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ISO 9001 — Quality Management Systems

Background

ISO 9001, often just referred to just as ISO 9000, was most recently revised in the year 2000 making its current revision level ISO 9001:2000. This standard, published by the International Organization of Standardization, is intended to provide a framework for companies to ensure customer satisfaction and improvement. It applies equally to all organizations, regardless of size, location, or industry (although several industries have added additional requirements by creating their own standards based on ISO 9001). This is quite a tall order and because of this the requirements of the standard can often seem vague, unclear, or even not applicable to your business. Developing a Quality Management System which will support registration to ISO 9001 in the face of this ambiguity can be challenging.

Challenges to Registration and Beyond

The difficulties in achieving ISO 9001 registration is not so much in the attainment of registration but in the maintenance of registration. This means that the while companies can certainly have difficulty in getting registered, these problems tend to expand over time and make ISO 9001 an impediment to doing business rather than a tool with which to manage the company effectively and efficiently. These problems are generally due to three things: over-documentation, lack of top management commitment, and a failure to integrate ISO 9001 into daily activities. Let’s take each of these one at a time:

Over-Documentation

Many companies look at ISO 9001 and interpret it to mean that everything anyone does has to be documented. Companies often create large amounts of documentation that is difficult to create, edit, and manage. Because of this difficulty it is common for the documentation and how the company actually operates to become more and more separated over time. This not only makes compliance difficult, but eliminates all of the advantages of having documentation. There is a balance that needs to be achieved between controlling activities with documentation and allowing for flexibility and creativity in daily activities. Finding this balance is critical to any organization and is something that we spend much effort on with our clients. As part of our Accelerated Registration Program®, we develop all of your procedural documentation in a balance of efficiency, consistency, and flexibility making the documentation both useful and easy to manage.

Lack of Management Commitment

Even with the best of intentions, without top management commitment to the Quality Management System, any ISO 9001 system will have severe difficulties. Often management becomes interested in ISO 9001 because it is something customers demand or can be used as a market advantage. While these are certainly not insignificant reasons to want ISO 9001 registration, they should not drive the development or management of the Quality Management System. Focusing on the sales aspect of registration can lead companies to create systems "just to get registered", which in the long term cause both internal and registration problems.

ISO 9001 must be seen as a tool that the organization can use to increase efficiency, reduce errors, and effectively satisfy customers. These factors directly impact the bottom line in equal, if not greater proportion, to any increase in sales due to registration alone. Because of this, Clydesdale assists its client’s top management to see the full and long-term value of ISO 9001 through training, process development, and data analysis. This is a key component of our Accelerated Registration Program®.

Failure to Integrate

Companies, once registered, often find themselves in a position where the documentation and systems they created become the "ISO system" and not the way the company actually does business. The cost of maintaining such as system is high. Companies may find they need dedicated staff to try and maintain the documentation, and/or that they have to hustle each year before the auditor arrives to make everything "compliant", and/or that the systems slow them down making it more difficult to do business.

While this is often the result of over-documentation or lack of management commitment, it is also symptomatic of trying to fit your business into ISO 9001 instead of the other way around. ISO 9001, when used as a tool, can be your guide to efficient and effective systems. If instead it is seen as "the ISO system", the resulting Quality Management System will be built based on what people think the registrar or the customer wants, and not necessarily what makes good business sense.

Clydesdale spends a lot of effort showing the benefit of using ISO 9001 as a tool to improve the business as part of its Accelerated Registration Program®. This often means going beyond the requirements of the standard or interpreting the standard in such a way as to relieve perceived burdens.

• ISO 9001
• ISO 14001
• ISO 13485
• AS9100
• TL 9000
• TS 16949
• ISO 17025