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ISO 9001 Lead Implementer | Self-Study


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In Partnership with PECB (Professional Evaluation and Certification Board)

Master the implementation and management of Quality Management Systems
(QMS) based on ISO 9001


    • Certification and examination fees are included in the price of the training course.
    • PECB will provide over 500 pages of instructional materials containing explanations, guidance, and practical examples.
    • An attestation of course completion worth 31 CPD (Continuing Professional Development) credits will be issued to participants who have attended the training course.
    • In case of exam failure, the candidate can retake the exam once for free within 12 months following the initial exam date.

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Published initially in 1987, ISO 9001 is the first international management system standard (MSS) that specifies the requirements for the establishment, implementation, operation, maintenance, and continual improvement of a quality management system (QMS) in an organization.

ISO 9001 is based on seven quality management principles and it aims to help organizations be more efficient and improve customer satisfaction. A common misconception is that ISO 9001 is intended for larger companies and manufacturers. However, the requirements of ISO 9001 are generic and applicable to any organization, regardless of its type, size, or the products or services it provides.


Learning Objectives

By the end of this training course, the participant will be able to:

    • Explain the fundamental concepts and principles of a quality management system (QMS) based on ISO 9001
    • Interpret the requirements of ISO 9001 for a QMS from the perspective of an implementer
    • Initiate and plan the implementation of a QMS based on ISO 9001, by utilizing PECB’s IMS2 Methodology and other best practices
    • Support an organization in operating, maintaining, and continually improving a QMS based on ISO 9001
    • Prepare an organization to undergo a third-party certification audit


Why should you attend?

The PECB ISO 9001 Lead Implementer is a five-day training course that aims to help you develop the competence necessary to establish, implement, operate, maintain, and continually improve a QMS. This training course aims to equip you with in-depth knowledge on ISO 9001 requirements, as well as the best practices and approaches used for the implementation and subsequent maintenance of a QMS.

By attending this training course, you can help organizations utilize a structured and evidence-based approach for managing the quality of their products and services. Apart from this, you will also learn about the importance of customer focus and benefits of setting the foundations of an organizational culture which enables and supports quality.

The training course is followed by a certification exam. If you pass, you can apply for the “PECB Certified ISO 9001 Lead Implementer” credential. UKAS accredited and internationally recognized, the “PECB ISO 9001 Lead Implementer” certificate validates your competence to implement a QMS based on the requirements of ISO 9001.


Who should attend?

The ISO 9001 Lead Implementer training course is intended for:

    • Personnel responsible for maintaining and improving the quality of the products and services of the organization
    • Personnel responsible for meeting customer requirements
    • Consultants, advisors, professionals wishing to obtain in-depth knowledge of ISO 9001 requirements for a QMS
    • Professionals wishing to acquaint themselves with PECB’s IMS2 Methodology for implementing a QMS
    • Individuals responsible for maintaining the conformity of QMS to ISO 9001 requirements
    • Members of QMS implementation and operation teams
    • Individuals aspiring to pursue a career in quality management


Educational Approach 

This training course is learner-centered and contains:

  • Theories, approaches, and best practices used in management system implementation, operation, maintenance, and continual improvement
  • Theoretical basis supported by practical examples, throughout the four days of the training course
  • Interaction between the trainers and participants by means of questions and discussions
  • Essay-type homework exercises at the end of each day
  • Quizzes with stand-alone items (after each section) and scenario-based quizzes (at the end of each day), intended to prepare the participants for the certification exam



The main requirements for participating in this training course are a basic knowledge of ISO management system standards, overall knowledge of ISO 9001, and the MS implementation principles. An understanding of ISO’s quality management principles may also facilitate the learning process.


Training course structure

Introduction to ISO 9001 and the initiation of a QMS implementation
    • Training course objectives and structure
    • Overview of ISO, management systems, and ISO 9000 family
    • Introduction to quality and QMS based on ISO 9001
    • Initiation of the QMS implementation
    • Leadership and commitment
    • Quality policy
    • Roles, responsibilities, and authorities
Implementation plan of a QMS
    • Context of the organization
    • QMS scope
    • Actions to address risks and opportunities
    • Quality objectives
    • Change management
    • Resources
    • Competence
Implementation of a QMS
    • Awareness and communication
    • Management of documented information
    • Requirements for products and services
    • Design and development of products and services
    • Outsourcing
    • Production and service provision
    • Monitoring, measurement, analysis, and evaluation
QMS monitoring, continual improvement, and preparation for the certification audit
    • Internal audit
    • Management reviews
    • Nonconformities and corrective actions
    • Continual improvement
    • Preparation for the certification audit
    • Closing of the training course
Certification Exam
  • Exam Duration : 3 hours



