Featured Product
This Week in Quality Digest Live
Standards Features
Eliot Dratch
Responding to the organization in the mirror
Taran March @ Quality Digest
The Olympus CIX100 inspection system enables 21 CFR Part 11 compliance
Rajesh Talpade
Effective data stewardship requires that people and technology work in unison to foster a culture of quality standards and best practices
Ann Brady
ISO 44003 encourage will encourage more SMEs to consider how they can harness collaboration
Clare Naden
Yesterday’s maps and travel agents have been replaced by technology

More Features

Standards News
First trial module of learning tool focuses on ISO 9001 and is available now
Both quality professionals and their business leaders agree that openness and communication is essential to moving forward
July 8, 2021, at 12:01 p.m Pacific standard time, 12 p.m GST, and 10 a.m Beijing time
ISO 37301 provides everything needed to develop, implement, maintain, and improve an effective compliance management system
Two new standards join the ISO series
Design, develop, implement, continually improve risk management in systems and software engineering
ISO/IEC/IEEE 16085 has just been updated
Patient safety is a key focus in update of ISO 14155, the industry reference for good practice in clinical trials.

More News

Corey Brown

Standards

Inside the Mind of an ISO Auditor

Key touchpoints for a productive ISO audit

Published: Wednesday, July 14, 2021 - 12:02

Getting inside the mind of an ISO 9001 auditor is crucial to a successful ISO audit. Think of it like a gift: Even the best of presents can be unappealing when wrapped in crumpled, messy newspaper and duct tape.

Understanding the background and motivating factors for ISO auditors will help you portray the excellence of your operation in the best light possible. This article can help.

Where do auditors come from?

ISO creates standards but doesn’t enforce them
The International Organization for Standardization (ISO) develops standards such as ISO 9001—“Quality management systems—Requirements,” but it doesn’t provide certification of those standards to companies; this is where third-party auditors come in. These third-party auditors are accredited bodies that perform audits and issue certifications to companies.

Who certifies the auditors?
Accreditation of the certification bodies falls to yet another independent organization, typically unique to each country, that verifies the competence of the certification bodies. While accreditation is not required to become a certification body, it’s safe to assume that most “credible” certification bodies will have accreditation.

Say what you do, do what you say
At the end of the day, an ISO quality audit consists of a third party evaluating the accuracy and effectiveness an organization’s processes. An auditor compares the outputs of said processes to the planned arrangements and analyzes how well they match.

In other words, are you doing what you’re saying you’re doing?

The mind of an ISO auditor

ISO auditors can’t look at everything. As a result, they’ve been trained to look for key indicators that reflect the overarching quality standards for an entire organization. Optimizing for these indicators will ensure that your ISO audit goes smoothly and that you’ve presented the best version of your quality management system. Below are the most impactful indicators that auditors are reviewing.

1. Dissemination of organizational knowledge
At this stage, most companies are documenting processes in some shape or form. Where many companies fall short is in their methods for accessing and distributing the information. Auditors want to see that finding and using information is easy.

Show this by using a document management system that makes accessing information simple and intuitive. Auditors will interview a range of employees, and you don’t want to worry about training your entire workforce on how to access important information.

2. Hold yourself accountable.
Auditors want to know that you’ve written quality policies, and that you have some way to hold yourself accountable in the future. That said, having policies in place and using them are two completely distinct acts.

Show this by documenting your standard process for internal audits and quality checks, in addition to standard operating procedures. Show that teams are following these procedures by logging their activity and verifying data by requiring sign offs by supervisors.

3. Roles and responsibilities
Understanding how individuals fit into the overall goals of quality policies is key to understanding their importance. The primary motivation for connecting quality standards to employee responsibilities is to align an organization’s quality management system (QMS) with individual ownership of improvement.

Show this by using QMS software that connects approved procedures to the proper teams and personnel. Employees should be familiar enough with these procedures to articulate them in their own words and explain how their roles contribute to company policy goals.

 4. Engage in process improvement
Another element of employees interacting with documented processes is their ability to engage with the processes for corrective actions and process improvement. Auditors want to see that employees have the ability and will to provide feedback and implement improvements.

Show this by establishing a standard practice for providing feedback, and be sure to share this with all employees to improve engagement. More important, this feedback mechanism should take place where the work happens (at the gemba).

ISO differences

Same standard, new challenges

The underlying goals of ISO 9001 haven’t changed, but ISO did make some key changes in the 2015 update to adapt the standard to the global market. It now places a heavy emphasis on process improvement and risk-based thinking. Make sure that you’re prepared for your audit to reflect that.

First published on the Dozuki blog.

Discuss

About The Author

Corey Brown’s picture

Corey Brown

Corey Brown is the lead researcher and editor for manufacturing resources on Dozuki.com. With a background in engineering and technical communication, Corey specializes in quality management, standard work, and lean manufacturing.