ISO 9001

ISO 9001 definition

ISO 9001 is an international standard that sets out the requirements for a quality management system.

International standards can help businesses of all sizes build confidence with consumers, meet regulatory requirements and gain access to world markets.

ISO 9001 is part of a larger family of ISO 9000 quality assurance standards. The International Standards Organization (ISO) currently lists more than 24,000 standards.

ISO 9001 Quality Management Systems help businesses demonstrate that they have processes in place to provide quality products and services. It is used by hundreds of thousands of organizations around the globe to minimize risk and maximize opportunity.

Implementing ISO 9001 helps you to take care of your clients because its requirements are designed to make sure your product or service is what they expect.

ISO 9001 was first published in 1987 and has since gone through several updates. The current version, ISO 9001: 2015 Quality Management Systems, is the most popular standard in the ISO 9000 series. 

Why ISO 9001 is important?

Simply put: ISO 9001 gives your business a framework for consistently delivering quality products and services.

It’s a management system that allows you to analyze and improve each element of your operation—from product development and supplier selection to distribution and invoicing.

ISO 9001 is not an overly prescriptive standard, but it does spell out a clear process for businesses to stop doing things in an ad hoc fashion and work in a more systematic, organized manner.

ISO 9001 is a set of management principles that lets you show potential customers that your business is well run and consistently produces reliable products. It helps you punch above your weight.

What types of businesses can benefit from using ISO 9001?

ISO 9001 isn’t intended for a particular industry or type of business. It was created to enable all types of organizations—public or private, large or small, from community groups to multinational corporations—to assess risk and ensure the delivery of quality products or services.

The standard helps improve performance, be it for an entire organization or one department, plant or site. That said, it is usually most effective when implemented at all levels of an organization.

“It's not just for one kind of industry—it’s for everyone,” explains Isabelle Ledoux, Senior Business Advisor, BDC Advisory Services. “Although earlier versions of ISO 9001 were geared toward larger corporations, updates over the past two decades have made the standard simpler to use for smaller companies. In fact, even sole proprietors can use ISO 9001 certification.”

What are the main benefits of being ISO 9001 certified?

Being ISO 9001 certified offers a long list of benefits for any type of business. For example, the standard can:

  • Build trust
    Certification gives your customers confidence in your products and/or services. It acts as a stamp of approval, demonstrating that your business is reputable and reliable.
  • Fuel innovation
    The standard allows a business to capitalize on new opportunities. By focusing on your organization’s core activities, you can free up time and resources to develop new products and services or improve the ones you already have.
  • Break down trade barriers
    Because it’s recognized around the world, ISO 9001 can improve trade. In fact, in many jurisdictions outside Canada, certification is a must for doing business—from Europe to the Middle East to parts of Africa. Even within Canada, compliance is often a prerequisite to doing business, especially when dealing with larger companies or government entities across the country.
  • Boost employee engagement
    Studies have shown that ISO 9001 helps businesses keep staff engaged. Employees who work in a well-run organization, with clear rules and good problem solving, are more motivated and committed. This is important in a world where employee retention is an issue.

How does ISO 9001 help a business manage risk?

The standard requires businesses to use “risk-based thinking” to identify and control any risks inherent in their operations and re-evaluate them regularly. By adhering to the standard, you can identify possible bumps along the road before they can cause problems—ensuring that systems and protocols are in place if problems do occur.

“The risk assessment component is really about learning how to evaluate your company in terms of risk and also identify opportunities for getting better,” explains Ledoux. “It may be that you are very good at delivering on time. But where are you more at risk?”

For example, the standard could help you examine risks to your company’s supply chain. What risks might you be taking, for example, by relying on a sole supplier for a necessary component? Is the sole supplier located in a geographically unstable area? Should you consider expanding your supplier base?

By anticipating possible problems, your business will be more resilient in the future—and can continue to provide reliable, quality products and services to customers.

It makes you look at each of your activities and ask: ‘What could go wrong and how are we going to mitigate this? And what could be the potential impact, not only on our business, but on our customers and business partners?’

How to implement ISO 9001 and where to go for certification

There are several steps to becoming ISO certified. They include:

  • mapping out your operation’s processes
  • doing a risk assessment
  • creating a quality policy and determining quality objectives (or key performance indicators)
  • implementing any new or modified procedures needed to achieve your quality policy and objectives
  • collecting data about your organization’s performance
  • finding a certification body and conducting an internal audit

Your business can conduct its own audit or hire an organization, like BDC, to do it. Depending on the results, you may need to modify certain procedures to meet the standard.

Once you receive certification, it’s recommended you perform an internal audit regularly—monthly, biannually or yearly—to make sure your business is following the rules set out in the standard.

How much does it cost to be certified?

The cost of ISO 9001 certification alone will vary depending on the size and complexity of your business. It starts at around $5,000 for smaller businesses and can reach $35,000 for a larger one. External consultants, like BDC, can make sure you don’t miss critical steps in the certification project, which can decrease some of your costs in the long term.

“Cost varies a lot,” says Rowda Mohamud, Solution Development and Portfolio Management Specialist, BDC Advisory Services. “If you are in manufacturing, what are you manufacturing? Is there research and development involved? Do you have subcontractors? All these things can affect the cost.”

It will also depend on how many employees you have, the square footage of your operation, the number of locations, and whether you have sites in different provinces or countries.

The three main types of costs cover:

  • development—the time spent documenting and implementing the quality management system (QMS)
  • training—to help employees prepare the necessary documents, and to plan and conduct effective internal audits
  • conducting the audit and registering the management system

How long does it take to become ISO certified?

Achieving certification can take anywhere from six to 12 months, depending on the complexity of your operations and other factors.

Next step

Find out how you can achieve internationally recognized certifications and increase customer confidence by visiting our certifications page.