IAF MD 5 and MD 9 Trainings

Our Training Content

We can define IAF (International Accreditation Forum) as a worldwide association of accreditation bodies and other organizations involved in conformity assessment in areas such as management systems, products, processes, services, personnel, verification, and validation, among other similar conformity assessment programs. The primary role of IAF is to develop a single global conformity assessment program that reduces risks by ensuring businesses and customers can trust accredited certificates and declarations.

The IAF MD 5 document is a mandatory publication by the International Accreditation Forum (IAF) that defines the audit time required for Quality, Environmental, and Occupational Health and Safety Management Systems. The primary goal of the document is to ensure consistency in the audit duration for Quality Management Systems (QMS), Environmental Management Systems (EMS), and Occupational Health and Safety Management Systems (OHSMS).

The IAF MD 9 document is another mandatory publication by the International Accreditation Forum (IAF), which relates to the application of ISO/IEC 17021-1 in the certification of Medical Device Quality Management Systems according to the ISO 13485 standard. The document outlines the requirements and guidelines necessary to ensure conformity in certification processes compliant with the ISO 13485 standard.

Training Method

• Interactive Presentations: Dynamic and interactive presentations prepared by subject matter experts.
• Updated Information: Learning through real-world scenarios and case studies.
• Assessment Exams: Tests to reinforce knowledge and assess understanding of regulations.

Who Is It For?

• Auditors: Individuals responsible for auditing and evaluating management systems.
• Quality Management Systems Experts: Professionals involved in the implementation and management of systems in compliance with ISO standards.

Training Dates and Registration

Our training is conducted online, offering flexible time slots. For registration and more information, please visit our website or contact us at support@pcatrainings.com.tr.

What Will You Gain from the Training?

IAF MD 5 Training (Determining Audit Time)

• Expertise in determining audit time: Participants will gain a systematic approach to accurately determining audit time for different management systems (Quality, Environmental, Occupational Health and Safety) in line with the ISO/IEC 17021-1 standard.
• Risk assessment: Learn to identify different risk levels (high, medium, low) and understand how they impact audit time, gaining competence in risk-based audit planning.
• Complexity analysis: Understand how to evaluate organizational complexity (size, structure, processes) and its impact on audit duration.
• Effective personnel count calculation: Learn the significance of effective personnel count in determining audit time and how to calculate it accurately.
• Application: Reinforce theoretical knowledge through practical scenarios and examples.
• Consistency and reliability: Learn a standardized approach to ensure consistency across different organizations and auditors.

IAF MD 9 Training (Application of ISO/IEC 17021-1 for Medical Devices)

• In-depth knowledge of ISO 13485 and ISO/IEC 17021-1 standards: Participants will learn about these two key standards for certifying quality management systems for medical devices in detail.
• Expertise in medical device technical areas: Gain comprehensive knowledge about different categories of medical devices and related technical fields, essential for determining the audit scope and selecting the appropriate audit team.
• Risk assessment and management: Learn how to evaluate the risks associated with medical devices and integrate them into the management system.
• Compliance with UDK requirements: Understand the requirements and responsibilities necessary for conformity with the ISO/IEC 17021-1 standard as a UDK, focusing on impartiality, competence, and independence.
• Improvement of audit processes: Learn practical methods to make audit processes more effective and efficient.

At PCA Training Institute, we are here to support your success in the industry by providing you with the most comprehensive and up-to-date training on the IAF MD 5 and MD 9 documents.