Ever since its publication in September 2015, ISO 9001:2015 – Quality management systems – Requirements has rooted itself as the recognized international system for quality management systems within any applicable organization, having been adopted throughout 183 countries. ISO 9001, like the many other management system standards that have borrowed from it, is not prescriptive to be widely applicable. For certain types of organizations to meet the quality management system requirements, however, further assistance is needed.
This is true for small and medium enterprises (SME), which are essential to global economies. In fact, more than 95 percent of the world’s enterprises are small- to medium-sized, and they are highly influential in powering economic growth and employment. At this significance, it would be irresponsible to overlook small businesses and not grant them the benefits brought on by an ISO 9001 quality management system.
To fulfill this purpose, ISO has published the ISO 9001:2015 for Small Enterprises – What to do? handbook, which gives small business owners the knowledge necessary to adequately make use of ISO 9001. As stated in the handbook, as an SME, “the key issue that you need to recognize is that your approach and your quality management system will need to be unique to your organization to be effective, due to your products and services, processes, structure, people, etc.”
In other words, the general requirements of ISO 9001:2015 must be adapted to appropriately work for your organization; in some instances, two organizations can implement a completely different quality management system that works for them, even if they are both following the same content provided ISO 9001. The ISO 9001:2015 for Small Enterprises – What to do? handbook helps SMEs uniquely enhance customer satisfaction, provide assurance about quality with external providers, and harvest many other benefits.
The early parts of this document closely parallel ISO 9001:2015, since they discuss the choices in implementing a quality management system, including the decision of making use of one at all. The main difference with the handbook is that it provides guidance on external places that the organization can refer to for support in establishing their quality management system, even covering the topic of hiring a consultant.
Major considerations that the handbook mentions as important for this part of the process, and ultimately, the entire system, are the particular challenges that SMEs face that larger organizations would not have to confront. These include minimal available resources, costs involved in setting up and maintaining the quality management system, and difficulty in understanding and applying the system. These can be huge roadblocks that can actually hinder the system’s implementation.
The rest of the ISO 9001:2015 for Small Enterprises – What to do? handbook breaks down the content of ISO 9001:2015 section-by-section, addressing each quoted part for further guidance. For example, it is stated in the Introduction of ISO 9001:2015 that “risk-based thinking is essential for achieving an effective quality management system,” later mentioning that “a positive deviation arising from a risk can provide an opportunity, but not all positive effects of risk result in opportunities.”
The handbook elaborates on the concept of risk-based thinking and risk management in a quality management system. It states that a “deviation on the expected results can be the consequence of changes in the operational environment, political decisions, lack of information, unknown information or a variety of aspects.” According to the handbook, this clause highlights the idea that you need to “plan and implement actions to address risks and opportunities to prevent negative effects and improve results.”
In the format of ISO 9001:2015 for Small Enterprises – What to do?, the explanations of ISO 9001:2015 requirements and their applicability to smaller organizations are often followed by an example to demonstrate how certain small and medium enterprises handle those requirements. Such an example derives from the ISO 9001 section titled “Quality management system and its processes”, which strongly indicates that process that are simple by their nature usually only need simple explanations to convey them to their customers.
To better understand this idea, the handbook exemplifies the sale process in a scenario in which a two-person enterprise sells vintage clothing through a website. When a sale has been made, they receive an automatic email, confirming payment and detailing what has been sold, who to, and where it needs to be sent. The owners copy these details into an electronic worksheet, and then send out an email thanking the customer, conveying how the product will be sent and to get in touch with them if there is an issue. Since their process is simple but effective, the communication with the customer mirrors it with a simple but clear message.
ISO 9001:2015 for Small Enterprises – What to do? also includes case studies to explain the applicability of ISO 9001 requirements to small businesses. One such study included in the handbook is relevant to the ISO 9001 clause stating that the organization should “maintain documented information to support the operation of its processes.” In this case, a cheese manufacturer already has a quality management system in place, but wants to adhere to ISO 9001. It also already has a lot of existing information its processes, compiled in notebooks, paper folders, wall charts, photographs, and a computer system.
However, it is soon discovered, through meetings held to determine what is vital to the organization, that some of this information is out of date. To determine what needs to be kept as documented information, the business divides the information into three categories: vital information to carry out business activities properly (the documented information), information that is useful but does not need to be formally kept (to be used when needed), and information that is no longer necessary (to be disposed of).
These two examples demonstrate the thoroughness of the handbook in guiding the user through the implementation of the quality management system covered in ISO 9001:2015, but they also indicate the widespread applicability of its guidelines. While ISO 9001:2015 is applicable to any organization that needs to harness a reliable quality management system, ISO 9001:2015 for Small Enterprises – What to do? is useful for any smaller organization to meet those same means. However, this does not inhibit the establishment of the guidelines covered in the handbook, since it has been written with considerations that are overarching in relevance to SMEs.
Users should note that the handbook is comprised of recommended guidelines, and it is not intended to supersede the information provided in ISO 9001:2015.
The ISO 9001:2015 for Small Enterprises – What to do? handbook is now available on the ANSI Webstore.