2003 Newsletter Articles

Whittington to Speak at Quality Conferences

Dec 20, 2003 in Newsletter | 0 comments

The 12th Annual International Conference on ISO 9000 will be held in Orlando, FL on February 23-25, 2004. The presentation tracks will be: 1. ISO 9000 and Expanding Horizons 2. Integration and Implementation 3. ISO 9000 and Business Synergy 4. Value-Added Auditing 5. Continual Improvement 6. Healthcare and Medical Devices 7. Cutting Edge Tools and Technology 8. Performance Indicators Larry Whittington will speak on “ISO 9001:2000 Auditing – The Process Approach”. To register, go...

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Most Common ISO 9001:2000 Audit Findings

Dec 20, 2003 in Newsletter | 0 comments

A report on the user experience with ISO 9001:2000 is available at: <http://standardsgroup.asq.org/news/psi/IMS06-2002E-Implementing_ISO_9001-BD.pdf>. The 227 survey responses included a ranking of the most common audit findings: Most Common Internal Audit Findings 1. Customer satisfaction data and assessment 2. Documentation gaps 3. Continual improvement process 4. Objectives not measurable 5. Collection and analysis of data 6-7. Top management commitment and responsibility 6-7. Record keeping gaps 8-9. Competency requirements 8-9....

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Registration Totals for ISO 9000 in USA

Dec 20, 2003 in Newsletter | 0 comments

As of September 2003, the total number of registrations for ISO 9000 and related standards in the USA were: Standard ISO 9000 AS9100 TL 9000 QS-9000 TS 16949 ISO 13485 ISO 14001 Totals 43113 954 229 7969 186 959 3078 ISO 9000 includes ISO 9001:2000, ISO 9001:1994, ISO 9002:1994, and ISO 9003:1994. AS9100 includes AS9100 and AS9000. ISO 13485 includes ISO 13485 and ISO...

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What Changes are Planned for ISO 9001?

Dec 20, 2003 in Newsletter | 0 comments

Many of you have just completed the transition to ISO 9001:2000 and may not be ready to hear that  work begins this month on the next ISO 9001 edition. However, don’t panic, the publication date will likely be in 2008. The changes to ISO 9001 are expected to be minor and driven by the users of the standard. Any changes will be to clarify the requirements and any additions will be to increase the value of using the standard. Most of the revisions will probably be to the ISO 9004 guidance document. The US representatives have agreed to...

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New and Revised ISO Standards

Dec 20, 2003 in Newsletter | 0 comments

Are you aware of the following new ISO standards under development? ISO/AWI 10001 – External customer dispute resolution systems ISO/AWI 10002 – Market-based codes of conduct ISO/DIS 10018 – Complaints handling – Guidelines for organizations ISO/DIS 10019 – Guidelines for the selection of quality management system consultants and use of their services ISO/DIS 21247 – Quality plans for product acceptance – Combined accept-zero and control procedures AWI = Approved Work Item; DIS = Draft International...

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Are You Setting SMART Quality Objectives?

Dec 20, 2003 in Newsletter | 0 comments

George Doran published an article in the November, 1981 issue of Management Review titled, “There’s a S.M.A.R.T. Way to Write Management Goals and Objectives.” SMART has become a useful acronym for setting objectives that are Specific, Measurable,Achievable, Relevant, and Timed. Specific: Identify the expected result. Be precise on the desired outcome. All the concerned persons should know what is required. Measurable: Quantify the result and ensure you have a reliable system for measuring it. You should know when you have achieved...

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ISO 15489 – Benchmark for Records Management

Nov 20, 2003 in Newsletter | 0 comments

Recent scandals, terrorist attacks and natural disasters have highlighted the need for a clear and systematic approach to record keeping, Mike Marsh, European Liaison, ARMA Geneva told a group of information professionals at the Inaugural seminar on ISO 15489 for records management. The discussion was among the events held at a recently concluded seminar held in Geneva, Switzerland, designed to teach participants how to implement ISO 15489, Information and documentation – Records management – Part 1, and thereby help them to...

