SUPPLIER AUDITS

Control of suppliers is a key focus of ISO 13485:2016 (clause 7.4) and a regulatory requirement for medical device companies in all jurisdictions. Without regular evaluation of supplier performance, manufacturers may risk receiving non-conforming products (e.g. raw materials, or product key-components) and services (such as sterilisation, or out-sourced manufacture). Our auditors, find that majority of product issues stem from poor oversight of key suppliers.

With AuditMan You Can:

 

Schedule your supplier audits

Conduct remote/onsite supplier audits, from anywhere, anytime

Send audit requests to suppliers and review their response

Manage several supplier audits at the same time

Have Access Control over all audit evidence

Streamline supplier nonconformances and corrective actions (SCARs)

Generate audit reports and statistics with 1 Click

Although a large portion of audits can be conducted remotely or partially-remotely, the inability to conduct effective remote-audits forces companies to perform fully-onsite audits, The costs associated with conducting onsite audits of suppliers include airfare or travel, food and accommodation, and most importantly, time. AuditMan supplier audit module is the ultimate tool for conducting effective remote supplier-audits to enforce ongoing compliance of suppliers. Our clients report significantly reduced amount and frequency of onsite supplier audits through great control that comes with AuditMan.