ISO 9001:2015 Basics
What is a QMS?
Does It Apply to Me?
Lots of Bureaucracy?
The ISO 9001 standard is a set of requirements that your company needs to follow in order implement a "quality management system" at your company. You may then have an independent organization verify that your company in fact meets the ISO 9001 requirements and issue your company an "ISO 9001 certification".
The ISO 9001 standard is a set of requirements for a quality management system. It was published by the International Organization for Standardization (ISO), an independent, non-governmental body that produces more than 20,000 standards that improve health and safety across a variety of industries worldwide.
ISO 9001 is one of the most well-known and popular ISO standards. It is used by all sorts of companies, big and small, from various industries, including energy, medicine, technology, and manufacturing. Periodically, the ISO 9001 standard is revised and updated. The current standard is ISO 9001:2015 (2015 refers to the year).
When you implement ISO 9001, you will set up a quality management system that will impact many different areas of your business for the better, including production, fulfillment, and customer service. Processes will be improved, supply chain mechanics may be repaired, and costs can be significantly reduced. Additional benefits of ISO 9001 include greater prestige (resulting in more customers), more opportunity to bid on projects (that may require ISO 9001 certification), and a more satisfied workforce.
Once you have set up the ISO 9001 quality management system and your company follows the requirements of ISO 9001:2015, you may have your ISO 9001 system audited and apply for ISO 9001 certification.
What Is a Quality Management System?
A quality management system is an integrated approach to operating a company (or any other organization) with the aim of achieving high customer satisfaction and efficiency.
A quality management system (QMS), as the name implies, is directly related to management. It gives management on all levels of the company tools that help them do their job as good as possible. Depending on how well organized your company currently is, these may be all new tools or it may be a set of tools your managers already use.
Those management tools are not just any tools. They are tools that affect quality. When ISO talks about "quality" it takes a very broad view. ISO's definition of quality is not the colloquial one (for example, that a product doesn't break down) but the following: quality is how we meet customer requirements. This definition of quality can become quite broad when we realize that customer requirements are not necessarily specified by the customer but may simply be expected. For example, when ordering a dish in a restaurant, we may read or hear the description of the dish and request some changes or substitutions; rarely we would specify how the taste should be or how healthy the dish should be. If, however, we don't like the taste for whatever reason or if we find out that residue of a pesticide are in the food, we would be dissatisfied. And that's the point about quality in the sense of ISO: if we don't meet customer requirements, the customer will be unhappy, ultimately resulting in fewer customers and lower sales. But there is even more to it: a company that has much rework and other internal problems that affect operations will likely not be able to satisfy their customers either; as a starter, there may be delays or price increases as a result of rework.
Some readers may now think that a quality management system is how management engages in quality control inspections. Actually, quality control inspections are just one of the many tools that managers may use when applying an ISO 9001 quality management system. In fact, we are talking about integrated management processes, or a system, that affect virtually all areas of the company. ISO 9001 reaches from strategic planning to the control of documents to the calibration of measurement devices.
What Are the Benefits?
Implementing an ISO 9001 quality management system at your company can bring numerous benefits to your business, which we would like to present in three distinct categories:
Many people don't realize the potential of the other benefits and consider the marketing benefits the only reason to implement ISO 9001. And it is true, the ISO 9001 certification can be a wonderful marketing tool. ISO 9001 is the most famous quality standard in the world with well over a million of companies proudly showing off their ISO 9001 certification and with a large share of potential customers aware of the quality benefits. If your competitors haven't achieved ISO 9001 certification yet, you could gain a significant competitive advantage by utilizing your ISO 9001 certification in marketing (we consider this a very important aspect so we include a marketing guide with our ISO 9001 implementation packages). And if your competitors are already ISO 9001 certified, then it is a matter of urgency for you to catch up and gain ISO 9001 certification.
More and more customers actually not only prefer ISO 9001 certified companies over uncertified competitors but make the certification an absolute requirement. The trend to make ISO 9001 certification a purchase requirement is ever increasing as many ISO 9001 certified companies turn around and require ISO 9001 certification from their suppliers. We have had countless cases in which we were asked for the fastest way to achieve ISO 9001 certification as an all-important customer just made that a requirement. As you can imagine, it is always better to have ISO 9001 already in place rather than struggling to accomplish it under the impatient eyes of an important customer.
If your customer is a government agency or if your industry is tightly regulated by a government agency, chances are that your government either requires ISO 9001 certification or accepts it in lieu of their own standard. This is particularly true in the pharmaceutical and defense industries.
Many people don't realize that the most important benefits of ISO 9001 may actually be the operational benefits of the standard bringing to your company. In fact, ISO 9001 was designed as a tool for companies to improve their operations and bottom line; certifications and marketing benefits came later. Companies that utilize the ISO 9001 quality management system can expect good results in the following areas:
Reduced rework and scrap expense
Detecting inferior raw materials before using them
Improved delivery time
Reduction in the cost of quality leads to significant profit increases
Reduced customer claims
Reduction in defects and warranty expenses
Improved consistency of products and services
Higher customer satisfaction
Improved internal communication and employee morale leads to higher employee retention and improved employee performance
Improved productivity and efficiency
Improved bottom line
Considering these significant benefits would make ISO 9001 an ideal tool for any company (or any other organization). At this point, you may ask about the downsides and the cost involved. We will address these issues later so please read on.
