Mastering the implementation and management of a Quality Management System (QMS) based on ISO 9001 Summary 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 a sustainable development. Moreover, this training is fully compatible with ISO 9004 guidance’s (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 Learning objectives 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 the 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 Course Agenda 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 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 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 Prerequisites ISO 9001 Foundation Certification or a basic knowledge of ISO 9001 is recommended Educational approach 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 playings and oral presentations Review exercises to assist the exam preparation Practice test 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 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 General Information Certification fees are included in the exam price A student manual containing over 450 pages of information and practical examples will be distributed to participants A participation certificate of 31 CPD (Continuing Professional Development) credits will be issued to participant In case of failure of the exam, participants are allowed to retake the exam for free under certain conditions