2002 Newsletter Articles

State Tax Credits for ISO 9000 Training

Dec 12, 2002 in Newsletter | 0 comments

Is your organization using state funding for your ISO 9000 training? Some states, like Georgia, provide a retraining tax credit to foster the profitability and competitiveness of its industry by encouraging workforce development. In Georgia, up to $500 per retraining program per employee is eligible for the state income tax credit. Eligible costs include instructor fees, materials, equipment, and employee wages. Check with your state to see if a similar credit is available to offset your ISO 9000 training costs. A quick Internet search using...

Read More

ROI for Software Improvement

Dec 12, 2002 in Newsletter | 0 comments

Return on Investment (ROI) is used to quantify the financial return of an investment. In more technical terms, ROI is the value developed by comparing program costs to benefits, measuring the magnitude of benefits relative to costs, the net benefit after expending some level of resources, or profit computed by dividing net income by assets used. A basic model to estimate ROI for software process improvement (SPI) methods, as well as, a complete process to apply these simple equations, are described in an online article by David Rico at:...

Read More

Most Significant ISO 9001:2000 Findings

Dec 12, 2002 in Newsletter | 0 comments

The US TAG to ISO/Technical Committee 176 implemented a Product Support Initiative (PSI) as a means of seeking input on the new standards. The specific goals of PSI are to help enhance the value of the ISO 9000:2000 family, help organizations conform to ISO 9001:2000, and provide inputs on their implementation experiences. The online PSI survey of these quality management systems indicates that internal and external audits are most frequently identifying these findings: Most Frequently Identified Nonconformities  Respondents 1....

Read More

Easy Reading is Damned Hard Writing

Dec 12, 2002 in Newsletter | 0 comments

Easy reading is damned hard writing. Nathaniel Hawthorne, writer (1804-1864) To prepare an effective document, you must follow a good writing process. The process starts before the document is written and continues after it is completed. The process also involves more than just the writer.   1. Plan: What is being written? Why are we writing it?   2. Investigate: Collect information and generate ideas.   3. Organize: Group your thoughts into a document outline.   4. Write: Create a draft of the document in the agreed format.   5. Review:...

Read More

Toughest ISO 9001:2000 Requirements

Dec 12, 2002 in Newsletter | 0 comments

As I teach, consult, and audit, I find that some organizations have a difficult time understanding a few of the new ISO 9001:2000 requirements. They either don’t know how to interpret a requirement, or they don’t know the practices to implement for a conforming system. The toughest new ISO 9001:2000 requirements seem to be:    4.1 General Requirements (and 0.2 Process Approach)    5.1 Management Commitment 5.4.1 Quality Objectives 5.4.2 Quality Management System Planning (vs. 7.1 Planning of Product Realization 6.2.2 Competence,...

Read More

Business Conduct Guidelines

Dec 12, 2002 in Newsletter | 0 comments

The Ethics Officer Association (EOA) is a professional association for managers of ethics, compliance, and business conduct programs. It was founded in 1992 by a dozen ethics officers and today has over 800 members, including ethics officers from more than half of the Fortune 100. In addition, EOA membership includes non-profits, municipalities, and other organizations, including: the American Cancer Society, the Australia Department of Defense, the City of New York, the New York Stock Exchange, and the Securities Industry Association. The EOA...

Read More

ISO 9001 for Small Businesses

Nov 12, 2002 in Newsletter | 0 comments

ISO 9001 for Small Businesses is now available on ANSI’s Electronic Standards Store (ESS). This newly revised handbook, designed for small to medium-sized organizations, offers advice on implementing ISO 9000 quality standards. This updated version of ISO 9001 for Small Businesses, offers advice based upon ISO 9001:2000,  which replaced ISO 9001:1994, ISO 9002:1994, and ISO 9003:1994. The new standard defines the requirements for a quality management system based on “the process model” and is aimed at achieving customer...

Read More

Engineering Statistics Handbook (Free)

Nov 12, 2002 in Newsletter | 0 comments

The National Institute of Standards and Technology (NIST) and SEMATECH have introduced a new e-Handbook for Engineering Statistics. The goal of the free handbook is to help scientists and engineers incorporate statistical methods in their work as efficiently as possible. You can use your browser to navigate the handbook at: <http://www.itl.nist.gov/div898/handbook>. The eight chapters of the handbook cover: 1. EXPLORE – Exploratory Data Analysis       1.Introduction       2.Assumptions       3.Techniques      ...

Read More

Corrective, Preventive, or Continual Improvement?

Nov 12, 2002 in Newsletter | 0 comments

I find that some organizations are having trouble distinctly identifying the three types of improvement in clause 8.5: corrective, preventive, and continual. Fixing an actual, detected problem in such a way as to prevent its “recurrence” is corrective action. When you anticipate a potential problem (based on risk planning or trend analysis) and take action to prevent its “occurrence”, that is preventive action. Some people think that by correcting a known problem so it is prevented from happening again, they have taken...

