ISO 9001 Lead Implementer

About The Course

ISO 9001 Lead Implementer

ISO 9001 Lead Implementer, a five-day intensive course designed to inculcate participants and enable them to develop the expertise necessary to implement and manage a Quality Management System (QMS) based on ISO 9001:2015. Participants will gain a thorough understanding of best practices for implementing quality processes based on ISO 9001 requirements. 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).

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 ISO 9000 family standard
  • 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
  • Identification and analysis of customer needs and requirements
  • Writing a business case and a project plan for the implementation of a QMS
  • Implementation of a document management framework
  • Drafting a QMS (quality manual, procedures, records)
Day 3
Implementing a QMS based on ISO 9001
  • Development of a training & awareness program and communicating about the Quality Resource Management Processes (human resources, infrastructure and work environment)
  • Product realization processes
  • Purchasing process
  • Operations management of a QMS
Day 4
Controlling, monitoring and measuring a QMS and the certification audit of a QMS in accordance with ISO 9001
  • 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 a ISO 9001 certification audit
Day 5
Certification exam

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

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 ISO9001and 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
  • The “Certified ISO 9001 Lead Implementer” exam fully meets the requirements of the PECB Examination and Certification Program (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 passed the exam and comply with all the other requirements related to the selected credential
  • For more information about ISO 9001 certifications and PECB certification process, refer to PECB section on ISO 9001 Lead Implementer Certification

Learning Methods

On-site Training

On-site training will require you to travel to the city the training is held in and may require accommodations. It gives you the advantage to be in the class with other participants and ask questions as needed as well as seek the advice of the trainer when you require help in understanding the topic. You will also be able to take the exam after finishing the training classes which is included in the cost.

Self Study

Self-Study is an excellent opportunity for those that don’t have the time to travel and can work on their own. Once we have received your request and payment, you will receive an email with instructions on how to access your training material via PECB’s KATE application. If you prefer to get a printed book shipped to you, contact us and we can arrange that for an additional cost. When you are ready, you will receive a voucher for the exam and instructions on how to set-up the online exam. Contact us with any questions.

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