For decades, the medical device industry has largely viewed the US Quality System Regulation (QSR) as a regulatory speedbump on the path to market access. Despite the regulation’s name, product quality has typically taken a back seat to regulatory compliance for manufacturers.
That’s understandable, since FDA’s inspection-oriented approach has rigorously emphasized compliance with specific aspects of 21 CFR Part 820. In recent years, FDA has had an epiphany of sorts. FDA inspectors had been seeing a high volume of the same issues year after year and, after talking with numerous industry stakeholders, FDA concluded that the regulations simply were not sufficient on their own to ensure high product quality and patient safety.… » Read more
This is the final installment of a 3-part blog series on ISO 13485 auditing. We’ve combined all three posts into one easy-to-read PDF. Download it here.
In our previous blog posts, we talked about how to prepare and plan for your ISO 13485 audit and provided tips on how to conduct the QMS audit. In this final post, we will discuss the preparation of the audit report and your obligations for following up to ensure corrective actions are being addressed.
Preparing Your Written ISO 13485 Audit Report
You’ve spent weeks preparing for your audit and several days conducting it.… » Read more
This is the second installment of a 3-part blog series on ISO 13485 auditing. We’ve combined all three posts into one easy-to-read PDF. Download it here.
In our previous post on ISO 13485:2016 auditing, we talked about how to plan your ISO 13485 QMS audit. In this post we will take the next step and provide tips on how to conduct the opening meeting, interact with auditees, and conduct the closing meeting.
The Opening Meeting of the On-Site Audit
You have spent weeks preparing for your audit.… » Read more
This is the first installment of a 3-part blog series on ISO 13485 auditing. We’ve combined all three posts into one easy-to-read PDF. Download it here.
Congratulations! You have been chosen (or perhaps conscripted) to conduct or participate in an ISO 13485 internal quality management system (QMS) audit. For many, the prospect of coordinating and conducting an audit can be terrifying. However, believe us when we say the terror subsides with each hour of planning you do. In this white paper we will talk about how you can lay the foundation to ensure that your ISO 13485 audit progresses smoothly, yielding input that’s useful to your company’s management review as well as its corrective and preventive action (CAPA) processes.… » Read more