Read More

Ten Tips for Choosing a Training Provider

Nov 12, 2002 in Newsletter | 0 comments

Successful companies have well trained and competent employees. They know how to perform their jobs efficiently and effectively. However, employees may not have the necessary knowledge and skills for new assignments. I wrote a “Practical Guide for Choosing a Training Provider” for BSI-CEEM. You can see the full article at <http://www.ceem.com/guides.asp>. Part of the article is summarized below: Based on training needs and your evaluation of training methods, you may decide to acquire the training solution from outside your...

Read More

ISO 19011:2002 Now Available

Nov 12, 2002 in Newsletter | 0 comments

ISO 19011:2002, the combined auditing standard for quality and environmental management systems, has been published. It replaces six older standards in the ISO 9000 (quality) and ISO 14000 (environment) families. Using ISO 19011 will give organizations a more integrated and balanced view of their operations, making it an outstanding tool for improving business excellence. It is also intended to help organizations optimize their management systems and ease the integration of quality and environmental management. Combined audits of both systems...

Read More

Baldrige, Six Sigma, and ISO 9001

Nov 12, 2002 in Newsletter | 0 comments

The National Institute of Standards and Technology (NIST) has published a free, two-page issue sheet, “Baldrige, Six Sigma, and ISO: Understanding Your Options.” It provides insight on how to choose among these three performance improvement tools and how they can be used together to ensure the overall success of any organization. The CEO issue sheet: explains the differences among the three systems discusses how they can be used individually, or in combination, to meet organizational needs In addition, it describes how four...

Read More

RAB Decision on Transition Training

Oct 12, 2002 in Newsletter | 0 comments

The RAB Auditor Certification Board announced last week their decision on the deadline for ISO 9001:2000 transition training. 1. The deadline for auditors to submit evidence of completion of transition training remains December 15, 2002.  Those that do not have evidence of acceptable transition training on file by that time will lose their certification. 2. The deadline for RAB approval of transition training providers has been extended until December 15, 2003.  Any RAB approved transition training provider may continue to claim RAB approval...

Read More

What is FSIX and FS 9000?

Oct 12, 2002 in Newsletter | 0 comments

FSIX stands for the Financial Standards International Xchange. FSIX is a non-profit association of financial industry service providers and organizations that provide support to the financial services industry. FSIX provides guidance to the financial services (FS) industry in standardizing and improving financial processes. The FSIX mission is to provide a non-competitive forum for firms within the FS industry to share information about best practices for improving the key processes affecting their customers. In other words, FSIX will provide...

Read More

What are “Actions” other than Training?

Oct 12, 2002 in Newsletter | 0 comments

The training process begins with an analysis of the competence needs for current and planned activities. The next step is to determine the competence level of the personnel assigned to, or already performing, these activities. You are now ready to identify any gaps that exist between the required competence and available resources. This information is used to define possible training solutions. Clause 6.2.2 (b) of ISO 9001:2000 refers to providing training, or taking other actions, to satisfy the competence needs. However, what are these...

Read More

Software Supplements Planned for AS9100

Oct 12, 2002 in Newsletter | 0 comments

The America’s Aerospace Quality Group (AAQG) is working on software supplements for the AS9100 aerospace standard. One supplement will be for “delivered” software and the other supplement for “nondelivered” software. The reason for this special attention being given to software is that: Software is too often ignored in ISO 9001 audits Software environments and methods are so different AS9100 may be inconsistently applied for software Suppliers would receive recognition for their software capability through a...

Read More

New Brochure on EMS and ISO 14000

Oct 12, 2002 in Newsletter | 0 comments

A new (free) brochure on Environmental Management is available as a PDF document at the ISO web site: http://www.iso.org/iso/en/prods-services/otherpubs/pdf/iso14000environmentalmanagement.pdf The brochure has sections on: ISO and the Environment Benefits of the ISO 14000 Family of International Standards The Future of the ISO 14000 Family – At Look at the Issues Business Benefits of ISO 14001 The ISO 14000 Family of Standards, Guides, and Technical Reports Application of the IS0 14000 Family Products and Sources of Information on ISO...

Read More

ISO Standard for Corporate Social Responsibility

Oct 12, 2002 in Newsletter | 0 comments

The ISO Committee for consumer policy (COPOLCO) has recommended establishing a multi-stakeholder strategic advisory group to explore the issue of whether or not the organization should launch the development of standards for Corporate Social Responsibility (CSR). About 170 representatives from business, industry, and consumer organizations, as well as, standards bodies around the world, met during the summer to examine the feasibility and needs for ISO to develop internationally accepted parameters and to recommend the type of document that...

