ISO 9001 - Based Gap Analysis

ISO 9001, TS 16949, TL 9000, AS9100, ISO 13485

Determining the GAP between your organization's current business practices (Management System) and the requirements of ISO 9001, TS 16949, TL 9000, AS9100, or ISO 13485 is an important step in the planning, rationalization, development, and implementation process. A thorough analysis saves organizations thousands of dollars by providing the executive leadership with the means to:

  1. rationally understand the requirements of the ISO 9001, TS 16949, TL 9000, AS9100, or ISO 13485,
  2. identify where implementation will have the greatest impact,
  3. accurately determine the required resources, and
  4. formalize an implementation plan.

Starting down the wrong path can be detrimental to budgets, morale, efficacy of the QMS, and the certification timetable.

First, a Pinnacle Project Director conducts a Documentation Review of your existing Management System. For this you are asked to provide your existing policies, procedures, and a master list of documents and records, if available. Then the Project Director visits your location(s), interviews staff, research policies, and evaluate the existing business processes through the lens of ISO 9001, TS 16949, TL 9000, AS9100, or ISO 13485. The result of this review is a detailed report that identifies where your current practices meet requirements and where "gaps" exist.

The outcome of the Gap Analysis can then be used to develop a draft Project Plan and a custom tailored Lean QMS® Curriculum.

As an option, the Project Director can also conduct an Executive Briefing and Process Discovery Session. The Executive Briefing is targeted to your management team and key implementation project participants. The Project Director reviews the results of the Gap Analysis while conducting a clause-by-clause review of the requirements of ISO 9001, TS 16949, TL 9000, AS9100, or ISO 13485 and their applicability of the requirements to your business.

Finally, the Project Director facilitates a Process Discovery Session to identify and rationalize your organization's Core and Support Processes. The output is a comprehensive set of processes (not procedures) that govern all activities of your organization. This set of processes is an input to project planning, scheduling, and resource allocation.


  • Review and identify current business practices and processes.
  • Assess compliance with applicable standard and identify areas of weakness.
  • Determine resources required to achieve certification.
  • Train executive leadership on the requirements and applicability of ISO 9001, TS 16949, TL 9000, AS9100, or ISO 13485.
  • Develop a draft Project Plan.
  • Identify training needs.
  • Make recommendations about how to address the requirements of ISO 9001, TS 16949, TL 9000, AS9100, or ISO 13485.
  • Design and/or tailor a Lean QMS® Curriculum.


The Gap Analysis serves as the foundation for Pinnacle's Lean QMS ® Curriculum and provides your organization with a true indication of the status of your QMS and its readiness for certification. This allows you to establish realistic budgets, time lines, and expectations. You will also have a firm understanding of how to proceed from where you are. The report is straightforward and easy to read. It focuses on specific areas of concern and overall impressions. As a result, you are able to get a clear understanding of how ISO 9001, TS 16949, TL 9000, AS9100, or ISO 13485 must be applied to your organization's business system.

Contact Pinnacle to discuss the Gap Analysis.

Next Topic: Executive Overview
Previous Topic: Process Mapping

Back to the Quality Management System Consulting Page (ISO 9000, ISO 9001)