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New Body of Knowledge for CQA Exam

Nov 20, 2003 in Newsletter | 0 comments

A new Body of Knowledge (BOK) has been published for the ASQ Certified Quality Auditor Exam. The new BOK can be viewed atCQA Body of Knowledge – 2004. If you are an auditor, even if you are not a candidate for the CQA exam, you should still be competent in the topics of the 2004 BOK. The 1999 BOK will be the basis of the CQA exams through the May 23, 2004 exam. The exams after that date will use the 2004 BOK and include case studies. Each case study will include a brief scenario about an audit situation. In addition, each case study...

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Eradicate Jargon with Bullfighter

Nov 20, 2003 in Newsletter | 0 comments

Bullfighter™ is a free software tool from Deloitte Consulting to help eliminate business jargon. “We’ve had it with repurposeable, value added knowledge capital and robust, leveragable mindshare. Enough, already,” says Brian Fugere, partner at Deloitte Consulting. “If Corporate America wants to restore public trust, we need to start speaking and writing more clearly. Less empty rhetoric about openness, honesty and accountability, and more straight talk.” Bullfighter runs in Microsoft Word and PowerPoint, within Microsoft...

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Record Control – Basic and Extended

Nov 20, 2003 in Newsletter | 0 comments

You may know the ISO 9001 record control requirements, but what about the industry extensions for AS9100, ISO/TS 16949, ISO 14001, as well as, ISO 15489? They may suggest good practices beyond the basic ISO 9001 record control requirements. According to ISO 9001:2000, clause 4.2.4, the record control process must: Establish and maintain records as evidence of conformity to requirements Use records to show effective operation of the quality management system Keep records that remain legible, readily identifiable, and retrievable A documented...

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Guidance on “Outsourced” Processes

Oct 20, 2003 in Newsletter | 0 comments

A new ISO 9000 “Introduction and Support Package” guidance document on outsourced processes is available at:<http://isotc176sc2.elysium-ltd.net>. The aim of the draft document is to provide guidance on the intent of ISO 9001:2000 clause 4.1, regarding the control of outsourced processes, and to clarify the relationship between this requirement and those contained in ISO 9001:2000 clause 7.4 (Purchasing). A final version of the document is expected by YE2003.

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Quality Conference: October 27-28, 2003

Oct 20, 2003 in Newsletter | 0 comments

The Southeastern Quality Conference will be held at the Cobb Galleria Centre in Atlanta, Georgia on October 27-28, 2003. The conference is sponsored by the Atlanta ASQ Section, Institute of Industrial Engineers, and Georgia Tech Economic Development Institute. Thirty speakers in up to four conference tracks will present quality subjects across a variety of industry sectors. The price is only $325 and includes lunch both days. Speakers include: Larry Whittington on ISO 9001:2000 Requirements: The Dirty Dozen Dan Morris and Joe Davis on ISO...

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Metrics for Customer Satisfaction

Oct 20, 2003 in Newsletter | 0 comments

The TL 9000 Metrics Handbook (for the telecommunications industry) contains guidance on customer satisfaction metrics that would be useful for ISO 9001 quality management systems. It gives basic guidelines for a customer feedback mechanism and refers to a detailed customer satisfaction survey. This information may assist you in the design or review of your own customer feedback program. The purpose of the described metrics is to measure and improve the degree of customer satisfaction with your organization and its products from the customer...

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Answers to ISO 9001:2000 Questions

Oct 20, 2003 in Newsletter | 0 comments

The U.S. Technical Advisory Group to ISO Technical Committee 176 created the Product Support Initiative (PSI) to aid in the understanding and implementation of ISO 9001:2000. The PSI web site <http://standardsgroup.asq.org/news/psi/index.html> contains answers to the following typical questions: 1. What are some examples of ways in which customer satisfaction can be measured to meet the requirements in Subclause 8.2.1? 2. What different ways or measures can an organization use to determine training ? 3. Have the requirements for...

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Document Control – Basic and Extended

Oct 20, 2003 in Newsletter | 0 comments

You may know the ISO 9001 document control requirements, but what about the industry extensions for AS9100, ISO/TS 16949, and TL 9000, as well as, those for ISO 14001? These additional requirements may suggest good practices beyond the basic ISO 9001 document control. According to ISO 9001:2000, clause 4.2.3, the document control process must: Approve documents for adequacy prior to issue Review, update as necessary, and re-approve documents Identify changes and the current revision status of documents Ensure relevant versions of applicable...

