The FDA has come up with the initiative to harmonize FDA QSR 21CFR 820 with the ISO 13485:2016 – Medical devices — Quality management systems — Requirements for regulatory purposes. The goal is to refresh and modernize the quality regulations presented in the FDA QSR 21CFR 820. This means a revision. And revision means changes; changes in the FDA QSR 21CFR 820 and change to quality systems that act upon these regulations.
I am getting quite a few questions from readers in the last few months regarding this issue. I decide to collect them and off course my answers.
Why does the FDA make the transit to the ISO 13485:2016?
The intention of the FDA is to harmonize the QSR 21CFR 820 quality regulations with the quality requirements of the ISO 13485. One specific target of this revision is to help all organizations in the medical branch that need to maintain 2 quality systems; one compliant with QSR 21CFR 820 regulations and the second with the ISO 13485:2016 standard.
What does it mean to harmonize the QSR 21CFR 820 with the Standard ISO 13458:2016?
To harmonize is to bring requirements and regulations of QSR 21CFR 820 into correspondence with the ISO 13485:2016 quality requirements and make them compatible. In the quality management case, it is required to bring the applicable and relevant international, national, local, and regulatory requirements into consonance with quality management system aspects. In other words, the processes of the QMS (designed and implemented according to the QSR 21CFR 820) should be adaptive to changes and requirements demanded by other requirements – the ISO 13485:2016 Standard.
Which aspects of the Quality Management System will be affected from the alignment of the QSR 21CFR 820 to the ISO 13485:2016 Standard?
- The planning and implementation of designated processes and activities
- Design and maintenance of documentation according to those requirements
- Training and qualification of human resources
- Planning and controlling infrastructures and work environment
- Implementation of risk management activities
- Implementing safety measures and controls during the realization of the MD
When is the alignment planned?
According to the FDA – Fall 2019. But, and there is a big BUT – it will take some years to accomplish the transition. So relax and take your time.
Why does the FDA make such a move?
Since 1996 the FDA QSR 21CFR 820 serves quality regulations and is based on the first edition of the ISO 13485. But fact is that it was not updated since. So, it is time.
I am managing a quality management system according to the FDA QSR 21CFR 820. How this transition will affect my quality management system?
You must expect and plan some changes to your QMS. At the end of the day your quality management system will look like a quality management system required by the ISO 13485:2016 – no escape there. How exactly? Too early to say because the FDA had not yet published its new regulation (this article was written on 20.09.2019). But good news are that there are many similarities between the 2 documents. In other words, if you already comply to the FDA QSR 21CFR 820, you are already do most of the ISO 13485:2016 Standard requirements.
What changes are expected?
I do not know exactly. In the first step the FDA will perform a gap analysis and assess the differences between the FDA QSR 21CFR 820 and the ISO 13485:2016. Until today (20.09.2019) it has not yet been published.
What should I do in the mean time?
I suggest the following:
Get acquainted with the ISO 13485. In a matter of fact there are many overlapping requirements between the requirements. Here is a comparison matrix between the FDA QSR 21CFR 820 and the ISO 13485:2016.
Important notice regarding the matrix – it refers to the current FDA QSR 21CFR 820 and not to one to come.
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