Internal & Supplier Audits
Onsite and remote audits nationwide.
We Offer
Supplier Audits
Supplier audits can reduce waste, rework, customer complaints, recalls, warranty claims and reputational damage.
When you hire a contract manufacturer your reputation is in their hands. Supplier audits are the best way to identify and solve their problems before they become your problems.
Internal Audits
A robust internal audit program is essential to running a medical device company. Internal audits reduce regulatory risk, increase product quality and reduce cost.
Qualomics is qualified to perform your internal audit with independent auditors for ISO 13485, and FDA 21 CFR 820.
Our Process
Quote
We ask a series of questions to help us understand your goals. Audits may be conducted for a variety of reasons and our goal is to give you a useful product.
Plan
We prepare a custom audit plan to ensure the audit is compliant and meets your goals. We send a list of requested materials before the audit to make audit day more efficient.
Audit
Whether on-site or remote, we start with a review of documents, followed by a review of records. We ask clarifying questions as we seek out areas of the QMS that should be strengthened.
Report
You will receive a draft audit report for review before sending the final version for signature. Findings are written to point your quality team towards valuable corrective actions.
Frequently Asked Questions
What is the timeline for an audit?
We can get an audit done in as little as two weeks. We prefer that you schedule your audit in advance.
How much does it cost?
We can’t publish detailed numbers here because the costs vary based on your audit requirements, the size of your company, the number of products you make, etc. We are confident that our pricing is competitive, and you will be happy with the product.
What regulations can you audit?
US FDA quality system regulation (QSR) or 21 CFR 820 and ISO 13485:2016 are our bread and butter, having worked in this space for 15 years. We also have experience with a variety of regulations that often accompany medical devices such as tissue products, biobanking and clinical laboratory requirements.
What happens after the audit?
After we finalize the audit report, we can help you with any corrective actions (CAPAs), effectiveness checks and process improvements that are identified in the internal audit.