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Mar 23, 2010

an ISO 9001 Quality Management System

ISO 9001 certification will almost certainly enhance an organization's reputation. The ISO 9001 standard requires the implementation of a documented quality management system to facilitate enhanced performance and efficiency.
ISO 9001 certification is intended for any organization regardless of size, type or product including service. According to the ISO 9001 standard there are a number of system requirements which an organization needs to fulfill in order meet customer requirements. Ensuring customer satisfaction through the quality management system is a key aim of the standard. The ISO 9001 standard also includes elements that require monitoring and measurement of processes and continual improvement.

In order to achieve certification an organization should have a documented quality management system and not a system of documents. The three main objectives of the documentation should be for communication of information, evidence of conformity and knowledge sharing. Quality management system documentation may be in any form or type of medium such as paper, electronic or picture. A compliant quality management system will need to address key elements of the standard. There are five sections that outline the requirements of a compliant system, section 4 Quality Management System, section 5 Management Responsibility, section 6 Resource Management, section 7 Product Realisation and section 8 Measurement Analysis.

ISO 9001 section 4 requires that an organization has a documented system with procedures in place to control documents and records. Section 5 requires the quality management system to include a quality policy and for senior management to demonstrate management commitment, allocate responsibility and authority, and conduct management reviews

Section 6 of the standard requires your system to address and review requirements for resources, human resources and training, infrastructure and work environment. Section 7 of the standard defines the requirements for planning, design and development, purchasing, production, control of customer property and monitoring and measurement. Section 8 defines the quality management system requirements for measurement, monitoring and improvement and includes sub-clauses internal audit, control of non-conforming product, corrective action and preventative action, all of which are compulsory procedures as defined by the standard.

ISO 9001:2008 refers specifically to only 6 documented procedures, however, other documentation may be required by an organization in order to manage the processes that are necessary for the effective operation of the QMS. In addition to the minimum document requirements the standard defines twenty one specific requirements for records.

The documentation required in a system to achieve ISO 9001 certification is no longer as onerous as prior to 2000 and the value of ISO 9001 certification for an organisation has never been higher. Certification sends a clear message to all interested parties that an organization is committed to high standards and continual improvement.
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