ISO 9001 Certification
What comes to mind when you think of ISO 9001 certification?
We hope you think of world-class quality, continual improvement, and customer satisfaction. But for some people, other things come to mind—things like “complicated,” “difficult,” “piles of paperwork,” or “a big scary audit at the end of the process.”
In this article, we want to break down these common misconceptions. We’ll outline exactly what’s required for ISO 9001, so you can achieve certification and show your badge of quality to the world.
There’s no need to panic. The ISO 9001 certification process isn’t as complicated or difficult as it may appear from the outside. It’s all about documenting and improving what you already have in place. It’s designed to help you achieve success. Even your third-party audit (the most dreaded part of the process) serves to help you succeed—especially when you work with a registrar that understands small business.
Every year, hundreds of businesses—even small businesses—go through this process. They evaluate their systems, comply with ISO 9001 requirements, and achieve certification. You can do it, too.
So what’s actually required for ISO 9001 certification? Continue reading to learn more.
How to Get ISO 9001 Certification: 8 Essential Steps
Even small businesses can achieve ISO 9001 certification and reap the benefits.
It starts with a correct mindset. ISO 9001 isn’t about filling out paperwork or checking boxes. It’s a process of whole-business improvement.
As you implement ISO 9001, you will think about your organization in terms of individual processes. This helps you gain visibility, identify risks, and discover opportunities for improvement. The ISO 9001 standard and its requirements will guide you along the way.
This requires learning the requirements—and understanding how to satisfy them. Once you dig in and get past the “ISO jargon,” you might be surprised at the simplicity of the requirements. In 2015, ISO 9001 was revised to make the standard more accessible for small businesses.
These requirements shape around your business and your processes. They can apply to any business in any industry.
You can break the entire certification process into 8 basic steps:
1. Choose to pursue certification. The process can’t begin until you’ve officially decided to achieve ISO 9001 certification.
2. Purchase a copy of the standard. In order to learn the ISO 9001 requirements, you need to buy a copy of the standard and read it.
3. Decide whether you need a consultant. Many businesses work with an ISO 9001 expert to help interpret the standard and implement the requirements. If you choose this path, you will need to select an ISO 9001-certified consultant from an ISO 9001-certified firm. If you choose to forego consulting help, you will need to assign the project to someone within your organization.
4. Compare the standard’s requirements to your processes. Once you understand what the standard requires, measure your organization against those requirements.
5. Determine whether your processes meet the requirements. If they do, that’s great! Keep doing what you’re doing. If not, you will need to make improvements until you’ve achieved compliance.
6. Contact CertFast or another third-party registrar to begin the audit process.
7. Fix any nonconformances discovered during your third-party audit. You will have time to make these corrections.
8. Receive your official ISO 9001 certificate.
As you dive into the standard, you will discover the flexibility of the requirements. This flexibility can make the requirements appear complicated at first glance. But in reality, it simplifies compliance, allowing any businesses of any size to implement ISO 9001. It allows you to customize your Quality Management System (QMS) to fit your processes and serve your goals.
ISO 9001 doesn’t provide cookie-cutter requirements. Instead, the standard shapes around your business. It helps you build a blueprint for continuing success—whatever success means for you.
What’s Not Required for ISO 9001 Certification in a Small Business?
Let’s take a moment to address two common misconceptions. Here are two things you’re not required to do in order to achieve ISO 9001 certification.
1. No Extra Hires Required
You don’t need to hire extra personnel to handle ISO 9001 certification. However, you should assign an existing team member to oversee the project. Choose an organized, quality-focused individual to lead the certification effort. Some businesses work with outside consultants to help this process along. But rest assured: You don’t need to hire a full-time employee just to handle ISO.
2. No Extra Paperwork Needed
Some people associate ISO 9001 with mountains of paperwork. You’ll be glad to know this isn’t the case. The standard simply asks you to document your existing processes in a clear, accessible way. You’re not adding new processes; You’re just organizing the processes you already have in place. You might already have much of the required documentation. Speaking of which:
Documentation: What Documents Do I Need for ISO 9001 Certification?
ISO 9001 deals with two major types of documentation:
1. Documented information determined by you
2. Documented information required by the ISO 9001 standard
Let’s briefly look at each type of information in turn.
1. Documented information determined by you
This comes back to the idea of flexibility. ISO 9001 requires you to keep a handful of specific documents (more on that below), but for the most part, you determine what documents and records to keep. These documents should show your planning and control across the processes you’ve chosen. They show evidence that you’ve applied the principles of ISO 9001 to the essential processes of your businesses.
2. Documented information required by the ISO 9001 standard
ISO 9001 outlines several different documents you must maintain or retain. The documents you maintain include plans, policies, and other items that may change over time. The documents you retain are records. These do not change.
