Newsletter

Word Meanings Can Affect Interpretation

Feb 12, 2001 in Newsletter | 0 comments

An important part of reading and understanding the standards is being clear on the meaning of some key words. You know the difference between Shall as used in ISO 9001 and Should as used in ISO 9004, but how do you interpret words like Can, May, Appropriate, Applicable, Competence, Necessary, Suitable, Determine, Identify, Evaluate, and Review? Shall is used to indicate a requirement that must be strictly followed to conform to the Standard. For example, clause 6.4 states the organization shall determine and manage the work environment...

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RAB-Approved ISO 9001:2000 Transition Classes

Jan 12, 2001 in Newsletter | 0 comments

Our Auditor Refresher for ISO 9001:2000 was one of the first courses approved by the RAB for the required transition training for certified auditors and lead auditors. However, the course is also valuable for trained internal auditors wanting to understand the new ISO 9001:2000 requirements and recognize how their audit methods may be affected. Our course is also accepted by the IRCA for its transition training. See last month’s newsletter to read the outstanding comments received from students that attended our first two classes....

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Emphasis on Communications in ISO 9001:2000

Jan 12, 2001 in Newsletter | 0 comments

When you are implementing or auditing the new ISO 9001:2000 requirements, it is important to look across the clauses for related activities. For example, top management must communicate its commitment, the quality policy, responsibilities and authorities, as well as, establish an internal communications process regarding the effectiveness of the quality management system. The infrastructure must provide communications services, plus arrangements must be made for communicating with customers. Communications is also referenced in design planning...

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Requirements in ISO 9001:2000 for Planning

Jan 12, 2001 in Newsletter | 0 comments

Some of you have asked about the expanded requirements for planning defined in the new ISO 9001:2000 standard. The key clauses related to planning are: 5.4 for quality objectives and the quality management system 7.1 for product realization 8.1 for monitoring, measurement, analysis, and improvement Resource planning is addressed at the system-level in clause 5.4 (through its reference to clause 4.1) and covered at the product-level in clause 7.1. 5.4 Planning Clause 5.4.1 covers the planning necessary to establish measurable quality...

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Changes in the Standards from the FDIS Versions

Jan 12, 2001 in Newsletter | 0 comments

The key changes from the FDIS to the IS versions of the ISO 9000:2000 family of standards are described below. Links to more complete lists of the changes are at the end of each section. ISO 9000:2000 Three terms were removed from the ISO 9000 definitions: audit scope, auditor qualifications, and qualified auditor. A definition for competence was added to the Standard. These changes caused nine terms in section 3.9 to be renumbered, as well as, the references to them in other definitions. The text of some definitions were slightly modified:...

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Release of the ISO 9000:2000 Family of Standards

Jan 12, 2001 in Newsletter | 0 comments

The year 2000 revisions of the ISO 9000 series of quality management standards were officially released by the International Organization for Standardization on December 15, 2000. In order to ensure the simultaneous availability of the ISO 9000:2000 series in as many countries as possible, electronic versions of the standards were placed on a secure server accessible to approximately 90 (out of 137) of the ISO national member institutes which are connected to Internet. Paper copies were sent by courier to all members on December 14. The...

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ISO 9000 Standards to be Published on December 15, 2000

Dec 12, 2000 in Newsletter | 0 comments

The revised ISO 9000, ISO 9001, and ISO 9004 standards have been overwhelmingly approved by ISO’s membership of national standards institutes. The International Organization for Standardization (ISO) has announced it will publish the year 2000 revisions of its ISO 9000 series of quality management standards on December 15, 2000. Compared to the Final Draft International Standard (FDIS) versions, only minor “editorial” modifications to improve clarity have been made to the texts which will be published as International Standards...

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Schedule of RAB-Approved ISO 9001:2000 Transition Classes

Dec 12, 2000 in Newsletter | 0 comments

Our Auditor Refresher for ISO 9001:2000 was one of the first courses approved by the RAB for the required transition training for certified auditors and lead auditors. However, the course is also valuable for trained internal auditors wanting to understand the new ISO 9001:2000 requirements and recognize how their audit methods may be affected. Our first public class was held in Atlanta, Georgia on November 20-21. We had limited the class to 25 students and they all said they would recommend the course to others. In fact, the overall course...

