Quality Management System Requirements The ISO 9001:2008 standard is meant to be generic and applicable to all kinds of organizations. Therefore, organizations from both the public and private sectors, including non-governmental organizations can benefit from the ISO 9001quality management system model, regardless of whether they are small, medium or large organizations. The immediate benefit that can be realized from the implementation of ISO 9001 is the collective alignment of the activities of internal processes that are focused towards the enhancement of customer satisfaction which will result in many other benefits, whether internal or external. The magnitude of these benefits are determined by how effective the processes are in achieving its objectives.
Document Review In ISO 9000 Standards The ISO 9000 Standard requires that documents be reviewed. Previously the implication was that the review was a check by potential users that the document was fit for purpose before it was offered for approval. It could be construed that for a document to receive approval it must be checked and therefore review and approval in this context are one and the same and the requirement is in this instance enhanced rather than relaxed. A review is another look at something. Therefore document review is a task that is carried out at any time following the issue of a document. This requirement responds to the Continual Improvement principle. Reviews may be necessary when: - Taking remedial action (i.e. Correcting an error) - Taking corrective action (i.e. Preventing an error recurring) - Taking preventive action (i.e. Preventing the occurrence of an error) - Taking maintenance action (i.e. Keeping information current) - Validating a document for use (i.e. When selecting documents for use in connection with a project, product, contract or other application) - Taking improvement action (i.e. Making beneficial change to the information)
Reviews may be random or periodic. Random reviews are reactive and arise from an error or a change that is either planned or unplanned. Periodic reviews are proactive and could be scheduled once each year to review the policies, processes, products, procedures, specification etc. for continued suitability. In this way obsolete documents are culled from the system. However, if the system is being properly maintained there should be no outdated information available in the user domain. Whenever a new process or a modified process in installed the redundant elements including documentation and equipment should be disposed of.
