March 11-12, 2019,  Hyatt Regency San Antonio Riverwalk, San Antonio, TX USA

The World’s Leading Conference on ISO 9001 & Related Standards

Internal Auditor Competency: So, How Will You Audit Risk-Based Thinking?

Angelo G. Scangas, President, Quality Support Group, Inc., Peabody, MA, USA

Keywords: Internal Auditing, Auditor competency, Risk-based Thinking

Industry: Manufacturing

Level: Intermediate


The ability to predict, evaluate and mitigate potential failures is crucial. Whether you work in a complex engineering company, a manufacturing environment, or a process-oriented one, such as a hospital, laboratory or school system, risk assessments are integral to meeting the requirements of ISO 9001:2015.

A sound approach to quality risk management utilizes the knowledge and experience of the entire team in your organization. The Team includes the people participating in the risk assessment, the people executing the mitigations as well as the internal auditors who need to evaluate the effectiveness of the process. Everyone needs to work together to assure Customer and Business satisfaction.

Auditors continue to struggle with effective and efficient audit execution of Risk Assessments. Common deficiencies include an over-reliance on checklists and inadequate understanding of the documentation risk assessments, including linkage of audit procedures to the risks they are designed to address. So what exactly does that mean?

In plain English, this means the auditor needs to:

Understand where, within the company s quality/business system are the highest product/process risks.

Tailor his or her audit program to evaluate risk management effectiveness.

Know how to audit the Severity, Occurrence and Detectability criteria

Evaluate the effectiveness of the mitigations to reduce risk

Audit for value

You'll learn to:

Determine the right time to audit Risk Assessments

Identify the critical requirements for the product or process to be included in a risk assessment

Identify and classify potential failure modes

Evaluate potential failure mode severity

Evaluate potential causes to the failures

Evaluate potential probability

Determine how to ensure the process is living

This presentation will discuss the application of risk assessments showing the vital role an effective auditor plays in maximizing the effectiveness of risk management in making continual improvements throughout the product lifecycle.

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A Step-by-Step Guide to ISO 9001:2015 Transition

ISO 9001:2015
Management Training

“ISO 9001 is used by millions of people and organisations around the world and the upcoming 2015 revision will have a big impact on those who work with the standard.

The impact of this revision will be similar to, if not greater than the 2000 edition, which was a major change for accreditation bodies, certification bodies, training organisations, implementing organisations, procurement organisations, consultants and customers.”

An excerpt from IRCA Resources on “ISO 9001: IRCA Supporting the 2015 Revision”, October 2013