ISO 19011:2018 Changes: How They Impact Medical Device QMS Auditors

ISO 19011:2018Management system standards such as ISO 13485:2016 define the requirements that auditors are reviewing for conformance – the what – but they don’t get into the details of how to audit against them. ISO 19011, on the other hand, does just that – it provides a methodology to guide auditors in doing their work by adding further context and guidance.

ISO 19011 was previously updated in 2011. Since then, the practice of auditing has evolved in the ways that audits are managed, planned, and executed.…

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The US FDA Case for Quality (CfQ): What It Is and Why You Should Care

FDA's Case for QualityFor 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.…

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Whew. You Successfully Finished Your ISO 13485 Internal or Supplier Audit. Now What?

This is the final installment of a 3-part blog series on ISO 13485 auditing. 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. 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.…

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Day 1 Conducting Your ISO 13485:2016 Audit. How to Ensure it Goes Smoothly.

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.…

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