Auditing a Process Based System

摘要

An important component of the Product Support Initiative (PSI) supporting ISO 9001:2000 is its IDEAS (information, discussion, examples, analysis and sources) Q&As, which provide help for organizations during implementation. Thus far the PSI has responded to 12 questions in the pages of the Informed Outlook, a monthly newsletter co-published by Inform and ASQ. One of the questions dealt with auditing a process based system: Clause 0.2, process approach, notes ISO 9001:2000 "promotes the adoption of a process approach when improving the effectiveness of a quality management system (QMS). For an organization to function effectively, it has to identify and manage numerous linked activities." Subclause 8.2.2, internal audit, requires the organization to conduct internal audits to determine whether the QMS is effectively implemented and maintained―which brings up some interesting issues. In the past, many organizations planned internal audits with scopes determined by the element or clause. ISO 9001:2000 has many linkages throughout the various requirements, which may now require an auditor to take a process approach to determine effective implementation.