Mark Hammar Many people have the misconception that ISO 9001 is strictly for managing the quality department, but a closer look at the standard requirements easily shows that this is not the case. While the ISO 9001 standard refers to itself as quality management system requirements, it may be more beneficial to think of the standard as a set of business management system requirements. Many of the obstacles seen with ISO 9001 implementation can be removed when the standard is viewed in this different way.
ISO 9001 as a business management system?
When you look at the ISO 9001 standard requirements, you will see that there is so much more included than just the responsibilities of the quality department. The requirements include all activities required to provide a product or service to meet customer requirements and improve customer satisfaction. Some of these include requirements control, design, management of all resources, purchasing management, control of production and service provisions and process improvement.
The requirements in ISO 9001 are the basic standards for managing a company, including all resource and top-level management processes. Every aspect of the business is included in the scope of the management system, from sales and planning through delivery and post-delivery activities. In fact, some companies have evolved to the point where the term “quality” is no longer used. The management system has just become the way of doing business.
Effectively, ISO 9001 allows almost infinite flexibility in how you achieve the requirements. It tells you what basics need to be done, but not how to do them. For instance, the standard says you need to ensure the current revision status is known for a document, but you can choose how you want to do this (by date, revision number, etc.). By being so flexible, ISO 9001 not only allows you to utilize any processes that you already have in place, but it becomes the first basic standard upon which a company can build other standards and management systems. It becomes easy to include a system for environmental management or IT management as part of an already existing ISO 9001 management system. The benefits of merging systems can compound when resources become shared in this way.
What obstacles can be addressed by a business management system approach?
Here are just a few of the comments and obstructions that can easily be addressed by viewing ISO 9001 as a business management system (BMS), but if you have tried selling the idea of implementing ISO 9001 you will probably have others of your own:
Why is management commitment and review so important? If you are viewing the system as the way you do business, rather than just the job of the quality department, then it is obviously critical that management be intimately involved in how the system is working, how resources are applied, and where improvements are made to benefit the company the most. Management review of the critical aspects of the business become the way that management controls the flow of resources and directs the output of the company. Why would top management not want to be involved in this?
We don’t need ISO 9001 to tell us how to run our business. This is true, and this is also the reason that the ISO 9001 standard is non-prescriptive. This means that the requirements in the standard are stated in such a way that they can be addressed by many different methods. For instance, the ISO 9001 requirements state that you plan and carry out production and service provision under controlled conditions, then gives some conditions that might apply, but doesn’t say which need to be used. This only makes sense, as you don’t want your employees to take the design and do whatever they want with it. The employees need to take the design and produce it as it is specified – in other words, in a controlled manner, but how you control this is up to you. The ISO 9001 requirements are there not to tell you how to do the job, but to make sure that you do not miss any controls that should be in place to provide products and services that meet your customer requirements.
We don’t need all the documentation of ISO 9001; we’re a small company. ISO 9001 is written to be used by any company in any industry, so the size of your company is not important. Any company can use ISO 9001 as a way to improve the processes they have in place to provide products and services to their customers. Additionally, ISO 9001 does not require that you document everything. There are only six mandatory documented processes required by the standard, and these make sense to be written down so that they are equally understood by everyone. Any other written procedures are at the discretion of the company if they are “determined by the organization to be necessary to ensure effective planning, operation and control of its processes.” To learn more about what documents are needed and what additional documents you might want to add, see this white paper on Mandatory Documentation Required by ISO 9001:2008.
The ISO 9001 requirements can be seen as a framework to help you build a better business system to manage how you provide customer satisfaction by meeting requirements. By doing this, you will see that you can implement best practices to all processes throughout your organization. By using the ISO 9001 structure, built on improvement of the system, you can start with the processes you have in place and work towards creating a better system that is tailored to you and your customers. Why wouldn’t you want to investigate a better way to improve and please your customers to keep them coming back for more?
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