ISO 9001: A Standard That Creates Trust

That standard, ISO 9001, has over 1.1 million certified participating organizations in 178 countries, making it the world’s most prominent QMS. The standard follows seven underlying principles:

• Customer focus
• Leadership
• Engagement of people
• Process approach
• Improvement
• Evidence-based decision making
• Relationship management

As a business leader, you understand how following these principles could benefit your company and its stakeholders. Not only will implementing ISO 9001 into your business increase your company’s profits and productivity, but it will also improve the experiences of your customers, employees, suppliers and all other stakeholders. You’ll see customer satisfaction go up. You’ll also attract new customers, and you’ll reduce operating costs. Complying with ISO 9001 also ensures you’re following all relevant statutory and regulatory requirements. 

Before you can reap these benefits, you must, of course, know how to implement ISO 9001, and it’s an attainable goal for businesses of any size. Some businesses feel that implementing a QMS, as well as maintaining compliance, will be too expensive and time-consuming and require creating a position dedicated solely to ISO 9001 implementation. Some fear they will have to change their processes entirely. This, however, is not typically the case, as your QMS should be based on the systems you currently use.

The QMS implementation process can, in reality, require relatively little funding and time. Besides, the benefits of compliance significantly outweigh the costs if the process is executed accurately and efficiently — especially since compliance typically results in increased profits.

The Resources You Need To Succeed

You need to thoroughly prepare for implementation, understand the steps to implementing ISO 9001 and determine how best to proceed with your business’ needs and current situation in mind. This will help you to get the most out of your new QMS.

This guide can serve as a valuable resource and will help you understand the process of implementing ISO 9001 as it applies to your company. It will cover the basics of ISO 9001 and how it can benefit your company and its stakeholders. It will also take into account your current compliance status and guide you through the steps from preparing for the process to implementing the standard and what to do afterward.

Another way to get the most out of the process of attaining and maintaining compliance involves working with an accredited certification body such as NQA. We can perform the audits you need to meet the requirements of the standard and improve your organization’s performance.

Not only will we inform you of the gaps you need to fill to meet the standards, but we’ll identify ways for you to improve your organization. We help you to understand the technical requirements and steps of the certification process, so that you can implement changes correctly and efficiently. We seek to provide as much value as possible through our audits, all for a fair price.

In addition to this guide, our website contains other valuable resources. If you need more information or are interested in our services, please contact us. Thank you for using this guide as you seek to improve your organization.

What Is ISO 9001?

The International Organization for Standardization (ISO) established the standard known as ISO 9001 to create benchmarks for quality management systems. These systems, often called QMS, are sets of processes designed to ensure a company consistently meets the needs of customers and other stakeholders. The process, for instance, helps the business to reliably provide customers with products of a high quality.

The Purpose Of ISO 9001

Although following the standard will create changes that reverberate through all areas of a company, one can categorize the eight underlying principles mentioned earlier as creating two primary enhancements: improved efficiency and increased customer satisfaction. Implementing ISO 9001 also has many other effects. Another central tenet of the standard is continual improvement of a business’ operations in the following areas:

Improved Efficiency

Adequate processes and systems related to these principles increase a company’s efficiency and effectiveness. Though improving in these areas may indirectly increase customer satisfaction, they directly improve the company’s operations:

• Allows for better leadership: This principle focuses on those leading an organization and encourages them to set clear objectives and expectations.
• Keeps employees informed: This is the principle of keeping employees informed about and involved in what the company is doing. It encourages accountability among staff and creates enhanced employee motivation and performance.
• Improves process approach:: Using a process approach means thinking about your work as a set of activities that together help you reach a goal, rather than a string of separate tasks. This keeps you more organized and focused on your objective.
• Establishes a systematic approach to management:: This principle involves grouping your interrelated process together into systems to achieve more efficient management. It requires you to manage operations proactively, rather than reactively.
• Facilitates fact-based decision-making:: ISO encourages businesses to use data and analysis to make decisions, rather than relying on opinions, immediate reactions, traditions or other means.

Increased Stakeholder Satisfaction

Meeting customers’ needs is the primary goal of any business. These principles directly help business to meet their expectations, as well as those of other stakeholders:

• Customer focus: This is the first principle that ISO 9001 lists, signaling its importance. It says that businesses should focus their attention on what customers need and how to meet or surpass those expectations.
• Mutually beneficial supplier relationships: Businesses and their suppliers depend on each other to reach their goals. This principle encourages strong relationships with suppliers that benefit both the business and the supplier.

The fifth principle, improvement, deals with all aspects of a business. It asserts that always improving products, services and internal operations should be a primary business goal. You can utilize the Plan, Do, Check, Act — or PDCA — Cycle to achieve this improvement. The PDCA Cycle says you should create a plan, implement that plan, evaluate how successful it was and then improve it.

Who Is ISO 9001 For?

