ISO 13485 2016 Gap Analysis Tool

The following material will briefly introduce our Plain English Gap Analysis Tool.
However, it will not present the entire ISO 13485 product. Instead, it will show
you how our gap analysis tool is organized and how it is used. In addition,
it will show you a pdf sample of our approach. Once you've examined
our approach, we hope you'll consider purchasing our complete
ISO 13485 2016 Plain English Gap Analysis Tool (Title 46).

Our gap analysis tool will allow you to compare your organization's current
practices and processes with the new ISO 13485 standard. This comparison
will pinpoint the gaps (the areas that fall short of the standard).  Once you
know where to focus your attention, you can begin to make the changes
that are needed to comply with the new ISO 13485 2016 standard.

Our
gap analysis process consists of five questionnaires, one for
each of the five sections (4 to 8) that make up the core of the standard.
For each
question, three answers are possible: YES, NO, or N/A. A YES
answer means youíre in compliance with the standard, a NO answer means
youíre not in compliance, while an N/A answer means that a question is not
applicable in your situation. NO answers identify gaps that exist between
the standard and your organization's practices while N/A answers point
to items that arenít applicable in your case.

All gaps must be filled and all N/A answers must be justified before you
can claim that your quality management system (QMS) complies with the
new ISO 13485 standard. You may exclude or ignore any requirement in
sections 6, 7, or 8 if you can justify doing so because of the nature of
your organization's activities or products and if doing so does not
undermine regulatory compliance.

Once youíve completed all five questionnaires, study your NO answers,
your own comments, and our questions, and then use this information to
develop your own ISO 13485 2016 Quality Management Compliance Plan.
Use this information to formulate actions or steps that need to be taken
in order to bring your practices into compliance with the standard.

ISO 13485 2016 GAP ANALYSIS TOOL

TABLE OF CONTENTS (TITLE 46)

 

INTRODUCTION

 

1

Profile of Gap Analysis Project

3

2

Explanation of Gap Analysis Tool

4

3

Overview of ISO 13485 2016 Standard

6

 

PLAIN ENGLISH QUESTIONNAIRES 

 

4

Systemic Gap Analysis Questionnaire

9

5

Management Gap Analysis Questionnaire

20

6

Resource Gap Analysis Questionnaire

27

7

Realization Gap Analysis Questionnaire

PDF

8

Remedial Gap Analysis Questionnaire

61

 

PLAIN ENGLISH ANNEXES

 

A

Plain English Quality Management Definitions

78

B

License Agreement and Contact Information

98

Attention

Now that you understand our approach, please consider purchasing
our Title 46: ISO 13485 2016 Gap Analysis Tool
. If you purchase our
Gap Analysis Tool, you'll find that it's integrated, detailed,
exhaustive, and easy to understand. We guarantee it.

Title 46 is 99 pages long and comes in both pdf and Word file formats.

Sample PDF

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MORE ISO 13485 PAGES

ISO 13485 2016 Introduction

Quality Management Principles

Outline of ISO 13485 2016 Standard

Overview of ISO 13485 2016 Standard

ISO 13485 2016 versus ISO 13485 2003

Plain English ISO 13485 2016 Definitions

ISO 13485 2016 Translated into Plain English

ISO 13485 2016 Quality System Audit Program


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Updated on May 15, 2016. First published on April 18, 2016.

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