7 ISO 9001 Quality Management System Requirements & Benefits

    An ISO 9001 certification can be a game-changer for your company. This quality certification opens the door for you to be able to sell your product to new customers in new markets β€” in fact, some customers will only purchase from you if you have it.

    It's time to stop letting your competitors dominate your market. Over 2 million companies across the planet are certified to ISO 9001. If you're not certified, you're missing out.

    Before you can start down the path to ISO 9001 certification, you will need to identify a champion in your organization that can sell the idea to your internal leadership team.

    The story is all too common. An engaged employee has a vague notion of the importance of getting ISO 9001 certified but doesn't grasp the requirements and benefits enough to be able to pitch it effectively to other members of the organization. And the initiative falls flat.

    Getting ISO 9001 certified can be a big step in the right direction for your business, just like it has been for millions of others. A full understanding of the requirements and their benefits will put you in a position to be the champion your company needs to move forward.

    7 ISO 9001 Quality Management System Requirements and Their Benefits

    ISO standards are set in place to help companies like yours develop and service high-quality products that are safe and effective to use. It's about building a solid foundation that allows all the pieces to come together to ensure quality across your whole organization and deliver that quality to your customers.

    ISO 9001 is focused on the implementation of quality processes and standard operating procedures (SOPs).

    The 9000 Store has a great example of ISO 9001 applied to baking cookies:

    Whether it’s chocolate chip, sugar cookie, or garbage flavored, your customers will ultimately decide if your cookie is good. The standard tries to get you to achieve consistent results and continually improve the process. Thus, if you can make a good cookie most of the time, this helps you make it all of the time. Controlling and improving processes will yield better results!

    In their example, a simple 1-page cookie recipe was audited by the 9001 standard across several sections and resulted in an 8-page PDF that discussed:

    • Possible internal and external issues that could impact delivery β€” such as ingredient availability and the experience of the baker.
    • What the requirements are of each interested party β€” like the customer wanting to the cookie to taste good and the legal requirements for food safety and inspection.
    • How the cookies would be distributed β€” which flavors go to which locations and why.
    • The list goes on for six more pages...

    This may seem like overkill for baking a simple cookie, but for a company that cares about consistently producing high-quality products for their customers, these steps are necessary. And those types of companies win.

    Related Reading: The Risks of ISO 9001 Nonconformance (And How It Impacts Your Organization)

    The ISO 9001 quality management system standard is based on seven quality principles that you will need to understand. These fundamental principles will help you align all of your stakeholders and communicate the benefits.

    Quality Principle #1: Customer Focus

    Your customers must be satisfied with your product. As you develop your SOPs, you need to consider planning for:

    • Your customer's current and future needs
    • The requirements that your customers will place on your product
    • Gathering feedback from customers
    • Making adjustments based on that feedback to generate a better product

    Benefit: You will be in tune with what your customers want from you. Your success depends on their satisfaction.

    Quality Principle #2: Leadership

    Your leadership team should be striving to create and sustain an internal company environment that supports an emphasis on quality throughout your entire product lifecycle. Your leadership team should strive to:

    • Build trust between the leadership and employees
    • Equip and empower your team to do high-quality work
    • Recognize employee achievements and hard work
    • Set goals and keep employees motivated

    Benefit: Your employees are a crucial and unpredictable factor in your ability to consistently create high-quality products. You have to give them the tools they need to succeed and be invested in their success.

    Quality Principle #3: Engagement & Training of People

    Becoming ISO 9001 certified isn't going to happen overnight. There are a lot of things that need to happen in your organization first, and most of them will involve educating and training your team. Your organization will need to:

    • Provide access to educational materials and procedural information
    • Require employee training to make sure they have the understanding necessary to do their job in a compliant way
    • Create an environment where staff feel comfortable and confident asking questions and gaining clarification

    Benefit: An educated team is an empowered team. When they are confident they can do their job right, they will produce higher-quality outcomes for you.

    Quality Principle #4: Processes

    A process is a set of activities that use resources like people and machines to transform inputs into outputs. Every company creates products and delivers services by following a series of interacting processes.

    Some processes involved might include:

    • Checking your supplies for quality before manufacturing your products
    • Quality checking your product and making adjustments to meet quality standards
    • Performing a final inspection and placing into a container for shipping

    Benefit: Your desired result is typically achieved more efficiently, predictably, and reliably when the activities and their related resources are managed as a process.

    Related Reading: How to Ensure Your Quality Management System Processes and Procedures are Compliant

    Quality Principle #5: Continual Improvement

    Continual improvement is a necessary requirement for ISO 9001. Management should:

    • Encourage employees to make improvements
    • Measure the consistency of improvements
    • Make continual improvement an ongoing objective

    Benefit: Complacency is detrimental to a company. Adopting a methodology of continual improvement helps you avoid operational inefficiencies.

    Quality Principle #6: Decisions Based on Evidence

    This ISO principle states that effective decisions should be based on the analysis of data and information.

    • Continually evaluate your performance across all areas of your production lifecycle
    • Take corrective action to improve performance only when data reveals that an area is underperforming

    Benefit: Following this principle ensures that you take the time to investigate and determine the true root cause of a problem before jumping to potentially costly conclusions.

    Quality Principle #7: Relationship Management

    The development of your product and ability to provide services relies on your network of suppliers and other interested parties. You can't ensure quality in your end product if you can't rely on the same from your providers.

    Your organization is unique, but you will want to follow a few key steps:

    • Make sure you can manage and plan for your costs
    • Have processes in place to optimize resources
    • Determine how you will provide and receive value from your relationships

    Benefit: When you, your suppliers, and other stakeholders are invested in a relationship based on continual improvement, all parties will ultimately benefit. You will improve your product quality, reduce errors, and improve customer satisfaction.

    Tying Your ISO 9001 Quality Management System Together with the Right eQMS

    You might not think so now, but defining standard operating procedures (SOPs) and receiving your ISO 9001 quality management system certification is the easy part.

    Building that list of all the things you're going to do is simple. Training your team to do them is doable. Maintaining it all is hard.

    So many companies think that all the hard work is over when they have their certification. But, then the auditor comes back a year later, and that's when it all hits the fan. Their certification gets suspended because they aren't doing all the things they said they would just a year ago. Their SOPs are gathering dust on a shelf instead of providing guidance and instruction.

    That's why you need to implement an effective enterprise quality management system (eQMS). An eQMS software brings everything you need together in one place β€” instead of leaving it scattered in papers all over your company.

    What eQMS software do you need?

    At Qualio, we've built the industry-leading eQMS for startup and scale-up life sciences companies, but we know we're not the best fit for everyone.

    So, just like with the ISO 9001 quality management system certification, it's important to educate yourself before jumping in. We've assembled a free guide that will help you figure out what system will suit your unique needs.

    Download your free guide: 12 Questions to Ask Before You Buy an eQMS