Organizations of all types, sizes and sectors can benefit from implementing the ISO 9001 standard. One of the primary changes made in the most recent update of the standard seeks to make it more easily applicable to a wider variety of entities.

One common misconception is that ISO 9001 is too complex and resource-exhaustive for small business to employ. For example, organizations may think they need to hire a dedicated compliance employee, which could be cost-prohibitive to a small operation. While larger businesses might create such a position because it could be beneficial, doing so is not a requirement — nor is it necessary.

Other organizations might worry that their business’ systems won’t fit into the standard. When you explore ISO 9001, you’ll find that this is not an issue. ISO 9001 guides participants and asks them to define their own objectives. It doesn’t require that all certified organizations use the same structure in their systems or their documentation clauses, and it doesn’t require them to use ISO’s terminology within their organization.

Some businesses seek compliance certification because a supplier, trade group or large client requires it before they will work with them. In these situations, certification is extremely beneficial and, sometimes, necessary for a company’s success. It can also, however, provide advantages to organizations that do not have such requirements, as you’ll discover in the next chapter.

Versions Of ISO 9001

You can trace the history of ISO 9001 all the way back to Britain during World War II when the British Ministry of War created a standard to reduce mistakes in the manufacturing of ammunition. In 1979, after the government recommended a standard that applied to industries besides defense, the British Standards Institution created BS 5750, the first quality standard of its kind.

As this idea spread to the United States, ISO created an international version of the standard, ISO 1900: 1987. ISO revised their standard in 1994 to clarify aspects of the first version. This version focused more on quality assurance than the original did.

In 2000, it underwent its first significant revision, which made process management the standard’s main idea. ISO 9001:2000 also reduced the amount of documentation required and introduced the eight underlying principles. 

The standard saw a more minor revision in 2008. The changes primarily sought to offer clarification and increase the ability to integrate ISO 9001 with ISO’s other standards. Although ISO 9001:2008 is not the most recent version of the standards, it is still in use today, and certifications for it remain valid until September 2018.

The most recent update came about in 2015 and included more extensive changes than the 2008 revision did. ISO 9001:2015 sought to make the standard applicable to more types of organizations, increased the focus on risk management and introduced Annex SL, a new structure to be used across all of ISO’s standards.

Benefits of ISO 9001

ISO 9001 is so widely used across industries and countries because of the benefits it brings. It makes people more likely to work with or purchase from you, and those who do will typically be more satisfied. It achieves this by providing guidelines you can use to improve the internal processes of your company.

External Benefits

Becoming certified as an ISO 9001-compliant business can increase how likely people are to trust that you’ll provide them quality product and meet their needs. They’ll know you underwent independent audits that verified the processes you use against a widely accepted international standard.

Some clients, suppliers and other entities you may work with even require organizations they do business with to have this certification. This assures them that their partners will consistently provide them with quality results and won’t jeopardize their progress or hamper their efforts to meet their needs.

Even those that don’t require these credentials will likely still choose a certified company over a non-verified one. It shows them that you’ve taken the time to ensure quality and gives them a window into how your company operates.

The ISO 9001 principle of customer focus directly impacts customer satisfaction by encouraging companies to make meeting customer needs a priority and to establish processes for doing that. The principles that improve a company’s internal processes will also benefit customers because they help to produce a quality product more efficiently, effectively and consistently.

The customer is not the only stakeholder that implementing ISO 9001 can benefit, either. It impacts virtually all stakeholders including suppliers, employees and partnering businesses. The principle of mutually beneficial supplier relationships directly benefits suppliers. Working with an ISO 9001-certified business may also benefit them more indirectly, such as a reduction in the number of last-minute orders and more predictability in the needs of the business.

Internal Benefits

Along with meeting customer needs, another primary goal of any business is a healthy bottom line. Implementing ISO 9001 can help achieve this by reducing costs and increasing profits.

Well-defined and more effective internal processes mean that a business can operate more efficiently. This means it can produce more quality products in less time, increasing productivity and profitability. These consistent, high-quality results can also enable business to sell more of their products. One study from researchers at the University of California at Berkeley and Harvard Business School found that the adoption of ISO 9001 led to a 10 percent increase in sales.

A QMS helps to define the roles of individuals and departments, reducing overlap and making each employee more successful by enabling them to focus on what they need to know. In addition to making employees more productive, ISO 9001 certification can also lead to higher pay. According to the University of California at Berkeley and Harvard Business School study, wages at ISO compliant companies were approximately 7.5 percent higher than at non-certified firms. Total payroll, which includes salary increases and new hires, grew approximately 17.7 percent more at ISO-approved companies.

These improved processes also help to reduce the occurrence of mistakes. More efficient processes mean fewer mistakes will be made, and when they are made, employees will have an effective system in place for addressing the issue. Reducing mistakes also leads to less expense and fewer wasted funds.