Page 225 - The Handbook for Quality Management a Complete Guide to Operational Excellence

212 P r o c e s s C o n t r o l Q u a l i t y A u d i t s 213

When this occurs it is common practice to specify the revision of the appli-
cable standard to prevent future changes from automatically becoming
part of the contract.
Willborn (1993) reviews eight of the most popular quality audit standards
and provides a comparative analysis of these standards in the following
areas:
• General features of audit standards
• Auditor (responsibilities, qualifications, independence, performance)
• Auditing organizations (auditing teams, auditing departments/
groups)
• Client and auditee
• Auditing (initiation, planning, implementation)
• Audit reports (drafting, form, content, review, distribution)
• Audit completion (follow-up, record retention)
• Quality assurance

Auditing standards exist to cover virtually every aspect of the audit.
The reader is encouraged to consult these standards, or Willborn’s sum-
maries, to avoid reinventing the wheel.

Types of Quality Audits

There are three basic types of quality audits: systems, products, and pro-
cesses. Systems audits are the broadest in terms of scope. The most com-
monly audited system is the quality system: the set of activities designed to
ensure that the product or service delivered to the end user complies with
all quality requirements. Product audits are performed to confirm that the
system produced the desired result. Process audits are conducted to verify
that the inputs, actions, and outputs of a given process match the require-
ments. All of these terms are formally defined in several audit standards.

Product Audits
Product audits are generally conducted from the customer’s perspective.
ISO 9000:2000 divides products into four generic categories: hardware,
software, processed materials, and services.
The quality system requirements are essentially the same for all prod-
uct categories. ISO 9000 defines four facets of product quality: quality due
to defining the product to meet marketplace requirements, quality due to
design, quality due to conformance with the design, and quality due to
product support. Traditionally, product quality audits were conducted pri-
marily to determine conformance with design. However, modern quality

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