An in-person ISO 13485 gap analysis provides expert analysis and insights that help organizations understand requirements, scope their project appropriately, and develop a strong business case. It identifies an organization's compliance gaps against ISO 13485 requirements, proposes a management system scope, estimates internal resource needs, and provides a timeline for certification readiness. The gap analysis report details areas of compliance and non-compliance, offers recommendations, and presents options for scoping an ISO 13485 system to meet business objectives.

1. Gap Analysis
ISO 13485
BY INDUSTRY EXPERTS
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ISO 13485 Gap Analysis
Why get a customized, in-person ISO 13485 gap analysis
Questionnaire-based gap analysesdon’t provide the level of expert analysisand insights you get
from a specialist. With an in-person gap analysis, you will have a clear idea of the proposed
scope of the ISO 13485, be able to set realistic project expectations, and obtain customized and
detailedinformation necessaryto developa strong businesscasefor implementing a ISO 13485-
compliant Management System.
Organizations encourage ISO 13485 Gap Analysis to -
● Implement an ISO 13485 Standard based management system and would like to identify
the baseline to measure progress.
Earn a ISO 13485 management system certification in near future after having
implementedthe ISO management system.
Defeat the complacency that has set in over a period of time.
Identify and plug the gaps well before the client visit or customer audit.
Add new site to the existing Organizationscope of business.
Add new product or service to the existing scope of business.
Ramp up the work-force.
Carry out process re-engineering.
Organization restructuring.
identify global best practices in the ISO 13485 management system.
Know what makes ISO management systems work for 360 degree improvement in the
organization processes
conduct suppliers' systems capability & maturity appraisal from time to time
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6. ISO 13485 Gap Analysis Features
· Your management Systemscopeappliesto what product lines, ISO 13485 Standard clauses,
and facilities that you are planning on registering. You do not have to register every product
line. To define the scope within the Gap Analysis we look at what processes need to be included
and described within the Organization. The output is a draft process map. Next we examine
each clause of the ISO 13485 Standard. There are over hundreds of requirements that we count
to see which ones apply and how an organization may be conforming. These requirements
include mandatory records, and required procedures, manual, and many process needs that
must be fulfilled, but there is a lot of leeway on how you might fulfill those requirements.
· For example, collecting customer feedback on “deviations from needs & expectations”is a
required process and that must be measured,is a requirement, but how you do this is totally up
to you. You do not have to write a procedure for this or keep a record of measurements.As odd
as this sounds you have to free your mind of paper solutions and think of visual or electronic
methods that could accomplish this.
· The output of the ISO 13485 Standards “requirements” count is a histogram that shows
you how your organization stacks up, clause by clause, and a list of possible exclusions of areas
within clauses that may not apply. Each exclusion claimed will require a proper justification
within the Documented Framework. In the Gap Analysis we should be able to give you an idea
on possible exclusions.
Dedicated Specialists for ISO 13485 Gap Analysis
A specialist, in-person review of your current information security posture against the
requirements of ISO 13485
Get the true picture of your ISO 13485 compliance gap, and receive expert advice on how to
scope your project and establish your project resource requirements.
ISO 13485 Gap Analysis Brief Description
Our ISO 13485 Gap Analysis will provide you with an informed assessment of:
● Your compliance gaps against ISO 13485;
● The proposed scope of your ISO 13485 management system

7. ● Your internal resource requirements; and
● The potential timeline to achieve certification readiness.
What to expect from ISO 13485 Gap Analysis:
An ISO 13485 specialist will interview key managers and perform an analysis of your existing
information security arrangements and documentation.
Following this, you will receive a gap analysis report collating the findings of these
investigations.The report will detail areasof compliance and areas requiringimprovement,and
provide further recommendationsfor the proposed ISO 13485 compliance project.
ISO 13485 Gap Analysis report includes:
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The overall state and maturity of your information security arrangements;
The specific gaps between these arrangementsand the requirements of ISO 13485;
Options for the scope of an ISO 13485, and how they help to meet your business and
strategic objectives;
An outline action plan and indicationsof the level of internal managementeffort required
to implement an ISO 13485 and
A compliance status report (red/amber/green) against the management system clauses
(clause-by-clause),described in ISO 13485
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