ISO 9001:2015
ISO 9001 Quality Management System
ISO 9001 is the standard that defines the performance requirements during the installation of Quality Management Systems and is subject to certification audit.
Basic training
It is a training that will help you understand the basic requirements, definitions and explanations of ISO 9001:2015 in detail. With this training, the participant will understand the relationship with the Quality Management System system and other standards.
Application Training
this training , the participant will have the necessary knowledge and experience to implement the ISO 9001:2015 Quality Management System in his business. In this training, where standards and sector requirements are examined, you will gain a process-oriented perspective in production and service providing businesses.
Internal Auditor Education
With this training, the participant will learn how to conduct internal review and 2nd party supplier review. It is recorded whether the training results have mastered examination techniques such as planning examinations, performing and reporting treatment, within the scope of ISO 19011 . They will increase their experience regarding the activities to be carried out together with the internal audit activity to be implemented .
ISO 14001:2015
ISO 14001 Environmental Management System
ISO 14001 is an international standard for controlling and improving a company's activity, i.e. process disruption.
Basic training
This is training that will help you understand the basic requirements, definitions and explanations of the ISO 14001:2015 Environmental Management system in detail. With this training, the participant will understand the Environmental Management System concepts and their relationships with other standards.
Application Training
this training will provide the necessary knowledge and experience to implement the ISO 14001:2015 Environmental Management System in its business. In this training, where standards and industry requirements are examined, a process-oriented perspective will be gained in businesses that provide production and services.
Internal Auditor Education
In the organization of these training processes, you will be taught how to learn by examining the environment within the scope of the Environmental Management System . Participants will learn ISO 14001:2015 inspection techniques within the scope of ISO 19011. They will plan the investigations, report and report to the analysis participants. They will increase the reporting activities of the findings opened.
ISO 22000:2018
ISO 22000 Food Safety Management System
ISO 22000 is an international standard to ensure the requirements of a food safety management system covering all management in the food chain "from farm to plate".
Basic training
It is a training that will help you understand the basic requirements, definitions and explanations of the Food Safety Management system in detail. With this training, the participant will understand the relationship with Safe Food production and other standards.
Application Training
this result will provide the person with the necessary knowledge and experience to implement the ISO 22000:2018 Food Safety Management System in his business. In this training, where standards and sector requirements are examined, you will gain a process-oriented perspective in businesses that provide Safe Food production and service.
Internal Auditor Education
After this training, students will be able to interpret and apply food safety management system requirements in the body. With this training, students will be able to learn the characteristics and techniques of the food safety management system through examination within the scope of ISO 19011.
ISO 45001:2018
ISO 45001:2018 Occupational Health and Safety Management System
The ISO 45001 standard will help you protect your most valuable assets, your employees, and ensure resilience to business excellence.
Basic training
The main purpose of this training is to teach IS&S principles and IS&S conditions .
Internal Auditor Education
The main purpose of this training is; It will enable them to understand the theoretical principles regarding the IS&G conditions that will carry out the IS&S review and to reinforce their knowledge with the applications to be made.
ISO 13485:2016
ISO 13485 Quality Management System of Medical Devices
ISO 13485 for Quality Management System of Medical Devices is a quality management system that includes special conditions for medical devices.
Basic training
It is a training that will help you understand the basic requirements, definitions and explanations of ISO 13485:2016 in detail. With this training, the participant will understand the relationship with the regulation QMS system and other standards in organizations providing medical production or services.
Application Training
this training will have the necessary knowledge and experience to apply the QMS in its business within the scope of the requirements for ISO 13485:2016 Medical devices - Quality management systems - general information . In this training, where standards, sector and product requirements are examined, you will gain a process-oriented perspective in production and service providing businesses.
Internal Auditor Education
this training , the participant will learn the ISO 19011 rules and quality management system process reviews organized according to the ISO 13485:2016 standard.
ISO 14971
Risk Management in Medical Devices
This standard contains a procedure for estimating, evaluating, controlling, and indicating the risks associated with devices intended to eliminate hazards associated with a manufacturer's therapeutic devices, including body chart diagnostic devices (IVDs).
Education
management under the Medical Device Regulation (MDR) education all medical device manufacturers It is necessary for this . At the end of this equation , the participant will have the necessary tools to manage the risks of the product in compliance with an international standard .
CE Marking
CE Mark
compliance with CE marking zones, certain ranges and intervals , and allows users to know the basic quality and safety distribution of the product . CE Mark (mark) is known by many users as a symbol of quality.
Education
this training , they will be able to experience the necessary steps to minimize the risks in current Medical Device production and the procedures in the EU legal legislation .
Post-Market Surveillance and Vigilance
Education
Surveillance after placing on the market , all effects of the quality management system. It is a legal requirement to include your post-market maintenance, with proactive and reactive information resources available for all products. By developing a plan for tracking launches, you can target and track information sources that are cost-effective and enable a product launch. It will determine the needs of consumers who are financially correct after the launch, providing continuous sleep opportunities to the directives and providing continuous product rest opportunities.
After this training, you will be able to develop:
Medical Device Regulatory Requirements (MDR)
Education
To understand basic information about (EU) Medical Devices regulatory requirements (MDR (MDR 2017/745/EU)); Including management, it is possible to see independent subcontractors, suppliers, OEMs, authorized representatives, importers, distributors working as managers or project members in senior QM / QA, R& D , design, production, supply chain, customer service and sales units of organizations. makes .
Software Validation in Medical Devices
Education
Medical software software verification ISO 13485:2016 and ISO 14971:2018 after updates Part of the routine parts of medical devices in product distribution, but part of technical coolers. In this regard, solution partners continue to be a necessity. With this training, they will be able to gain moderate income and manage a more efficient process with their solution partners.
Preparation of Technical File for Medical Devices According to the New MDR (EU) 2017/745 Regulation
Education
The main documents that summarize the technical files that need to be prepared within the scope of the Medical Device Regulation ((EU) 2017/745) and the basic critical features of these main documents will be explained. The training process software will have basic level features on how to prepare the Technical File and what to pay attention to.
Sterilization Validation
Education
The necessary stages and documentation requirements for sterilization validation will be explained. At the end of the training, the critical parameters of sterilization, expected stages of validation, documentation and testing requirements will be understood.