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Key Changes in the ISO 9001:2000 Standard

Dec 12, 2000 in Newsletter | 0 comments

Most ISO 9001:1994 requirements are included in the ISO 9001:2000 standard. Some of the key changes in the new standard are: New process-oriented structure and a more logical sequence of contents Continual improvement process to enhance the quality management system Increased emphasis on the role of top management Consideration of legal and regulatory requirements Establishment of measurable objectives at relevant functions and levels Application concept (clause 1.2) to cope with a wide spectrum of organizations and activities Monitoring of...

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Online Magazines are a Quality Resource

Dec 12, 2000 in Newsletter | 0 comments

View these Quality Digest articles by clicking on their titles: Ensuring a Successful Simulation Modeling Project ISO 14001 Brings Change and Delivers Profits QS-9000 Drives Automotive Supplier Development Patient Safety, Six Sigma and ISO 9000 Quality Management 2000 Flowcharting & Process Simulation Software Buyers Guide  See these recent Quality magazine articles: Howmet Inspects Critical Parts in a Nondestructive Way Unlikely Initiative Tackles NDT Standards Software Helps You Mind Your APQPs Fix Your Grinding Problems Put Cells...

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Information Documents are Available for ISO 9001:2000

Dec 12, 2000 in Newsletter | 0 comments

You now have free electronic access to supplementary materials for ISO 9001:2000. Due to the dynamic nature of this information, these documents are subject to updating on a continuous basis. Descriptions and links to the documents are provided below: Frequently Asked Questions (FAQ’s): This is a comprehensive database of frequently asked questions and answers, designed to provide a concise and informative mechanism to assist users in understanding all aspects of the Year 2000 revisions. The questions address product introduction and...

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Word Count Shows the Emphasis of ISO 9001:2000

Dec 11, 2000 in Newsletter | 0 comments

ISO 9001:2000 has placed more emphasis on customers, customer satisfaction, planning, quality objectives, and improvement. This increased focus can be demonstrated by counting its use of these words compared to the ISO 9001:1994 standard: The word Customer is now used 48 times instead of 18 times Customer Satisfaction appears 8 times compared to only once The words Plan, Planned, or Planning occur 32 times versus 20 times Quality Objective can be found 11 times instead of only twice Improve or Improvement are included 21 times...

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RAB-Approved ISO 9001:2000 Transition Class in November

Nov 12, 2000 in Newsletter | 0 comments

You still have time to register for our Auditor Refresher class to be taught November 20-21 in Atlanta. The course has been approved by the RAB for the required ISO 9001:2000 transition training for certified auditors and lead auditors.

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Third Committee Draft for ISO 19011 Auditing Guidelines

Nov 12, 2000 in Newsletter | 0 comments

The Joint Working Group on Quality and Environmental Auditing has agreed to circulate its revisions to the second Committee Draft of ISO 19011 as a third Committee Draft (CD3). The three-month period of comment and balloting on CD3 is expected to complete in January 2001. This unanticipated review cycle will delay the Draft International Standard version of the Guidelines on Quality and Environmental Management Systems Auditing until the April 2001 timeframe. However, the Working Group felt it was important to present the significant changes...

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ISO 9000 Guidelines for the Health Sector

Nov 12, 2000 in Newsletter | 0 comments

An ISO workshop to develop guidelines for implementing ISO 9000 quality management systems in the health care sector will be held in January 2001. The Standards Council of Canada (SCC) is the ISO member hosting the workshop. The workshop is being held to develop health care sector-specific guidelines based on ISO 9004:2000, Quality management systems – Guidelines for performance improvements, and publishing them as the first Industry Technical Agreement. An ITA is an alternative to full-fledged International Standards when swift development...

