“a systematic, independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.”

In other words, an audit is a planned, organized, and documented set of activities performed by impartial and objective auditors. The audit process collects evidence from an area to evaluate conformity to the applicable requirements. Audit evidence is factual, not based on opinion or hearsay.

The sources of audit evidence are:

• Statements (noted during audit interviews)
• Observations (made watching the activities)
• Documents (reviewed before and during the audit)
• Records (examined to evaluate past conformity)

The primary audit criteria are:

• Standard (e.g., ISO 9001:2000)
• Company (organization’s requirements)
• Customer (as expressed in contracts and orders)
• Legal (from statutes and regulations)

The definition of a Process is a set of interrelated or interacting activities which transforms inputs into outputs. The inputs of a process are the outputs from other processes.

The standard promotes the adoption of the process approach to develop, implement, and improve. An effective process based auditor should “Identify the Relationship to the Standard.” How does the process intersect with the standard requirements? Next, you need to “Learn the Process.” Before you can audit a process you must become familiar with it. You need to learn how it is supposed to work, what it supposed to do, what are the inputs, outputs, activities, resources, measures, and controls.

A “Document Review” requires reading and understanding the associated documentation for the process you are auditing. Another important step is to develop auditing questions based on the standard’s requirements and the “Process Interfaces.” The interfaces are the process handoffs. In essence we are not looking at does the requirements exist, but are they clearly defined and understood by the process using them.

The ultimate goal of auditing a process based management system is to ensure the system is effective, improves the business, and satisfies the standard requirements.

A structured methodology for moving your audit results from boring to brilliant can be learned.

The data mining period, which extended from January 2006 until August 2006, garnered about 340 comments and change recommendations to 9100.

Some of the items that were challenged were the aerospace requirements in subclauses 4.2.2 and 8.2.2. In subclause 4.2.2, “Quality manual,” users were having a difficult time understanding the intent behind the requirement to show the relationship between the standard’s requirements and documented procedures; in some cases this caused unnecessary, nonvalue-added work. In subclause 8.2.2, “Internal audit,” the aerospace requirement to measure the effectiveness of selected audit tools generally wasn’t understood, and even when it was, the cost often exceeded the benefit. In either case, auditability of this requirement is an issue. Both of these topics, as well as the other valid challenges to existing requirements, will be reviewed to determine if the requirements can be clarified, revised in scope or deleted.

Other items to be clarified include statistical sampling in subclause 8.2.4 (What’s statistically valid? What’s the statistical validity of this requirement as written?), and first-article inspection (FAI) in subclause 8.2.4.2. (Is it necessary to perform FAI or only have a process for it? What’s a “part,” and does it include assemblies?) Clarifications were also requested in other sections of the standard–in particular, subclauses 7.3, “Design and development”; 7.4, “Purchasing”; and 7.5, “Production and service provision.” These requests are understandable, given the high number of aerospace requirements in these subclauses.

As announced at the November 2006 meeting of ISO/TC 176 in Busan, Korea, the amended ISO 9001:2000 standard is scheduled to be released in May 2009. The IAQG 9100 Team is working to release the 9100 revision as soon as possible after the release of the ISO 9001 standard.