What Documents do I Need to Maintain?
The documents you must maintain include:
• The scope of your Quality Management System (4.3)
• Documented information necessary to support the operation of processes (4.4)
• Your Quality Policy (5.2)
• Your Quality Objectives (6.2)
What Documents do I Need to Retain?
The documents you must retain include:
• Monitoring and measuring equipment calibration records, if applicable (7.1.5.1)
• Training records, skills, experience, and qualifications (7.2)
• Product/service requirements review records (8.2.3.2)
• Records about design and development (8.3)
• Product and Service requirements (8.5.1)
• Records about customer property (8.5.3)
• Change control records (8.5.6)
• Record of conformity of product or service with acceptance criteria (8.6)
• Record of nonconforming outputs (8.7.2)
• Results of the quality objective data that is monitored and measured (9.1.1)
• Internal audit reports (9.2)
• Management review meeting minutes (9.3)
• Results of corrective actions (10.1)
But wait—you said ISO 9001 doesn’t add extra paperwork!
This might look like a lengthy list. But when you look past the “ISO jargon,” you’ll notice that you likely already keep many of these documents as part of your current processes. ISO 9001 simply helps you organize this documentation and wield it for improvement.
How Do I Store These Documents?
You don’t need piles of paperwork or a closet full of binders. The standard allows you to keep records in any medium. Today, many businesses organize their documents digitally. At CertFast, we love working with businesses who keep well-organized digital records. This makes it quick and easy for the auditor to see your documentation at work.
Taking Control of ISO 9001 Implementation
The flexibility of ISO 9001 allows you to take control of the implementation process. But make sure to seriously consider what documents and measurements you need to achieve success. Your auditor will want to see that you’ve put thought into meeting the requirements.
At the start of the implementation process, you’re required to look at the context of your organization (Clause 4.1). This is all about thinking through your specific situation. You will consider your strengths, weaknesses, opportunities, and the threats you face. You will also take stock of your risks. Together, these planning steps help you figure out how ISO 9001 maps onto your organization. It helps you set goals that work for you.
ISO 9001 also helps you unite your organization around these goals. Your auditor will want to see that your employees know and understand your Quality Policy. Your team members should know this policy, and they should know how their specific work serves your quality objectives.
What does this mean for you? It requires you to meet the communication requirements of ISO 9001. You can find these requirements in Clause 7.3 of the standard. Again, these requirements allow for flexibility. You must determine the most effective means of communicating company goals to your team. Good communication builds participation in your QMS, creating a “quality culture” in your company.
This level of flexibility might look complex at first. But it allows you to align your business goals with your ISO 9001 quality management system. It transforms the certification process from busywork into a real tool for your success.
Some businesses work with consultants to help navigate the requirements. If you chose this path, make sure to pick a consultant who has successfully achieved ISO 9001 certification.
What is required for the Third-Party ISO Audit?
With your implementation complete, it’s time for the audit. You will work with a third-party registrar like CertFast to accomplish this step.
This is the part of the process that everyone dreads. But the certification audit isn’t about “passing” or “failing.” It’s about accountability for the goals you’ve set as part of your QMS. Your auditor will measure your processes and talk to your team to make sure you’re living up to your QMS requirements.
This third-party review gives your ISO certificate its power. You’re not just claiming compliance for yourself. Your quality is backed by proof from neutral third-party experts.
During this process, your auditor may discover a nonconformance—something that doesn’t measure up to your QMS. Again: Don’t panic. This doesn’t mean you’ve failed the audit. You will have an opportunity to fix any issues discovered before you receive your certification.
It’s not about passing or failing. It’s about getting a fresh set of eyes on your goals and processes, so you can push forward toward improvement.
The Benefits of ISO 9001 Certification
By this point, we hope you see that ISO 9001 doesn’t simply prove your quality. It also improves your quality.
As a registrar, we want to see more than well-organized documents—although we love well-organized documents. We want to see your QMS at work. We want to see that your team understands the importance of your quality goals. We want to see management driving this effort from the top. In other words: We want to see that the pursuit of world-class quality has become part of your company culture.
When you implement ISO 9001 correctly, these elements fall into place. Your operations run smoothly, your employees understand their roles, and customer satisfaction increases.
Ultimately, ISO 9001 certification boosts your business performance. Then it proves that performance to the world.
Making Certification Work for You with CertFast
At CertFast, we understand the needs of small businesses. We want to carry out your audit in a way that works for you, with an eye to helping you achieve your goals. Our streamlined process helps you save time and money through offerings such as virtual audits and other small business considerations.
When you work with our auditors, you work with real people. A CertFast audit isn’t about passing or failing. It’s about helping your business achieve success.
Contact us today for a no-hassle quote.