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Quality Conference: October 27-28, 2003

Sep 20, 2003 in Newsletter | 0 comments

The Southeastern Quality Conference will be held at the Cobb Galleria Centre in Atlanta, Georgia on October 27-28, 2003. The conference is sponsored by the Atlanta ASQ Section, Institute of Industrial Engineers, and Georgia Tech Economic Development Institute. Thirty speakers in up to four conference tracks will present quality subjects across a variety of industry sectors. The price is only $275 with early registration (before September 15, 2003) and includes lunch both days. A partial list of speakers includes: Larry Whittington on ISO...

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ISO 10007:2003 for Configuration Management

Sep 20, 2003 in Newsletter | 0 comments

ISO 10007:2003 provides organizations with guidelines for “configuration management” to help them improve customer satisfaction and product quality by managing the activities related to product design and maintenance. Use of ISO 10007 should provide a better understanding of, and control over, the physical and functional changes to products, as well as, the subsequent effects on documents, processes, and resources throughout their life cycle. For example, the components of a vehicle are heavily interrelated and any change made to...

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Toughest ISO 9001:2000 Requirements (8.5.3)

Sep 20, 2003 in Newsletter | 0 comments

In an earlier newsletter, I identified twelve ISO 9001:2000 clauses as the toughest requirements to interpret and implement.Clauses 4.1, 5.1, 5.4.1, 5.4.2, 6.2.2, 6.3, 7.3.1, 7.5.2, 8.2.1, 8.4, and 8.5.1 have been addressed in past newsletters. This article completes the list with clause 8.5.3, Preventive Action..  ISO 9001:2000, clause 8.5.3, states The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the...

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ISO 10006:2003 for Quality in Business Projects

Sep 20, 2003 in Newsletter | 0 comments

ISO 10006:2003, Quality Management Systems – Guidelines for Quality Management in Projects, offers a structured approach for the optimal management of all processes involved in the development of any project (that may cut across both the internal and external boundaries of organizations involved in its development). It can be used by organizations to ensure that they are applying the process-based approach of ISO 9001:2000 to projects, although the use of ISO 10006 in third-party certification is not a requirement. It can, however, be...

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ISO Standard for Medical Laboratories

Aug 20, 2003 in Newsletter | 0 comments

ISO 15189:2003 has been published for medical laboratories to implement quality management systems based on ISO 9001:2000. “The new standard will help medical laboratories to organize their operation efficiently”, said John Zlockie, Secretary of the technical committee which developed the new standard. “It will help them to comply with regulatory requirements, to meet the expectations of their clients and, most importantly, to improve or maintain their service to patients.” ISO 15189:2003 (Medical Laboratories –...

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ISO 15288 – Next Standards Phenomenon?

Aug 20, 2003 in Newsletter | 0 comments

ISO 15288:2002 may be the next standards phenomenon. It’s timeliness and applicability to organizations in all sectors could give it a considerable impact on the world of business, similar to ISO 9000. Just as the ISO 9000 family of standards has distilled the essential characteristics of quality management into a set of generic requirements, ISO 15288 (Systems Engineering – System Life Cycle Processes) offers a portfolio of generic processes for the optimal management of all stages in the life of any product or service. Many...

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Toughest ISO 9001:2000 Requirements (8.5.1)

Aug 20, 2003 in Newsletter | 0 comments

In an earlier newsletter, I identified twelve ISO 9001:2000 clauses as the toughest requirements to interpret and implement. Clauses 4.1, 5.1, 5.4.1, 5.4.2, 6.2.2, 6.3, 7.3.1, 7.5.2, 8.2.1, and 8.4 have been addressed in past newsletters. This article picks up with clause 8.5.1, Continual Improvement. ISO 9001:2000, clause 8.5.1, states The organization shall continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and...

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Challenges to U.S. Manufacturing

Aug 20, 2003 in Newsletter | 0 comments

According to a study released by the National Association of Manufacturers, “intense global competition and the rising cost of doing business in the U.S. threaten manufacturing’s capability to maintain the nation’s economic strength and standard of living.” The report cites the causes of the decline of U.S. manufacturing as: Increased competition Declining export opportunities Decreased R&D investments Lack of a skilled workforce See the report, “Securing America’s Future: The Case for a Strong...

