2001 Newsletter Articles

Possible ISO Standards for Social Responsibility

Dec 12, 2001 in Newsletter | 0 comments

ISO’s Committee on consumer policy (COPOLCO) is carrying out a feasibility study on standards for corporate social responsibility and has launched an online forum to gather your views. The forum, hosted by the Canadian Office of Consumer Affairs, has been set up for worldwide discussion of the possible role of standards in defining the elements of corporate social responsibility. The forum has been designed to increase awareness and promote constructive discussion of new and existing corporate social responsibility initiatives, as well...

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ISO 9000 Guidelines for the Health Care Sector

Dec 12, 2001 in Newsletter | 0 comments

The guidelines for implementing ISO 9000 quality management systems in the health care sector have been published by ISO as its first “International Workshop Agreement”. IWA 1 was developed from an earlier draft jointly developed by the American Society for Quality (ASQ) and the Automotive Industry Action Group (AIAG). IWA 1, Guidelines for Process Improvements in Health Service Organizations, is based on ISO 9004:2000, Guidelines for Performance Improvements. IWA 1 contains much of the text of ISO 9004:2000, supplemented by...

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Customer Satisfaction

Dec 12, 2001 in Newsletter | 0 comments

Clause 8.2.1 of ISO 9001:2000 requires an organization to “monitor information relating to customer perception as to whether the organization has met requirements”. It also requires methods be determined for “obtaining and using this information”. Your organization should define the process for requesting, measuring, and monitoring customer feedback on a continual basis. Sources of information include customer complaints, product returns, questionnaires, user surveys, focus groups, trip reports, comment cards, service...

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Ten Tips for Selecting and Using a Consultant – 1. Understand the reasons for using a consultant

Dec 12, 2001 in Newsletter | 0 comments

Why do organizations use consultants? An organization may realize it lacks the expertise, time, experience, or objectivity to perform the work without outside assistance. Expertise: One of the most common reasons for hiring a consultant is when you need expertise that is not available within your own organization. Although your staff may have been trained on ISO 9001:2000 requirements, they may not have the in-depth knowledge needed to establish the quality management system on their own. Many consultants are also certified auditors and able...

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Ten Tips for Selecting and Using a Consultant – 2. Identify the services you need from a consultant

Dec 12, 2001 in Newsletter | 0 comments

Now that you understand the basic reasons why your organization may want to use a consultant, you must determine the needed range of services. Competent consultants should be able to plan the activities, document your processes, suggest good practices, teach onsite classes, conduct internal audits, and recommend system improvements. A typical sequence of services is for the consultant to teach a class on quality concepts and ISO 9001:2000 requirements, followed by a gap analysis to determine the compliance level of your current system. Using...

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Ten Tips for Selecting and Using a Consultant – 3. Decide on the selection criteria

Dec 11, 2001 in Newsletter | 0 comments

Once the decision is made to use a consultant, and the proposed services are defined, you must agree on the criteria for selecting the right consultant for your organization. Consider the following factors: Credentials: See if the consultant is an RAB or IRCA certified auditor or lead auditor. This certifies the person is qualified to audit ISO 9001 quality management systems. Although some competent consultants may not be certified auditors, those that are can speak from experience when they interpret requirements and assess your...

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Ten Tips for Selecting and Using a Consultant – 4. Find the consultant

Dec 10, 2001 in Newsletter | 0 comments

After you’ve decided on the criteria for choosing a consultant, it is time to locate possible candidates. Unfortunately, finding the right consultant can be a frustrating experience if your organization doesn’t go about it in a thoughtful and methodical way. You have settled on the selection criteria, but it may still be difficult to confidently assess the consultants before the work is done. As a result, it is very important to identify a good set of consultants to enter the evaluation process. Prior Use: The ideal way to find a good...

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Ten Tips for Selecting and Using a Consultant – 5. Request a proposal

Dec 9, 2001 in Newsletter | 0 comments

Now that you have identified a group of possible consultants, you should ask them to submit proposals for your evaluation. To help them propose the appropriate services, include the following information in your request: Scope: Describe the expected scope of work. Are you looking for specific documentation help or general consulting assistance? Do you want onsite training classes or an audit of your system? If you are not sure what you need, then request a discovery stage where the consultant performs a gap analysis and proposes the project...

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AS9100 for ISO 9001:2000 Now Available

Nov 12, 2001 in Newsletter | 0 comments

The international aerospace quality system standard, AS9100, has been revised to include: ISO 9001:2000 requirements Aerospace unique requirements Original AS9100 based on ISO 9001:1994 AS9100 contains about 80 unique aerospace requirements and 18 amplifications of the ISO 9001 requirements. These additional requirements are necessary to address the civil and military aviation and aerospace needs. For more information, or to order AS9100, call SAE at 877-606-7323 or visit their web site at:...

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ISO/TS 16949 for Automotive Suppliers

Nov 12, 2001 in Newsletter | 0 comments

Will the Big Three car companies require suppliers with QS-9000 certificates to move to ISO/TS 16949? The Supplier Quality Requirements Task Force, which administers QS-9000, stated at AUTO-TECH 2001 that the Big Three firms will announce their plans regarding the second edition of ISO/TS 16949 by the end of this year. The SQRTF is represented on the International Automotive Task Force (IATF) that is responsible for ISO/TS 16949. The Ford, DaimlerChrysler, and General Motors positions so far have been to encourage, but not require,...

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Nonconformity, Nonconformance, Defect, Finding, or Observation?

