Latest News on ISO 9001:2008

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Performance Improvement Solutions for Your Business Needs July 2008
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  • Latest News on ISO 9001:2008
  • FMEA 4th Edition
  • ISO 38500 for IT Corporate Governance
  • Lean Software Development
  • Safer at Work or Home?
  • Training Courses
  • 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.

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    Latest News on ISO 9001:2008
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    The ISO/DIS 9001:2008 has been approved and the proposed standard is being submitted for voting as a Final Draft International Standard. If the FDIS is approved, the new edition should be published in the October-November 2008 time frame. The proposed ISO 9001:2008 does not introduce any additional requirements beyond the current ISO 9001:2000.

    Although certification is not compulsory, it is estimated that over one million ISO 9001 certificates have been issued to organizations in private and public sectors, in manufacturing and services, and in 170 countries. The new edition, however, will not require any specific reassessment for certification.

    ISO 9001:2008 will be the fourth edition of the standard which was first published in 1987. The third edition, published in 2000, represented a thorough revision, including new requirements and a sharpened customer focus, reflecting developments in quality management and experience gained since the publication of the initial version.

    Compared to the current 2000 edition, ISO 9001:2008 represents fine-tuning. It introduces clarifications to the requirements in ISO 9001:2000, based on user experience over the last eight years, and changes that are intended to improve further compatibility with the ISO 14001:2004 environmental standard.

    To accompany the publication of this new edition, ISO is working on implementation guidance for ISO 9001:2008, a reference table comparing and contrasting ISO 9001:2000 and ISO 9001:2008, and answers to Frequently Asked Questions.

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    FMEA 4th Edition
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    The new Potential Failure Mode and Effect Analysis (FMEA) Reference Manual, Fourth Edition, can improve the management of risks associated with product and process failure modes.

    FMEA is one of the Automotive Quality Core Tools developed by representatives of Chrysler, Ford, and General Motors. Point: FMEA’s are not just for automotive industry gains. This tool has been used sucessfully for process improvement by manufacturing and service industries for decades.

    Methods described in the new reference manual include those applicable to the DFMEA (product design at the system, subsystem, interface and component level) and to the PFMEA (process control at manufacturing and assembly operations).

    Improvements incorporated in the FMEA Reference Manual, Fourth Edition, include:

    • New format for improved readability, including an index, visual cues, and icons to indicate key paragraphs
    • Additional examples and text to provide a clearer explanation of the steps to develop a robust failure mode analysis
    • Reinforcement of the need for management participation in, and support of, the FMEA process
    • Clarification of the linkage between DFMEA and PFMEA, as well as, linkages to the other core tools
    • Improved clarity in definition of the Severity, Occurrence, and Detection ranking tables
    • An introduction to the alternative methods currently being applied in industry
    • Clarifications are provided in the use of RPN, including alternative methodologies

    An emphasis on problem prevention is included to eliminate the sources of failures. This has many advantages:

    • Improved quality, reliability, and safety of a product/process
    • Early identification and elimination of potential failure modes
    • Reduced system development timing and cost
    • Reduced potential for warranty concerns
    • Increased customer satisfaction and competitiveness
    • Reduced need for inspection

    You can order the new FMEA manual at the AIAG website.

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    ISO 38500 for IT Corporate Governance
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    An inadequate information technology (IT) system can hinder the performance and competitiveness of your organization or expose it to the risk of not complying with legislation. The new ISO 38500 standard provides broad guidance on the role of top management in regards to the corporate governance of IT.

    Most organizations use IT as a fundamental business tool and few can function without it. IT is also a significant enabler in the future business plans of many organizations. ISO 38500 will help the governing body to evaluate, direct, and monitor the use of IT.

    ISO 38500:2008, Corporate Governance of Information Technology, is applicable to organizations of all sizes, including public and private companies, government entities, and not-for-profit organizations. This standard provides a framework for effective governance of IT to assist those at the highest level of organizations to understand and fulfill their legal, regulatory, and ethical obligations in their use of IT.