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Find Out Who Is ISO 9001 Registered

Jul 20, 2003 in Newsletter | 0 comments

If you want to see if a company is registered to ISO 9001, or want to identify all registered companies in a specific city or state, see this web site: http://www.whosregistered.com Click on the icon to the left of the displayed company name to see the firm’s scope statement and the name of their registrar.

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Guidelines for Publicizing ISO 9001 Registration

Jul 20, 2003 in Newsletter | 0 comments

Free, updated guidelines providing organizations with “good practice” for publicizing their certification to the ISO 9001 and ISO 14001 standards are now available. The new edition has been revised to take into account ISO 9001:2000. You can view the document online, or download the Word file, at: <http://www.iso.org/iso/en/iso9000-14000/publicizing/index.html>. The introduction to the new edition of Publicizing your ISO 9001 or ISO 14001 certification says, “By using ISO’s guidelines, you will avoid the...

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Toughest ISO 9001:2000 Requirements (8.4)

Jul 20, 2003 in Newsletter | 0 comments

In an earlier newsletter, I identified twelve ISO 9001:2000 clauses as the toughest requirements to understand and meet with conforming practices. Clauses 4.1, 5.1, 5.4.1, 5.4.2, 6.2.2, 6.3, 7.3.1, 7.5.2, and 8.2.1 have been addressed in past newsletters. This article picks up with clause 8.4, Analysis of Data. ISO 9001:2000, clause 8.4 : The organization shall determine, collect, and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the...

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Transition to ISO/TS 16949:2002

Jul 20, 2003 in Newsletter | 0 comments

According to Hank Gryn, DaimlerChrysler’s representative to the International Automotive Task Force (IATF), car companies representing 80% of all vehicle sales will migrate their suppliers from QS-9000:1998 to ISO/TS 16949:2002 by 12/15/06. DaimlerChrysler, Renault, and PeugeotCitreon have set an earlier date of 7/1/04 for suppliers to move from QS-9000:1998 to ISO/TS 16949:2002. All ISO/TS 16949:1999 organizations must complete the transition by 12/15/04. Go to <http://www.iaob.org> to see the DaimlerChrysler, Ford, and General...

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Top Management as Ethical Role Models

Jul 20, 2003 in Newsletter | 0 comments

The 2003 Baldrige Criteria for Performance Excellence has placed extra emphasis on ethical activities. Don Evans, US Commerce Secretary, says “For America to have a sound economy, we need sound businesses with ethical, responsible leaders.” The Baldrige leadership criteria now asks how the organization’s governance system ensures management and fiscal accountability and independence in audits, while protecting stockholder and stakeholder interests. The Results category now asks for evidence of fiscal accountability, ethical...

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Guidance on Statistical Techniques for ISO 9001:2000

Jun 20, 2003 in Newsletter | 0 comments

ISO/TR 10017:2003 has been released to provide guidance on the use of statistical techniques for ISO 9001:2000. The technical report covers the selection of statistical techniques that may be useful in developing, implementing, maintaining, and improving an ISO 9001-based quality management system. This is done by examining the ISO 9001 requirements that involve the use of quantitative data, and then identifying and describing the statistical techniques that can be useful when applied to such data. You can order a copy for $76.00 at the ANSI...

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Registration Totals

Jun 20, 2003 in Newsletter | 0 comments

As of March, 2003, the total number of registrations for ISO 9000 and related standards in the USA were: Standard ISO 9000 AS9100 TL 9000 QS-9000 TS 16949 ISO 13485 ISO 14001 Totals 42,245 572 193 8,409 97 523 2739 ISO 9000 includes ISO 9001:2000, ISO 9001:1994, ISO 9002:1994, and ISO 9003:1994. AS9100 includes AS9100 and AS9000. ISO 13485 includes ISO 13485 and ISO...

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Transition to Process Auditing

Jun 20, 2003 in Newsletter | 0 comments

Auditing with the Process Approach ISO 9001:2000 promotes the process approach by its structure and requirements. Yet, many internal audit programs still conduct audits by clause instead of by process. A “process” is an activity that uses resources to transform inputs into outputs. The output of one process is often the input to another process. The “process approach” identifies the system of related processes, along with their interaction and management. Organizations must identify and manage numerous linked activities to function...

