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What Is ISO 9001?
17 December 2020
ISO 9001 is the world's best known and most popular quality standard. Learn more about what it is, the benefits it can bring and the best way to achieve certification.
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ISO 9001 was introduced in 1987 and is published by ISO (the International Organization for Standardization). There are currently well over a million organizations in 190 countries certified to ISO 9001, spanning all sizes, sectors and industries.
Before getting certified you need to implement ISO 9001 at your organization and set up a quality management system. While the ultimate aim is to increase quality and customer satisfaction, ISO 9001 also improves operational processes throughout the organization, leading to a wide range of benefits and efficiency gains. Additional plus points include greater prestige (resulting in more customers), more opportunity to bid on projects and a more satisfied workforce.
Once you have set up the quality management system and your company follows the requirements of ISO 9001:2015, you can get your system audited and apply for certification.
The ISO 9001 Quality Management System
ISO 9001 covers much more than just quality control. In fact, it requires the implementation of a comprehensive quality management system (QMS) - an integrated approach to operating a company or organization that can improve its overall performance.
A quality management system is directly related to management. It gives management on all levels of the company a set of tools that help them perform their various tasks. Depending on how well organized your company currently is, these tools might already be in use or they may all be new for you.
You may think that an ISO 9001 quality management system is how management engages in quality control inspections. It's true that QC inspection is a quality management tool - but just one of many. ISO 9001 takes a broad approach to quality, defining it as the degree to which customer requirements are met. And these requirements may not even be expressed by the customer but simply be expected.
The ISO 9001 quality management system refers to an entire suite of integrated management processes, or a system, that affect almost all areas of the company. This system spans everything from strategic planning to document control to the calibration of measurement devices.
What Are the Benefits?
Just as ISO 9001 affects a wide range of business activities, your company can also gain from it in numerous ways. In fact, if you implement ISO 9001 well, you should see all of the following benefits.
ISO 9001 certification can be a wonderful marketing tool. Being the world's best known quality standard, the certification mark signals quality and reliability to domestic and international customers alike. If your competitors haven't achieved ISO 9001 certification yet, you could gain a significant competitive advantage by marketing your certification. And if your competitors have achieved certification, it's a matter of urgency for you to catch up.
Using ISO 9001:2015 helps ensure that customers get consistent, good quality products and services, which in turn brings many business benefits.
International Organization for Standardization
For an ever increasing number of companies, ISO 9001 certification is becoming a necessity. Accreditation used to be a requirement only for government contracts and the defense and pharmaceutical sectors. Nowadays a growing number of ISO 9001 registered companies require their suppliers to be certified as well. In fact, we have seen many emergencies where clients needed quick ISO 9001 certification to keep an all-important customer. Our advice for you: it is always better to have ISO already in place rather than struggle to implement it under the impatient eyes of a valued customer.
Many people don't realize that the most important benefits of ISO 9001 may be operational rather than marketing. In fact, ISO 9001 was designed as a tool for companies to improve their operations and bottom line; certifications and marketing benefits came later. Internal benefits can include everything from reduced rework and scrap to increased productivity and efficiency, from lower employee turnover to higher customer satisfaction. In short, there can be massive benefits that will show on your bottom line.
Does ISO 9001 Apply to My Organization?
Yes, ISO 9001 is designed to apply to any kind of organization in any industry in any country. It doesn't matter if your organization is a manufacturing company, a legal firm, a school or government department. It also doesn't matter if your organization is for profit or not, or if your organization is a one-person outfit or a large enterprise. And because it's an international standard, it applies equally to any country in the world (some countries publish ISO 9001 - without changing its content - under the name of their accreditation board, for example ANSI in the USA).
What Does It Take to Get Certified?
It obviously takes time and money, but how much? The answer depends a lot on the approach you choose and on your company's circumstances. There are generally three different approaches to ISO 9001 implementation:
Have a consultant do it
This is the approach that many large enterprises take. It is the quickest and most convenient option, but requires the biggest budget. Equally important considerations are customization and creating ownership. First, you need to choose a consultant who is capable of implementing an efficient QMS that's customized to the individual needs of your company. Second, it's crucial that the consultant creates motivation and ownership among management and staff to ensure long-term success.
Do it all from scratch
This is an option for companies whose top management have enough spare time and an interest in learning everything about ISO 9001. Done correctly, an ISO system developed and implemented in-house will enjoy a great deal of staff support. However, the significant time requirements and strong likelihood of error tend to make this approach impractical. If you are considering this route, purchase the ISO 9001:2015 standard and read it carefully. If you find the contents easy to understand, this approach may be right for you.
Use a certification kit
This approach lies somewhere between the others and combines the benefits of both. It's also the least expensive. A good certification kit contains documentation templates that are business friendly, easy to adapt to your situation and includes step-by-step instructions on how to customize and how to implement. If the kit also includes professional training and support, you should be able to set up a good ISO system quite quickly.
No matter which approach you choose, the next step is to apply for certification. This requires a contract with an ISO 9001 registrar who will perform an on-site audit. Once the registar has verified that your QMS complies with ISO requirements, he will issue the certificate. Those in a rush should consider that well-connected consultants may get priority scheduling.
Bureaucracy and Paperwork?
ISO 9001 is not without opponents. The most common criticisms voice concern about excessive paperwork and bureaucracy. To some extent these points are true – but only for companies that either use inferior resources during implementation or take the wrong approach to ISO 9001.
A properly implemented ISO 9001 system increases efficiency. Documentation must be purposeful, with the benefits and time savings outweighing the efforts. Applying due diligence is critical when selecting consultants, kits and training resources to aid your implementation.
The goals you set for your ISO9001 system will determine the outcome. If your only goal is to achieve accreditation for marketing purposes, you are likely to realize far fewer operational benefits than companies that focus on a wide range of internal benefits.
An ISO 9001 quality management system – if set up correctly – can be surprisingly lean and easy to manage. Likewise, the potential benefits depend on the approach and resources you use and the goals you set.
Executives who need more information will learn everything necessary with our concise online course.
No matter which implementation approach you ultimately choose, you may want to read more on how to get ISO 9001 certified in five steps.
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