Training Services

Our internationally recognized (IRCA approved) Lead Auditor Trainings are designed for professionals who want to make a career in the field of management systems auditing. This intensive program provides participants with the knowledge and skills to plan, conduct, report, and follow up on first, second, and third-party audits necessary to evaluate the compliance of a management system (ISO 9001, ISO 13485, etc.) with the standard. At the end of the training, participants gain the competence to lead audit processes and guide organizations to elevate their quality standards to the highest level.

Internal Audit Training is of critical importance for an organization to evaluate how effectively its own management system works. This training teaches your employees how to audit their own processes according to standard requirements. Participants gain competence in detecting non-conformities, performing root cause analysis, planning corrective actions, and supporting a continuous improvement culture. Internal audits are an indispensable tool for preparing for external audits and keeping the system alive.

One of the cornerstones of management systems is effective documentation. This training teaches how to create, manage, and maintain the policies, procedures, instructions, forms, and records required by standards. Our goal is to help you establish lean, understandable, and practical documentation systems suitable for the organization’s needs, instead of complex and cumbersome document piles. Correct documentation ensures the standardization of processes, competency of personnel, and traceability of the system.

This training aims to explain the basic philosophy and requirements of a management system standard (e.g., ISO 9001:2015) to employees at all levels of the organization. At the same time, it covers in detail the changes brought by the last revisions in the standards, new approaches, and transition processes. This ensures that the whole team understands and adopts the purpose of the standard and adapts rapidly to current requirements, thereby completing transition audits smoothly.

Risk Management, which is an absolute necessity for the medical device industry, is handled in all details in this training based on the EN ISO 14971 standard. Participants learn to systematically identify hazards that may arise throughout the entire life cycle of a medical device, analyze risks, evaluate them, and implement control measures to reduce them to acceptable levels. This training provides the methodology necessary to meet one of the core expectations of regulatory authorities like MDR and FDA.

This training, which is of vital importance for all manufacturers, importers, and distributors offering medical devices to the European market, comprehensively explains the new and tightened rules brought by the European Medical Device Regulation (MDR - 2017/745) and the In Vitro Diagnostic Devices Regulation (IVDR - 2017/746). Critical topics such as classification rules, clinical evaluation, post-market surveillance (PMS), UDI (Unique Device Identification) system, and new responsibilities of economic operators are discussed. This training will be your roadmap to ensure legal compliance and secure your market access.