This text is from the second edition of ISO 9001, The Standard Companion. It is based on the now obsolete 1987 version of the ISO 9001 Standard. The third edition, based on the current 1994 standard, is available from Simply Quality.
Have independent auditors verify whether work activities in development, manufacturing, installation and service are being carried out in accordance with the documented quality system. Choose cost effective time intervals for conducting such audits, based on the importance of these activities to the quality of the product.
Document procedures not only for carrying out these audits but also for follow-up action based on results of the audits. A written report is to be made of audit findings, with the manager of the area being audited quickly correcting any problems found.
Rigorous internal audits keep the Quality System alive and prevent it from becoming just another forgotten set of documents. On a planned schedule, trained auditors will read the latest version of the procedures documents that comprise the Quality System, starting with the Quality Manual, to determine if it satisfies the requirements of ISO 9001. They will visit workers selected at random and ask them what work they are doing, what procedures documents they are using to guide their work, whether they have a current copy of the needed procedures document, how they know it is the current issue, whether they have read and can demonstrate understanding of the document, whether they have ready access to the quality records required by or resulting from use of the procedure, and what qualifies them to carry out the particular work they are performing.
The auditor will then read the procedures document and request objective evidence that each step of the process is being carried out in accordance with the procedure. Objective evidence consists of written and properly authorized (i.e., signed) forms, log entries, meeting notes or other quality records that accrue as the procedure is carried out. Noncompliance (discrepancies between the written procedure document and the available objective evidence) will be documented and witnessed on the spot. Each noncompliance will be cited in the audit report. The management of the group being audited is required to respond to (i.e., take corrective and preventive action to solve the identified problem) each noncompliance in a timely manner. The auditor will track the corrective action to its completion.
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