Mastering the implementation and management of a Quality Management System (QMS) based on ISO 9001

This four-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).

For more information, please visit PECB.

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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 program

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

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 présentations;
  • Review exercises to assist the exam preparation;
  • Practice test similar to the certification exam.

Exam & 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)
  • The exam is available online, please refer to PECB Exams User Manual ;
  • Duration: 3 hours
  • For more information about exam, refer to ISO 9001 Lead Implementer Exam;
  • 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 ISO 9001 Lead Implementer Certification.

Winning Rate:

100%

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