Does This Apply to My Organization?
Yes, it does.
Actually, ISO 9001 is designed to apply to any kind of organization in any industry and in any country worldwide. It doesn't matter if your organization is a small or large manufacturing company, a lawyers office, a school, or a government department, ISO 9001 applies equally to all. It also doesn't matter if your organization is for profit or not, or if your organization is a tiny one-person outfit or a large enterprise. And because ISO 9001 is an international standard, it applies equally to any country in the world (some countries prefer to publish ISO 9001 under the name of their accreditation board, for example ANSI in the USA, but the actual standard is identical to ISO 9001).
What Does It Take to Become ISO 9001 Certified?
It takes both time and money. Well, you probably could have guessed this. The question is, how much time and how much money. The answer depends much on the approach you choose as well as on the circumstances of your company.
There are generally three different approaches to pursue ISO 9001 implementation:
Have a consultant do it.. This is an approach that many large enterprises take. It is by far the most expensive option and should only be considered with a budget that is significantly larger than the initial cost estimate of proposal by the consultant. Expect the cost to be in the tens or even hundreds of thousands of dollars. As far as time is concerned, the use of a consultant or even consultant team could be your fastest option if you or your staff doesn't have time to spend on the ISO 9001 implementation. Depending on the size and complexity of your company, a consultant could set you up in anywhere from 1 month to 1 year (remember, even the best consultant doesn't know your company so there will be quite some time spent just learning about your business).
Do it yourself from scratch. This approach would be the other extreme. It may be an option for those companies whose top management has significant spare time on their hands and is interested in learning all the details about the ISO 9001 standard. Unless you are an expert in ISO 9001 or another quality management system, this approach would require a lot of training before you can get started. If you are considering this approach, we encourage you to first purchase the ISO 9001:2015 standard and try to read and understand it; if it is obvious and clear to you, this approach may actually be right for you.
Use an implementation package. This approach is probably the least expensive and also the fastest if you have some extra time each day to spend on ISO 9001 implementation. The use of pre-written templates along with step-by-step instructions allows you to apply your knowledge of your company and simply modify the templates. Documentation is an important part of your ISO 9001 implementation and the pre-written templates could make this quite easy and fast. Other parts of the implementation project are covered by the project guide. The cost of this approach is equal to the cost of the ISO 9001 implementation package (about USD 900), the ISO 9001 standard itself (about USD $150), any optional training you may need (an online course for the person implementing ISO 9001 is less than USD $200), and the cost of the certification by a third-party registrar (starting at USD $2,000). Also, you need to consider the cost of the time spent by yourself and others in your organization. Depending on the size and complexity of your operations, it could be done in anywhere between less than a month and a year (small companies may complete this in 2-4 weeks).
Lots of Bureaucracy and Paperwork?
An often heard criticism of ISO 9001 is that it involves much paperwork and its bureaucracy impedes the efficient operations of the company. It's true. At least for many companies that take the wrong attitude and approach towards ISO 9001. If you want ISO 9001 solely for marketing reasons and you think that it won't have any value otherwise, then you will likely end up with cumbersome system. This is particularly true if you choose approach 1 (consultant) or a bad implementation package (yes, they also exist).
On the other hand, if you knuckle down, put all your efforts and ambition into it and do everything from scratch, then you will likely end up with an efficient and lean ISO 9001 system. You may make some mistakes on the way but eventually you will have a good system (if you don't give up).
We decided for approach 3 (implementation package) not only because it's fast and inexpensive, but also because the resulting ISO 9001 QMS (quality management system) can be very good. An implementation kit doesn't need complexity to sell well; a consultant, on the other hand, may present you with an unnecessary complex system, which may be useful for a large enterprise, in order to justify the high fees. However, approach 3 (the use of an ISO 9001 implementation kit) is not without dangers as a bad implementation kit could also lead to an inefficient QMS with lots of bureaucracy and paperwork.
No matter if you choose to use a consultant or an ISO 9001 implementation kit, it is important to choose wisely. Take your time evaluating before you decide. Your choice will have an impact on your operations and bottom line that shouldn't be underestimated.
What Else Is There to Know?
Actually, a lot, but for the purpose of an introduction to ISO 9001, we will limit the information to a few more facts that may interest you.
ISO 9001 is published by the International Organization for Standardization (ISO), an organization consisting of representatives of countries around the world, and whose job it is to create worldwide standards (these are usually product standards but, as in the case of ISO 9001, also some management standards are published). Over 160 nations participate in standards development.
There are over a million companies and other organizations certified to ISO 9001 worldwide. The popularity of ISO 9001 is increasing with more and more companies certified each day.
ISO 9001 gets periodically (about every 7-8 years) revised in order to ensure it remains relevant to the marketplace and takes into account any new challenges that businesses may face. The current revision was published in September 2015 and is called ISO 9001:2015.
If you want to learn more about ISO 9001 and how it could be implemented at your company, please read about the 5 Steps to ISO 9001 Certification.