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ISO 13485 2003

GAP ANALYSIS TOOL

 

 

 

ISO 13485 2003 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 У 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.

 

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 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:

  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 У PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED. VER 1.0
PART 7 PRODUCT REALIZATION GAP ANALYSIS TOOL PAGE 65

 
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