ISO 13485:2016 Medical Devices Quality Management Internal Auditor Training Course
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:
- Knowledge of ISO 13485 requirements
- Professional experience, including in medical devices management systems – ISO 13485 (recommended)
- Knowledge of the methods and techniques of assessment.
Authorized Partners:
Teaching requirements:
Trainer should to be a qualified ISO 13485 Lead Auditor
Objectives to achieve: To get the necessary knowledge and skills to:
- Be qualifiable as ISO 13485 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 13485 internal audits.
Quality Management Representative in Facility Management – compact course
Description: Competences include
- Ability to generate Quality Management documents
- Ability to identify processes, to create a process model, to monitor and control processes
- Ability to address risks and opportunities
- Ability to understand the basic requirements of ISO 41001
- Ability to determine requirements (e.g. from customers, legal requirements, internal requirements)
- Ability to FM planning for saving the requirements
- Ability to plan and conduct an internal audit and contract audit by writing the audit report and identify activities for improvement
- Ability to apply basic quality management methods.
Previous skills/knowledge: Basic knowledge of quality management and facility management with its methods and tools (targeted at operational staff, directors, top managers, group leaders and department managers from all areas).
Authorized Partners:
Teaching requirements:
Trainer work-experience in the area of quality management system and facility management
Objectives to achieve: To get the necessary knowledge and skills to:
- To be able to apply the most important methods and tools in the area Quality Management and facility management
- To be able to understand the basic normative requirements of ISO 41001
Quality Management Representative in Health Care – Compact Course
Description: Competences include
- Ability to generate Quality Management documents
- Ability to identify processes, to create a process model, to monitor and control processes
- Ability to address risks and opportunities
- Ability to understand the basic requirements of EN 15224:2016
- Ability to determine requirements (e.g. from customers, legal requirements, internal requirements)
- Ability to plan inspection activities and sampling
- Ability to plan and conduct an internal audit and write the audit report and identify activities for improvement
- Ability to apply basic quality management methods.
Previous skills/knowledge: Basic knowledge of quality management and its methods and tools (targeted at operational staff, directors, top managers, group leaders and department managers from all areas).
Authorized Partners:
Teaching requirements:
Trainer work-experience in the area of quality management system and health care
Objectives to achieve: To get the necessary knowledge and skills to:
- To be able to apply the most important methods and tools in the area Quality Management
- To be able to understand the basic normative requirements of EN 15224:2016.
ISO 21001 Lead Auditor
Description: Competences detailed in ISO 21001 EOMS Internal auditor, plus
- To participate in the selection of the audit team
- To prepare of the audit plan
- To represent of the audit team before the customer
- To give instructions to the audit team
- To inform of any relevant obstacle identify during the audit process
- To be responsible of all the audit steps
- To present the audit report
- To follow up and close the audit process.
Previous skills/knowledge:
- Demonstrable knowledge of ISO 21001 EOMS requirements
- Demonstrable evidence of participation in ISO 21001 audits (>1 audit recommended)
- Knowledge or professional experience in educational products and services (recommended).
Authorized Partners:
Teaching requirements:
Trainer to be qualified ISO 21001 – Management Systems for Ed-ucational Organizations (EOMS) , or Trainer to be a qualified ISO 9001/QMS Lead Auditor and have comprehensive experience (>5 years) working for organizations providing educational products
Objectives to achieve: Objectives detailed in ISO 21001 EOMS internal auditor, plus
To get the necessary knowledge and skills to:
- Apply the proper interpretation of the standard in actual audit situations
- Plan the audit
- Carry out EOMS management system audits
- Define the responsibilities of the audit team´s members
- Know the functions and attitudes that an auditor must follow
- To effectively coordinate meetings with the audit team members and/or with auditee personnel
- Identify and write non-conformities and other deviations and suggest ways in which the effectiveness of corrective action might be verified
ISO 21001 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 audit the effective implementation of EOMS specific operations and tools
- 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 21001 requirements
- Professional experience, including related to QMS/EMS/OHSAS (or other international standard based) management systems (recommended)
- Knowledge or professional experience in educational products and services (recommended).
Authorized Partners:
Teaching requirements:
Trainer to be qualified ISO 21001 – Management Systems for Educational Organizations (EOMS) , or Trainer to be a qualified ISO 9001/QMS Lead Auditor and have comprehensive experience (>5 years) working for organizations providing educational products
Objectives to achieve: To get the necessary knowledge and skills to:
- Be qualifiable as ISO 21001/EOMS internal auditor (additional requirements from qualifying entity may apply)
- Understand the process and 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 21001/EOMS internal audits.
Certificate Course for Business Process Management Partner/IQNet
Description:
- Quality and process management: The participants know the basics of quality and process management. They know about the requirements of ISO 9001: 2015
- Project Management with a focus on system design: The participants know the basics of project management in terms of QM and know procedures and tools for analyzing the general situation and the difference in relation to the respective standard
- Management system according to ISO 9001 and internal audit: The participants know the requirements in terms of process orientation. They can create their own process landscape, and can identify the relevant processes. They know the efficient way to successfully carry out internal audits
- KPI and process indicators / Management Review: The participants know the different types of KPIs and how they are used. They know the value of a smart management review
- Strategic management for SME: The participants can use proven and practice-oriented tools for systematic strategy development and strategy implementation
- Process-oriented integration of sustainability topics. The participants know about the importance of the aspects EM / OHS / KM / RM.
