ISO 13485 Lead Auditor
Description: Knowledge and skills to:
- Manage the audit team members and the audit process.
- Represent the audit team in communications with the personnel managing the audit programme, audit client and auditee.
- Lead the audit team to reach the audit conclusions.
- Prepare and conduct the audit activities.
- Collect and analyze appropriate evidence to determine the audit findings and define the audit conclusions.
- Prepare and present the audit report.
- Follow up and close the audit process.
Previous skills/knowledge:
- Demonstrable knowledge of ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes and applicable regulation requirements.
- Demonstrable evidence of participation in ISO 13485 audits (>1 audit recommended)
- Professional experience, including in quality management systems and medical devices quality management systems (recommended).
Authorized Partners:
Teaching requirements: - Trainer to be a qualified ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes Lead Auditor.
Objectives to achieve: To get the necessary knowledge and skills to:
- Fully understand and interpret the requirements of ISO 13485.
- Understand the requirements of the applicable regulations and be able to compare these to the requirements in ISO 13485.
- Understand the terminology of the ISO 13485 and how these apply in a Medical Device Environment for regulatory purposes.
- Learn and apply the main terms, principles, and techniques used during the activities of the audit process, according to the responsibilities assigned to a lead auditor, for the assessment of an ISO 13485 Medical Devices Management Systems, based on the ISO 19011 guidelines for auditing management systems
ISO 21001 Quality Systems Manager in Educational Organizations
Description:
- Ability to design, implement and evaluate quality management systems in educational organizations, guaranteeing continuous improvement and satisfaction of interested parties.
- Ability to understand and apply the requirements of the ISO 21001 standard in different educational contexts.
- Competence to lead and manage multidisciplinary teams, promoting a culture of quality and continuous improvement.
- Ability to develop and execute strategic plans focused on educational quality, aligned with institutional objectives and ISO 21001 standards.
- Ability to design and implement educational quality evaluation and monitoring systems, promoting a cycle of continuous improvement.
- Competence in the identification, analysis and optimization of key educational processes to improve organizational efficiency and effectiveness.
- Ability to identify, evaluate and manage risks in educational organizations, ensuring the continuity and quality of the educational service.
- Ability to collect, analyze and interpret relevant data for making informed decisions in the management of educational quality.
Previous skills/knowledge:
- Basic knowledge of quality management systems.
Authorized Partners:
Teaching requirements: Trainer work-experience in the area of quality management systems in the educational sector and to have demonstrable knowledge of ISO 9001:2015 and ISO 21001:2018.
Objectives to achieve: To get the necessary knowledge and skills to:
- Be able to understand the ISO 21001 basic standard requirements
- Be able to implement a Quality Management System in the educational sector
Sustained Success Management According to ISO 9004:2018
Description:
- Recognize the relation between ISO 9001:2015 and ISO 9004:2018
- Identify stakeholders and understand their roles and importance in achieving sustained success
- Identify factors affecting an organization’s success and how to face them
- Understand how to implement the improvement and innovation to support the sustained success
- To implement a self-assessment tool in order to identify actions to achieve the sustained success
Previous skills/knowledge:
- Demonstrable knowledge of ISO 9001:2015 or quality management systems.
- Professional experience, in quality management systems.
Authorized Partners:
Teaching requirements: Trainer to have teaching experience in QMS min 2 years, demonstrable knowledge of ISO9001, professional experience in QMS as teacher or auditor. Shall include theoretical and practical approach.
Objectives to achieve:
- Acquire the knowledge on how to apply fundamental concepts of sustained success
- To understand the general structure of ISO 9004:2018 standard
- To acquire the knowledge on how to perform a self-assessment of the model of sustained success.
Quality Costs. An Approach to The Financial Management of Quality.
Description:
- Apply the principles of financial management and the tools that allow establishing the costs and profitability of the quality management system.
- Identify and control the hidden costs of poor quality.
- Carry out the analysis of the benefit-cost relationship of investment in a quality management system.
Previous skills/knowledge:
- Demonstrable knowledge of ISO 9001:2015.
- Professional experience in quality management systems.
Authorized Partners:
Teaching requirements: Trainer must have as a teacher experience in quality management system of minimum two year. Trainer to have demonstrable knowledge of ISO 9001:2015. Trainer to have professional experience in QMS. Shall include theoretical and practical approach.
Objectives to achieve:
- Acquire knowledge on the methodology for the identification and calculation of quality costs, as part of the quality management system (QMS).
- Analyse the participation and impact of the costs of quality and non-quality in the financial results of organizations.
Quality Management Systems for the Educational Sector. Specific requirements complementary to ISO 9001:2015, according to ISO 21001:2018
Description:
- Understand the scope and the structure of the requirements of ISO 21001:2018.
- To align the strategic drivers with the pedagogical model of an educational institution.
- Contextualize the requirements of ISO 21001:2018 in an educational institution.
Previous skills/knowledge:
- Demonstrable knowledge of ISO 9001:2015 or quality management systems
- Professional experience, in quality management systems and educational management systems
Authorized Partners:
Teaching requirements: - Trainer to have quality management systems’ teaching experience and knowledge on the educational sector of min 2 years. Trainer to have demonstrable knowledge of ISO 9001:2015 and ISO 21001:2018 . Shall include theoretical and practical approach.
Objectives to achieve:
- Understand the possibilities of evolution of a management system of an educational institution from the perspective of ISO 21001:2018 standard.
