How to Pass Every Quality Management Audit Without Breaking a Sweat

Over one million companies around the world have passed ISO certification. So, don't let a quality management audit scare you to death.

Many quality managers before you have shepherded their teams through the process of proving that they meet industry standards. You’ve probably heard that “practice makes perfect.” It's true. However, you need to practice in the right ways, so you don't spin your wheels. You also shouldn’t assume you’re “safe” for any reason.

As an enterprise Quality Management System provider, we help keep life sciences companies maintain a constant state of audit-readiness. With the right preparations, you'll always be in position to pass your next quality management audit with ease.

How to Pass a Quality Management Audit with Ease

ISO auditors don’t release public data on the top reasons companies fail certification or recertification audits. However, data from the FDA tells a story about some of the most common reasons for citations and warnings on similar regulations. Companies often struggle when it comes to managing non-conformances, dealing with customer complaints, purchasing controls, and process validation. If you look deeper than the surface, you’ll see a common thread of life sciences organizations who aren’t up to standards with:

• Creating SOPs
• Maintaining SOPs
• Following SOPs

Another common root cause of warnings is poor transparency throughout the enterprise. Many times, companies fell short because no one noticed that lab records weren’t signed-off when someone went on vacation, or an employee didn’t complete training on time.

Human error happens. Your operations won’t organically meet all ISO requirements without concerted effort. However, the key is to have checks and balances in place, such as internal audits, and to establish visibility long before an ISO rep steps foot in your facility.

RELATED READING: FDA Audit: Medical Device Companies Should Watch Out for These 7 Mistakes

Implement the Right eQMS

If you want to pass an audit, the right eQMS can help. Having a cloud-based QMS like Qualio helps you create standard workflows, achieve visibility, and consistently follow SOPs for quality management. The right QMS creates order out of chaos and helps you bring your operations in line with ISO and regulatory standards. Qualio offers a lightweight, purpose-built design crafted specifically in accordance with ISO and FDA cGMP.

We know we're not the best fit for every company, but if your life sciences organization is in the startup or scale-up phase with 5-500 employees, we've designed our eQMS to fit your needs. Our solution is simple and configurable, two essential attributes which will enable your company to get to market quickly and scale fast. Learn more here.

Prep the Team

Your people should be prepared on-paper and off-paper for interactions with the auditors. Keep your personnel qualified by providing training, certifications, and courses. Make sure every training activity has a paper trail attached. ISO auditors will be looking for evidence that your team knows how to do their job, received timely training, and that your organization performed corrective training in instances where an employee failed a knowledge test.

Your employees also need to be prepared for conversations with the auditor. Never assume that an auditor won’t engage with someone because their role or project “isn’t important,” or their documentation is in order. Train your people to answer auditors carefully and refer to SOPs when needed. No auditor expects your employees to have your QMS documents fully committed to memory. Instead, they expect employees to know how to access, follow, and understand the quality documents that prescribe procedures.

Clean and Get Organized

Auditors collect evidence through Observation, Records, and Questioning. You can expect a balance of all three audit methods. An external auditor will take a careful look at your physical facilities, inspect your information and documents, and ask your employees questions.

It’s guaranteed that your auditor will ask to see specific SOPs or records from training, the lab, or other areas of the QMS. You don’t want to come up short or discover that you’re missing key documentation. Audit preparation is the perfect time to get your entire QMS software and physical facility in tip-top shape by cleaning and organizing the lab, the document management system, and verifying that every SOP and record is up-to-date.

Treat the Audit as a Helpful Event

Ultimately, your ISO auditor is there to help. They don’t want to fail anyone. Their job is to measure your company against an objective standard by shining light on shortcomings. This isn’t a test, and the worst-case scenario is that you’ll receive a report showing specific areas for improvement before you can be certified or recertified.

The first step is to take full advantage of internal audits as an opportunity for improvement. Ask your colleague to provide detailed feedback on areas where you fell short. When the external auditor arrives on site, don’t let your nerves take over. Refer to company policies and listen to the questions carefully as they review your QMS.

Use a Standard-Specific Checklist

Far too often, companies are unprepared to pass an ISO audit because their internal audit activities weren’t a simulation of the real thing. Sometimes, internal auditors perform superficial assessments that don’t uncover common skeletons in the closet, like missing documentation or other small errors. Sometimes, the culture doesn’t support continuous improvement, and external auditors uncover a lot of shortcuts, like identical reports or lazy nonconformance investigations. There’s a lot that can go wrong when an ISO auditor steps on-site, especially if your internal auditors are winging it or rushing through audits.

Practice makes perfect. The best way to be prepared is comprehensive internal audits which are as close to the real thing as possible. Your internal audits can avoid dangerous shortcuts by using a checklist specific to your ISO standard to make sure they’re not overlooking any ghosts or closet skeletons. Both experienced and inexperienced internal auditors need a checklist to avoid common pitfalls and bias.

To learn more, read: The Best ISO 13485 Checklists on the Web

Audit Yourself

It’s impossible to underestimate just how important internal audits are to prepare for the real thing. These activities are your opportunity to understand how your organization’s QMS stacks up to the real thing. Your internal auditor needs to be objective and provided with access to the entire QMS. Having employees audit their own work against a checklist isn’t enough.

Don’t wait until the week before your certification audit to start thinking about an internal assessment. Internal audits should be an ongoing activity. Avoid taking any shortcuts, and finish comprehensive audits well in advance of the big day. Your internal audit should result in areas for improvement, so make sure employees have enough time to make necessary corrections.

Don't Write Yourself Into a Corner

“Writing yourself into a corner” is something we've seen time and time again. This common pitfall can occur at companies of any size or stage, but especially startups or scale-ups preparing for a first-time certification audit. Include enough detail in your SOPs but not too much. You need enough detail to show that you comply with all applicable standards, but not so much that you’re writing deviations for pen color.

SOPs with too little detail create ambiguity and room for human error. Auditors will be looking at the level of detail included in your procedures to make sure you’ve hit all the points necessary for compliance. However, too much detail is more common and carries its own risks. More detail means more documentation and more opportunities for an auditor to observe failures to follow SOPs.

Are You Prepared to Pass Your Quality Management Audit?

Are you sure you’re prepared for your audit? The key to achieving a pain-free certification is loads of preparation and practice, with effective internal audits, strong SOPs, and an eQMS that delivers simplicity and visibility. Audits can be nerve-wracking, but you can approach the process with confidence.

As we mentioned above, our eQMS and team of specialists are designed to keep small and growing life sciences companies is a constant state of audit-readiness. You can learn more about our solution here.