Q1 Quality Management   ›  Q1.02 Audits and the Audit Process

There are some important differences between this concept of a diagnostic audit and a quality audit. A quality audit is defined (ISO 9000:2000) as:
A systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.

“Audit evidence” is defined as verifiable records, statements of fact or other information relevant to audit criteria. “Audit criteria” is defined as sets of policies, procedures or requirements used as a reference. Procedures are “specified” ways to carry out an activity or process, and may or may not be documented. “Requirements” are needs or expectations that are stated, implied or obligatory.

There are two general types of quality audits, one being 'adequacy' audits which seek to answer the question "does this system comply with the Standard?" and the other being 'compliance' audits which seek to answer the question "is the practice doing what its system says it should be doing?". All quality audits are formal affairs, and must be conducted with objectivity and impartiality.

In contrast, a diagnostic audit can be more informal and relaxed. The purposes are not to test the practice in any way, but to help it to evaluate itself as a first step in embracing the introduction of new systems.

A secondary purpose is to efficiently inform the assessor about the practice, where that assessor will go on to help the practice develop its quality systems.