By Gene Russell, Manex President and CEO

In this article, I explain why ISO certification is important for manufacturing companies, and how an ISO Gap Analysis can be useful.

What is ISO?

ISO is an international standard containing practical information and best practice. According to ISO, the standards help:

• Make products compatible so they fit and work well with each other
• Identify safety issues in products and services
• Share good ideas and solutions, technological know-how, and best management practices

Why should I care about ISO International Standards?

• Become more competitive by offering products and services that are offered globally
• Enter new markets more easily
• Raise profits by offering products with increased quality, compatibility, and safety
• Reduce costs by using available resources better rather than reinventing the wheel
• Benefit from the knowledge and best practice of leading experts around the world
• Increase your trust and credibility throughout the supply chain

What is the first step in establishing an ISO project?

Determine the current state and plan the activities necessary to change it to the desired state. This requires a Gap Analysis. To maintain discipline and increase the certainty of a successful audit outcome, it is important to understand the current state and document it. Skipping the Gap Analysis is in my opinion almost always a mistake.

What resources are needed to move the ISO project forward?

You need someone who has the skills of an auditor, and you also need the skills of a consultant with a deep understanding of the specific ISO Standard. Otherwise, you are going to change things that don’t require changing and not change things that do. Beyond knowledge of the standard, your team needs to have a broad understanding of organizational processes rather than relying exclusively on a checklist.

What is an ISO Gap Analysis? Why is it an ISO recommended approach?

The ISO Gap Analysis should identify what processes exist within your company and these should be laid out in detail. They should be identified from the perspective of how well defined they are by the company procedures, what controls exist and how strong are those controls. Examples of controls include forms, software, whiteboards, and other items that cause the process to operate in a particular way.

Strong controls are necessary in a process that is likely to deviate in the execution/production of a product. Strong controls leave little chance of deviation and thus a great chance of success. Weaker controls leave a lot of wiggle room or individual interpretation in how things happen and may lead to failure to achieve the intended goal of the process.

How does Lean play a role in the ISO Gap Analysis?

It is always important to understand the intended outcomes or objectives in the process, what measurement or monitoring takes place to indicate that the process is performing correctly, and what resources are used in the process. Process theory and particular process techniques such as LEAN can provide very good detail of what goes to make up a process and what is important in different situations. Having a team or consultant with both ISO and LEAN practitioners is a good idea.

In the next blog, I will discuss ISO requirements that may go unaccounted for in your organization, and the traps people fall into on new ISO requirements. Specific examples for ISO 9001 2015 will be given.