ISO 13485 2003 Gap Analysis Tool

If you need to comply with the new ISO 13485 standard or want to improve
the overall performance of your quality management system, you need our
Gap Analysis Tool. Our Tool will tell you exactly what you need to do
to comply with the new standard or improve the performance
of your organization's quality management system.

More precisely, our Tool will help you to identify the gaps that exist
between the new 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
new ISO 13485 standard, but you will also improve the overall
performance of your quality management system.

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 new ISO 13485 medical device standard.

Our ISO 13485 2003 Gap Analysis Tool is easy to understand and
ready to use. It is focused, detailed, and complete. We guarantee it!

Overview of our Plain English Gap Analysis Tool
The following material will introduce our ISO 13485 2003 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.

PART	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 Ó PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED.	VER 1.0

Our ISO 9001 2000 Gap Analysis Tool has two phases.
The following material will introduce these two phases.

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 ISO 13485, 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:

Quality Management Process Development Form
Resource Management Process Development Form
Regulatory Research Process Development Form
Market Research Process Development Form
Product Design Process Development Form
Purchasing Process Development Form
Production Process Development Form
Service Provision Process Development Form
Product Protection Process Development Form
Customer Needs Assessment Process Development Form
Customer Communications Process Development Form
Internal Communications Process Development Form
Document Control Process Development Form
Record Keeping Process Development Form
Planning Process Development Form
Training Process Development Form
Internal Audit Process Development Form
Management Review Process Development Form
Monitoring and Measuring Process Development Form
Nonconformance Management Process Development Form
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:

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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

JAN 2005	COPYRIGHT Ó PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED.	VER 1.0
PART 7	PRODUCT REALIZATION GAP ANALYSIS TOOL	PAGE 65

If you would like to see the rest of this Gap Analysis questionnaire, please consider purchasing the complete ISO 13485 2003 Gap Analysis Tool.


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ISO 13485 2003
GAP ANALYSIS TOOL