Previous skills/knowledge:
- Several years of professional experience in technical, commercial or business management fields
- Interest in business contexts and topics of organizational development
- Practical relevance: Participants should already have had an insight into companies and have the opportunity to gain insight into the documentation and systems of the various functions and departments
- Participants who can not demonstrate the above-mentioned possibilities of practical relevance at the time of the course may apply for cooperation with a participant with practical relevance.
Authorized Partners:
Teaching requirements:
Trainer to be qualified ISO 9001/QMS Lead Auditor
Objectives to achieve: The participants will be empowered to play a decisive role in the long-term competitiveness of a company. The participants
- know the common models of quality and process management systems
- know how to implement the topic of quality and process management in companies and organizations in the context of project management
- have developed their competencies in the field of building a management system
- are able to conduct internal audits and identify potential for improvement
- learn about the relevant aspects of efficient and effective leadership processes at strategic and operational levels
- can take over the responsibility of the process-oriented quality management system in their company.
Quality Management Representative-Compact Course
Description: Competences include:
- Ability to generate Quality Management documents
- Ability to identify processes, to create a process model, to monitor and control processes
- Ability to address risks and opportunities
- Ability to understand the basic requirements of ISO 9001: 2015
- Ability to determine requirements (e.g. from customers, legal requirements, internal requirements)
- Ability to plan inspection activities and sampling
- Ability to plan and conduct an internal audit and write the audit report and identify activities for improvement
- Ability to apply basic quality management methods.
Previous skills/knowledge: Basic knowledge of quality management and its methods and tools (targeted at operational staff, top managers, group leaders and department managers from all areas).
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:
- To be able to apply the most important methods and tools in the area Quality Management
- To be able to understand the basic normative requirements of ISO 9001:2015.
Quality Management System Requirements ISO 9001:2015
Description:
-
Participants from all types of organizations that may need to apply a process approach to their operations and manage their quality requirements in a systematic way.
Previous skills/knowledge: - No technical requirements
Authorized Partners:
Teaching requirements:
- Trainer to have experience in the implementation, management or auditing of ISO 9001:2015 quality management systems - The course shall include both theoretical and practical approach. Exhibition and practical workshops are advised.
Objectives to achieve: - Provide knowledge of the implications of each of the components of a quality management system accord-ing to the requirements of ISO 9001: 2015
- After this course, participants will have detailed knowledge of what each of the requirements that should be applied in a systematic quality management, according to the latest model of ISO 9001: 2015, to demonstrate the ability to provide goods and Services that increase customer satisfaction, considering the context of the organization and its strategy at the highest level.
- After this course, participants will have detailed knowledge of what each of the requirements that should be applied in a systematic quality management, according to the latest model of ISO 9001: 2015, to demonstrate the ability to provide goods and Services that increase customer satisfaction, considering the context of the organization and its strategy at the highest level.
ISO 9001 Lead Auditor
Description: Competencies detailed in ISO 9001 Internal Auditor MTS 001, plus
- To participate in the selection of the audit team
- To prepare the audit plan
- To represent the audit team before the customer
- To give instructions to the audit team
- To inform any relevant obstacle identified during the audit process
- To be responsible of all the audit steps
- To present the audit report
- To follow up and close the audit process.
Previous skills/knowledge:
- Demonstrable knowledge of ISO 9001 requirements (2015 version recommended)
- Demonstrable evidence of participation in ISO 9001/QMS audits (>1 audit recommended)
- Professional experience, including in quality management systems - QMS (recommended).
Authorized Partners:
Teaching requirements:
Trainer to be a qualified ISO 9001/QMS Lead Auditor
Objectives to achieve: Objectives detailed in ISO 9001 Internal auditor MTS 001, plus to get the necessary knowledge and skills to:
- Apply the proper interpretation of the standard in actual audit situations
- Plan the audit
- Carry out quality management system audits
- Define the responsibilities of the audit team´s members
- Know the functions and attitudes that an auditor must follow
- To effectively coordinate meetings with the audit team members and/or with auditee personnel
- Identify and write non-conformities and other deviations and suggest ways in which the effectiveness of corrective action might be verified.
ISO 9001 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 9001 requirements (2015 version recommended)
- Professional experience, including in quality management systems - QMS (recommended).
Authorized Partners:
Teaching requirements:
Trainer to be a qualified ISO 9001/QMS Lead Auditor
Objectives to achieve: To get the necessary knowledge and skills to:
- Be qualifiable as ISO 9001/QMS 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 competencies that any auditor must have to carry out first, second party, and certification audits
- Be able to apply auditing guidelines to ISO 9001/QMS internal audits.