Step 2: Perform a Gap Analysis
What is an ISO 9001 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 9001 standard. This is most commonly called a Gap Analysis.
Recommended steps to be completed before conducting the Gap Analysis:
- Identify one or more people to conduct the Gap Analysis; it is helpful if they have some quality system experience or audit experience.
- You may also want to consider having assistance from a consultant.
- Create or purchase a Gap Analysis Checklist.
ISO 9001 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 9001 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 9001 Gap Analysis:
- Step 2a: Scheduling the Gap Analysis
- Step 2b: Conducting the Gap Analysis
- Step 2c: How to use the Results of the Gap Analysis: The Report
The 9000 Store sells a Gap Analysis Checklist for $39. The toolkit includes:
- Gap Analysis Checklist: a detailed, 37 page checklist with guidance on what to look for to evaluate your current processes and their compliance to the ISO 9001 Requirements.
- Project Plan
- Project Plan Template
- Employee Flyer to use to explain the Gap Analysis to employees