Are your ISO inspections painful? How to make your QMS really useful

Are ISO inspections painfulMany quality managers find that as an ISO audit approaches, their stress levels increase. Are all the procedures being followed properly? Are employees working from the correct documents and records? How can I be sure we are on top of everything the auditor will be checking?

Finding a quality management system (QMS) that makes it easier to comply with ISO requirements should be a priority for any quality manager. A good QMS will lighten the load and ease the responsibility that comes with ISO compliance preparation and inspection. But the real benefit comes when you are able to use it to help your entire operation run more smoothly and effectively.

A really useful QMS has two main components: a powerful document management and control functionality; and an easy to understand and use graphical interface.

The first component ensures your documentation, processes and procedures are locked down with the latest, approved versions. The second helps make them easy to access, use and maintain. Together, they make up a QMS that can make ISO inspections pain free.

In this post, we’ll discuss some of the features of a graphical QMS that help reduce the pain of an ISO audit.

A strong document management foundation

A good QMS should start with a strong document management system (DMS) foundation.

By using a DMS to manage the documents you use in your processes, especially product development and delivery but also other business processes, you are able to control how completely and accurately they are mapped out.

A good DMS helps you deliver ISO standard-compliant procedures for information governance. Almost every aspect of auditing and compliance verification is determined through the scrutiny of documented evidence.

Document control

You need the evidence in place to prove the effective operation, planning and control of company processes. So the documents used in the execution of those processes are crucial.

But you also need to prove that employees are working with the correct documents. And you need to ensure they are using them. A strong QMS with a graphical interface allows you to do both. By tightly controlling access to only the approved versions of documents, employees can’t work with the wrong ones. And by providing an interactive, graphical diagram of each procedure, with links to each document, you make it easy for employees to find and work with those documents.

Many a quality manager has been dismayed to discover employees with printed versions of out-of-date documents on their desks. The arguments they hear are that the employees find the documents more useful that way - they always know where they are and can access them quickly.

The problem is that the ISO 9001 requirements state that you need to prevent the unintended use of obsolete documents. So, by controlling document access to only the approved latest version and by making it easy, even enjoyable to find and use those documents on the company intranet, you avoid the pain of the nonconformity if an auditor spots those printouts.

If you employ a graphical QMS, it allows you to develop all your processes as dynamic flow chart diagrams and to publish them through a web interface. And by linking the interface to your document management system, employees are always just a click away from the right document(s) for the next step in every procedure.

How to Build a QMS Your Team Will Actually want to Use

A user-friendly quality approach

Implementing a quality plan and quality management system can rub employees the wrong way. It can take them out of their comfort zone and away from familiar, institutionalised practices. Anything that can make it easier or more palatable will contribute to its success.

On the list of desired QMS attributes, user friendliness isn’t often near the top. But arguably it should be.

Employees are the ones who will use the QMS. If it is hard to grasp and use, it will make it that much more difficult to implement.

A graphical QMS will reveal the entire quality plan and approach in a visual and logical way, helping the entire organisation get onboard with the effort.

Quality goals and plans should be integrated with overall strategic plans of the business. For executives, a QMS should give an accessible overview of the full quality programme. And it should be able to expand to operate across the entire organisation; in effect a business management system.

At operational levels, the quality plan takes on the role of an actionable plan and the QMS the framework for carrying out that plan day-to-day. It is easier to understand complex procedures for development, procurement, manufacturing and quality control when they are visual. By diagramming the steps and processes in each of your business procedures, employees can follow the steps accurately, and training in new procedures is easier.

ISO 9001:2015 advocates taking a risk-based approach to quality systems. This requires you to define the likelihood of a risk, define the consequences of a risk, define the risk level and then take appropriate steps to mitigate that risk. A graphical QMS is perfect for this, in that it visually depicts the correct processes and makes them readily available to all users, so everyone fully understands their roles and responsibilities. This in turn, greatly reduces the chances of accidents, near misses and non-conformances from occurring.

The main goal of implementing a really useful QMS is to help your organisation satisfy its customers’ demands and expectations. Crucial documents are managed, controlled and easily accessed and processes are clear and followed.

The byproduct of this is that the assurance and user friendliness that makes it so useful for the organisation also makes it helpful for the auditor. At a glance, he or she can prove that the processes are in place, correct and adhered to, making ISO audits pain free.

The value of DMS for Product Development

Tags: ISO 9001:2015

Joe Byrne

Written by Joe Byrne

Joe Byrne is the CEO of Cognidox. With a career spanning medical device start-ups and fortune 500 companies, Joe has over 25 years of experience in the medical device and high-tech product development industries. With extensive experience in scaling businesses, process improvement, quality, medical devices and product development, Joe is a regular contributor to the Cognidox DMS Insights blog where he shares expertise on scaling and streamlining the entire product development cycle, empowering enterprises to achieve governance, compliance, and rigour.

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