Audit Prep: Some Advice After Our ISO Certification

Audit Prep: Some Advice After Our ISO Certification

Increased demand.

Beautiful words in the ears of just about any businessperson, right? Of course, so long as the business can grow to meet it. Scaling to meet the increased demand we see during this coronavirus pandemic is one of our top priorities at MDC Associates.

You see, manufacturers of in vitro diagnostics (IVD) face an avalanche of new and changing regulatory requirements over the next six to eighteen months on top of an evolving effort to harmonize many of the quality standards accepted globally. Requests for assistance from Quality and Regulatory consulting firms, and especially from notified bodies, are high regardless of the pandemic and related applications for Emergency Use Authorization.

As we ramp up both capability and capacity to help, we’re pleased to share that we’re doing so under a new commitment to quality and continuous improvement, having achieved ISO 9001:2015 certification. We also have some advice for those of you preparing for your next audit.

Picture this: it’s the year 2020, quality and regulatory changes are raining down, the diagnostics industry is trying to keep pace without slipping, a coronavirus pandemic comes pouring in, emergency use authorization becomes a household term, and we at MDC decide it’s a great time to ASK to be audited. Crazy? Maybe a little, but we knew ISO 9001:2015 certification would help us standardize how we do things, enhance our focus on our clients’ unarticulated needs, and ultimately make MDC Associates a stronger company.

Operating under somewhat similar quality standards as our clients provides an invaluable first-person perspective on the kinds of challenges our clients face. Already, we’ve been able to offer new, practical ways to address them.

How did we do? Zero findings, though you should expect no less from the team you go to regularly for audit and quality management advice. How’d we do it? Honestly, as the saying goes, “Even a dentist needs to brush often.” It took planning, a commitment from leadership, and a lot of diligence. Given the circumstances, we’re enormously proud of how the team came together to achieve this milestone.

Based on this first-hand experience, and after representing clients in countless audits and helping them build hundreds of quality management systems, here’s the advice we have for preparing for quality audits in 2021. First, make audit-readiness a quarterly focus instead of an annual one. Break down your quality system into bite-sized pieces that you and your team can chew through in the ordinary course of business. Easily said, we know, but you’ll be so glad you did. Start small and make sustained momentum throughout the year your primary goal. Eventually, you’ll touch the entire business in a year and know where you need to focus your attention moving forward.

Second, to prepare for the number of imminent quality and regulatory changes, make sure that you have a plan —at minimum, for assessing and implementing them, even if you are not practically going to finish implementation before your next audit. For example, don’t skip the Planning Stage when preparing for the upcoming Risk Management changes in ISO 14971. Undergoing an audit while still halfway through the implementation of new requirements may be less of a concern to auditors when you have a thorough Change Plan in place and demonstrate you are using that plan to make steady progress. Without a plan? Well, that’s any auditor’s guess.

Above all, try to keep a big-picture perspective when preparing for upcoming audits and avoid being surprised by changes in requirements or areas of emphasis because you’re focusing on just one or two scary areas. This forward-looking quality planning effort is often where we can help most, so reach out and let us know what you’re working on now or planning for next year.

—Joanne Lebrun, VP Quality Systems