Management System and Relevant Standards

It is nearly impossible to work in medical device quality systems without encountering ISO 13485, the standard for “Medical devices — Quality management systems —Requirements for regulatory purposes.” The most current date revision is 2016 and is also available as a harmonized European Normative revision. These will be marked as EN ISO 13485:2016.

You can break down these standards into sub-genres. For example, there are standards about management systems, quality systems, or quality management systems, depending on your preferred terminology. Examples of these include ISO 13485:2016 and ISO 9001:2015 Quality Management Systems – Requirements.

Then some standards address processes, and sometimes those processes are only applicable to specific types of medical devices. Suppose you are producing a device under the U.S. FDA’s jurisdiction. In that case, you will note that their stance on Human Factors Engineering is simply that Usability is just a single portion of the overall design validation of a device.

That snippet of the QSR may be a bit ambiguous, but if you check out the ‘Definitions’ section of the FDA’s 2016 Usability guidance document they make their stance a little more clear.

This brings us to the point I am trying to make. Some standards address Quality Management Systems as a whole. Standards that address individual processes such as Risk Management and Human Factors Engineering may be required by authorities having jurisdiction. Then some standards may only apply if you have a specific type of device. For example, if you have Software as a Medical Device, then AAMI TIR 57 may be applicable. In contrast, ISO 10993-1:2018 probably wouldn’t apply as it is a standard for the biological evaluation of medical devices.

Of course if your device is patient contacting and has software components, both standards may apply.

Loosely framed in accordance with the ISO 9000 series of standards 13485 is tailored specifically to the medical device industry.

ISO 13485:2016 is broken down into clauses that address the following:

• 4. Quality Management System
• 5. Management Responsibility
• 6. Resource Management
• 7. Product Realization
• 8. Measurement, Analysis, Improvement

Standards are constantly evolving and changing. Many EN harmonized standards were harmonized with inclusion of ‘Z’ annexes to the Medical Device Directives, or MDD. The MDD was replaced with the Medical Device Regulations or (EU) MDR. This change means that not all ‘EN’ standards are yet harmonized with the current EU regulations, and you will need to independently verify the needs of your QMS.

Also note that the FDA has more than once stated their intention of transitioning from the QSR to ISO 13485.

The FDA has not yet made that transition or defined the timeline for which that will occur yet. As of July 2021, the FDA has not yet mandated compliance or certification with ISO 13485 and still utilizes 21 CFR 820.

You will also need to determine what other standards are relevant to your QMS. This will vary by market, and the type of device/s that are under your QMS.

Examples

ISO 14971:2019 Medical devices—Application of risk management to medical devices

IEC 62366-1:2015 Medical devices — Part 1: Application of usability engineering to medical devices

AAMI TIR57:2016 Principles For Medical Device Security – Risk Management

ISO 10993-1:2018 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process

IEC 60601-1-11:2015 Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

Standards change, but those changes do not always result in a brand-new date revision. Sometimes date revisions of standards will receive an Amendment to add additional information and clarify concepts. For example:

IEC 62366-1:2015 Medical devices — Part 1: Application of usability engineering to medical devices. This is a 2015 date revision, and a standard that has a 2020 Amendment.

IEC 62366-1:2015/AMD 1:2020 Medical devices — Part 1: Application of usability engineering to medical devices — Amendment 1.

Helpful Links

The International Standards Organization (ISO) store website URL- https://www.iso.org/store.html

The International Electrotechnical Commission (IEC) store website URL- https://webstore.iec.ch/

The Association for the Advancement of Medical Instrumentation (AAMI) store URL- https://store.aami.org/s/store