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Differences between FDIS and DIS versions of ISO 9001:2000

Nov 12, 2000 in Newsletter | 0 comments

Numerous changes were introduced in the ISO/FDIS 9001:2000 standard. A sampling of the differences are listed below. Introduction Added a NOTE that the Plan-Do-Check-Act (PDCA) methodology can be applied to all processes. Also added Risk Management to the list of management system requirements not included in ISO 9001. Scope Changed title of clause 1.2 from “Permissible Exclusions” to “Application”. Also clarified that wherever the term “product” occurs, it can also mean “service” Quality...

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ISO 9001:2000 Planned for Publication in December

Nov 12, 2000 in Newsletter | 0 comments

The Year 2000 revisions of the ISO 9000 quality management standards moved to the final development stage with their publication on September 14, 2000 as Final Draft International Standards (FDIS) by ISO (International Organization for Standardization). The revised standards were distributed to the national standards institutes that make up ISO’s worldwide membership for a two-month ballot, closing on November 14, 2000. If at least 75 % of the member votes are cast in favor, the documents will be published as full-fledged International...

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FDIS Changes to ISO 9001:2000 Requirements

Oct 12, 2000 in Newsletter | 0 comments

The FDIS version of ISO 9001:2000 is expected to have some clause numbering changes, as well as, numerous text revisions. For example, quality plan (5.5.5), document control (5.5.6), and record control (5.5.7) of the Management Responsibility section of the DIS version will be moved to Documentation Requirements in 4.2.2, 4.2.3, and 4.2.4, respectively. The old 5.5 Administration section will become Responsibility, Authority, and Communication. Another numbering change is the movement of process validation from 7.5.5 in the DIS to 7.5.2 in the...

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QS-9000 Plans for ISO 9001:2000

Oct 12, 2000 in Newsletter | 0 comments

The QS-9000 Task Force (consisting of representatives from Ford, DaimlerChrysler, and General Motors) has stated they have no plans at present to adapt or upgrade QS-9000:1998 for the new ISO 9001:2000 standard. However, the alternative document, ISO/TS 16949, will be updated by late first quarter or early second quarter 2001 (based on the expected November release this year of ISO 9001:2000).  ISO/TS 16949 is a Technical Specification for worldwide automotive requirements and an alternative to QS-9000. Since QS-9000 is based on ISO...

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Are Quality Violations Becoming Common Practice?

Oct 12, 2000 in Newsletter | 0 comments

The 2000 Organizational Integrity Study published by KPMG reports that quality violations in industry may have become a routine occurrence. An analysis of the survey responses found:  76% had observed a violation of company standards 37% in manufacturing reported shipping low quality or unsafe products  50% said the witnessed misconduct was due to inadequate training  Many of the suggestions for fixing these problems are already addressed by ISO 9001 and its year 2000 edition:  50% said a stronger management commitment is...

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New Focus on Customer Satisfaction

Oct 12, 2000 in Newsletter | 0 comments

The ISO 9001:2000 standard includes a new requirement to monitor information on customer satisfaction as a key performance measurement for your quality management system. The standard requires that you determine the method for obtaining and using this information.  Your organization should define the process for requesting, measuring, and monitoring customer feedback on a continual basis. It should address conformance to requirements, meeting customer needs and expectations, as well as, price and product delivery.  Examples of sources of...

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ISO 17799 for Information Security Management

Oct 12, 2000 in Newsletter | 0 comments

British Standard BS 7799 is the basis for the new ISO/DIS 17799 standard for information security management. Key concerns for the standard will be the confidentiality, integrity, availability, and accountability of all kinds of sensitive information.  The new standard is being developed to make sure organizations have the most appropriate controls and systems in place to manage the storage and exchange of information, whether it is in paper or electronic form. Registration to the standard is expected to demonstrate the effectiveness of your...

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Auditor Refresher for RAB Certified Auditors

Oct 12, 2000 in Newsletter | 0 comments

In our last newsletter, we noted that the Registrar Accreditation Board (RAB) will require that certified auditors receive transitional training on the new ISO 9001:2000 standard to maintain their certification.   Our new Auditor Refresher course has been submitted to the RAB for pre-approval as transition training for ISO 9001:2000. The first class will be offered in Atlanta on November 20-21, 2000.   See our previous newsletter for more information on the RAB requirements. For more information, see the planned ISO 9001:2000...

