Irith testified that this was a very successful audit, done purely online. “I was impressed of how powerful the tool is, it was as easy as clicking a button to get the information I needed, during the audit…..
“You are the first company I gave 0 grade since I have started giving audits on MDSAP…” said the auditor for STEP I
As Irith Bouwman, Director of QA with over 20 years of experience explained, the MDSAP audit is a very unique audit in a way that it takes both the standard of the ISO 13485:2016 together with the regulation of the regions the company is about to act and making sure that the SOP reflects those regulations in the SOP.
The lowest the grade is the better your audit. Grade Above 4 it is not recommended to go to stage II. If there is missing regulation in the SOP the grade start from 2, and more points are added during the audit finding.
In addition, during the audit, there is a new factor added to the audit grade is the RESPONSE TIME of the organization to request of the auditor. In that sense, it usually gives 10 min to retrieve a document from the quality system. During the audit, the retrieval time that it took our customer was less than 30sec. You may see the auditor put a stopper on the desk during the audit.
The reference to documents is also tested and the revision of the documents and the obsolete management of documents. Orcanos e-DMS system serves all those requirements electronically with almost zero human interaction and 0 errors.
Orcanos is proud to serve some of the leading medical device manufacturers, helping them to move their paper-based quality management system into an electronic template-based system, thus saving time and money and reduces overall cost.
Get your MDSAP audit-ready today www.orcanos.com