The “PECB Certified ISO 9001 Lead Implementer” exam fully meets the requirements of the PECB Examination and Certification Programme (ECP). It covers the following competency domains:

  • Domain 1: Fundamental principles and concepts of a quality management system
  • Domain 2: Initiation of a QMS implementation
  • Domain 3: Planning of a QMS implementation based on ISO 9001
  • Domain 4: Implementation of a QMS based on ISO 9001
  • Domain 5: Monitoring and measurement of a QMS based on ISO 9001
  • Domain 6: Continual improvement of a QMS based on ISO 9001
  • Domain 7: Preparation for a QMS certification audit

For specific information about exam type, languages available, and other details, please visit the List of PECB Exams and the Examination Rules and Policies



Upon the successful completion of the exam, you can apply for one of the credentials shown in the table below. You will receive a certificate once you fulfill all the requirements related to the selected credential. For more information about ISO 9001 credentials and the PECB certification process, please refer to the Certification Rules and Policies.

The credentials in the PECB ISO 9001 certification scheme have the following requirements:

 ISO 9001 Lead Implementer - EN PECB

ISO 9001 Lead Implementer – EN PECB


Note: PECB certified individuals who possess both the Lead Implementer and Lead Auditor credentials are qualified for the respective PECB Master Credential, given they have taken 4 additional Foundation Exams related to this scheme. For more information about the Foundation Exams and the overall Master Requirements, please go to PECB Master Credentials.

To be considered valid, the audit activities should follow best audit practices and include the following:

  1. Drafting a QMS implementation plan
  2. Managing or leading a QMS implementation
  3. Initiating a QMS implementation project
  4. Implementing a QMS
  5. Conducting process mapping activities
  6. Managing documented information
  7. Establishing performance indicators and evaluating the QMS performance
  8. Performing continual improvement activities


Benefits of ISO 9001 for organizations

Benefits of implementing a QMS based on ISO 9001

Benefits of implementing a QMS based on ISO 9001



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Ever since its initial publication, ISO 9001 has been the most recognized and widely used management system standard. A QMS based on ISO 9001 enables organizations to ensure success in the long term. In addition, a certified QMS provides additional assurance to customers and business associates, which further improves the business of an organization.

Even though ISO 9001 sets the minimum requirements that must be met, it still allows organizations to tailor the QMS to their needs. Thus, organizations should determine their overall context in order to identify issues, constraints, and opportunities that are specific to their context. In addition, they should set objectives and establish processes which contribute to the achievement of those objectives.

A distinct feature of a QMS based on ISO 9001 is that it puts customers first. “Meeting customers’ needs and exceeding their expectations” is engraved in the quality management principles, and is implied continuously on the requirements stated in clauses 4 to 10 of the standard. As such, organizations that implement and establish a QMS based on ISO 9001 will maintain the focus on their customers by continuously identifying their needs and requirements, obtaining feedback from them, and continually improving their products and services to fulfill their needs. This focus on customer satisfaction is one of the key factors that have allowed the ISO 9001 to achieve the landmark status.

Like most of the management system standards, ISO 9001 is structured according to the High-Level Structure (HLS) and shares the common terms and core definitions. This alignment enables an easier integration with other management systems based on standards such as ISO 14001, ISO/IEC 20000-1, ISO/IEC 27001, ISO 22301, etc. Apart from ensuring consistency and reducing costs, integrating several management systems can improve the organization’s ability to successfully address other organizational commitments.

Why should you attend one of our ISO 9001 training courses?

While ISO 9001 can be used by organizations to obtain many benefits, many organizations are unable to fully realize the benefits of a QMS implementation. There are different factors which contribute to the inability to integrate the QMS into the organization’s processes. Such factors include, but are not limited to:

The perception of the QMS as a system of documentation.
The inability to identify nonconformities.
The inability to ensure continual improvement.
PECB’s training courses, both lead implementer or lead auditor, are tailored to overcome such challenges.

Globally recognized, PECB certifications demonstrate an individual’s professional capabilities to contribute in an organization’s QMS, as an auditor, implementer, or QMS implementation team member.

Obtaining a certificate in ISO 9001:

Distinguishes you from other quality management consultants/auditors
Demonstrates your awareness and knowledge of an internationally recognized standard for the management of quality in organizations
Demonstrates that you have the necessary competencies to guide and support organizations through the implementation and management of a QMS (PECB Certified ISO 9001 Lead Implementer)
Demonstrates that you have the necessary competencies to assess the conformity of a QMS against the requirements of ISO 9001 and the organization’s own requirements (PECB ISO 9001 Lead Auditor)
Qualifies you to conduct third-party certification audits on behalf of conformity assessment bodies (PECB ISO 9001 Lead Auditor)
Provides you with opportunities to further improve your career in quality management, either as an auditor, implementer, or a member of auditing/implementation team