ISO 9001 Lead Implementer


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. 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).

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

Course Content:

  • Course objective and structure
  • Standard and regulatory framework
  • Quality Management System (QMS)
  • Initiating the QMS implementation
  • Understanding the organization and clarifying the quality objectives
  • 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
  • Operations Management
  • Training and awareness plan
  • Communication plan
  • Product and service requirements, design, and purchasing process
  • Product and service realization and control
  • 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

Duration:

5 Days

Exam Information:

  • Duration : 3 Hours
  • Question format : Essay-type questions
  • Exam language : English

Pre-requisite:

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

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