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:

  • Has the requirement been met?
  • Has the gap been identified?
  • 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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