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17 December 2020
ISO 9001 is the world's best known and most popular quality management standard. Any organization can adopt it and achieve the prestigious certification. We explain what ISO 9001:2015 is, what it means for your business and its operations, and what it takes to get certified.
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ISO 9001 refers to a quality management standard that was originally introduced in 1987 and is published by ISO (the International Organization for Standardization). Now in its fourth revision (referred to as ISO 9001:2015), the standard has become an increasingly popular tool for businesses to improve their operations and increase their customer appeal. 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 an ISO quality management system. While its ultimate aim is to increase quality and customer satisfaction, ISO 9001 also improves other operational processes throughout the organization, leading to a wide range of benefits and efficiency gains. Implemented well, ISO is an excellent tool for general business improvement.
Nevertheless, for many companies ISO 9001 is mainly a marketing tool as it means greater prestige (resulting in more customers), more opportunity to bid on projects, and a more satisfied workforce. It's actually the benefits of ISO certification that these companies refer to. To achieve them, you'll first need to set up an ISO 9001 quality management system and follow all requirements, then have your company audited for compliance and apply for certification.
ISO 9001 is much more than just quality control or even quality assurance. 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.
It's important to stress that the QMS is an integral part of the business processes. It doesn't operate in isolation nor outside the "regular" business. Quality happens everywhere, in every process, in every department. Consequently, ISO 9001 affects every process and every department.
Just as the standard affects a wide range of business activities, your company can also gain from ISO 9001 in numerous ways. In fact, if implemented well, ISO 9001 will mean all of the following benefits to you.
ISO 9001 certification can be a wonderful marketing tool. Being the world's best known quality standard, the ISO 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 are certified, 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.
What many people don't realize is that ISO 9001 is the basis for vast operational improvements – not just a useful certification. 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, ISO 9001 has the potential for massive benefits that will show on your bottom line.
Yes, it does.
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, ISO 9001 applies equally to any country in the world (some countries publish ISO 9001:2015 – without changing its content – under the name of their accreditation board, for example ANSI in the USA).
It obviously takes time and money, but how much? The answer depends a lot on the implementation approach you choose and on your company's circumstances. ISO 9001 is usually implemented using one – or a combination – of the following approaches:
Have a consultant do it
This is the approach that many large enterprises take. An all-inclusive ISO 9001 certification service is the quickest and most convenient option, but requires the largest budget. Equally important considerations are customization and creating ownership. First, you need to choose an expert 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 option. A good ISO 9001 certification toolkit contains documentation templates that are business-friendly, is 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.
This approach leverages the benefits of doing it yourself and professional consultancy while limiting the cost. It combines the certification kit with a custom selection of consultant services. The hybrid approach is ideal for companies with the resources to implement ISO 9001 in-house but struggling to get the project off the ground or simply wishing to accelerate it. It also allows you to get certified without becoming an expert in ISO implementation. Another benefit is to get the certification guarantee that we can offer.
No matter which approach you choose, the last step is to apply for certification. This requires a contract with an ISO 9001 registrar who will perform an audit of your organization. Once the registrar has verified that your QMS complies with ISO requirements, they will issue the certificate. Those in a rush should consider that well-connected consultants can get priority scheduling.
We'd be happy to analyze your situation and give you custom advice. Simply contact us.
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 don't understand the basics of ISO 9001, 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.
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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