Read More

ISO Guidelines for Education Sector

Oct 12, 2002 in Newsletter | 0 comments

Guidelines for implementing ISO 9000 quality management systems within organizations providing educational services will be developed at a workshop in Mexico in October 2002. While ISO 9000 users already include educational establishments, the guidelines will help this sector implement the new ISO 9001:2000 standard. The guidelines are to address all levels and types of education, including: elementary, medium, and higher education; special and adult education; and distance and e-learning. ISO will publish the guidelines as its second...

Read More

Top Ten Registrars in the United States

Sep 12, 2002 in Newsletter | 0 comments

According to the Quality System Update Registrar Index, the top ten ISO 9000 registrars in the United States are (based on numbers of certificates):   1 BSI 3714   2 QMI 3121   3 UL 2866   4 BVQI 2431   5 PJR 2411   6 DNV 2307   7 LRQA 2018   8 Intertek 1755   9 NQA 1729 10 NSF ISR 1590 These ten registrars have issued almost two-thirds of all the current ISO 9000 certificates in the United...

Read More

DaimlerChrysler Sets July 1, 2004 Deadline

Sep 12, 2002 in Newsletter | 0 comments

DaimlerChrysler has announced a July 1, 2004 deadline for its suppliers to achieve ISO/TS 16949 registration. The letter issued to its suppliers stated:  In October of 1999, we communicated to you our acceptance of quality registration to either VDA 6.1 or QS-9000. You were also informed that registration to ISO/TS 16949, including company specifics, would be acceptable as quality registration. An added note was that this new Technical Specification may become the Quality Management standard of the future. DaimlerChrysler is a global...

Read More

ISO 9000 and ISO 14000 at Record Levels

Sep 12, 2002 in Newsletter | 0 comments

Record increases took place last year in the number of registration certificates issued to organizations for ISO 9000 quality management systems and ISO 14000 environmental management systems. This record setting development was revealed in the 11th cycle of The ISO Survey of ISO 9000 and ISO 14000 Certificates. The annual survey by the International Organization for Standardization (ISO) provides a snapshot of the worldwide impact of ISO’s best-known standards. ISO 9000: By the end of December 2001, at least 510,616 ISO 9000...

Read More

Chrysler, Ford, and GM on ISO/TS 16949:2002

Sep 12, 2002 in Newsletter | 0 comments

DaimlerChrysler, Ford, and General Motors sent a joint letter to their automotive suppliers in August, 2002 regarding the recognition of ISO /TS 16949:2002 and the expiration of QS-9000:1998. They reminded their suppliers that the agreement between QS-9000 and ISO to include ISO 9001:1994 in QS-9000:1998 expires on December 14, 2006. Beyond that date, ISO/TS 16949:2002 will replace QS-9000. Suppliers currently registered to QS-9000 were strongly urged to upgrade their sites to ISO/TS 16949:2002 at the expiration of their current QS-9000...

Read More

Single or Multiple ISO 9001 Certificates

Sep 12, 2002 in Newsletter | 0 comments

Due to timing differences or process variations, some organizations have accumulated separate registration certificates across their sites. While that might have been the best solution at the time, these organizations should consider merging the registrations into a single scope of registration and certificate. If an organization qualifies, the benefits of a single, multi-site certificate are: Single audit of shared services Sampling plan for remote sites Reduced audit visits and costs More uniform system over time Of course, the remote...

Read More

More Auditor Days for ISO/TS 16949:2002

Aug 12, 2002 in Newsletter | 0 comments

Moving from QS-9000:1998 to ISO/TS 16949:2002 may involve more than conforming to new and changed requirements. Your organization may be subject to additional on-site auditor days under ISO/TS 16949:2002. Audit Days The number of on-site auditor days for the initial audit, and the first two years of surveillance visits, have not changed from QS-9000:1998 to ISO 16949:2002. However, most organizations will require more days in Year 3 for the ISO/TS 16949:2002 re-certification audit. Number of Employees Initial Audit On-site...

Read More

Fitness-for-Use a Liability Exposure?

Aug 12, 2002 in Newsletter | 0 comments

If your organization is not responsible for design, then it can exclude ISO 9001:2000 clause 7.3 from its system. Of course, this exclusion must be identified and justified in the quality manual. If your customer is fully design-responsible, then your organization’s role in product development will be very limited, or even non-existent. So, if you’ve excluded clause 7.3, how will your organization ensure product fitness-for-use as required by clause 7.2.1.b? Clause 7.2.1.b states an organization must determine any requirements not...

Read More

Southeastern Quality Conference

Aug 12, 2002 in Newsletter | 0 comments

The theme for the 22nd Annual Southeastern Quality Conference is “Quality Through Technology”. The conference will be held at the Cobb Galleria Centre on October 21-22, 2002 in Atlanta, Georgia. The Southeastern Quality Conference is sponsored by the Greater Atlanta Section of the American Society for Quality, Lockheed Martin Aeronautics, the Institute of Industrial Engineers, and the Programs in Quality Assurance and Industrial Engineering at Southern Polytechnic State University. You can select from 30 speakers in multiple tracks...

