While undertaking your ISO Quality Management System implementation or transitioning from an old version to a new version the requirement is to compare your current system with the requirements of the ISO standard. The objective is to find out the gaps in your organization which have to be filled. This is called Gap Analysis.

ISO Gap Analysis

The first thing to do is to identify one or more people to conduct the Gap Analysis. If they have some quality or audit experience then it is helpful. You can also consider using an ISO Consultant to carry out the Gap Analysis.  After that you should create or purchase a Gap Analysis Checklist.

The auditor uses this Gap Analysis Checklist to compare the Quality Management System that is in place with the requirements of the standard. Where there is a shortfall it is called a gap.

The checklists helps the auditor with recommendations of what documents to look for, examples of what meets the requirements and guidance on auditing to the standard. The checklist also provides the auditor with a place to document what they saw that did or did not meet the standard.

Scheduling the Gap Analysis

In the first step you must schedule the Gap Analysis and inform all the employees about what is being done and why.

To make the employees comfortable with answering the auditor’s questions, you can send a newsletter to the employees about the Gap Analysis to be performed, when and why and by whom it is going to be performed.

  • Decide if you will audit by process/procedure or by area of the organization.
  • Divide the area of the facility into manageable regions, if you are auditing by the area.
  • Divide time to audit each part of the standard that applies to a specific area.
  • If you have an audit team, then assign them various areas of the organization.
  • Arrange the Gap Analysis Checklists so that each auditor has sections of the standard that are applicable to the area they will cover.

Conduct the Gap Analysis

  • Closely follow the audit schedule that you have prepared. Go to each area of the organization to evaluate the management system.
  • Concentrate on what is in –place and what is not in place. You must tell the auditors that they are not focusing on compliance or non-compliance to the current management system or standard but on the design of the system and how it matches the standard’s requirements.
  • Develop notes on what is not in place and what is in place and what needs to be developed and what needs to be changed, Reference documents and examples from the existing system.
  • Document where the processes link to other processes in the system.

Complete the Gap Analysis Report

Finally you should summarize the audit findings as a task or to do list.

You have to identify several types of tasks such as:

  • Processes that are documented and comply with the standard.
  • Processes that must be documented and comply with the standard.
  • Processes that must be redesigned because they don’t comply with the standard.
  • Processes that are not currently in place but are required by the standard.

You have to identify the status of the system with each requirement of the standard. The information gained from this exercise will be used by the ISO steering team to assign timelines responsibilities to teams. Task teams will get responsibilities for development of specific procedures.

Develop a plan for implementation

To make a plan for implementation you have to decide on your goals for the ISO project. You have to answer the following questions:

  • When will you start the ISO project? You can consider Gap Analysis as the start of your project.
  • When do you want to complete the ISO project?

You must schedule the Gap Analysis and inform the employees about its objectives and its importance as the start of the ISO project. You have to make the employees comfortable with answering the auditor’s questions.

The shorter that time that you plan for ISO certification the more resources will be required by the project during implementation. You have to set a realistic date for certification. Find out if there are any company goals attached to certification like client requirement. As you start implementing the project your target date may be revised. As you move along the gap analysis and create the task list you shall be able to determine if your target date is realistic. It depends on what documentation and quality level you have in place in your system and how many resources are you able to dedicate to the project.

A Gap Analysis will normally take between two to five days to complete. It depends on the size of your organization, the level of your current quality or other system, the number and experience of the auditors.