Audits & Accreditations at HC21 Group – Safeguarding Quality, Driving Progress

You’ve heard us talk about audits—internal, external, and everything in between—but what’s behind all those ticked boxes and certificates? Here’s why our accreditations aren’t just fancy plaques on the wall, but the backbone of how we run our business and protect our customers.

Why Does This Matter?

Audits and accreditations are more than paperwork—they’re how we stay sharp, compliant, and trustworthy. Our day-to-day activities, from paperwork to packaging, all tie into these rigorous standards. Your commitment to following processes and procedures is what keeps us compliant and ahead of the curve.

2025: Q1&Q2 of Successes

2025 so far has seen over multiple successful audits take place, across the business.

• ISO13485 Change to approval audit – allowing all ISO13485 Audits across HC21 to be on one certificate, meaning less individual audits for the business and one audit report and certificate. A great improvement for the Company.

• ISO27001 – transition Audit to the 2022 standard

• HPRA Audit for Xograph Healthcare Ireland

• DSP Toolkit Audit for Xograph Healthcare Ltd

• Supplier Audits – just to name a few, Fuji, Aortic Lab, Leidos and Orthoscan

• ISO13485 / ISO9001 Internal Audits for Macclesfield, Basingstoke, and Stonehouse

With more audits on the horizon, we’re not slowing down—each check/audit is a chance to improve, innovate, and strengthen the trust our customers place in us.