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Top 10 Quality Checklist for ISO 9001 Compliance

Your customers expect the best when it comes to quality. What does it take to meet the international standards and specifications of the ISO 9001:2015?

“ISO 9001:2015.” When you hear those words, do you just quietly groan? I admit any ISO standard is a surefire way to make me run and hide! But as all quality and compliances professionals know, ISO 9001 is just one of the many important standards that manufacturing companies must follow to ensure high quality products, lower costs, and greater customer satisfaction. 

Despite our—or at least my—silent dread of ISO standards, millions of companies around the world have become ISO 9001 certified, showing they consistently deliver products and services that meet stringent customer and regulatory requirements. ISO 9001:2015 is a wide-ranging standard that covers everything from management responsibilities, oversight of resources, and, of course, requirements for a Quality Management System (QMS).

For many companies, you may be perfectly content with your current QMS. But you may face one of the following situations where you need to take a fresh look at your QMS and how you should comply with ISO 9001:2015:

  • Is your company using a paper-based system, but you’re starting to run into delays, errors, and other limitations? This is a common scenario with young or fast-growing companies, where the speed of innovation can be hampered by cumbersome Excel spreadsheets and hard-to-follow email threads. 
  • Similarly you may already have a QMS, but it’s slowing you down because it can’t adapt to your changing business processes. This could arise from your company’s rapid growth, a proliferation of new products and services, or other recent business changes. Trying to update your QMS may be just too time-consuming and expensive!
  • Your company has acquired one or multiple companies, and now you face multiple QMS platforms that should be more consistent and centralized. It’s probably a good time to consider having a single flexible QMS that can span multiple business models. 

Even though ISO 9001 has been around for ages, you may be in a situation where you need to reconsider your approach to your QMS and ISO. What are the top 10 things you need to think about for ISO 9001:2015 compliance and certification?

Your Top 10 ISO 9001:2015 Compliance Checklist to Ensure a Best-in-Class QMS

OK, so you realize it’s time to look at a new approach to QMS and ISO 9001:2015. Based on Propel’s experience with hundreds of manufacturing companies, here are the top 10 things our customers think about.

In the old days of ISO standards, companies had binders containing all the details on their business policies and quality processes. And even though we’re in the 21st century, having solid control of your documents is still core to a successful ISO 9001:2015 certification program. Solid document management capabilities for a QMS is a table stakes requirement for ISO 90001:15, helping you reduce risk across your entire organization. Look for essential features like document versioning, change control, document hierarchies, and watermarking.

Consistent processes and procedures are the key to a successful ISO 9001 organization. A QMS should be easy to set up and manage for all your quality processes like document approvals, customer complaints, Corrective and Preventive Actions (CAPAs), non-conformances (NCRs), supplier evaluations, etc. Workflows should be able to consistently capture all the relevant quality information you need, so you can drive quality in a streamlined fashion.

While workflows are critical for maintaining well controlled quality processes, it’s also important to have your QMS foster more ad hoc collaboration without introducing risk. While we still continue to discuss things in emails, Zoom meetings, and Slack threads, a modern QMS should also make it easy for team members to collaborate with each other within the same platform as your quality data and processes—and not in siloed third-party tools that lack traceability. Smoother collaboration will make it much easier and faster for your team to respond to quality challenges. 

One of the key goals for any ISO 9001:2015 certification is passing the dreaded audit. Make sure your QMS has robust history tracking, reporting, and swift management should there be any audit findings. Modern QMS platforms should at a minimum be able to provide your auditors with regulatory reports in a single click. If you want to be really transparent, next time an auditor wants to review your quality processes, modern QMS solutions make it easy for you to walk an auditor through your quality processes in real time, where you can show them the latest relevant documentation, traceability, history, and reports.

Quality shouldn’t live in a vacuum. If you’re a product company, your quality data needs to be tied to your product data, and vice versa. That way you can easily determine which products or components are impacted by quality issues, and make sure that everyone across the company—quality, operations, and engineering—are all looking at the same data to resolve any outstanding quality issues. You can also see if there are any trends across products, product lines, or suppliers that deserve special attention. Long term, integrating quality and product data through the entire product lifecycle will drive higher quality and lower costs.

Just like quality and product data should be tightly integrated, so should quality and customer data. If a customer reports quality issues with your product, you need to make sure that you can respond quickly to their concerns, and be able to see if there are any other potentially impacted customers to address proactively. Keeping an eye on product quality after launch and when customers are actually using your products is imperative for mitigating risk on later revisions or new products. Tying customers and quality together will help drive customer satisfaction and revenue retention.

If you have quality, customer, and product data all tied together, you can now have a closed loop process that really ensures a high quality ISO 9001:2015 organization. Being able to tie customer incidents to quality processes to design updates will make it possible for your company to drive long-term customer growth and product success.

Ideally, your company is growing and changing to meet the rapid evolution of the market. Make sure your QMS solution can easily adapt to and extend your business needs. Can you or someone on your team configure updates yourselves, instead of hiring costly, time-intensive programmers to customize your IT systems and integrations?

Today’s hybrid work model demands a cloud-first approach. As people have to work at home and at the office, make sure your QMS is built on a cloud platform that can work around the clock and around the world.

Finally, make sure you need to get your ISO 9001 certification and QMS up and running super fast. You’ll want someone running the process who has a solid track record of streamlined implementations.

Vixar: A Real-World Example of ISO 9001:2015

Vixar manufactures high performance, cost-effective Vertical Cavity Surface Emitting Laser (VCSEL) products that are used in 3D sensing applications from medical devices, industrial automation, and consumer products. In a recent webinar for Propel customers, Vixar’s Director of Quality Paul Grette discussed how he uses Propel to manage their ISO 9001:2015 processes. Here’s some of the things that Paul shared:

  • Propel helps Vixar capture and manage ISO 9001:2015 clauses 4-10, including documents and procedures, audit findings, CAPAs and complaints, SCARs and NCMRs, project documents, and part information.
  • Vixar has oversight into all aspects of product quality and ISO 9001:2015 within Propel. ECRs, ECOs, NCMRs, and other quality processes can be related to each other, so everyone is aware of the latest product and quality changes. 
  • The flexibility of Propel has allowed Vixar to manage processes like PCNs (Process Change Notifications) as well. PCNs are integrated with the ECR/ECO process at Vixar and used to notify impacted customers.

What’s Next?

Just like Vixar, make sure you find a QMS that’s right-sized for you now, and can grow with you in the future. The last thing you want to do is implement a QMS that meets your needs today, but as market demands and technology change over time, you wind up having to get rid of it just a few years later. 

Similarly, don’t try to boil the ocean. Don’t just settle for something that you may have used 10 years ago—QMS solutions continue to evolve rapidly. Look for something that has the features you need, and be cautious about building in unnecessary scope creep just because some feature sounds interesting. 

As you investigate the world of QMS companies, a lot of QMS platforms may look the same. Really think about what makes one QMS different from another. One of the things that makes Propel unique is the tight integration of quality, product, and customer data, enabling companies like Vixar to have a complete closed loop to quickly respond to any quality challenge for their customers. And being built on a modern cloud platform like Salesforce means our customers have a rock-solid foundation for years to come.

Learn more about Propel’s QMS offering and see it in action.

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Post by
Miguel Tam
Former VP of Product Success, Propel

Miguel has successfully launched new products at companies like Apttus, Oracle, CA/Niku and i2. He brings over two decades of experience as a marketing executive in product marketing, corporate marketing and sales enablement.

Fun Fact: If you unscramble Miguel’s full name, it's "I'm gruesome talent."

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Miguel Tam