Read More

New QS-9000 Sanctioned Interpretations

Aug 12, 2002 in Newsletter | 0 comments

The International Automotive Sector Group (IASG) issued new QS-9000 Sanctioned Interpretations on May 28, 2002 that became effective on July 1, 2002. A new interpretation was added on Requirements and another regarding Registration. Entry C10 was added on Ford Motor Company specific requirements. Unless waived in writing by Ford for a supplier site, third party registration to QS-9000 or ISO/TS 16949 is required to meet the “capable quality management system” element of Q1 2002. In the past, Q1 did not require registration. Q1...

Read More

EPA Promotes Use of ISO 14001

Aug 12, 2002 in Newsletter | 0 comments

The Environmental Protection Agency (EPA) has issued a Position Statement on Environmental Management Systems (EMS). The statement promotes broader use of the systems, which are described as effective management tools to help companies and other organizations fulfill their environmental responsibilities. The use of an EMS complements needed regulatory controls and enables a facility to comprehensively manage the environmental footprint of its entire operation. This includes unregulated aspects such as energy, water use, climate change, odor,...

Read More

Word Power for Quality Documents

Aug 12, 2002 in Newsletter | 0 comments

Are you using the full power of Microsoft Word in your quality documentation activities? I find many students in my Quality System Documentation classes are unaware of one or more of the following Word functions: 1. Review Comments If you have been asked to review a draft document, don’t return your comments in an email note. There is a much easier way to provide your comments to the author. Use the Comment feature of Word to annotate the electronic copy of the document. Select the text for your comment and click on Comment in the...

Read More

New AS9100 Auditor Certification

Jul 12, 2002 in Newsletter | 0 comments

The Registrar Accreditation Board (RAB) has introduced a new certification program for aerospace auditors. The AS9100 auditor certification was developed in cooperation with the Registrar Management Committee of the Americas Aerospace Quality Group (AAOG). Two certifications will be available for aerospace auditors, depending on experience levels. AS9100 Auditor (AA) candidates must provide evidence they have completed an approved QMS lead auditor course and approved training on the AS9100 standard. Applicants for Aerospace Experienced Auditor...

Read More

Measurement Systems Analysis

Jul 12, 2002 in Newsletter | 0 comments

The 3rd edition of the Measurement Systems Analysis reference manual is available from the Automotive Industry Action Group (AIAG). The guidelines document has been rewritten and is nearly double in size. The first chapter provides General Measurement Systems Guidelines and has sections on terminology, measurements, effects of variability, measurement strategy and planning, gage source selection process, measurement issues, uncertainty, and problem analysis. The chapter on General Concepts for Assessing Measurement Systems covers selecting and...

Read More

Language Barriers in an Audit

Jul 12, 2002 in Newsletter | 0 comments

How do you audit a system when some of the employees can only communicate in a language other than your own? And what if they can’t read the available work instructions? According to the ANSI-RAB National Accreditation Program Criteria, the audit team must be able to communicate effectively, both in writing and orally, in the required languages. The ISO 19011:2002 auditing guidelines say to consider the languages to be used during the audit, as well as, social and cultural aspects, when establishing an audit team. The guidance also says...

Read More

New ISO/TS 16949:2002

Jul 12, 2002 in Newsletter | 0 comments

To be eligible for certification as an ISO/TS 16949:2002 auditor, candidates must be sponsored by an IATF contracted registrar. The auditor qualification criteria include: 1. ISO 9001:2000 Qualification Qualified per rules of the relevant accreditation body Competency in ISO quality standards and audit management Competency in interview techniques and team techniques 2. Automotive Industry Specific Skills Automotive core tools knowledge and competence 3. Minimum Work Experience ISO 9001:2000 Audit Experience At least three ISO 9001:2000...

Read More

Code of Conduct for Internal Auditors

Jul 12, 2002 in Newsletter | 0 comments

I created this proposed Code of Conduct for internal auditors using the Code of Ethics from the Institute of Internal Auditors and the Code of Conduct for internal auditors certified by the Registrar Accreditation Board. Audit program managers could ask their internal auditors to sign this code of conduct each year to emphasize the importance of adhering to the principles and ethics of the organization. Purpose To communicate the integrity, objectivity, confidentiality, and competence expected of internal auditors, as well as, to provide a...

Read More

Improve Quality or Reduce Payroll?

