Archive for September, 2009

Major Changes to New ISO 9004:2009 Standard

Thursday, September 10th, 2009

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.

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:

  • Scope
  • Normative references
  • Terms and definitions
  • Managing for the sustained success of an organization
  • Strategy for policy formulation, planning and development
  • Resource management
  • Process management
  • Monitoring, measurement, analysis and review
  • Improvement, innovation, and learning
  • Annex A: Self-assessment tool
  • Annex B: Quality management principles
  • Annex C: Correspondence between ISO 9004-2009, and ISO 9001:2008
  • Bibliography

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.

We will keep you informed when the ISO 9004:2009 is published.

Major Changes to New ISO 9004:2009 Standard

Tuesday, September 1st, 2009
Performance Improvement Solutions for Your Business Needs September 2009
In this issue

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.

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Major Changes to New ISO 9004:2009 Standard
Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet.

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.

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:

  • Scope
  • Normative references
  • Terms and definitions
  • Managing for the sustained success of an organization
  • Strategy for policy formulation, planning and development
  • Resource management
  • Process management
  • Monitoring, measurement, analysis and review
  • Improvement, innovation, and learning
  • Annex A: Self-assessment tool
  • Annex B: Quality management principles
  • Annex C: Correspondence between ISO 9004-2009, and ISO 9001:2008
  • Bibliography

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.

Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet.

 

Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet. Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet. Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet.

Auditing Design and Development
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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:

  • the organization’s strategic planning;
  • market intelligence and research;
  • service reports;
  • customer feedback and demand;
  • new or changed statutory and regulatory requirements;
  • process changes;
  • new technology, and suppliers.

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:

  • what is the overall flow of the design planning process?
  • what resources and competencies are required?
  • who is responsible and are the authorities defined?
  • how are (internal and external) interfaces between various groups identified and managed?
  • are the required verification, validation and review points defined?
  • is the implementation and effectiveness of the plan monitored?
  • is the plan updated and communicated to all relevant functions as necessary?

When auditing the design and development inputs, auditors should develop an understanding of how the organization identifies its own inputs based on:

  • the organization’s products and processes;
  • financial, environmental, health and safety issues;
  • organizational risks and impacts;
  • customer’s requirements and expectations;
  • statutory and regulatory requirements applicable to the product.

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:

  • marketing, sales and purchasing;
  • production and quality assurance;
  • information for service provision and maintenance of the product after delivery.

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.

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Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet. Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet. Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet.

TL9000 Handbook Release
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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:

  • Risk management
  • Supplier management
  • Design for manufacturability

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.

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In the News
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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.

Visit the ISO Cafe.

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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Web-Based Training
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We are now offering Web-Based Training Courses!

Benefits of training include:

  1. Maximize Your Budget – More affordable with no travel.
  2. Minimize Time from the Office – Training is self- paced.
  3. Higher Retention of Content – Increased material understanding.

The courses are offered through our Virtual University. View our current courses and demos including new courses starting in October.

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Training Courses
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            training

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

Phoenix Training – Reduced Pricing!!

  • AS9100C:2009 One-Day Course Sept 17th.
  • AS9100C:2009 Internal Auditor Sept 29-30th.
  • ISO 9001:2008 Internal Auditor October 12- 13th.

Up to $100.00 off each course. Contact us for reduced pricing and registration.

Understanding and Implementing ISO9001:2008

ISO 9001:2008 Process Based Internal Auditor

Documenting Your Quality Management System

Understanding and Implementing AS9100C:2009 Aerospace – NEW

AS9100C Process Based Internal Auditor-NEW

Documenting Your Quality Management System

Understanding and Implementing ISO/TS16949:2009 Automotive – NEW

ISO/TS16949:2009 Process Based Internal Auditor-NEW

Documenting Your Quality Management System

Understanding and Implementing ISO14001:2004 Environmental

ISO14001:2004 Process Based Internal Auditor

The Five Pillars of a Lean Workplace Organization

Continuous Process Improvement

Lean Six Sigma

8 Disciplines (8D) of Problem Solving – NEW

Understanding and Implementing ISO 13485:2003 Medical Devices

ISO 13485 Process Based Internal Auditor

Understanding and Implementing ISO 27001:2005 Information Security

ISO 27001 Process Based Internal Auditor

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Quick Links
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FORWARD TO A FRIEND!