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Update on FDIS Changes to ISO 9001:2000

Oct 12, 2000 in Newsletter | 0 comments

The FDIS version of ISO 9001:2000 has changed some clause numbering, as well as, added or revised numerous requirements.  Clause Numbering Quality plan (5.5.5), document control (5.5.6), and record control (5.5.7) of the Management Responsibility section of the DIS version are now under Documentation Requirements in 4.2.2, 4.2.3, and 4.2.4, respectively. The 5.5 Administration section has become Responsibility, Authority, and Communication.  Another numbering change is the movement of process validation from 7.5.5 in the DIS to 7.5.2 in the...

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ISO 9001/2/3 Registrations in USA Continue to Grow

Sep 12, 2000 in Newsletter | 0 comments

Mid-2000 registrations to ISO 9001/2/3 are up 19% in the USA the past year to a total of more than 32,000 certificates. Registrations to QS-9000 (automotive sector) are up 15% in the USA to more than 5000 certificates, while AS9000 registrations (aerospace sector) are up almost 50% to nearly 200 certificates. The worldwide total of ISO 9001/2/3 certificates issued last year was 343,643. This was a 26.4% increase over the previous year. For more information,...

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Healthcare Guidelines Proposed as First ITA Document

Sep 12, 2000 in Newsletter | 0 comments

The Industry Technical Agreement (ITA) is a new way for ISO to quickly issue documents through open workshops involving the interested parties. The first proposal for an ITA deliverable is a draft 70-page document named “Quality Management Systems – Guidelines for Process Improvements in Healthcare Organizations”. The ASQ Healthcare Division and the Automotive Industry Action Group (AIAG) jointly developed the proposed guidance to help healthcare organizations prevent errors, reduce variation, and continuously improve. The...

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Proposal to Simplify Lab Accreditation

Sep 12, 2000 in Newsletter | 0 comments

The National Institute of Standards and Technology (NIST) and the National Cooperation for Laboratory Accreditation (NACLA) have proposed a partnership for a broadly recognized lab accreditation system. According to NIST, the United States has about 50,000 testing labs and over 100 lab accreditation programs. Multiple accreditation audits may be required for a testing lab to satisfy government and industry programs. The goal is to simplify the process for complying with domestic and foreign requirements. You can see the memorandum of...

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TL 9000 Metrics Provide Benchmark Data

Sep 12, 2000 in Newsletter | 0 comments

TL 9000 is a telecommunication sector derivative of the ISO 9001 standard. It was developed by the Quality Excellence for Suppliers of Telecommunications (QuEST) Forum. QuEST was founded to foster continued improvements to the quality and reliability of the telecommunications service. TL 9000 Quality System Requirements – Book 1 (Release 2.5) establishes a common set of requirements for suppliers of hardware, software, and services. The requirements are built upon ISO 9001. TL 9000 Quality System Metrics – Book 2 (Release 2.5)...

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ISO 9001:2000 Training for RAB Certified Auditors

Sep 12, 2000 in Newsletter | 0 comments

The Registrar Accreditation Board (RAB) has announced that certified auditors must take transitional training on the new ISO 9000:2000 standards to maintain their certification. You will have 24 months to complete the training after ISO 9001:2000 is issued (which is expected to be November or December of this year). You must complete the training before conducting audits to the new standard if you want to use those audits for maintaining your certification. You may continue to use ISO 9001:1994 audits to maintain your certification for up to 3...

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Reduction in Requirements for QMS Auditor

Sep 12, 2000 in Newsletter | 0 comments

The Quality Management System (QMS) auditor certification program administered by the Registrar Accreditation Board (RAB) has been revised in three key areas: Work Experience The work experience requirement for applicants with a secondary school diploma or equivalent has been reduced from a minimum of 10 years to a minimum of 8 years. Auditor Experience The witnessed audit option for the QMS Auditor grade has been eliminated and your education level is no longer used to determine the required audit experience. All candidates must now perform a...

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FDIS Changes to ISO 9000:2000 Fundamentals and Vocabulary

Sep 12, 2000 in Newsletter | 0 comments

The ISO 9000 Fundamentals and Vocabulary standard is considered a “normative” reference  to ISO 9001:2000 and can be considered an extension to the Requirements standard. Definitions changed in the final draft version of  ISO 9000:2000 are expected to be: Work Environment (DIS): a set of conditions under which a person operates. Since this definition did not consider processes that operate without the direct involvement of a person, it will be changed to: (FDIS): a set of conditions under which work is...

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FDIS Changes to ISO 9001:2000 Requirements

Sep 11, 2000 in Newsletter | 0 comments

The FDIS version of ISO 9001:2000 is expected to have some clause numbering changes, as well as, numerous text revisions. For example, quality plan (5.5.5), document control (5.5.6), and record control (5.5.7) of the Management Responsibility section of the DIS version will be moved to Documentation Requirements in 4.2.2, 4.2.3, and 4.2.4, respectively. The old 5.5 Administration section will become Responsibility, Authority, and Communication. Another numbering change is the movement of process validation from 7.5.5 in the DIS to 7.5.2 in the...

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New American Standards Proposed for Quality Auditing

Aug 12, 2000 in Newsletter | 0 comments

The ASQ Quality Audit Division has voted to start development of two new national standards for quality auditing. One standard will focus on process and product audits. The other standard will cover audits that evaluate the effectiveness and suitability of the audited requirements (referred to as management or performance audits). Although progress is being made to develop a combined international standard for auditing quality and environmental management systems, it is viewed by QAD as only addressing compliance auditing at the system...

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Will ISO 9001:2000 Change Your Quality Policy?

Aug 12, 2000 in Newsletter | 0 comments

Clause 5.3 on Quality Policy in ISO/DIS 9001:2000 states that top management must ensure the policy: Is appropriate for the organization Includes a commitment to: meeting requirements continual improvement Provides a framework for: establishing quality objectives reviewing quality objectives Is communicated and understood Is reviewed for continuing suitability Does you current policy statement include a commitment to meeting requirements and continual improvement? The new standard will also require use of the quality policy as a...

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Guidance on Permissible Exclusions for ISO 9001:2000

Aug 12, 2000 in Newsletter | 0 comments

The current ISO 9001, ISO 9002, and ISO 9003 standards are being replaced by the single ISO 9001:2000 standard. As a result, some of its requirements may not be applicable to all organizations. Clause 1.2 of ISO 9001:2000 defines the conditions under which an organization can exclude certain requirements that are not relevant to their quality management system. Requirements may only be excluded if they do not affect an organization’s ability, or absolve it from its responsibility, to provide product that meets customer and applicable...

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ISO 9000 Revisions Move to Final Draft (FDIS) Status

Aug 12, 2000 in Newsletter | 0 comments

More than 300 delegates from 46 countries participated in the ISO Technical Committee 176 working sessions during July in Kyoto, Japan. The Year 2000 revisions of the ISO 9000 standards received a positive vote and were elevated to the final draft stage. Only one member voted against elevating ISO 9001 (Japan) and only one member cast a negative vote for ISO 9004 (France). All of the US concerns on the standards were resolved to the satisfaction of the US TAG delegation. TC 176 Chairman, Dr. Pierre Caillibot, stated: “The new ISO 9000...

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Aerospace Standard to be Aligned with ISO 9001:2000

Jul 12, 2000 in Newsletter | 0 comments

The International Aerospace Quality Group (IAQG) has agreed to align the current AS 9100 industry specific requirements with the new ISO 9001:2000 standard. An internal team of IASG members is expected to complete the revisions this summer. The existing AS 9100 standard, based on ISO 9001:1994, will be retained until November 2003.

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ISO/TS 16949: Adopt Now or Wait for the Revision?

Jul 12, 2000 in Newsletter | 0 comments

The International Automotive Task Force (IATF) announced late last year a common registration scheme for ISO/TS 16949, the new worldwide automotive standard. The Big Three (Daimler-Chrysler, Ford, and General Motors) currently consider registration to ISO/TS 16949 as an alternative to QS-9000. The IATF is moving ahead to align ISO/TS 16949 with the new ISO 9001:2000 standard. According to a Ford spokesperson, an updated document is expected by the end of next year. It appears that ISO/TS 16949 may become the sole quality standard in the...

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Occupational Health and Safety Management Standard

Jul 12, 2000 in Newsletter | 0 comments

The proposal from British Standards Institution to create an ISO committee for an Occupational Health and Safety Management standard failed to receive the necessary two-thirds majority vote. North America, China, and most of the European Union members voted against the BSI proposal. However, OHS activity is continuing on other fronts. The International Labor Organization (ILO) is working on a document that companies and governments could use for guidance. The American National Standards Institute (ANSI) has accepted the American Industrial...

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The 6-R’s for Evaluating Your Training Effectiveness

Jul 12, 2000 in Newsletter | 0 comments

Organizations will be required by clause 6.2.2.d of the new ISO 9001:2000 standard to evaluate the effectiveness of their training. You may want to consider using these 6-R’s: Reaction: What was the reaction of the participants? This measure is an assessment of the student satisfaction as expressed on an evaluation form at the end of the training session. Retention: What learning has taken place? This measure can be determined through a pre-test and post-test to indicate how much information has been retained by the students. It can show...

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Project Management Using the Guidelines in ISO 10006

Jul 12, 2000 in Newsletter | 0 comments

Project Management Using the Guidelines in ISO 10006 Use of the ISO 10006 Guidelines to Quality in Project Management can help you complete projects on time, under budget, within specifications, and to the satisfaction of the customer. The section on Concept Development states customer needs for products and processes should be translated into documented requirements and agreed upon by the customer. In other words, define the project charter. Stakeholder Identification emphasizes the importance of identifying very early the various players...

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Process for Continual Improvement

Jun 12, 2000 in Newsletter | 0 comments

Continual improvement should be a key strategy for every organization. Improvement actions enhance the features and characteristics of products, as well as, increase the efficiency and effectiveness of the processes that produce and deliver the products. There are two fundamental approaches for improving performance: breakthrough projects and small-step improvements. Breakthrough projects typically lead to major revisions of existing processes or the implementation of new processes. Cross-functional teams usually carry out these...

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ISO 9004 Self-Assessment Guidelines

Jun 12, 2000 in Newsletter | 0 comments

The new ISO/DIS 9004:2000 Guidelines document includes an appendix that can be used to assess your quality management system. This self-assessment methodology is intended to provide a simple, easy-to-use approach to determine the relative degree of maturity of your system and to identify areas for improvement. Each major clause of ISO 9004 is evaluated for the quality management system and a score assigned from 1 (no formal system) to 5 (best-in-class performance). Guidance is given in the form of typical questions that should be asked during...

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New ISO 19011 Standard for Auditors

Jun 12, 2000 in Newsletter | 0 comments

The certification criteria for evaluating quality management system auditors are based on the current ISO 10011 auditing guidelines. As reported in an earlier newsletter, that document and the similar guidelines for environmental management systems (ISO 14010, 14011, and 14012) will be replaced with a new ISO 19011 standard. The second committee draft of ISO 19011 has been released for review and comment. The draft international standard (DIS) is planned for October of this year, the final draft (FDIS) for March, 2001, and the official ISO...

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Transition Training for ISO 9001:2000

Jun 12, 2000 in Newsletter | 0 comments

Since the ISO 9000:2000 series of standards differ significantly from the current 1994 family, auditors must be trained on the new requirements. In addition, auditors will need to understand the process-based approach necessary for effective auditing against the new standard. It is expected that the RAB and IRCA will require mandatory training on the new standard as part of their Continuing Professional Development requirement for auditor recertification. Early reports indicate the RAB will require at least 7 hours of ISO 9001:2000 training...

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Software Engineering Body of Knowledge

May 12, 2000 in Newsletter | 0 comments

The IEEE Computer Society and the ACM have been actively promoting software engineering as a profession and a legitimate engineering discipline. The Joint ACM-IEEE Computer Society Software Engineering Coordinating Committee authorized the preparation of a Guide to the Software Engineering Body of Knowledge. The purpose of the Guide is to characterize the contents of the software engineering discipline, to promote a consistent view of software engineering worldwide, to clarify the place of, and set the boundary of, software engineering with...

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Baldrige Stock Index Outperforms S&P 500

May 12, 2000 in Newsletter | 0 comments

The Baldrige Index is a fictitious stock fund made up of publicly traded companies that have received the Malcolm Baldrige National Quality Award. Last year it outperformed the Standard and Poor’s 500 by a factor of 4.8 to 1. Quality improvement is a great business strategy! Information on the Baldrige National Quality Program is available at: http://www.quality.nist.gov

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Positive Vote on the Draft ISO 9000 Family of Standards

May 12, 2000 in Newsletter | 0 comments

A May 18, 2000 press release from the International Organization for Standardization states the national standards institutes have returned a positive vote on the Draft International Standard (DIS) versions of the ISO 9000 revisions currently being developed. The documents – ISO 9000, ISO 9001, and ISO 9004 – will now undergo further revision before their release as Final Draft International Standards (FDIS) in September 2000 for a two-month ballot. If that vote is positive, the ISO 9000 revisions will be published as full...

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What is Quality?

May 12, 2000 in Newsletter | 0 comments

The dictionary defines quality as a degree of excellence. Other interpretations for quality include: fitness for purpose value for money conformance to requirements This may explain why some say quality is in the eye of the beholder. They may not be able to define it, but will know it when they see it. Others try to be more precise and say quality is actually conformance to requirements. A measure of quality may also be how well a product exceeds expectations and pleases the customer. Of course, many customers are also concerned with price,...

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QS-9000 Quality Survey Report Issued by AIAG

Apr 12, 2000 in Newsletter | 0 comments

With the release of the fourth annual Quality Survey Report from the Automotive Industry Action Group (AIAG), the automotive industry continues to demonstrate the significant value of implementing QS-9000 and other quality initiatives. “From the results of the survey, we were encouraged to find that in the first year of QS-9000 certification, savings averaged more than six percent for our respondents,” said Larry Higgason, chairman of AIAG’s Annual Quality Survey. “And if you base that figure on average company sales of...

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New Requirements Coming in ISO 9001:2000

Apr 12, 2000 in Newsletter | 0 comments

In addition to being restructured into a process model format, the draft ISO 9001:2000 standard introduces some new requirements (at new clause numbers): 5. Management Responsibility: – More emphasis on top management commitment – An expanded focus on customer satisfaction – Extension of measurable objectives to lower levels – More staff awareness of customer requirements – New requirement on internal communications – Expanded process description in quality manual – Specific inputs and outputs for...

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Writing Effective Quality System Documentation

Apr 12, 2000 in Newsletter | 0 comments

You must follow a good writing process to prepare an effective document. This process starts before the document is written and continues after it is completed. The process also involves more than just the writer. The basic steps in a good writing process are to: Plan: What is being written? Why are we writing it? Investigate: Collect information and generate ideas. Organize: Group your thoughts into a document outline. Write: Create a draft of the document in the agreed format. Review: Ask users to look at the draft document. Test: Use the...

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New Health and Safety Standard?

Mar 12, 2000 in Newsletter | 0 comments

The British Standards Institution (BSI) has submitted a proposal for the creation of a new ISO technical committee on occupational health and safety management standards. BSI already has a health and safety standard (BS 8800). ISO is circulating the BSI proposal for voting and is having discussions with the International Labor organization regarding the possible new standards.

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Plans for the ISO 9000 Family of Standards

Mar 12, 2000 in Newsletter | 0 comments

The current ISO 8402 and ISO 9000-1 standards will be withdrawn when the ISO 9000:2000 Fundamentals and Vocabulary standard is published in 4Q/2000. The ISO 9002 and ISO 9003 standards will be withdrawn when the new ISO 9001 Requirements standard is published in 4Q/2000. The ISO 9004-2, ISO 9004-3, ISO 9004-4, and ISO 10005 standards will be withdrawn when the new ISO 9004 Guidelines standard is published in 4Q/2000. The ISO 9000-3 and ISO 9000-4 standards may be transferred to from TC 176 to another committee for ownership. The ISO 10011, ISO...

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ISO Guide 25 Replaced by ISO 17025

Mar 12, 2000 in Newsletter | 0 comments

ISO 17025, “General Requirements for the Competence of Testing and Calibration Laboratories,” has been approved as a replacement for ISO Guide 25. The American Association for Laboratory Accreditation (A2LA) plans to begin assessing to ISO 17025 this July. After a phase-in period of two years, ISO Guide 25 will be withdrawn. The new document defines requirements to be met for laboratories to be recognized as competent to carry out tests and calibrations. Six new requirements are included, along with a number of significant changes to...

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Internal Auditor Certification Program

Mar 12, 2000 in Newsletter | 0 comments

The Registrar Accreditation Board (RAB) offers an internal auditor certification package from their web site at http://www.rabnet.com You can review the certification requirements and download an application file for submission. Candidates are evaluated in five basic categories: education, training, work experience, audit experience, and personal attributes. We offer an ANSI-RAB NAP accredited auditing course that satisfies the training requirement. You can become a certified internal auditor with as few as eight audits covering at least 12...

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Implementing Quality Management Systems

Mar 12, 2000 in Newsletter | 0 comments

The ISO 9000 standards help organizations of all types and sizes implement and operate effective quality management systems. According to the draft ISO 9000:2000 Fundamentals and Vocabulary, a “quality management system” is a set of interacting elements to establish a quality policy and quality objectives and to achieve those objectives. To implement a quality management system: – Determine the needs and expectations of customers – Establish your quality policy and quality objectives – Define the necessary processes and...

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New Auditing Guidelines Document

Feb 12, 2000 in Newsletter | 0 comments

The ISO 10011 auditing standard for quality management (ISO 9000) is being combined with the ISO 14011 auditing standard for environmental management (ISO 14000). The first committee draft of the new standard has been issued as ISO 19011. ISO 19011 is expected to be finalized late in 2001 and offer improved descriptions of: the typical audit process, audit program management, and qualifications of auditors.

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ISO 9001:2000 Transition Planning

Feb 12, 2000 in Newsletter | 0 comments

Representatives of TC 176, CASCO, IAF, and IATCA have agreed on consistent guidance for the implementation of ISO 9001:2000. The key elements of the cooperative agreement are: 1) Registration certificates may not be issued against the new standard until the final International Standard is published (expected in 4Q-2000). 2) Registrars may perform audits to the latest draft of ISO 9001:2000 prior to the publication of the International Standard (the DIS is available now; the FDIS is expected in 3Q-2000). 3) Certificates issued to ISO...

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New Standard for Lean Operations

Feb 12, 2000 in Newsletter | 0 comments

The Society of Automotive Engineers has issued an official standard for lean operation. The document, “Identification and Measurement of Best Practice in Implementation of Lean Operation” is called SAE J4000. The standard can be used as a yardstick for defining “lean” and measuring the lean status of your manufacturing operation. It also provides a method for comparing your operation with the most successful lean operation systems. Lean operations can save significant time and cost by eliminating waste in the value...

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Tax Deduction for ISO 9000 Costs

Feb 12, 2000 in Newsletter | 0 comments

The Internal Revenue Service has issued a ruling that allows businesses a tax deduction for the costs of implementing and maintaining ISO 9000 registration. Several organizations had petitioned the IRS to permit firms to deduct ISO 9000-related costs in a single year instead of spreading the expenses over several years. The IRS ruling stated, “Although ISO 9000 is voluntary, it increasingly is a contractual requirement for doing business with many organizations, both public and private, worldwide.” A prior unofficial IRS position...

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