- Identify the aspects to improve in a management system of an educational institution.
Crisis management for SMEs
Description:
- Identify the crisis situations and the necessary actions to ensure recovery from a crisis.
- Understand how to address the main elements for an effective crisis management capacity.
- Acquire the knowledge to lead and to take strategic effective decisions in crisis.
Previous skills/knowledge:
- Demonstrable knowledge of ISO 9001:2015 or quality management systems
- Professional experience, in quality management systems and risk management
Authorized Partners:
Teaching requirements: Trainer to have quality management systems’ teaching experience of minimum 2 years. Trainer to have professional experience in quality management systems and risk management in a teaching or auditor position. The course shall include both theoretica.
Objectives to achieve:
- Understand the main elements of a crisis and how they can affect a small or medium organization.
- Acquire knowledge of the most relevant aspects for the construction and strengthening of organizational capacities that allow small and medium-sized companies to manage the crisis and better respond to it.
ISO IEC 17025 Internal Auditor
Description:
- To follow the instructions of the lead auditor and support him
- To collect and analyze enough evidences (e.g. through interview, observation and sampling of documentation) to determine the audit findings and define the audit conclusions
- To document the audit findings
- To collaborate in drafting the audit report
- To interchange information with the rest of the members of the audit team and with the auditee personnel.
Previous skills/knowledge:
- Demonstrable knowledge of ISO IEC 17025 requirements (2017 version recommended)
- Professional experience, including in quality management systems in the area of testing and calibration laboratories.
Authorized Partners:
Teaching requirements: Trainer work-experience as Quality Manager in the area of testing and calibration laboratories according ISO IEC 17025
Objectives to achieve: To get the necessary knowledge and skills to:
- Be qualifiable as ISO IEC 17025 internal auditor (additional requirements from qualifying entity may apply)
- Understand the principles of internal audit
- Be able to assume responsibilities in any activity of the internal auditing process
- Understand the functions and competences that any auditor must have to carry out first, second party, and certification audits
- Be able to apply auditing guidelines to ISO IEC 17025 internal audits.
ISO IEC 17020 Internal Auditor
Description:
- To follow the instructions of the lead auditor and support him
- To collect and analyze enough evidences (e.g. through interview, observation and sampling of documentation) to determine the audit findings and define the audit conclusions
- To document the audit findings
- To collaborate in drafting the audit report
- To interchange information with the rest of the members of the audit team and with the auditee personnel.
Previous skills/knowledge:
- Demonstrable knowledge of ISO IEC 17020 requirements (2012 version recommended)
- Professional experience, including in quality management systems in the area of conformity assessment bodies.
Authorized Partners:
Teaching requirements: Trainer work-experience as Quality Manager in the area of conformity assessment bodies according ISO IEC 17020
Objectives to achieve: To get the necessary knowledge and skills to:
- Be qualifiable as ISO IEC 17020 internal auditor (additional requirements from qualifying entity may apply)
- Understand the principles of internal audit
- Be able to assume responsibilities in any activity of the internal auditing process
- Understand the functions and competences that any auditor must have to carry out first, second party, and certification audits
- Be able to apply auditing guidelines to ISO IEC 17020 internal audits.
ISO 9001 Quality Systems Manager
Description:
- Abiltiy to understand the quality principles and quality management
- Abiltiy to understand and apply the basic requirements of ISO 9001
- Ability to develop the necessary documentation for the quality management system
- Ability to identify processes, to create a process model, to monitor and control processes
- Abiltiy to address risks and opportunities
- Abillity to identify the competences of the staff involved in the quality management system
- Abiltiy to coordinate and motivate the work team
- Ability to analyse the information provided by the quality management system
- Ability to apply basic management methods
- Ability to plan and conduct an internal audit and identify activities for improvement
- Ability to support the senior management in the system review.
Previous skills/knowledge: Basic knowledge of quality management systems.
Authorized Partners:
Teaching requirements: Trainer work-experience in the area of quality management system
Objectives to achieve: To get the necessary knowledge and skills to:
- Be able to understand the ISO 9001basic standard requirements
- Be able to implement a quality management system
IATF 16949:2016 Automotive Industry Management Internal Auditor Training Course
Description: Competences include:
- Competent as IATF 16949 Internal Auditors and to apply ISO 19011 guidelines to auditing IATF 16949
- To collect and analyze enough evidences (e.g. through interview, observation and sampling of documentation) to determine the audit findings and define the audit conclusions
- To document the audit findings
- To collaborate in drafting the audit report
- Trainees also learn how to assess the organizations use of risk-based thinking to identify threats and opportunities as well as the effective use of the Core Tools (APQP, FMEA, MSA, SPC and PPAP) and other methods required by IATF 16949
- To interchange information with the rest of the members of the audit team and with the auditee personnel.
Previous skills/knowledge:
- Knowledge of IATF 16949 requirements
- Knowledge of applicable ISO 9001 & IATF 16949 requirements (recommended)
- Knowledge of applicable core tools
- Professional experience, including in quality management systems (recommended)
Teaching requirements: Trainer should to be a qualified IATF 16949 Lead Auditor
Objectives to achieve: To get the necessary knowledge and skills to:
- Be qualifiable as IATF 16949 internal auditor
- Understand the principles of internal audit
- Be able to assume responsibilities in any activity of the internal auditing process
- Understand the functions and competences that any auditor must have to carry out first, second party, and certification audits
- Be able to apply auditing guidelines to IATF 16949 internal audits