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PECB Certified ISO 9001 Lead Implementer

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. Participants will also gain a thorough understanding of best practices used to  implement quality processes based on requirements from ISO 9001. This training is consistent with the project management practices established in ISO 10006 (Quality Management Systems - Guidelines for Quality Management in Projects). 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 an quality team
  • Expert advisors in Quality Management Systems

  • Technical experts wanting to prepare for an 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 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 9001 and 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 Quality Management System (QMS) concepts as required by ISO 9001

  • Introduction to management systems and the process approach
  • Fundamental principles of Quality
  • Presentation of the standards  ISO 9000 and quality framework
  • Understanding the requirements of ISO 9001:2015 clause-by-clause,
    • Quality Management System
    • Management responsibility
    • Resource management

    • Product/Service realization
    • Measurement, analysis and improvement

Day 2: Initiating a QMS project based on ISO 9001

  • Selection of the approach and implementation methodology
  • Creation of quality team
  • Definition of the scope
  • Definition of quality policy and objectives
  • Identification and analysis of customer needs and requirements

  • Writing a business case and a project plan for the implementation of a QMS
  • Drafting a QMS

Day 3: Implementing a QMS based on ISO 9001

  • Implementation of a document management framework
  • Development of a training & awareness program and communicating about the Quality
  • Resource management processes (human resources, infrastructure and work environment)
  • Product/service realization processes

  • Purchasing process
  • Operations management of a QMS

Day 4: Controlling, monitoring and measuring a QMS;certification audit of a QMS

  • controlling and monitoring a QMS
  • Measurement of customer satisfaction
  • ISO 9001 internal Audit
  • Management review of a QMS
  • Implementation of a continual improvement program

  • Preparing for an ISO 9001 certification audit
  • Plan for registration with the certification body

Day 5: Certification Exam


ISO 9001 Foundation Certification or a basic knowledge of ISO 9001 is recommended

Educational approach

This training is based on both theory and practice:

  • To benefit from the practical exercises, the number of training participants is limited
  • 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 test similar to the certification exam

To benefit from the practical exercises, the number of training participants is limited

Examination and certification

  • The “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 “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 PECB section on ISO 9001 Lead Implementer Exam
  • After successfully completing the exam, participants can apply for the credentials of Certified ISO 9001 Provisional Implementer, Certified ISO 9001 Implementer or 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

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 CPE (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

Price: 7.950,00 Kn + VAT


ZIH d.o.o., tel:  01/4855-271, 4855-273, fax: 01/4855-272, e-mail: