ISO 13485 2003

GAP ANALYSIS TOOL

The following material will introduce our Plain English Gap Analysis Tool.
However, we will not present the complete product. Instead, we will show
you how our Gap Analysis Tool is organized and how it is used. In addition,
we will show you some examples of our approach. Once you've examined
our approach, we hope you'll consider purchasing our complete
ISO 13485 2003 Plain English Gap Analysis Tool (Title 46).

If you need to comply with the ISO 13485 2003 standard or want to
improve the performance of your quality management system (QMS),
you need our Gap Analysis Tool. Our tool will help you to identify the
gaps that exist between the standard and your organization's actual
processes. Once you know exactly where your gaps are, you can take
steps to fill them. By using this approach, you will not only comply with
the  standard, but you will also improve the performance of your QMS.

Use our Gap Analysis Tool either to develop a brand new quality
management system or to upgrade your existing system. If you're
currently ISO 13485:1996 or ISO 13488:1996 certified, you can
use our Gap Analysis Tool to upgrade your quality management
system to the new ISO 13485 2003 standard. And if you're currently
ISO 9001, 9002, or 9003 certified you can use our Gap Analysis Tool
to ensure that your quality management system complies with
the ISO 13485 2003 medical device standard.

Our Plain English Gap Analysis Tool is easy to understand and
ready to use. It is focused, detailed, and complete. We guarantee it!

ISO 13485 2003 GAP ANALYSIS TOOL

PART

TITLE 46: TABLE OF CONTENTS

PAGE

1

Profile of Gap Analysis Project

3

2

Introduction to ISO 13485 2003

4

3

Explanation of Gap Analysis Process

13

4

Systemic Gap Analysis Questionnaire

17

5

Management Gap Analysis Questionnaire

26

6

Resource Gap Analysis Questionnaire

36

7

Realization Gap Analysis Questionnaire

44

8

Remedial Gap Analysis Questionnaire

74

9

Quality Management System Development Plan

90

10

Administrative, Legal, and Contact Information

112

JAN 2005

COPYRIGHT © PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED.

VER 1.0

Our Plain English Gap Analysis Tool has two phases.
The following material will introduce these two phases.

OVERVIEW OF GAP ANALYSIS PROCESS

 

PHASE ONE: IDENTIFY GAPS

 

ANSWER EACH GAP ANALYSIS QUESTION

ANSWER "YES" 

REQUIREMENT
HAS BEEN MET

NO ACTION
REQUIRED

ANSWER "NO"

GAP HAS BEEN
IDENTIFIED

REMEDIAL ACTION
SHOULD BE TAKEN

ANSWER "N/A" 

REQUIREMENT IS
NOT APPLICABLE

NO ACTION
REQUIRED

FOR EACH "NO" ANSWER SELECT THE QUALITY
PROCESSES THAT NEED FURTHER DEVELOPMENT

 

PHASE TWO: FILL GAPS

 

PREPARE PROCESS DEVELOPMENT PLANS
 USING OUR PROCESS DEVELOPMENT FORMS

IMPLEMENT YOUR PROCESS DEVELOPMENT
PLANS AND TRACK IMPLEMENTATION USING
OUR PROCESS DEVELOPMENT FORMS

 

Phase One: Identify Gaps

Phase One asks you to identify gaps by performing a Gap Analysis.
Use our five Gap Analysis Questionnaires (4 to 8) to carry out your
analysis. These five questionnaires list the five sets of requirements
that make up the ISO 13485 2003 standard. But, instead of listing ISO's
requirements in the form of statements, they are listed as questions.

Each Gap Analysis question has either two or three possible answers.
Whenever a question refers to a requirement that must be met in order
to comply with the standard, we offer two possible answers: Yes and
No.  A Yes answer means that you have already met one of ISO's
requirements while a No answer points to a gap that must be filled.

However, whenever a requirement may be excluded or ignored, we
offer a third option: N/A. Select N/A if the requirement is not applicable
in your situation. The N/A option is added to every section 7 question
because you may exclude or ignore any section 7 requirement if you
can justify doing so. You can exclude any section 7 requirement if it is
not applicable in your situation because of the nature of your products.

You can also exclude subsection 7.3 design and development
requirements if official regulations allow you to do so and if you
have made other arrangements that comply with these regulations.

Occasionally, throughout the standard, ISO uses the phrases
“if appropriate” or “where appropriate”. Whenever a requirement
uses one of these phrases, you may ignore or exclude it if the
requirement is not appropriate in your situation.

No answers reveal gaps that exist between the ISO 13485 standard
and your organization's processes. Whenever you answer No to a
question, you are stating that at least one process fails to meet an
ISO 13485 requirement. A No answer tells you that at least one 
process needs some work. It tells you that at least one of your
processes needs to be developed, modified, or improved. So
whenever you answer
No to a question, you must consider
your processes, and decide which ones need to be changed.

Phase Two: Fill Gaps

Once you've identified all of your gaps, you can begin to fill them.
In general, you fill your gaps by preparing and implementing Process
Development Plans
using the following Process Development Forms:

  1. Quality Management Process Development Form

  2. Resource Management Process Development Form

  3. Regulatory Research Process Development Form

  4. Market Research Process Development Form

  5. Product Design Process Development Form

  6. Purchasing Process Development Form

  7. Production Process Development Form

  8. Service Provision Process Development Form

  9. Product Protection Process Development Form

  10. Customer Needs Assessment Process Development Form

  11. Customer Communications Process Development Form

  12. Internal Communications Process Development Form

  13. Document Control Process Development Form

  14. Record Keeping Process Development Form

  15. Planning Process Development Form

  16. Training Process Development Form

  17. Internal Audit Process Development Form

  18. Management Review Process Development Form

  19. Monitoring and Measuring Process Development Form

  20. Nonconformance Management Process Development Form

  21. General Systemic Process Development Form

Use these Process Development Forms to prepare your Process
Development Plans
. Each Form is used to list the remedial actions
that should be taken to fill your gaps.

Of course, before you can list your remedial actions, you need
to formulate them. In general, remedial action statements can be
formulated by turning our Gap Analysis questions into simple action
statements
. For example, the Product Realization Gap Analysis
question number 409 asks: "Do you protect your monitoring and
measuring devices?"
In order to prepare a remedial action statement,
all you have to do is re-write it as follows: "Protect monitoring and
measuring devices"
. This remedial action statement is then listed on
our Monitoring and Measuring Process Development Form. In most
cases, that's all there is to it. However, in some cases, you may need
to be more specific, or you may need to formulate a slightly different
action statement for several different processes.

Once you’ve done this for all gaps, you will have several Process
Development Plans
which, taken together, make up a very detailed
Quality Management System Development Plan that will be unique
to your organization. And once you’ve implemented your Quality
Management System Development Plan
, you will have an
ISO 13485 2003 compliant quality management system.

The following example will show you what our Gap
 Analysis Tools look like. This example is taken from
7. Product Realization Gap Analysis Questionnaire.

NOTE: ISO 9001 2000 questions use black text,
whereas ISO 13485 2003 questions use blue text.

ISO 13485 2003 GAP ANALYSIS TOOL

7. PRODUCT REALIZATION GAP ANALYSIS QUESTIONNAIRE

7.5.3 IDENTIFY AND TRACK YOUR PRODUCTS

7.5.3.1 DEVELOP PROCEDURES TO IDENTIFY PRODUCTS

1

Have you established procedures to identify
your products and to maintain their identity
throughout product realization?

YES

NO

N/A

 

 

2

Have you documented procedures to identify
your products and to maintain their identity
throughout product realization?

YES

NO

N/A

 

 

3

Do you maintain procedures to identify your
products and to maintain their identity
throughout product realization?

YES

NO

N/A

 

 

4

Do you use your procedures to establish
the identity of your organization’s products?

YES

NO

N/A

 

 

5

Do you use your procedures to maintain
the identity of your products throughout
product realization?

YES

NO

N/A

 

 

6

Have you established procedures to
control what is done with your medical
devices when they are returned to your
organization?

YES

NO

N/A

 

 

7

Do your procedures identify
returned medical devices?

YES

NO

N/A

 

 

8

Do your procedures distinguish
between returned medical devices
and conforming products?

YES

NO

N/A

 

 

9

Have you documented procedures to control
what is done with medical devices when
they are returned to your organization?

YES

NO

N/A

 

 

10

Have you implemented procedures to control
what is done with medical devices when
they are returned to your organization?

YES

NO

N/A

 

 

11

Do you maintain procedures to control what
is done with medical devices when they
are returned to your organization?

YES

NO

N/A

 

 

7.5.3.2 ESTABLISH PROCEDURES TO TRACK PRODUCTS

7.5.3.2.1 ESTABLISH PRODUCT TRACEABILITY PROCEDURES

12

Have you developed product
traceability procedures?

YES

NO

N/A

 

 

13

Do your product traceability procedures
specify how extensive your traceability
process should be?

YES

NO

N/A

 

 

14

Do your product traceability procedures
describe the records that need to be
maintained to support your product
traceability process?

YES

NO

N/A

 

 

15

Have you documented your
traceability procedures?

YES

NO

N/A

 

 

16

Have you implemented your
traceability procedures?

YES

NO

N/A

 

 

17

Do you maintain your
traceability procedures?

YES

NO

N/A

 

 

18

Do you control the unique
identity of your products?

YES

NO

N/A

 

 

19

Do you record the unique identity of
your products (when traceability is
a requirement)?

YES

NO

N/A

 

 

7.5.3.2.2 ESTABLISH RECORDS FOR IMPLANTABLE DEVICES

20

Have you established traceability records to
support your implantable medical devices?

YES

NO

N/A

 

 

21

Have you established traceability records to
support active implantable medical devices?

YES

NO

N/A

 

 

22

Do your traceability records identify all
product components whenever these
components could undermine your
medical device’s ability to meet
specified requirements?

YES

NO

N/A

 

 

23

Do your traceability records identify all
materials used whenever these materials
could undermine your medical device’s
ability to meet specified requirements?

YES

NO

N/A

 

 

24

Do your traceability records identify all work
environment conditions
if these conditions
could undermine your medical device’s
ability to meet specified requirements?

YES

NO

N/A

   

25

Do your distributors maintain a record
of their medical device distribution
activities and results?

YES

NO

N/A

 

 

26

Do your distributors’ records
facilitate product traceability?

YES

NO

N/A

   

27

Are distributors’ records
available for inspection?

YES

NO

N/A

 

 

28

Do your agents maintain a record
of their medical device distribution
activities and results?

YES

NO

N/A

 

 

29

Do agents’ distribution records
facilitate product traceability?

YES

NO

N/A

 

 

30

Are your agents’ records
available for inspection?

YES

NO

N/A

 

 

31

Do all traceability records specify where
medical device packages are shipped to?

YES

NO

N/A

 

 

32

Do all traceability records specify who
medical device packages are consigned to?

YES

NO

N/A

 

 

7.5.3.3 PRESERVE PRODUCT IDENTITY AND STATUS

33

Do you identify the monitoring
status of your products?

YES

NO

N/A

 

 

34

Do you identify the measurement
status of your products?

YES

NO

N/A

 

 

35

Do you maintain the identity of your products,
including their monitoring and measurement
status, throughout the production process?

YES

NO

N/A

 

 

36

Do you maintain the identity of your products,
including their monitoring and measurement
status, during the storage process?

YES

NO

N/A

 

 

37

Do you maintain the identity of your products,
including their monitoring and measurement
status, during the installation process?

YES

NO

N/A

 

 

38

Do you maintain the identity of your products,
including their monitoring and measurement
status, throughout the servicing process?

YES

NO

N/A

 

 

39

Are your products dispatched only if they
have passed all tests and inspections or
have been released under an authorized
concession?

YES

NO

N/A

 

 

40

Are your products used only if they have
passed all tests and inspections or have been
released under an authorized concession?

YES

NO

N/A

 

 

41

Are your products installed only if they have
passed all tests and inspections or have been
released under an authorized concession?

YES

NO

N/A

 

 

42

Etcetera ...

 

 

 

 

 

 

ORGANIZATION:

YOUR LOCATION:

COMPLETED BY:

DATE COMPLETED:

REVIEWED BY:

DATE REVIEWED:

JAN 2005

COPYRIGHT © PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED.

VER 1.0

PART 7

PRODUCT REALIZATION GAP ANALYSIS TOOL

PAGE 65


Attention

Now that you know what our Gap Analysis Tool looks like, please
consider purchasing Title 46: ISO 13485 2003 Gap Analysis Tool.
If you purchase our Plain English Gap Analysis Tool, you'll find that it's
integrated, detailed, exhaustive, and easy to understand. You'll find that
we've worked hard to create a high quality product. In fact, we guarantee it.

Title 46 can be delivered to you on CD or as an email attachment.
Title 46 is 113 pages long and comes in pdf and MS doc file formats.

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OTHER ISO 13485 WEB PAGES

Introduction to Quality Management Standard

Medical Device Quality Management Definitions

Overview of ISO 13485 Quality Management Standard

ISO 13485 2003 Standard Translated into Plain English

How to Develop a Quality Management System for Medical Devices

Quality Management Audit Program for Medical Devices

OTHER GAP ANALYSIS TOOLS

Quality Management Gap Analysis Tool

Food Safety Management Gap Analysis Tool

Environmental Management Gap Analysis Tool

Occupational Health and Safety Gap Analysis Tool

Aerospace Quality Management Gap Analysis Tool

Information Security Management Gap Analysis Tool


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Updated on July 17, 2012. First published on January 6, 2005.

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