Jul 12, 2002 in Newsletter | 0 comments

Tough economic times may require hard decisions by management for the survival of the organization. Too often, the first solution seems to be cutting costs by reducing the payroll. Business results can be very sensitive to minor improvements in performance. For example, the Institute of Directors (IoD) reported in Business Excellence that a 1% boost in efficiency has a typical profit improvement of 1.9%, the same as for a 1% payroll reduction. However, quality programs that reduce costs or waste by 1% typically have a 7.9% increase in...

Read More

ISO 17799 for Information Security Management

Jun 20, 2002 in Newsletter | 0 comments

  Organizations of all sizes and from all sectors have a common problem – the inherent vulnerability of their information systems. If your information is not safe, your future is not secure.   No matter how well protected an organization may seem, sensitive data can be lost or leaked without you realizing it. Information security is not just an issue for computer experts. A single breach of security could severely reduce profits and damage your image and reputation.   All information in all departments, whether in computer...

Read More

QS-9000 Certificates Expire in 2006

Jun 20, 2002 in Newsletter | 0 comments

The QS-9000 Task Force and the International Automotive Task Force have announced that adherence to ISO/TS 16949:2002 will become a requirement after December 15, 2006 for all suppliers subject to QS-9000. Special permission has been granted for QS-9000 to continue using ISO 9001:1994 until that date. However, earlier dates may be established by the original equipment manufacturers, for example, BMW has set December 15, 2003 for its suppliers to have ISO/TS 16949:2002 registration. Also, suppliers that are required by their non-automotive...

Read More

Lean Directions e-Newsletter

Jun 20, 2002 in Newsletter | 0 comments

The Society of Manufacturing Engineers (SME) has introduced a free e-Newsletter called Lean Directions. Each monthly issue offers five highly focused articles for a quick and easy way to stay up-to-date with one of today’s hottest topics — Lean Manufacturing. You can subscribe to Lean Directions at SME e-Newsletters. You can also subscribe to their free 6-Sigma e-Newsletter.

Read More

Conformity, Conformance, or Compliance?

Jun 20, 2002 in Newsletter | 0 comments

Do you say conformity or compliance?  Is it okay to use conformance instead of conformity?  Does it matter? The ISO 9000:2000 Fundamentals and Vocabulary standard defines conformity as the fulfillment of a requirement. A note says conformance is synonymous, but deprecated (meaning use of that term is considered obsolete). ISO 9000 definesnonconformity as the non-fulfillment of a requirement. It doesn’t define compliance. Although QS-9000 doesn’t define conformity, it does define nonconformity as a...

Read More

Sharing Information on ISO 9000 Complaints

Jun 20, 2002 in Newsletter | 0 comments

ISO (International Organization for Standardization) and the IAF (International Accreditation Forum) have announced they will begin sharing information on complaints received about ISO 9000 certification and the actions taken regarding the complaints. Pooling information on complaints will help protect the image and integrity of conformity assessment. The groups said in their efforts to protect the customers and users from unethical or inappropriate practices, they had identified three kinds of problems: 1. Malpractice (unethical and dishonest...

Read More

Benjamin Franklin and ISO 9001:2000

Jun 20, 2002 in Newsletter | 0 comments

Benjamin Franklin said, “Tell me and I forget. Teach me and I remember. Involve me and I learn.” According to ISO 9001:2000 clause 6.2.2, an organization must: determine competency needs provide the necessary training evaluate training effectiveness An organization must also ensure its personnel are aware of: the relevance and importance of their activities how they contribute to achieving quality objectives These requirements go beyond just training. Evaluating training and ensuring people are aware of their roles and...

Read More

Information Needed About ISO 9001:2000

Jun 10, 2002 in Newsletter | 0 comments

A recent Inside Quality survey by Quality Digest identified six key areas where companies making the transition to ISO 9001:2000 would like more information. The survey respondents should look at the back issues of our e-newsletter for guidance: 1. ISO 9001:2000 and customer satisfaction (See our December 2001 article on customer satisfaction) 2. ISO 9001:2000 and management participation (See our October 2001 article on ways to show management commitment) 3. Auditing to ISO 9001:2000 (See our October 2001 article on ten tips for auditing to...

Read More

ISO 9001:2000 and Quality Management Principles

May 20, 2002 in Newsletter | 0 comments

Clause 0.1 – Introduction to ISO 9001:2000 says the eight quality management principles stated in ISO 9000:2000 and ISO 9004:2000 were considered in the development of ISO 9001:2000. According to ISO 9000:2000, these principles can be used by management to lead an organization towards improved performance. Now the big question: Will the registrar assess the degree to which your organization has applied these principles? In a fashion, yes – because the quality management principles were used to develop the requirements of ISO...

Read More

Revised Guidance for Accreditation of Registrars

May 20, 2002 in Newsletter | 0 comments

The International Accreditation Forum (IAF) has published Issue 2 of their guidance document on the application of ISO Guide 62. The guidance will be adopted by the accreditation bodies by July 1, 2002 and become part of their general rules of operation. ISO Guide 62 specifies the criteria for registrars that operate assessment and registration of quality management systems. The IAF guidance is used by the accreditation bodies to ensure consistent accreditation of registrars. Annex 2 provides guidance to registrars on the amount of time...

