Difference between a gap analysis and a pre-assessment in relation to an activity that takes place prior to the full compliance audit

The primary difference between a gap analysis and a pre-assessment is that a gap analysis applies to management systems such as ISO 9001:2008, ISO TS29001 or others. A gap analysis is typically the initial step in the QMS certification process. It is used to identify areas within a quality management system that do not meet defined requirements for certification. This can include processes, persons or product. The results of the gap analysis are based upon objective evidence, such as records reviewed, interviews conducted and observations made, to evaluate an Auditee's conformance with requirements.

A pre-assessment is usually the initial phase of the accreditation process. A pre-assessment, or a practice assessment, is conducted prior to a conformity assessment to identify areas that must be improved or corrected before accreditation can be obtained. Unlike a compliance audit where the Auditor verifies conformance based upon objective evidence as mentioned earlier, an Assessor is also focused on assessing an organization's competencies and performance of required tasks, such as measurement of uncertainty (MU), metrological traceability and proficiency testing (PT) as defined by ISO 17025:2005 and referred to by some as the "big three".

A commonality shared by a gap analysis and a pre-assessment is that they both identify nonconformities or gaps between what exists and what is required by the standard or other defined criteria.

As you are aware, "gap analysis" and "pre-assessment" are not interchangeable terms. A gap analysis is associated with QMS certification or registration as issued by a Registrar and pre-assessment or practice assessment is associated with an activity performed prior to conducting a conformance assessment for accreditation. ISO 9000:2005 and ISO 17000:2004 provide vocabulary and terms for ISO 9001:2008 and ISO 17025:2005 quality management systems, respectively. Additional vocabulary and terms, as applicable to ISO 17025:2005, are provided in ISO/IEC Guide 99:2007, International Vocabulary of Metrology.

Bill Aston, Managing Director
Aston Technical Consulting Services, LLC
Kingwood, TX 77339
Website: www.astontechconsult.com