ISO Audit

Guide
Preparing your business or facility for ISO Audits.
 The Unstressful Audit

Usually, folks associate the term “audit” with something negative, stress-
inducing, or just plain unpleasant—IRS audits, work performance audits, etc.
But in the case of an ISO audit, these connotations are misguided.

Instead, the attitude toward ISO audits should be of anticipation and curiosity.
After all, ISO audits either teach managers where improvements need to be
made or prove to clients or suppliers that the company is backing up its claims
with action and strong kaizen practices.

ISO audits can help facilities hold themselves accountable, and can help
reaffirm or establish a sterling reputation with suppliers and customers.

Let’s first breakdown what ISO is, and why these audits are so important.

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 What is ISO, anyway?

The International Organization for Standardization (ISO) is a non-governmental

international organization devoted to creating clear documentation to ensure
consistent standards throughout the world. Part of what ISO has done is make
it easier for customers and vendors to trust their working partners.

In 1987, the International Organization for Standardization (ISO) composed

the first version of ISO 9001 in an effort to create an international standard
to help manufacturers manage quality and improvement in their production
and, perhaps more importantly, ISO wanted to create a certification that would
allow customers and end-users to know they were getting a certain quality in
their products. After all, it can be hard knowing whether or not manufacturers
produce consistent, quality products; the ISO 9001 certification would make
choosing companies easier, provide a bit more peace of mind and assurance in
the often-chaotic world of business.

The standards outlined in ISO 9001 are revised occasionally to accommodate

changes in various industry environments. The latest version of ISO 9001 was
released in 2015.

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 Who is ISO 9001: 2015 designed for?

This Quality Management System (QMS) applies to any organization, regardless

of size, industry, or budget. Over a million facilities all across the world have
added the ISO 9001 standards to their quality management systems.

The benefits of ISO 9001:

• Organize and standardize processes

• Improve the efficiency of processes

• Foster a culture of continuous improvement

How ISO 9001: 2015 Works

ISO 9001 employs already-established Lean manufacturing practices like Plan-

Do-Check-Act to maintain continuous improvement.

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 Establish standards

The ISO 9001 suggests a standard by which companies can abide. These
standards allow workers and managers to be on the same page, and to work
together toward continuous improvement.

One new change in the 2015 edition of the ISO 9001 is the addition of risk-
based thinking as an approach to QMS. This concept forces teams to be
proactive rather than reactive about potential problems, which fosters the
philosophy of continuous improvement.

For companies looking to get certified through ISO 9001: 2015, the following
timeline gives an idea of how the process of getting and maintaining certified
through this QMS works.

Surveillance Audit

Certification Audit
dit of System Recertification Audit
Recertifica

First, companies must establish their QMS documentation, which should

align with ISO 9001: 2015 standards. These documents should outline the
continuous improvement plan that workers and managers will be following.

Once the documentation is completed, it’s time to start audits.

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 Internal Vs. External Audits

To ensure that standards are enforced and maintained, ISO 9001 utilizes
two kinds of audits: internal and external. While both are to ensure that the
company is maintaining continuous improvement and abiding by the standards
imposed by the QMS, the differ in their desired outcomes.

Internal audits

These audits happen before external audits, and are designed to keep teams
honest and make sure continuous improvement is actually in action.

Internal audits are conducted by an assigned employee to assess conformity

to standards, evaluate effectiveness, and identify the areas that still need
improvement. The internal auditors are usually people with a comprehensive
understanding of quality control techniques in general and ISO 9001
specifically. These folks need to complete courses offered through ISO’s
Online Internal Auditor Training program to ensure they know how to identify
nonconformance and find opportunities for improvement.

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 External audits

External audits are done by independent entities. These audits are required to
get initial ISO 9001 certification, and then are required periodically (about once
a year) to maintain certification.

There are two types of external audits: second party audits and third party
audits. Second party audits (also called the supplier audit) are performed by lead
auditors within your company. Their purpose is to show companies that supply to
your company that you are walking the walk, so to speak, in terms of kaizen.

The third party audit is for the purpose of getting ISO certification.

To know how to find external ISO 9001 auditors, managers will have to consult
one of the many available ISO 9001 registrars, which contain directories of all
the auditors around the world.

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 Types of nonconformance

In these audits, auditors will be looking for two types of nonconformance.

The two different types are classified as major nonconformance and minor
nonconformance.

Major nonconformance. These infractions reflect a large issue within

the company that shows that there is still some work to do before
certification can be issued. An example of this might be the lack of floor
marking in a warehouse or a failure to red-tag items.

Minor nonconformance. These issues are small, and not at all an

indication that the company has major quality issues. More than
anything, this type of infraction can be seen as an opportunity to
improve. An example of minor nonconformance might be a manager’s
slow response to emails.

For companies looking for a QMS that improves production efficiency and
assures customers that they’re in good hands, ISO 9001: 2015 might just be
the right fit. Remember: an efficient facility is a successful facility. With that in
mind, it’s important that all businesses strive to improve processes. For other
ideas on how to improve efficiency and safety in your facility, check out Lean
manufacturing resources.

Looking for more solutions?

Wanting to get Lean but don’t know
where to start? Check out our
extensive library of free resources:

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 Tools to help get you audit-ready

This guide has provided you with a strong foundation of information about ISO
audits. Now it’s time to offer some tools to get you started.

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