Read More

Documents Available for ISO/TS 16949:2002

May 20, 2002 in Newsletter | 0 comments

You can order a copy of ISO/TS 16949:2002 by calling the Automotive Industry Action Group (AIAG) at 248-358-3003 and asking for publication code TS-2. The price of the document is $25 for AIAG members and $75 for non-AIAG members. Supporting documents will include: ISO/TS 16949:2002 Guidance Supplement (TS-GS): Provides guidance and clarifications for application of ISO /TS 16949:2002.  QSA Checklist to ISO/TS 16949:2002 (TS-QSA2): Similar to the QS-9000 checklist. Registrar auditors must cover all the...

Read More

New Edition of ISO/TS 16949:2002 Published

May 20, 2002 in Newsletter | 0 comments

A new edition of ISO/TS 16949 has been published for international automotive suppliers. An ISO press release stated that the technical specification is expected to become the common and unique basis for the automotive industry’s quality management system requirements worldwide, gradually replacing the multiple national specifications now used by the sector (e.g., QS-9000, AVSQ, VDA6.1, and EAQF). The official title is: ISO/TS 16949:2002, Quality management systems – Particular requirements for the application of ISO 9001:2000 for...

Read More

Feedback from Early Movers to ISO 9001:2000

May 20, 2002 in Newsletter | 0 comments

A March 2002 article in Quality System Update (and the April 2002 issue of Quality Progress) described survey results for organizations that have completed registration to ISO 9001:2000. One quarter of the respondents said they needed an extra audit day from their registrar to complete the registration. Another quarter reported it took them two extra audit days. Three or more additional days were needed by one fifth of the surveyed organizations. About one third said they completed the transition process without requiring any extra audit...

Read More

Transition Deadline for ISO 9001:2000

May 20, 2002 in Newsletter | 0 comments

Only 1 in 20 organizations registered to a 1994 version of ISO 9001, ISO 9002, or ISO 9003 have completed the move to ISO 9001:2000. The International Accreditation Forum (IAF) has issued a statement warning organizations that time is running out. Since 1994 certificates expire at midnight on December 14, 2003, only about half of the original 3 year transition period is remaining. The IAF consists of many of the world’s best known accreditation bodies, including the National Accreditation Program in the United States. Their statement...

Read More

Writing Nonconformity Reports

Apr 20, 2002 in Newsletter | 0 comments

Many nonconformity reports are poorly written. Follow these 6 C’s for improved statements: Complete (contains all the related facts) what -objective evidence why – the requirement where –  which work area when – the date and shift who – by title, if relevant Correct (accurately conveys all the facts) Concise (fully explained in brief terms) Clear (understood for prompt action) Categorized (severity listed, if applicable) Confirmable (traceable and verifiable) An audit is only successful if it is the...

Read More

Taking Notes in an Audit

Apr 20, 2002 in Newsletter | 0 comments

Our August, 2001 newsletter contained an article about preparing an audit checklist. One use of a checklist is as a repository for your notes. You need to be very precise when reporting the audit results. These details come from the notes you record during the audit. Explain to the person being interviewed that you will be taking notes to further your understanding of the process. Otherwise, the person may see you record something and assume you found a nonconformity. People may become reluctant to talk if they see you taking a lot of notes...

Read More

Questioning Techniques in an Audit

Apr 20, 2002 in Newsletter | 0 comments

When you conduct interviews during an audit, you are trying to determine if the: 1. Defined system meets the requirements – an assessment of process definitions and documents  2. Organization has implemented the declared system – do they practice what they preach  3. Quality system has been effectively implemented – do the results show the objectives were met Since interviews are critical for gathering evidence, we need to be careful how we ask our questions. Plan your questions in advance by preparing a checklist for an...

Read More

Interview Steps in an Audit

Apr 20, 2002 in Newsletter | 0 comments

An audit is a systematic, independent, and documented process to obtain objective evidence and determine the extent to which the audit criteria have been met.  You obtain this evidence by talking to people, reviewing documents, examining records, and observing operations. This article will focus on interviewing people to gather information and evidence. You begin an interview by putting the person at ease. Don’t jump right in with your first question. The person may be nervous about being interviewed. Lower the anxiety level with some...

Read More

Training Guidance in ISO 10015:1999

Apr 20, 2002 in Newsletter | 0 comments

  The ISO 10015:1999 Guidelines for Training (also ANSI/ISO/ASQ Q10015:2001) can help your organization to:   Identify and analyze training needs Design and plan the training Provide for the training Evaluate training outcomes Monitor and improve the training process As an example of the guidance, see the summary below for the stage on designing and planning the training. Design and plan the training   This stage identifies the actions to address any competency gaps that were identified in prior stage.   1. Training...

