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.
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
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
Implementation of a QMS
- Awareness and communication
- Management of documented information
- Requirements for products and services
- Design and development of products and services
- 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
- 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
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:
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:
- Drafting a QMS implementation plan
- Managing or leading a QMS implementation
- Initiating a QMS implementation project
- Implementing a QMS
- Conducting process mapping activities
- Managing documented information
- Establishing performance indicators and evaluating the QMS performance
- Performing continual improvement activities
Benefits of ISO 9001 for organizations