ISO 9001 Lead Implementer Course
Mastering the implementation and management of a Quality Management System (QMS) based on ISO 9001.
This five-day intensive course enables participants to develop the necessary expertise to support an organization in implementing and managing a Quality Management System (QMS) based on ISO 9001:2015. This training is consistent with the project management practices established in ISO 10006 (Quality Management Systems - Guidelines for Quality Management in Projects) and it is based on the quality management principles described in ISO 9000. Participants will also gain a thorough understanding of best practices used to implement quality processes that will address risks and opportunities and thus lead to the improvement of the overall performance and the basis for sustainable development. Moreover, this training is fully compatible with ISO 9004 guidance (Managing for the sustained success of an organization - A quality management approach).
Who should attend?
Project managers or consultants wanting to prepare and to support an organization in the implementation of a Quality Management System (QMS).
ISO 9001 auditors who wish to fully understand the Quality Management System implementation process.
Persons responsible for the Quality or conformity in an organization.
Members of a quality team
Expert advisors in Quality Management Systems.
Technical experts wanting to prepare for a quality function or for a QMS project management function.
• To understand the implementation of a Quality Management System in accordance with ISO 9001.
• To gain a comprehensive understanding of the concepts, approaches, standards, methods, and techniques required for the effective management of a Quality Management System.
• To gain knowledge and skills in identifying the risks and opportunities associated with an organization.
• To understand the relationship between the components of a Quality Management System and the compliance with the requirements of different stakeholders of an organization.
• To acquire the necessary expertise to support an organization in implementing, managing, and maintaining a QMS as specified in ISO 9001and ISO 9004.
• To acquire the necessary expertise to manage a team implementing ISO 9001.
• To develop the knowledge and skills required to advise organizations on best practices in the management of quality.
• To improve the capacity for analysis and decision-making in the context of quality management.
• To prepare an organization for an ISO 9001 audit.
Day 1: Introduction to ISO 9001 and initiation of a QMS.
• Course objective and structure.
• Standard and regulatory framework.
• Quality Management System (QMS).
• Initiating the QMS implementation.
• Understanding the organization and clarifying the quality objectives.
Day 2: Plan the implementation of the QMS.
• Analysis of the existing management system.
• Leadership and approval of the QMS project.
• QMS scope.
• Policies for quality management.
• Risk assessment.
• Planning of product and service provision.
• Definition of the organizational structure of the QMS.
• Definition of the document management process.
Day 3: Deploying the QMS.
• Operations Management.
• Training and awareness plan.
• Communication plan.
• Product and service requirements, design, and purchasing process.
• Product and service realization and control.
Day 4: QMS measurement, continuous improvement, and preparation for the certification audit.
• Monitoring, measurement, analysis, and evaluation.
• Internal audit.
• Management review.
• Treatment of problems and non-conformities.
• Continual improvement.
• Preparing for the certification audit.
• Competence and evaluation of implementers.
• Closing the training.
Day 5: Certification Exam
ISO 9001 Foundation Certification or basic knowledge of ISO 9001 is recommended.
This training is based on both theory and practice:
• Sessions of lectures illustrated with examples based on real cases.
• Practical exercises based on a full case study including role-playing and oral presentations.
• Review exercises to assist the exam preparation.
• Practice tests similar to the certification exam.
Examination and Certification
The “PECB Certified ISO 9001 Lead Implementer” exam fully meets the requirements of the PECB Examination and Certification Programme (ECP). The exam covers the following competence domains:
• Domain 1: Fundamental principles and concepts of Quality.
• Domain 2: Quality Management System Best Practice based on ISO 9001.
• Domain 3: Planning a QMS based on ISO 9001.
• Domain 4: Implementing a QMS based on ISO 9001.
• Domain 5: Performance evaluation, monitoring, and measurement of a QMS based on ISO 9001.
• Domain 6: Continual improvement of a QMS based on ISO 9001.
• Domain 7: Preparing for a QMS certification audit.
The “PECB Certified ISO 9001 Lead Implementer” exam is available in different languages (the complete list of languages can be found in the examination application form).
• Duration: 3 hours.
• For more information about the exam, refer to the section on ISO 9001 Lead Implementer Exam.
• After successfully completing the exam, participants can apply for the credentials of PECB Certified ISO 9001 Provisional Implementer, PECB Certified ISO 9001 Implementer, or PECB Certified ISO 9001 Lead Implementer, depending on their level of experience.
• A certificate will be issued to participants who successfully pass the exam and comply with all the other requirements related to the selected credential.
• For more information about ISO 9001 certifications and the PECB certification process, refer to the section on ISO 9001 Lead Implementer Certification.