Read More

ISO 9001 Guidelines for Food and Drink Industry

Mar 20, 2002 in Newsletter | 0 comments

ISO has published guidelines for the food and drink industry for implementing quality management systems based on ISO 9001:2000. The new ISO 15161, Guidelines on the Application of ISO 9001:2000 for the Food and Drink industry, is aimed at organizations involved in sourcing, processing, and packaging food and drink products. ISO 15161 allows an organization to integrate its quality management system with a food safety system such as HACCP (Hazard Analysis and Critical Control Point). It is available for $72.00 at the ANSI Electronic...

Read More

IEEE Certified Software Development Professional Designation

Mar 20, 2002 in Newsletter | 0 comments

After more than three years of extensive research among professionals, employers and their customers, the leaders of the IEEE Computer Society realized the time had come to develop and offer a Certified Software Development Professional designation Professional certification has three critical components: Exam-based testing demonstrating mastery of a Body of Knowledge (BOK); Extensive experience base in the performance of the work or profession being certified; and Continuing professional education, measured and relevant to the BOK. The...

Read More

Customer Focus using TL 9000 Requirements

Mar 20, 2002 in Newsletter | 0 comments

ISO 9001:2000 clause 5.2, Customer Focus, simply states: top management must ensure customer requirements are determined and met with the aim of enhancing customer satisfaction. Have you wondered about the appropriate response by top management for this requirement? The guidance in ISO 9004:2000 discusses the needs and expectations of customers. However, another source of ideas may be TL 9000. TL 9000, the telecommunications sector scheme, expands on the ISO 9001:2000 requirements in a number of areas, including Customer Focus. These TL 9000...

Read More

Guidance on ISO 9001:2000 Documentation

Mar 20, 2002 in Newsletter | 0 comments

An important objective for ISO 9001:2000 was to have the amount and detail of the required documentation be more relevant to the desired results of the organization’s process activities. It significantly reduced the documentation requirements and is much less prescriptive than the 1994 standard. An organization has more flexibility in the way it chooses to document its quality management system. Each organization should develop the minimum amount of documentation needed to demonstrate the effective planning, operation, and control of its...

Read More

New ISO Standard for Managing Business Records

Mar 20, 2002 in Newsletter | 0 comments

The first International Standard for managing business records is expected to result in cost savings for users, whether large or small enterprises, as well as, improved risk management. ISO 15489, Information and Documentation – Records Management, focuses on the business principles behind records management and how organizations can establish a framework to enable a comprehensive records management program. According to Robert McLean, member of ISO technical committee ISO/TC 46, Information and Documentation, Subcommittee 11,...

Read More

2nd Edition of ISO/TS 16949 Expected by March 2002

Feb 20, 2002 in Newsletter | 0 comments

ISO/TS 16949 for the automotive industry has been revised for ISO 9001:2000. Although the US delegation voted No, the draft  document received a 79% approval. An approval vote of 67% is needed to ratify an ISO Technical Specification, so publication is expected by March of this year. Since 8 countries voted No, the release of ISO/TS 16949 may end up being delayed to accommodate their concerns and comments. As a result, automotive suppliers should wait for the official final version instead of using the draft document that was approved. Watch...

Read More

Required ISO 9001:2000 Documents

Feb 20, 2002 in Newsletter | 0 comments

Clause 4.2.1 of ISO 9001:2000 identifies the requirement for a quality policy, quality objectives, quality manual, and procedures. Documented Statement of Quality Policy ISO 9001:2000, clause 5.3, requires top management to ensure the quality policy is: Appropriate to the purpose of the organization A framework for establishing and reviewing quality objectives Communicated and understood within the organization Reviewed for continuing suitability The policy must include a commitment to comply with requirements and continually improve...

Read More

Requirement Differences from ISO 9001:1994

Feb 20, 2002 in Newsletter | 0 comments

The key differences for the first five of the ISO 9001:1994 clauses are shown below (with the corresponding ISO 9001:2000 clause numbers identified).   4.1 Management Responsibility Emphasis on top management commitment (5.1) Policy on requirements and improvement (5.3.b) Measurable objectives at relevant levels (5.4.1) Awareness of customer requirements (5.1.a; 5.5.2.c) Resources for improvement and satisfaction (6.1.a) Requirement for internal communication (5.5.3) More duties for management representative...

Read More

Summary of ISO 9001:2000 Requirements

Feb 20, 2002 in Newsletter | 0 comments

5. Management Responsibility 5.1 Management Commitment Top management must provide evidence of its commitment to develop and implement the quality management system, as well as, continually improve its effectiveness by: Expressing the importance of meeting requirements Establishing the quality policy and quality objectives Conducting management reviews Ensuring the availability of necessary resources 5.2 Customer Focus Top management must ensure customer requirements are determined and met in order to improve customer...

