Training

Course Objective:

• Understanding of the IATF 16949 foundation
• Understanding of the roles of the top management in the Automotive QMS
• Understanding the requirements of the IATF 16949 that is relevant to top management

Course Objective:

• Understanding of the IATF 16949 evolution and requirements in details
• Understanding the gaps between IATF 16949 requirements vs current QMS in the organization
• Clause-by-clause implementation guide and the details on setup a QMS that meeting the IATF 16949 requirements.

Course Objective:

• Understanding of the ISO 14001 foundation
• Understanding of the roles of the top management in the ISO 14001 EMS
• Understanding the requirements of the ISO 14001 that is relevant to top management

Course Objective:

• Understanding of the IATF 16949 risk-based thinking requirements
• To have a full view on the risk-based thinking process in the QMS
• Practical knowledge & skills on how to determine the risks and opportunities within the organization
• Understanding on the documentation of the risks and opportunities.

Course Objective

• Understanding of the ISO 13485 foundation
• Understanding of the importance of ISO 13485 to an organization
• Understanding the requirements of the ISO 13485 that is relevant to shop floor employee

Course Objective:

• Understanding of the ISO 14001 foundation
• Understanding of the importance of ISO 14001 to an organization
• Understanding of the ISO 14001 requirements that is relevant to shop floor employee

Course Objective:

• Understanding of the IATF 16949:2016 Internal Auditing requirements
• Understanding of First- & Second-party Auditor Qualification requirements
• Understanding the automotive process approach for auditing, including risk-based thinking
• Understanding the auditing skills and technique and apply it to the actual audit

• Understanding what is medical devices
• Basic knowledge on the ISO 13485
• An interpretation of the ISO 13485 requirements

Course Objective: 

• Understanding of the ISO 14001 Foundation
• Understanding of the ISO 14001 requirements in detail

Course Objective:

• Understanding of the FMEA concept
• Understanding the complete methodology for developing the FMEA
• Knowledge on how to apply the evaluation criteria

Course Objective

• Understanding what is medical devices
• Basic knowledge on the ISO 13485
• An interpretation of the ISO 13485 requirements

Course Objective: 

• Understanding of the ISO 14001 foundation and requirements in details
• Understanding the gaps between ISO 14001 requirements vs current EMS in the organization
• Clause-by-clause implementation guide and the details on setup a EMS that meeting the ISO 14001:2015 requirements.

Course Objective:

• Understanding the major differences of the AIAG-VDA FMEA with AIAG FMEA 4th Edition
• Understanding of the AIAG-VDA PFMEA concept
• Understanding the complete methodology (7 steps) for developing the Process FMEA
• Knowledge on how to assign the Action Priority (AP)

Course Objective:

• General requirements for risk management system
• Risk analysis process, Risk evaluation process, Risk control and Evaluation of overall residual risk process
• Step-by-step of Risk Management Process
• Development of Risk Management File

Course Objective:

• Understanding of the ISO 14001 risk-based thinking requirements
• To have a full view on the risk-based thinking process in the EMS
• Understanding on how to determine the risks and opportunities within the organization
• Understanding on the documentation of the risks and opportunities.

Course Objective:

• Understanding of the ISO 9001 foundation
• Understanding of the roles of the top management in the ISO 9001 QMS
• Understanding the requirements of the ISO 9001 that is relevant to top management

Course Objective:

• Understanding on the general measurement system guidelines
• Understanding on the general concept for assessing measurement system
• Knowledge and skill to perform the variable measurement system study (bias, linearity, stability, Gauge Repeatability & Reproducibility) and attribute measurement system study

Course Objective:

• Understanding of the ISO 13485 Internal Audit requirements
• Understanding the audit principles
• Practical skills necessary to plan, conduct, report and close out an internal audit

Course Objective:

• Understanding of the ISO 14001 Internal Audit requirements
• Understanding the audit principles
• Practical skills necessary to plan, conduct, report and close out an internal audit

Course Objective:

• Understanding of the ISO 9001 foundation
• Understanding of the importance of ISO 9001 to an organization
• Understanding of the ISO 9001 requirements that is relevant to shop floor employee

Course Objective:

• Understanding on the general measurement system guidelines
• Understanding on the general concept for assessing measurement system
• Knowledge to perform the variable measurement system study (bias, linearity, stability, Gauge Repeatability & Reproducibility) and attribute measurement system study

Course Objective:

• Understanding the GDPMD requirements
• Awareness on the key elements to ensure medical device quality and safety along the supply chain.

Course Objective:

• Practical knowledge to determine the environmental aspects, considering a life-cycle perspective
• Methodology for determining significant environmental aspects with both adverse and beneficial impacts
• Understanding of how the environmental aspects are linked to compliance obligation and risks &

• Understanding of the ISO 9001 Foundation
• Understanding of the ISO 9001 requirements in details