Quality Management System Auditing

Quality Management System Auditing Function

Description

This training provides you with the necessary skills required to perform the job of a Quality Management System Auditor. The Quality Management System Auditor reviews all the documentation of the quality management system that is required to be in compliance with International Quality Standards and inspects for correctness, completeness and accessibility when needed. The Quality Management System Auditor publishes reports of audit findings after completing QMS audits, and then follows up on the minor and major nonconformances to validate the effectiveness of corrective actions taken to close all findings of nonconformances. The Quality Management System Auditor works with all departments within an organization to ensure QMS procedures are being followed and that everything is being properly documented.

Manufacturing organizations are required to meet the requirements of International Quality Standards and attain a Quality Management System certification in order to do business.

This training provides in depth knowledge and understanding of two Quality Management System certifications:

· ISO9001:2015 (International Organization for Standardization

· IATF16949:2016 (International Automotive Task Force – Automotive Industry Quality Standard)

Training Features

Sessions: 2

Duration: 3 hours / session

Cost: $250

Delivery: In Class or Online

Instructors: Sam D.

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Learning Objectives

Demonstrate an understanding of ISO9001:2015 and IATF16949:2016
Demonstrate an understanding of IATF16949:2016 Rules 5th Edition
Application of the process approach to auditing
Demonstrate an understanding of risk-based thinking
Application of effective auditing tools
Application of effective auditing strategies
Performing Internal Audits (Product Audits, Manufacturing Process Audits, QMS Audits)
Demonstrate an understanding of Process Turtles
Understanding of Minor and Major Nonconformances
Application of successful nonconformance closure

Training Outline

Deep Dive into ISO9001:2015
Deep Dive into IATF16949:2016
Deep Dive into IATF16949:2016 Rules 5th Edition
Auditing Fundamentals
Types of Quality Audits (1st party audit, 2nd party audit, 3rd party audit)
Internal Auditing (Product Audit, Manufacturing Process Audit, System Audit)
Process Turtles

Audit Planning and Preparation
Elements of the audit planning process
Auditing Tools and working papers (Checklists, Log sheets, Forms)

Audit Data Collection and Analysis
Conducting interviews with auditee’s employees
Observing work activities of auditee’s employees
Examining documents to identify audit trails (Management Review, Internal Audit, CAPA Process)

Organization of Objective Evidence
Classifying evidence in terms of significance, severity, frequency,

and level of risk.

Evaluation of Objective Evidence
Potential impacts on product, process, system

Development of Audit Report
Required content of an audit report
Audit results (Observations, Findings, Opportunities for Improvement, Nonconformances)
Established timeline for corrective actions

Audit Follow-up and Closure
Evaluation of Containment activities
Evaluation of Root Cause Analyses
Evaluation for acceptability of proposed Corrective Actions and schedule for completion
Verification of Corrective and Preventive Actions implementation and effectiveness

Audit Closure