How to Perform a ISO 13485 Gap Analysis

One of the first steps in your Quality Management System (QMS) transition or implementation project is to compare your current QMS to the requirements of the ISO 13485 standard. This is most commonly called a Gap Analysis.

Recommended steps to be completed before conducting the Gap Analysis:

1. Identify one or more people to conduct the Gap Analysis; it is helpful if they have some quality system experience or audit experience.

2. You may also want to consider having assistance from a consultant.

3. Create or purchase a Gap Analysis Checklist.

ISO 13485 Gap Analysis Checklist

• The most important tool for the Gap Analysis is the Gap Analysis Checklist. This is 
  a list of the requirements in the standard, written in question format.
• The auditor (person conducting the Gap Analysis) will use this list to compare the QMS that is in place with the requirements of the ISO 13485 Standard. Where there is a shortfall, it is called a "gap".
• The checklist provides the auditor with recommendations of what documents to look for, examples of what will meet the requirements and other guidance on auditing to the standard. The checklist also gives the auditor a specific place to document what they saw that did or did not meet the standard.

There are three main components to completing an ISO 13485 Gap Analysis. 

1. Scheduling the Gap Analysis
2. Conducting the Gap Analysis
3. How to use the Results of the Gap Analysis: The Report 
    

Step 1: Scheduling the ISO 13485 Gap Analysis

Review the project plan

• Schedule the Gap Analysis, and communicate to all employees what is being done, and why.
• You will want to be able to make the employees comfortable with answering your auditor's questions.You may want to consider sending out a newsletter to inform employees that the Gap Analysis will be performed, by whom, when and why the Gap Analysis is being performed. Use the Employee Newsletter which is included in the Gap Analysis Checklist Toolkit.
• Determine whether you will audit by process/procedure or by area of the facility. Our approach is usually to audit by area of the facility.
• Divide the facility into manageable areas.
• Schedule time to audit each section of the standard that applies to the area.
• If you are using an audit team, assign the team to cover the various areas of the facility.
• Arrange your Gap Analysis checklists so each auditor will have the sections of the standard that are applicable in the areas they will cover.

Step 2: Conducting a Gap Analysis

• Follow the schedule that you have prepared. Go into each area of the facility to evaluate the current quality system.
• Focus on what is in place, and what is not in place. Remind auditors that you are not focusing on compliance or non compliance to the current system, but on the design of the current system, and how it matches the ISO 13485 requirements.
• Take notes on what is in place, and what will need to be developed and changed. Take complete notes, reference documents and examples.
• Notice where all the processes link to other processes in the organization.

Step 3: Using the ISO 13485 Gap Analysis Report

Summarize the audit findings in the form of a task list.

You will usually identify several categories of tasks.

• Processes that comply with the standard and are documented.
• Processes that comply with the standard and must be documented.
• Processes that do not comply with the standard and must be redesigned.
• Processes required by the standard that are not currently in place.

For each requirement (or set of requirements) of the standard you will want to identify the status of the current system. The ISO 13485 Steering Team will use this information as they assign responsibility and timelines to Teams. Task Teams will be assigned responsibility for development of a procedure.