ISO 13485 Gap Analysis
ISO 13485 Gap
Analysis
Gap analysis is an important aspect of the ISO 13485 audit. The
ISO 13485 standard lists out requirements for a wide-ranging management system
for the manufacture and design of medical devices. When a
medical device organization performs a gap analysis, it is analyzing the gaps
that exist in its QMS vis-à-vis that prescribed in ISO 13485.
Why do the gap
analysis?
Performing the gap analysis is obviously of very high
importance to a medical device company. It helps the business understand the
shortfall it has in relation to meeting regulatory requirements set out by ISO
13485. It helps it identify areas of insufficiency.
When should it be
done?
It is best advised that organizations carry out the gap
analysis before its final QMS is put in place, because identifying gaps at this
stage is prudent. When carried out at this stage, it saves resources and time
by nipping in the bud issues that could pile up later on. When gap analysis is
not done at this stage, it becomes difficult to implement a QMS. As the old
saying goes, a stitch in time saves nine!
How to do it?
It is always a great idea to get an ISO consultant to
perform your organization’s gap analysis, because the professional knows best.
By dedicating that person for this task, you could not only get a neat job
done; you could also save on time and your own company resources.
Performing the gap analysis requires answering a set of
questions relating to the QMS. The consultant will frame a set of questions
that he/she will get you to answer. Some of these questions typically are of
this nature:
o
Has the requirement been met?
o
Has the gap been identified?
o
Has remedial action been taken, or is it not
necessary?
If the answer is “no” to any of these, it means that further
action is necessitated. Leaving your ISO 1385 gap analysis to an expert
requires your active support and cooperation.
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posted by Unknown @ 05:30
3 Comments
3 Comments:
I like this post very much.Thanks and nice keep posting......
ISO 13485 Consultant bangalore
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