ISO 9000 Quality Management Systems
Program Evaluation and Audit
Verl ‘Andy’ Anders1, Merle Pochop2, Chad M. Laux3
1Industrial Specialist, Center for Industrial Research and Service, Iowa State University, Ames, IA
2Field Specialist, Extension Outreach, Center for Industrial Research and Service, Iowa State University, Ames, IA
3Graduate Research Assistant, Industrial Technology Program, Department of Agricultural and Biosystems Engineering, Iowa State University, Ames, IA
EVALUATION BACKGROUND
An organization’s quality management system is an allencompassing collection of processes to fulfill a) the
customer’s quality requirements b) applicable regulatory
requirements, c) aims to enhance customer satisfaction
and d) achieve continual improvement of its performance
in pursuit of the objectives stated above (ISO, 2005). This
evaluation, or audit, will be performed to compare the
quality management system of a light manufacturing
facility, located in Iowa, to the International Standard
Organization (ISO) Quality Management Systems-Requirements: ISO 9001: 2000. ISO 9000 series of
standards are among the most widely known standards
ever and are implemented by 634,000 organizations in
152 countries (ISO, 2005).
CIRAS
The Center for Industrial Research and Service (CIRAS) is the
industrial extension arm of Iowa State University. The CIRAS
mission - to enhance the performance of Iowa industry - is an
integral part of the history of Iowa State and ISU Extension Service
(CIRAS, 2005).
The client of this evaluation audit is a customer of our
Iowa manufacturing facility. The client has mandated all
of its suppliers become ISO 9000 certified, or compliant,
by the end of 2005. The client gave the supplier
permission to have CIRAS conduct a ‘compliance’ audit of
the supplier’s quality management system.
The evaluation team consists of 3 people from CIRAS and
the Industrial Technology program in the Agricultural and
Biosystems Engineering Department.
OVERALL EVALUATION QUESTIONS
Questions that guide the ISU evaluation team include:
1. How does the supplier’s quality management system
meet the requirements of ISO 9001: 2000 standard?
2.What portions of the quality management system do not
meet the standard?
3.How can the supplier become ‘compliant’ with the ISO
standard based on the evaluation audit results?
GANTT Chart of ISU QMS Evaluation Audit
REPORT PLAN
The evaluation report contains a written report consisting
of: a) summary of findings and recommendation and b)
description of ‘major’ and ‘minor’ findings. Major findings
result in an evaluation audit failure and must be corrected
before compliance can be issued. Minor findings do not
result in evaluation failure but also require correction. If no
majors and/or a set number of minors findings are found,
compliance with ISO 9000: 2000 will be recommended for
customer approval.
CLIENT AND STAKEHOLDERS
The sponsor is our Iowa manufacturing facility, now
known as the ‘supplier’. The supplier is paying Iowa State
University’s CIRAS (Center for Industrial Research and
Service) program to provide the evaluation audit.
TIMELINE
PRELIMINARY RESULTS
CONCEPTUAL APPROACH
The mode of evaluation is a mixed approach using Provus’s
Discrepancy Evaluation Model (DEM), Eisner’s Expertise Model,
and Stake’s Countenance Framework. The purpose of using DEM
is to determine whether a discrepancy exists between the
performance of the supplier’s quality management system and the
standard (ISO 9001: 2000). The expertise approach is used
because the evaluation judgments are also based on evaluator
knowledge and expertise. Finally, the Countenance Framework is
used to interpret the data whereby the QMS performance will be
described and also judged based on the application of the ISO
standard.
DESIGN AND DATA COLLECTION
PROCEDURES
The data design is a descriptive study utilizing such measures
such as: a) observation of company processes, b) study of
existing company documents and records, and c) interviews of
various evaluation audit participants. The data is collected during
2 site visits by the ISU evaluation audit team to the facility.
Analysis is done through interpretation of the qualitative data
utilizing the above mentioned Countenance Framework whereby
inputs, processes, and outcomes will be described to look for
congruence between intents (the supplier documentation of what
company performance should be) and the actual performance.
Document Review Summary
Sample Section
RELEVANT STANDARDS
Formal Agreements – CIRAS has an obligation to treat all
company materials confidentially during evaluation audit
Program Documentation – For a fair and complete
assessment, the documentation in the audit is critical to
assessing the program accurately to the ISO standard.
Context Analysis – For the audit to have credibility with the
customer, the evaluation will be done impartially.
Evaluator Credibility – The supplier relies on the expertise
and experience of the CIRAS team for a cost effective audit.
REFERENCES
CIRAS. (2005). The history of CIRAS. Retrieved May 23, 2005, from http://www.ciras.iastate.edu/history.asp
ISO. (2005). ISO 9000 for busy managers. Retrieved May 23, 2005, from http://www.iso.org/iso/en/iso900014000/understand/basics/basics9000/basics9000_1.html