   Competence check or final examination Requirements: none Target group: Persons and managers involved in food production who want to introduce and effectively implement a management system. Duration: 3 days Literature: Seminar documents and relevant legal texts Price per participant open training:               1.550,00 EUR Price per company internal event:                 9.600,00 EUR

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 training almost summarizes the essential main points of the basics of the approval procedures and conformity of production and puts them together in a correspondingly focused way for the decision-makers in the companies. Mark Haacke, who can draw on almost 20 years of practical experience in this complex subject area, leads through the training. Do not bother to read legal texts and regulations or directives! Deal directly with the actions to be derived from them! Mark Haacke guides you in a relaxed, eloquent and practical manner through the individual elements of the training and gives you sufficient space for discussions and questions. The aim of the training is to support the management of the companies in the optimal implementation of the obligations, with clear knowledge of the rights, and to be able to define possible measures in the organization.

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. About: The training almost summarizes the essential main points of the basics of the approval procedures and conformity of production and puts them together in a correspondingly focused way for the decision-makers in the companies. Mark Haacke, who can draw on almost 20 years of practical experience in this complex subject area, leads through the training. Do not bother to read legal texts and regulations or directives! Deal directly with the actions to be derived from them! Mark Haacke guides you in a relaxed, eloquent and practical manner through the individual elements of the training and gives you sufficient space for discussions and questions. The aim of the training is to support the management of the companies in the optimal implementation of the obligations, with clear knowledge of the rights, and to be able to define possible measures in the organization.

About: 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, and it is important to find a reasonable balance between the costs incurred in providing all the required evidence and the risks that may arise from deviating from these requirements. With the appropriate knowledge, you will understand how you as a supplier can meet the requirements of OEM and authorities, who may and/or must communicate with the OEM or authorities and which measures can be taken for field and product monitoring. The training includes the following learning units- Summary of CoP and approval procedures- Product groups affected by market surveillance- Measures for active and passive market surveillance- Levels of recalls- Decision matrix- Organization and committees in the companys- Practical exercises and quizzes to consolidate the acquired knowledge- Learning success control

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, and it is important to find a reasonable balance between the costs incurred in providing all the required evidence and the risks that may arise from deviating from these requirements. With the appropriate knowledge, you will understand how you as a supplier can meet the requirements of OEM and authorities, who may and/or must communicate with the OEM or authorities and which measures can be taken for field and product monitoring. The training includes the following learning units- Summary of CoP and approval procedures- Product groups affected by market surveillance- Measures for active and passive market surveillance- Levels of recalls- Decision matrix- Organization and committees in the companys- Practical exercises and quizzes to consolidate the acquired knowledge- Learning success control

Every organization within the automotive supply chain is obliged to ensure the safety and conformity of its products. To this end, in the respective countries and regions current legal statutes on product integrity must be observed, also the justifiable safety expectations of the general public must be fulfilled. With products conspicuously “unsafe“ in the market, or whose conformity to legal requirements is questionable, those responsible are obliged to initiate the necessary actions. In order to be aware of and to understand the many demands addressed to a product safety representative, comprehensive information and qualification is necessary. This is the aim of this two-day qualification: it is specifically geared to the requirements in the participants’ daily work practice. The central topics of product integrity are explored, and the competence as product safety representative is developed in the scope of these five modules.   ObjectivesThe focus is on the communication of expert knowledge that enables the participants to handle their everyday work more professionally and in a more targeted fashion as prospective or existing product safety representatives. The responsibilities in the whole supply chain from development through manufacture and use up to the end of intended use are dealt with. After an introduction to the topic the organization of product integrity, product integrity in the product life cycle, guidance for product nonconformities and examples for tools and methods are discussed. Concept and MethodsDuring this training, technical lectures and exercises alternate in order to support the transfer of the topics into the participants‘ own work practice with a particular focus on exchanging experiences between participants and the trainer. Prerequisites for participationIn order to attend this training, a technical and / or business education is necessary as well as experience in automotive quality management, especially in complaints and recourse management. Furthermore, the participants should be qualified and experienced in the evaluation of technical product and process risks (e. g., FMEA facilitator, VDA 6.3 process auditor, designer / developer) and be knowledgeable about the use of the organisation’s products, the state of the art as well as the requirements from relevant laws and customer requirements. Target audienceAutomotive executives and personnel who are to be deployed as product safety representatives or who already hold that position. Qualification CertificateAfter passing the test, the participants will receive a certificate of qualification. Duration2 days Supplementary MaterialVDA Volume Product Integrity and Conformity

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.   ContentThe 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 historyMethods and basic principles of maturity level assurancePositive and negative examples from organizationsTypical conflict of interestsRole of the participants at the round tableOpportunities for cooperationGroup workPrerequisites for participationExperience in project work / product engineering process and / or parts/components qualification Target audienceQA 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 CertificateAt the end, you will receive a VDA certificate of qualification. Duration2 days LiteratureVDA volume Maturity Level Assurance for New Parts