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ISO 10012 for Measurement Management Systems

May 20, 2003 in Newsletter | 0 comments

ISO 10012:2003 has been released. Its title is Measurement Management Systems – Requirements for Measurement Processes and Measuring Equipment. It replaces ISO 10012-1:1992, Quality Assurance Requirements for Measuring Equipment – Part 1: Metrological Confirmation System for Measuring Equipment and ISO 10012-2:1997, Quality Assurance for Measuring Equipment – Part 2: Guidelines for Control of Measurement Processes. You can order an electronic copy for $60.00 at ANSI’s Electronic Standards...

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Book Review: Customer Satisfaction

May 20, 2003 in Newsletter | 0 comments

Craig Cochran is the author of a book titled, “Customer Satisfaction: Tools, Techniques, and Formulas for Success”. Craig begins by explaining how different customers can use the same product and yet have radically different views of its quality. He presents five tools to help your organization monitor and analyze customer satisfaction: 1. Call Reports – use of existing communication systems to probe customer perceptions 2. Field Reports – visits to customer sites to gather more in-depth information 3. Comment Cards...

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Toughest ISO 9001:2000 Requirements (8.2.1)

May 20, 2003 in Newsletter | 0 comments

In an earlier newsletter, I identified twelve ISO 9001:2000 clauses as the toughest requirements to understand and meet with conforming practices. Clauses 4.1, 5.1, 5.4.1, 6.3, 7.3.1, and 7.5.2 have been addressed in past newsletters. This article picks up with clause 8.2.1, Customer Satisfaction: As one of the measurements of the performance of the quality management system, the organization shall monitor information relating to customer perception as to whether the organization has met customer requirements. The methods for obtaining and...

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Writing for a Global Audience

May 20, 2003 in Newsletter | 0 comments

The English language contains thousands of idioms (phrases not meant to be taken literally). We use them in our speech so they may appear in documents. For example, “just as soon” should be “quickly” to avoid confusing readers of our documents in other countries. The specialized or technical language of a trade or profession is called jargon. Be careful to use only commonly accepted terms. Your local jargon may be unknown to the rest of the world. For example, a “seamless” process should be called a “well-integrated”...

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Checklist for Creating Procedures

May 20, 2003 in Newsletter | 0 comments

Keep this checklist of questions handy when writing a procedure: 1. What is the objective of the process? Know its purpose before starting. 2. Which activities are part of the scope? Agree on the coverage of activities. 3. Who is responsible for these activities? Identify the key process players. 4. What are the inputs and who supplies them? Identify the inputs and suppliers. 5. What are the outputs and who receives them? Identify the outputs and customers. 6. What is referred to as an information source? Identify any reference...

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Syntax: The Arrangement of Words

Apr 20, 2003 in Newsletter | 0 comments

To write an effective document, you should follow some basic rules for sentence construction. Use of the proper syntax will result in more clear communications. Grammar Usage If you do not use accepted grammar, readers may misunderstand the message of your document. Even if the errors do not confuse the reader, they may reduce your credibility as an author. Subjects and verbs must agree in number. For example, “the audits are complete” and “the audit is complete”. Writing “ensure one of the machines are in service”, instead of the...

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Top Ten Benchmarked Business Processes

Apr 20, 2003 in Newsletter | 0 comments

The following list shows the most actively benchmarked business processes by members of The Benchmarking Exchange. The data is collected from thousands of TBE members and ranked by the most benchmarked process for the past twelve months.   1. Employee Development Training 2. Information Systems Technology 3. Human Resources 4. Customer Service Satisfaction 5. Performance Measurement Improvement 6. Document Control; Records Management 7. Process Improvement Management 8. Call Centers; Help Desks 9. Accounting 10. Quality Improvement For more...

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Toughest ISO 9001:2000 Requirements (7.5.2)

Apr 20, 2003 in Newsletter | 0 comments

In an earlier newsletter, I identified twelve ISO 9001:2000 clauses as the toughest requirements to understand and meet with conforming practices. Clauses 4.1, 5.1, 5.4.1, 6.3, and 7.3.1 have been addressed in past newsletters. This article picks up with clause 7.5.2, Validation of Processes for Production and Service Provision. It states (in part): The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any...