    The framework is comprised of definitions, principles, and a model. It sets out six principles for good corporate governance of IT that express preferred behavior to guide decision making:

    • Responsibility
    • Strategy
    • Acquisition
    • Performance
    • Conformance
    • Human Behavior

    The purpose of the standard is to promote effective, efficient, and acceptable use of IT in all organizations by:

    • assuring stakeholders that, if the standard is followed, they can have confidence in the corporate governance of IT
    • informing and guiding directors in governing the use of IT in their organization
    • providing a basis for objective evaluation of the corporate governance of IT

    This standard is targeted at the Board of an organization, to assist the Board in delivering the maximum value from IT and information assets across the organization

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    Lean Software Development
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    Software development can greatly improve its business performance by discovering and embracing its kinship to classic (non-software) industries. Perhaps the most important thing software has to gain is guidance on how to implement Lean production.

    Lean production has, on average, doubled productivity and tripled quality for the classic industries. According to James M. Sutton with Lockheed Martin Aeronautics, early applications of Lean to software have exceeded those results.

    Software development is an ideal subject for Lean because its product is pure information that lacks the physical limitations of durable goods, as well as, most of the soft issues of service activities. In software development, Lean can remain focused on the primary issues of value and waste. This allows the Lean tools to work with unusual effectiveness.

    One of the biggest challenges for software development approaches has been to keep up with the growth in size and rigor of customer systems. Lean scales up easily for large systems. It works well in plan-ahead life cycles such as the Department of Defense acquisition system. Lean also provides the evidence and assurance needed for safety-critical and high-security applications. These capabilities make it well-suited for the defense and aerospace domains, and for most other domains as well.

    Mr. Sutton says it is time for software to take its place as a classic industry and leverage the strengths of Lean production. Lean enables faster code production, smoother integration with other products, fewer surprises to budget and schedule, better quality, and happier customers. Lean converts software from management’s biggest worry into one of its best means for assuring business success. Embracing Lean ushers software into the fold of classic industry as a welcome and synergistic partner.

    For more information, see Mr. Sutton’s article, Welcoming Software into the Industrial Fold, in the May 2008 issue of CrossTalk, the Journal of Defense Software Engineering.

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    Safer at Work or Home?
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    The idea of on-the-job safety has been incorporated into business policies and culture for decades. And, injuries at work have been lowered substantially. However, companies are now recognizing that a more serious threat exists: off-the-job injuries.

    According to the National Safety Council, for every person killed at work, 11 are killed away from work. And, for every person suffering a disabling injury on the job, two people are similarly injured off the job.

    Off-the-job injuries cause people to miss more than 3 times as many days from work as those suffered on- the-job. The cost of these off-the-job injuries exceeds those at work by $80 billion each year.

    As a result of these statistics, organizations are now talking “Safety 24/7”. They recognize that safety awareness shouldn’t be turned off when an employee leaves for home.

    To read more about off-the-job safety programs, see “Staying Clocked In”, an article written by Kyle Morrison, an associate editor with Safety + Health. For more information on the National Safety Council, which publishes Safety + Health, go to their Web Site at http://www.nsc.org.

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    Training Courses
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    To see the course description, schedule, and on-line registration click on the course title below. Courses are awarded Continuing Education Units.



    Understanding & Implementing ISO9001:2000

    ISO 9001:2000 Process Based Internal Auditor
    Documenting Your Quality Management System

    Understanding & Implementing AS9100B:2004
    AS9100B: 2004 Process Based Internal Auditor
    Documenting Your Quality Management System

    Understanding and Implementing ISO/TS16949:2002
    ISO/TS16949:2002 Process Based Internal Auditor
    Documenting Your Quality Management System

    Understanding and Implementing ISO14001:2004
    ISO14001:2004 Process Based Internal Auditor

    The Five Pillars of a Lean Workplace Organization
    Continuous Process Improvement
    Lean Six Sigma

    All courses can be delivered at your company. Don’t see a course, location, or date that fits your needs?

    Contact Us

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