1

Introduction to Quality Management System 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 clause-by-clause.

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).

3

Implementing a QMS based on ISO 9001

• Development of a training & awareness program and communicating about the Quality Resource Management processes.
• Product realization processes.
• Purchasing process.
• Operations management of a QMS.

4

Controlling, monitoring and measuring a QMS and the certification audit

• 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.

5

ANSI Accredited Certification Exam

• Domain 1: Fundamental principles and concepts in Quality Management.
• Domain 2: Quality Management 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: Preparation for a QMS certification audit.