ISO 9001 Lead Implementer Course

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

Career Path

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