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ISO 9000 Registration Earns Financial Rewards

Apr 20, 2003 in Newsletter | 0 comments

Companies traded on the New York Stock Exchange that are ISO 9000 registered show significant improvement in their financial performance compared to firms without the registration. Analyzing the impact of ISO 9000, researchers from UCLA, the University of Maryland, and the Universidad Carlos III in Madrid, found there is a direct correlation with a firm’s return on assets. “When we began this research in 1997, we were very skeptical and we were shocked by the magnitude of the effects,” says David Kirsch of the University of...

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Techniques to Detect Intrusions in Computer Systems

Mar 20, 2003 in Newsletter | 0 comments

A framework for the detection of intrusions in computer systems and networks are contained in a new ISO technical report, ISO/TR 15947, Information Technology – Security Techniques – IT Intrusion Detection Framework. The document focuses on the security principles behind the intrusion of computer systems by outsiders or trusted employees, and how organizations can establish a framework to enable a comprehensive intrusion detection system. “One of the problems that businesses have is being able to detect when their systems are being...

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Index for ISO 9001:2000 Terms

Mar 20, 2003 in Newsletter | 0 comments

Have you ever struggled to locate a particular term in ISO 9001:2000? For example, you know “outsource” is addressed in the standard, but you may not recall where to find it. Well, I have created an index for more than 300 terms used in ISO 9001:2000. The index includes the pages and clauses for each term. For example, Outsource (or Outsourced) is mentioned on page 2 (4.1, 4.1). The entry “4.1” is repeated twice in the index since the term appears twice in clause 4.1. You can find Quality Policy on page 2...

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Toughest ISO 9001:2000 Requirements (7.3.1)

Mar 20, 2003 in Newsletter | 0 comments

Manufacturing companies with design responsibility will likely have an established design and development process. However, clause 7.3 may be a tough new requirement for many service organizations. The transition document, Guidance on ISO 9001:2001 – Clause 1.2 Application, states “Design and development has traditionally tended to focus on tangible products, but is equally applicable where the product of an organization is a service”. In addition, ISO 9001:2000 states that “wherever the term “product”...

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Toughest ISO 9001:2000 Requirements (6.3)

Mar 20, 2003 in Newsletter | 0 comments

In the December, 2003 newsletter, I identified twelve ISO 9001:2000 clauses as the toughest requirements to understand and meet with conforming practices. Clauses 4.1, 5.1, and 5.4.1 were addressed in the past two newsletters. This article picks up with clause 6.3, Infrastructure. The next article in this newsletter deals with clause 7.3.1, Design and Development Planning. 4.1  General Requirements (and 0.2 Process Approach) – article in December, 2002    5.1  Management Commitment – article in January, 2003 5.4.1  Quality...

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Guidelines for Confidence and Security in e-Business

Mar 20, 2003 in Newsletter | 0 comments

Guidelines for the management of Trusted Third Party services used to facilitate secure e-business communications are contained in a new ISO technical report, ISO/TR 14516, Information Technology – Security Techniques – Guidelines for the Use and Management of Trusted Third Party Services. The document will enable businesses to identify the type and level of protection required from TTPs and how to use those services to gain customer confidence and increase e-business security. “Concerns about the security of e-business expressed...

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Free Online Course: “Why Standards Matter”

Feb 20, 2003 in Newsletter | 0 comments

“Why Standards Matter,” a free online course that introduces the basics of the voluntary standardization process, is available from the American National Standards Institute, a nonprofit organization that administers and coordinates the U.S. voluntary standardization system. Go to <http://www.standardslearn.org>.

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ISO Report on Merging Business and Environmental Goals

Feb 20, 2003 in Newsletter | 0 comments

The convergence of environment-friendly products with company profits is furthered by a new ISO technical report. ISO/TR 14062,Environmental Management – Integrating Environmental Aspects Into Product Design And Development, will enable organizations to identify the likely effects on the environment of their future products and make effective decisions during the design and development stages to improve their environmental performance. “More organizations are coming to realize that there are substantial benefits in integrating...

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Toughest ISO 9001:2000 Requirements (6.2.2)

Feb 20, 2003 in Newsletter | 0 comments

Clause 6.2.2, Competence, Awareness, and Training, states: The organization shall: a) determine the necessary competence for personnel performing work affecting product quality, Competence is defined in ISO 9000:2000 as the “demonstrated ability to apply knowledge and skills”. Competence involves the education, training, skills, and experience necessary for people to carry out their assigned tasks. It also includes people not directly involved in making the product, or delivering the service, because their work may affect quality...

