What is ISO 13485 Certification?
ISO 13485 Certification is the standard for a Quality Management
System ("QMS") for the structure and production of Medical Devices.
Certification to the standard requires an association's quality management
system (QMS) to pass an outsider Medical Device Single Audit Program, or
"MDSAP" Audit. Generally: ISO 13485 Certification = ISO 9001 +
Additional Medical Device Requirements.
While ISO 13485 Certification stays an independent report, it
lines up with ISO 9001 Certification. (Truly, 2008, not 2015.) This is on the
grounds that it doesn't follow the elevated level structure (Annex L) of the
most recent variant of ISO 9001 Certification (which is 9001:2015). Likewise,
the documentation and wellbeing necessities are a lot more noteworthy under ISO
13485 Certification, while ISO 9001 Certification puts center around consumer
loyalty and continuous improvement.
A couple of insights regarding ISO 13485 Certification:
ISO 13485 Certification is the principle Quality Management System
(QMS) standard for medical devices, albeit a few nations have their own
arrangement of guidelines. For instance, the United States intends to fit the
Food and Drug Administration (FDA) necessities for medical devices with ISO
13485 Certification. The extent of the QMS can be customized for an
association, especially in Section 7. The present rendition is ISO 13485 Certification,
which was distributed in March of 2016 (consequently the: 2016).
1.
It doesn't make a difference what size your
association is: 1 individual or 1 million individuals
2.
It is certainly not a standard for product. It
doesn't characterize product quality. This is a procedure based standard: you
use it to control your procedures, at that point your final result should meet
the ideal outcomes.
3.
It is certainly not an individual standard –
an individual can't get ensured to ISO 13485 Certification. Rather, an
association or organization gets confirmed. An individual, in any case, CAN
turn into an ISO 13485 Certified Lead Auditor following a 5-day instructional
class. This at that point permits them to review different organizations.
4.
It isn't an enrollment gathering. An
association can't "join" ISO 13485 Certification. To become ISO 13485
certify, your association must:
5.
Follow the means to actualize an ISO 13485 Certification
quality management System.
6.
Then a Certification Body (CB or Registrar)
reviews the presentation of your association against the most recent variant of
the ISO 13485 Certification Requirements. On the off chance that you pass this
review, the Registrar gives an ISO 13485 Certificate exhibiting that your
association is Registered to ISO 13485 Certification for a multi year time
frame. (See Who can concede confirmation)
7.
Finally, the association must be re-guaranteed
at regular intervals so as to keep up its ISO 13485 Certification status.
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