Our ISO 13485:2016 (+ FDA Requirements) checklist uses 120 audit items to covers all requirements of the standard, as well as the United States FDA Quality Systems Regulations (21 CFR 820, 830, 803, 806) that apply to all medical devices. This checklist covers all classes of medical devices. The checklist is in a ready-to-report format with columns for the questions to ask, the relevant clause, the evidence reviewed, and any finding arising from the checklist item.
Our audit checklists are designed for medical device companies who believe that:
– someone within their company can conduct internal audits instead of using 3rd-party internal-auditors
– they have been issued non-conformances from their latest external audit because their internal audit is not sufficiently robust or simply needs improvement
– they can identify gaps by following a systematic checklist rather than a “let’s see what we find” approach.
Our Audit Checklists are strategically put together by experienced medical-device auditors, checked, re-checked, and used several times to ensure coverage so you can identify underlying issues.
You’ll be glad to know that this is the same checklist that our auditors use to make sure you’re ‘Audit Ready’, and you CAN SHOW IT. Whether or not you ask us to audit your QMS, you will have the same checklist.
As always, our checklist are guaranteed to also serve as the most practical and to-the-point learning material for medical device quality and regulatory affairs personnel.
In all AuditAct checklists, we:
– What: explain the intent of the clauses
– Where: reference the source
– How: tell you how to implement
– Reinvest focus: We developed the checklists, so you can focus on ‘doing’ more than ‘planning’.
– Find Underlying issues yourself: Who knows your systems better than YOU?
– Ensure Coverage: Our checklists cover all clauses and sub paragraphs
– Fully customisable checklists (DOCX / XLS files provided)
– Made by experienced auditors: Audit what Notified Bodies and regulators audit.
– Save Time: By following a checklist rather than going blind
– Save Money: Reduce the need for consultants and 3rd party ‘internal’ auditors
– Full integration with AuditMan via the import function
See for yourself: First, view our free demo checklists.