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Toughest ISO 9001:2000 Requirements (5.4.2)

Feb 20, 2003 in Newsletter | 0 comments

In the December, 2003 newsletter, I identified twelve ISO 9001:2000 clauses as the toughest requirements to understand and meet with conforming practices. Clauses 4.1, 5.1, and 5.4.1 were addressed in previous newsletters. This article covers clause 5.4.2, Quality Management System Planning. The next article in this newsletter deals with clause 6.2.2, Competence, Awareness, and Training. 4.1  General Requirements (and 0.2 Process Approach) – article in December, 2002.    5.1  Management Commitment – article in January,...

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What are the “New” Audit Activities?

Feb 20, 2003 in Newsletter | 0 comments

If you are an auditor, chances are your auditing course was based on ISO 10011, Guidelines for Auditing Quality Systems. You were probably taught that an audit consists of five phases: Initiation, Preparation, Execution, Reporting, and Follow-Up. That terminology has changed somewhat with the replacement of ISO 10011 by ISO 19011, Guidelines for Quality and/or Environmental Management System Auditing. Audit phases are now called audit activities. Also, the “documentation review” activity has been separated from the old...

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ISO/TR 16982:2002 – Usability Methods

Jan 20, 2003 in Newsletter | 0 comments

Want to know how to achieve a happy marriage between people and computers? The methods for evaluating computer-based systems and products for ease of use by people are described in a new ISO technical report: ISO/TR 16982:2002, Ergonomics of Human-System Interaction – Usability Methods Supporting Human-Centered Design. The document is expected to increase user satisfaction and productivity, decrease support and training costs, and improve user health and well-being. The new technical report provides guidance on the different types...

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List of Quality Standards

Jan 20, 2003 in Newsletter | 0 comments

You are probably aware of the basic ISO 9000 family of standards: ISO 9000: 2000 – Quality Management Systems – Fundamentals and Vocabulary  ISO 9001: 2000 – Quality Management Systems – Requirements  ISO 9004: 2000 – Quality Management Systems – Guidelines for Performance Improvement However, are you aware of these other standards? As shown below, some of the standards are in the process of being revised to reflect ISO 9001:2000. ISO 9000-3: 1997 – Quality Management and Quality Assurance...

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AS9120 – Aerospace Requirements for Distributors

Jan 20, 2003 in Newsletter | 0 comments

AS9120, Quality Management Systems – Aerospace Requirements for Stockist Distributors, has been released. The standard is based on ISO 9001:2000 and specifies additional requirements that are applicable to stockist distributors. These additional aerospace requirements are highlighted in the document by bold, italic text. AS9120 is available at <http://www.sae.org> for $59 in hardcopy or electronic media. AS9110 for Aerospace Maintenance and Repair Facilities is in...

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Toughest ISO 9001:2000 Requirements (5.4.1)

Jan 20, 2003 in Newsletter | 0 comments

ISO 9001:2000 states that “Top management shall ensure that quality objectives, including those needed to meet requirements for product, are established at relevant functions and levels within the organization.” So, process and product objectives must be set at the relevant functions and levels within an organization. An example would be a manufacturing scrap target that is applicable to only a few departments. In addition, each department may have a different objective, depending on their current scrap levels. However, be careful how you...

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Toughest ISO 9001:2000 Requirements (5.1)

Jan 20, 2003 in Newsletter | 0 comments

In the last newsletter, I identified twelve ISO 9001:2000 clauses as the toughest requirements to understand and meet with conforming practices. That article explained the first clause, 4.1 General Requirements. This article will focus on clause 5.1, Management Commitment. The next article in this newsletter deals with clause 5.4.1, Quality Objectives.     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) 6.2.2 ...

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ISO 10018 on Complaints Handling

Jan 20, 2003 in Newsletter | 0 comments

A planned ISO standard on complaints handling is expected to help safeguard consumers. The committee draft, ISO/CD 10018, Complaints Handling, sets out an effective complaints handling process that would provide a fair result in the marketplace, as well as, give industry the capacity to recognize and address systematic consumer problems. The standard provides the essential elements for handling complaints: from initial receipt to the final assessment of complainant satisfaction, including those related to electronic commerce. According to Bill...

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