Systematic process improvement using ISO 9001:2000 and CMMI

254 Appraisal/Registration
readiness for a formal audit. The preassessment reviews the quality manual,
procedures, and implementation of those procedures. Gaps in documentation
are noted and the date for the formal audit is determined based on the
severity and magnitude of the detected gaps.
During the documentation review, the assessor reviews the organization’s
quality manual and the procedures required by the standard. Findings are
documented and reported. The documents to be reviewed fall into three
categories: organizational (typically plans), implementation (such as procedures,
work instructions, and process descriptions), and control (such as
measurements, reports, and checklists). Documentation deficiencies have to
be corrected before the organization can be recommended for registration.
If documentation was initially reviewed during the preassessment, the auditor
may choose to review only revised documentation during the assessment
to ensure that recommended changes were implemented correctly. An example
of the review form is shown in Table 8.5.
On the first day of the assessment, the auditor typically presents an
overview of the assessment process. The assessment follows the ISO
19011:2002 standard [8] and, in some instances, additional procedures that
were developed by the registrars themselves. The auditor then conducts indepth
reviews of the organization’s procedures and evaluates their implementation
for conformance with the ISO 9001:2000 standard.
In addition to the documentation review, the assessment will include
interviews and observations to determine the extent of the implementation
of the standard. Interview questions are typically derived from the requirements
of the ISO 9001 standard. If there is more than one auditor, specific
areas of activity may be examined in parallel. Through reviews, interviews,
and observations, the auditors examine objective evidence of process conformance
to the organizational documentation and conformance with the standard.
Most assessors develop tools to facilitate data collection and analysis.
For example, Tables 8.4 and 8.5 can be combined into one spreadsheet that
will indicate the documentation collected, documentation reviewed, the staff
to be interviewed, and the interview responses.
Table 8.5
Example of Typical Assessment Records
Clause Description Typical Evidence Reference Comments
6.2.2 Competency, • Records of course/
awareness, seminar completion
and training • Course attendance lists
• Mentoring/OJT records
• Résumés/waivers