Read More

Baldrige Award Winners Announced for 2001

Jan 20, 2002 in Newsletter | 0 comments

President George W. Bush and Commerce Secretary Don Evans today announced five winners of the 2001 Malcolm Baldrige National Quality Award, the nation’s premier award for performance excellence and quality achievement. For the first time in the history of the Baldrige awards, winners were named in the education category. The 2001 Baldrige Award recipients are: Clarke American Checks, Inc., San Antonio, Texas (manufacturing); Pal’s Sudden Service, Kingsport, Tenn. (small business); Chugach School District, Anchorage, Alaska...

Read More

New ISO Web Site Address

Jan 20, 2002 in Newsletter | 0 comments

ISO (International Organization for Standardization) has acquired a new Web site address – www.iso.org – which gives access to information on more than 13,400 International Standards for business, government and society. The iso.org address will eventually replace the currently used iso.ch in ISO’s Web location and e-mail addresses. However, in order to ensure a smooth transition, both iso.org and iso.ch will function in parallel in ISO’s Web and e-mail addresses for an indefinite period. ISO will gradually replace...

Read More

Guidelines for Statistical Process Control

Jan 20, 2002 in Newsletter | 0 comments

The language of ISO 9001:2000 is less manufacturing oriented for the benefit of its readers in the software and service sectors. As a result, “statistical techniques” seem to have been relegated to a lesser role. The old clause 4.20 in ISO 9001:1994 was entirely devoted to Statistical Techniques. Now the techniques are only mentioned in clause 8.1 of ISO 9001:2000 as possible methods for process monitoring, measurement, analysis, and improvement. However, look more closely. Clause 4.1 (c) requires determining the criteria and...

Read More

The Nine Deadly Sins of Project Planning

Jan 20, 2002 in Newsletter | 0 comments

The IEEE Software Magazine recently included an article on “The Nine Deadly Sins of Project Planning” by Editor in Chief, Steve McConnell. The project planning sins are listed below (with my comments): 1. Not planning at all (carefully consider your project needs). 2. Failing to account for all project activities (develop comprehensive plans). 3. Failure to plan for risk (attack the risks before they attack your project). 4. Using the same plan for every project (old plans may not work for new projects). 5. Applying prepackaged...

Read More

Evaluate the results

Jan 20, 2002 in Newsletter | 0 comments

When the project completes, evaluate the results. Were the deliverables acceptable? Were they produced on schedule? Did the outcome satisfy the objectives? This evaluation will give you insights on possible improvement activities. Assess the consultant’s performance. Did the consultant do a good job of planning? Was the plan followed without significant deviation? Were you kept informed throughout the project? Did the consultant work well with others and foster teamwork? Was the expertise of the consultant reflected in the results? Were the...

Read More

Manage the consultant

Jan 20, 2002 in Newsletter | 0 comments

Even an expert consultant needs to be managed well. Ensure the primary contact at your organization fully accepts this coordination role. Any issues or misunderstandings must be promptly resolved. Keep management informed. Remind your organization to strive for self-sufficiency. You want to avoid a prolonged dependence on the consultant. Give the consultant access to the appropriate people, documents, and records. Ensure the organization cooperates, but remember, the consultant makes suggestions, not business decisions. The project success...

Read More

Prepare the agreement

Jan 20, 2002 in Newsletter | 0 comments

At this point, the consultant has been selected and you need to prepare an agreement for both parties to sign regarding the scope of work. The agreement could be a legal contract or simply a letter of understanding. The bigger the job, the more formal the agreement. The agreement should describe the expected deliverables and their timing. Identify your contact for authorizing and scheduling the activities. Explain that monthly payments will be made based on completed work. Attach the consultant proposal to the agreement. Use the agreement to...

Read More

Negotiate the terms

Jan 20, 2002 in Newsletter | 0 comments

You have made a tentative selection. Discuss the specific dates for the initial visit. See if the consultant will reduce the quoted rate based on the size of the project. Depending on your location and the types of services, you may find the consultant is willing to lower the fee to gain your business. Remember that you’ve already decided this consultant is the best choice if the terms can be worked out to the satisfaction of both parties. Don’t automatically exclude the person if the fee cannot be negotiated to a lower...

Read More

Choose the consultant

Jan 20, 2002 in Newsletter | 0 comments

When you receive the proposals, you will evaluate them using the agreed selection criteria. Know in advance who will participate in the evaluation and make the recommendation. Will a committee make the decision, or an individual manager? In any case, you want the decision fully supported so the consultant can work effectively with your organization. You will evaluate their personal traits, especially their communication skills. You will also look at their experience in performing the defined scope of work. If you are dealing with consulting...

Read More