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Systematic process improvement using ISO 9001:2000 and CMMI

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252 Appraisal/Registration<br />

It is important to note that the SEI does not ‘‘certify’’ appraisal ratings.<br />

Although it keeps a database of all assessments <strong>and</strong> appraisals, it does not<br />

provide information about the scope or results of any organization’s appraisal<br />

to the public. On the other h<strong>and</strong>, an appraised organization is free to use<br />

<strong>and</strong> publicize the appraisal results as it sees fit.<br />

8.2 <strong>ISO</strong> <strong>9001</strong>:<strong>2000</strong> registration <strong>process</strong><br />

In this section we briefly describe the <strong>ISO</strong> assessment flow <strong>and</strong> the objective<br />

evidence needed for an <strong>ISO</strong> certification audit. Because the st<strong>and</strong>ard has<br />

been updated, there are at least two ways to approach an <strong>ISO</strong> <strong>9001</strong>:<strong>2000</strong><br />

audit. One is for organizations that have upgraded their QMS from the 1994<br />

version, <strong>and</strong> another is for those being audited for the first time <strong>using</strong> the<br />

<strong>2000</strong> version. We will concentrate on the later because it will, in general,<br />

encompass the former. The upgrade audit typically concentrates on the<br />

review of the requirements imposed by the <strong>ISO</strong> <strong>9001</strong>:<strong>2000</strong> st<strong>and</strong>ard, evidence<br />

that internal audits <strong>and</strong> management reviews foc<strong>using</strong> on <strong>process</strong><br />

changes have been conducted, <strong>and</strong> personnel training in the new QMS.<br />

Most organizations will perform a preassessment to determine if the QMS<br />

is satisfactory for the formal audit. <strong>ISO</strong> limits performance of the preassessment<br />

to only one instance. The flow of a typical registration <strong>process</strong> is shown<br />

in Figure 8.4.<br />

It is expected that the organization has already selected the registrar <strong>and</strong><br />

has the necessary information about <strong>ISO</strong> audit requirements. During the<br />

preparation phase, the auditor <strong>and</strong> the organization’s representative develop<br />

an audit plan, which identifies the organizational unit to be assessed <strong>and</strong><br />

the scope of the assessment. In addition, the optional preassessment will be<br />

arranged. Note that registrars are not allowed to provide consultation services<br />

because the st<strong>and</strong>ards require that they maintain their independence from<br />

the organizations that they will audit.<br />

During preparation, the auditor will inform the organization about the<br />

documentation they will be required to provide <strong>and</strong> the support that will<br />

be needed during the assessment. The goal of the audit is to review as much<br />

of the organizational documentation <strong>and</strong> its implementation as possible in<br />

the time allotted, typically a week. Although an audit of a large organization<br />

will be different from an audit of a small organization, the <strong>process</strong>es practiced<br />

in those organizations must be reviewed in both cases.<br />

A portion of a typical assessment plan is shown in Table 8.4. The plan<br />

indicates the areas of investigation <strong>and</strong> relates them to the responsible or<br />

cognizant organizational elements. Assessors develop questions at the level

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