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Greetings! Welcome to Sustaining Edge Solutions E- Newsletter Our newsletters provide guidance on operational and quality systems ISO 9001, AS9100, ISO/TS 16949, TL 9000, ISO 13485, ISO 14001, and others. This includes process improvement methods Six Sigma, Lean Enterprise, and other topics of interest to our readers. If you have any questions about the articles appearing in this issue, or you want to suggest topics for future issues, please let us know.
The new version has a title change. It’s now: “Managing for the Sustained Success of an Organization-A Quality Management Approach.” The new version is also shorter than its predecessor, ISO 9004:2000 at 44 pages compared to 56. This reduction is in part due to the removal of the ISO 9001 text that appeared at the start of each section. Although ISO 9001 and ISO 9004 are still “a consistent pair” of standards, ISO 9004 no longer has the same clause by clause naming as ISO 9001. This helps to emphasize that it is not a guide to ISO 9001. The contents of ISO 9004 (at the draft stage) are:
The aim of ISO 9004 is to help users of ISO 9001 to obtain long-term benefit from a broader, in-depth, quality management system (QMS) based on their existing QMS. It uses the same quality management principles as ISO 9001. It is not to be used for assessment or certification purposes. This standard will provide valuable guidance for managers on leading their organization towards long term success.and to build on existing quality management systems. ISO 9001 focussed on customers. ISO 9004 extends the focus to include all interested parties including society, suppliers, employees and shareholders.
The objective of auditing the design and development process is to determine whether it is managed and controlled to enable products to meet their intended use and specified requirements. In order for the auditor to determine if the organization is in fact involved in design and development, auditors need to establish who is responsible for defining the characteristics of the product or service together with how and when this is carried out. Auditors should establish what design and development projects have been, and are currently being, undertaken. Auditors should select a sufficient number of projects to be able to audit all stages of the design process. The need for design and development is generated from a number of sources including:
Auditors should evaluate whether organizations have in place, and perform, activities for the review of such needs. How is the decision to proceed with design and development taken, i.e. have risks and cost implications been considered and have all relevant functions (internal or external) been consulted. The following issues should be considered when auditing the Planning Function:
When auditing the design and development inputs, auditors should develop an understanding of how the organization identifies its own inputs based on:
Auditors should evaluate the risks, the possible implications for customer satisfaction and issues that the organization may encounter if some relevant inputs are not considered. The design and development outputs should comply with the identified needs in order to ensure that the resulting product can fulfill its intended use. Outputs can include information relevant to the following:
Auditors should obtain evidence from projects to confirm that information from stage completion is available; process is completed based on stage review; and outputs have been confirmed.
The QuEST Forum has issued Release 5.0 of the TL 9000 Requirements Handbook, the latest edition of the global quality standard used by the telecommunications industry. The R5.0 Handbook has an effective date of November 15, 2009 to ensure adequate time for organizations to complete their training and upgrade to the new release. The new standard can be used after November 15, 2009 and must be used after November 15, 2010. The QuEST Forum publishes the TL 9000 Requirements and Measurements Handbooks as the definitive guides to implementing the TL 9000 quality management system and performance measurements to assess progress and evaluate results of its implementation. Release 5.0 includes clarifications, additional adders, and many new notes. Three specific areas emphasized in the revision are:
The updated handbook also includes the new ISO 9001:2008 text. To see the changes in TL 9000 Requirements Handbook R5.0 versus R4.0, go to TL 9000 Changes PDF. For more information, go to the QuEST Forum Website.
Need to know about ISO and international standardization? The ISO Cafe is a valuable information resource which goes beyond quality, IT, and environmental standards. Examples from many areas of life and work show how ISO standards provide technical, economic and social benefits. Find information on everything from protecting children, climate change, records management, freight containers, and sports. The American Society for Quality (ASQ) is holding its 18th Annual Service Quality Conference on October 5- 6, 2009 in Long Beach, California. The conference theme is Service Quality: Surviving the Economic Storm. Walter Tighe, President of Sustaining Edge Solutions, is a speaker at this conference. The topic of his presentation is “Finding Lost Profits in Your Service Processes”. The American Society for Quality (ASQ) Audit Division is holding its Audit Division Conference on October 15-16, 2009 in Tucson, Arizona. The theme: Audit Revolution, focuses on the auditor’s role in achieving and reporting effective audit results to provide management with accurate data to make informed decisions. Quality News Today: ASQ brings quality related news from around the world.
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Understanding and Implementing ISO9001:2008
Understanding and Implementing AS9100C:2009 Aerospace – NEW
Understanding and Implementing ISO/TS16949:2009 Automotive – NEW
Understanding and Implementing ISO14001:2004 Environmental
The Five Pillars of a Lean Workplace Organization
Understanding and Implementing ISO 13485:2003 Medical Devices
Understanding and Implementing ISO 27001:2005 Information Security
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The latest draft of ISO 9004:2009 has received broad approval and the final draft of this International Standard (FDIS) is due to be released before the end of 2009. |
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