You’ll notice that we used the word “executive.” FDA and the ISO standard are serious about this. You may have excellent control over your records, but without the full support of executive management your QMS will not be effective at maintaining product safety and promoting continuous improvement of your processes. This is your record of how you followed the “recipe” to produce your device.

Device history record – (ISO 13485:2016 section 7.5.1, 21 CFR Part 820.184) – Requires you to maintain records of dates of manufacture, quantities manufactured, quantity released, lots, acceptance records, and more.

This is the actual “recipe” for your device.

Medical device file (ISO 13485:2016 section 4.2.3, 21 CFR Part 820.181) – Documents that demonstrate your conformity to the standard and regulation, including device description, labeling, IFU, intended use, specifications for manufacturing, storage, packaging, and much more.

You can think of this as the history of how you concocted the “recipe” for your device.

Design history file (ISO 13485:2016 section 7.3.10, 21 CFR Part 820.30) – Covers the plans, requirements, design review records, and design verification results.

A quality manual is not required by FDA but is highly recommended to help summarize your QMS. Your quality manual can serve as a guide to the system for an outside auditor.

Quality manual (ISO 13485:2016 section 4.2.2) – Provides an overall guide to your QMS and defines key information like the scope of your system.

There are several important documents you must maintain – this is only a partial list: Section 4.2 and other specific sections of ISO 13485:2016 outline your obligations, and so do various subparts of the FDA QSR, as indicated below. We can’t cover all aspects of the ISO standard and 21 CFR Part 820 regulation in this post, so we will focus on five key areas:Ī QMS cannot function without solid document control.

Five Broad Topics Covered in the ISO Standard and FDA Regulation We’ve combined all three posts into one easy-to-read white paper, plus added some extras.

In this final post we will take a look at key sections of ISO 13485:2016 and the FDA Quality System Regulations. In our previous blog posts, we provided a high-level overview of medical device quality management systems, followed by a discussion on key components of a QMS that meets US FDA and EU requirements. This is blog post 3 of 3 in our series on Medical Device Quality Management Systems.

En iso 13485 2016