ISO 9001:2015

By ETQ on January 28, 2022

While no mandates require companies to seek ISO 9001 certification, it can come with many benefits to your organization. First off, it creates a framework for quality management that improves consistency and efficiency, which lowers costs across the business. It also gives your customers more confidence in your products and encourages continuous innovation.   If you’re thinking about preparing for certification or want to know more about ISO 9001:2015 compliance, you’re in the right place. 

What is ISO 9001:2015 Certification?

The International Organization for Standardization (ISO) is a non-governmental organization responsible for creating market-relevant international standards supporting innovation and solving global challenges. 

Companies acquire the ISO 9001 certification by following specific standards for quality management. There’s a strong customer focus to this certification, and it ensures the delivery of consistent, top-quality products to end-users. It follows several fundamental quality management principles to increase customer satisfaction while using data to improve other areas of the business. 

How to prepare for ISO 9001 Certification

Preparing for ISO certification isn’t complicated, but there are some things you must consider to get you ready for your first ISO 9001:2015 audit. 

Step One: Understand Certification Guidelines 

It’s crucial to understand the guidelines and what ISO 9001:2015 compliance looks like in the context of your business. Take time to study the requirements as you begin planning. 

You can find the relevant documents on the ISO website. 

Step Two: Create a Customer-Centric Plan 

Because ISO 9001 is so customer-centric, you need to develop a plan that serves them. It’s best to consider your customers’ current and future needs and how your products can help them. This information can help you define your standard operating procedures and the direction your organization may take going forward. 

As part of your plan, consider how you’ll receive feedback from your customers. That’ll help you make further quality improvements to your products. 

Step Three: Execute Leadership Training 

Companies are only as strong as those in it. It’s vital to train your leaders as they’re responsible for motivating their teams, setting goals, and recognizing demanding work. With the proper training, your leaders can continually improve quality while ensuring buy-in from other employees as you move toward new ways of working. 

Step Four: Execute Team Training 

Developing your team is just as important as training your leaders. Encourage all employees to ask questions as they learn, this helps them as they train, but it’ll also help your organization improve.  

Step Five: Measure and Track Data 

Measuring and tracking data is a large part of ISO 9001 certification. Data can give you a deeper insight into quality within your business, including underperforming areas. Ensure you can properly track and measure relevant data, as this provides evidence to help you make informed decisions. 

Step Six: Streamline and Organize Processes 

The more streamlined and organized your processes are, the more efficient and consistent your business can be. The goal here is to achieve higher quality products with fewer mistakes or safety issues. That applies to both your manufacturing and business processes. By keeping these streamlined and organized, you can predict outcomes and collect and analyze data more effectively.  

Step Seven: Implement a Quality Management System 

Paper-based quality management has many disadvantages and is becoming increasingly outdated. Documents could be lost or damaged, vital information might get missed, and there’s nothing to help automate, track, or analyze.  

A cloud-based quality management system (QMS) puts all your important documents, processes, and workflows in one place. That allows your team to find everything they need when they need it. Further down the line, this also makes auditing and compliance much more manageable. 

ISO 9001 and ISO 13485: How They are Similar and Different 

While ISO 9001 and ISO 13485 cover different areas, there are several similarities. While ISO 9001 lays the groundwork for a quality management system relevant to all types of manufacturing, ISO 13485 is specific to the manufacture of medical devices. 


Both standards help a business achieve a more streamlined QMS System. Other similarities include: 

  • A customer-centric approach to improving quality 
  • A focus on risk assessments and mitigation 
  • The use of Deming Cycles (Plan-Do-Act-Check) 
  • A focus on competency and infrastructure for quality 


There are also some key differences between these two standards. The main thing to remember is, while ISO 9001 applies to most manufacturing processes, ISO 13485 is specific only to the medical device industry. As such, there are several specific requirements related to the safe production of these items. 

ISO 13485 Requirements You Should Know 

ISO 13485 has many additional requirements beyond the standards of ISO 9001, including: 

  • Documentation must occur for all procedures relating to product shelf life. 
  • A feedback system must be in place to give early warning of nonconformances. 
  • Monitor and measure products throughout production to maintain quality. 
  • Products must meet quality requirements before their release. 
  • Strict documentation of the rework of nonconforming products must occur. 
  • Companies must justify customer complaints that don’t result in CAPA. 
  • Put in place procedures for notifying regulators of adverse events. 
  • Regulatory documents with system documentation are required. 
  • Regulatory updates must include management review. 
  • Maintenance activity requires documentation. 
  • Specific document requirements for cleanliness, clothing, and personal health must be in place. 

There are many more specific requirements available on the ISO website. 

Learn How to Achieve Compliance with QMS Software 

The correct QMS supports you as you move towards ISO 9001:2015 compliance. Because many of the requirements are related to documentation, data, and proper reporting, a QMS does the hard work for you by bringing it to one place. When it comes to your first audit, adequate preparation and the right ISO 9001:2015 software helps you meet the required standards. 

It allows you to speed up automation and reduces the need to develop new processes and procedures continually. On top of this, it centralizes all necessary documentation, which supports training and compliance. It’s also possible to centrally store customer feedback and other essential data, making it easier to find opportunities for improvement and different ways to serve your customers better. 

ISO 9001 certification can bring several benefits to your business, but it’s not possible without the correct EQMS to organize your documents and data. Preparation is critical as you implement this software in the run-up to your first audit.