The Gap Analysis is a high-level review of your company's quality management system. It is conducted in order to evaluate what processes and procedures the organization operates by, compare them with the system elements outlined in the requisite standard (ISO 9001, AS9100, ISO 13485 or ISO 14001) and determine what additional effort is required for successful registration or conformance. A comprehensive gap analysis also identifies those areas that meet the requirements of the standard. The difference between the existing system and the requirements, the "gap," is supported by recommendations. Prioritizing those recommendations forms the basis of the implementation steps in the project plan.
All companies need operating systems in order to function. Through careful analysis, coupled with in-depth knowledge of the standards, The Victoria Group staff is able to incorporate the majority of current practices into the new ISO or AS-based system. Building on the current operating system reduces the amount of rework, minimizes the need for new processes and avoids excessive documentation. This also allows the consultant to assist the client in constructing an effective implementation program.
Documenting current practice is a major activity required for most companies implementing a management system. There are some common areas, which are typically weak until a formalized system is developed – these are internal audits, closed-loop corrective and preventive action and regular management reviews of the operating system. The challenge while implementing any ISO based system is skillful incorporation or merging into the existing management processes – there is no need to "reinvent the wheel", nor is there any value in so doing.
The deliverables from this activity:
Estimate of time depends on the standard being implemented, the size and complexity of the organization, the technologies in use, and the physical layout of the site or sites to be audited.
- Scope statement
- Report on the requirements, gap and recommendations for the system.