Nov 12, 2001 in Newsletter | 0 comments

Nonconformity Are you using the right term? What do you call it when a requirement is not met? ISO 9000:2000 3.6.2 defines the non-fulfillment of a requirement as a “nonconformity”. As expected, “conformity” is defined in 3.6.1 as the fulfillment of a requirement. Some auditors use “conformance” and “nonconformance”. Does it really matter? ISO 9000:2000 3.6.1 states that although conformance is synonymous with conformity, it is deprecated. What does that mean? Well, “deprecated” refers to a term that is considered obsolete...

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Benefits of CQA for RAB Certification

Nov 12, 2001 in Newsletter | 0 comments

If you are a Certified Quality Auditor (CQA) from the American Society for Quality (ASQ), you are due some new benefits from the Registrar Accreditation Board (RAB) that will save you both time and money. Based on an agreement signed recently by the RAB and the Audit Division of ASQ, holders of the CQA designation will receive a 20% discount on their initial RAB application for QMS auditor certification and a 10% discount on annual and recertification fees. Certified Quality Auditors will also be given automatic credit by the RAB for meeting...

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Ten Tips for Selecting and Using a Consultant – 6. Evaluate the effectiveness of the system

Nov 11, 2001 in Newsletter | 0 comments

Most auditors find it relatively easy to assess the compliance of a defined or documented process to the requirements of the standard. They even find it relatively easy to see if the actual practice matches the defined or documented process. However, auditors often struggle with, or even overlook, assessing how well the practice is actually performed. Every audit situation should be examined from three perspectives: 1. Intent: “Have you said what you do?” Do the defined or documented processes adequately express your...

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Ten Tips for Selecting and Using a Consultant – 7. Remind auditors how to verify conformity

Nov 11, 2001 in Newsletter | 0 comments

Internal auditors often rely just upon documents and records as evidence of process conformity and don’t adequately interview personnel and observe operations. After determining the audit criteria (requirements), objective evidence should be gathered in four different ways for more complete and effective audits: 1. Interview personnel Based on your audit planning and checklist questions, ask employees about their jobs. Listen to what they tell you. See if their explanations match the defined process. Use open-ended questions to elicit more...

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Ten Tips for Selecting and Using a Consultant – 8. Know how to audit an undocumented process

Nov 11, 2001 in Newsletter | 0 comments

You may have heard that ISO 9001:2000 specifically requires only six procedures. Those required procedures by clause are: 4.2.3 – Control of Documents 4.2.4 – Control of Records 8.2.2 – Internal Audit 8.3 – Control of Nonconforming Product 8.5.2 – Corrective Action 8.5.3 – Preventive Action ISO 9001:2000 clause 4.2.1.d states that other documents needed for effective process planning, operation, and control must also be included. Therefore, organizations should only develop the level of documentation they...

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Ten Tips for Selecting and Using a Consultant – 9. Improve your current internal audit practices

Nov 11, 2001 in Newsletter | 0 comments

Organizations with an existing internal audit program should review their results to ensure audit objectives are being met and to identify opportunities for improvement. Ask yourself the following questions: Are our internal audit plans and schedules being met? How well are departments meeting their requirements? Are our internal auditors writing good audit reports? How long is it taking to close audit corrective actions? What feedback are we receiving about our audits? Use the update of your internal audit process as an opportunity to take...

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Ten Tips for Selecting and Using a Consultant – 10. Schedule your internal audits differently

Nov 11, 2001 in Newsletter | 0 comments

The purpose of an internal audit program (schedule) is to plan the type and number of audits, as well as, to identify and provide the necessary resources to conduct them. The Plan-Do-Check-Act model can be applied to the management of internal audits: Plan:   Define the audit program Do:   Implement the audit program Check:  Review the audit program Act:   Improve the audit program The auditors need to understand how the new clause structure and requirements will affect their audit plans. Instead of auditing by clause, the organization...

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Ten Tips for Selecting and Using a Consultant – 1. Train your internal auditors on the new standard

Oct 10, 2001 in Newsletter | 0 comments

ISO 9000:2000 defines an auditor as a person with the competence to conduct an audit. Competence is further defined as the demonstrated ability to apply knowledge and skills. New internal auditors should attend a three-day ANSI/RAB-NAP accredited internal auditor class to learn good practices and how to interpret ISO 9001:2000 requirements. See the list of accredited course providers at: http://www.rabnet.com/qc_dir.htm Previously trained internal auditors should attend a two-day RAB approved auditor transition class to fully understand the...

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Ten Tips for Selecting and Using a Consultant – 2. Revise your internal audit procedure

Oct 10, 2001 in Newsletter | 0 comments

Even if you already have an internal audit procedure, you may need to revise it to address the requirements stated in ISO 9001:2000 clause 8.2.2 for Internal Audit. Although ISO 9001:1994 required an internal audit procedure, the new standard spells out that the procedure must define responsibilities and requirements for: Planning audits Conducting audits Reporting results Maintaining records Prior audit results must now be considered when planning the audit program (schedule), in addition to considering the status and importance of the...

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Ten Tips for Selecting and Using a Consultant – 3. Update your internal audit checklists

Oct 10, 2001 in Newsletter | 0 comments

Although checklists are not required by ISO 9001, most organizations use them to ensure their internal audits address all the stated requirements. Auditing courses promote the use of checklists and provide practice in creating them. However, audits to ISO 9001:2000 should cause us to rethink our use of checklists. As interview tools, they should help us audit effectively and provide valuable feedback on the results of the quality management system. If not, why use them? Well, there are good reasons to use them. Checklists, if developed and...

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Ten Tips for Selecting and Using a Consultant – 4. Adjust your audit approach

Oct 10, 2001 in Newsletter | 0 comments

The intent of ISO 9001:2000 is to encourage the adoption of the process approach to manage an organization. As a result, internal audits of your quality management system need to adopt a similar approach. An activity that uses resources to transform inputs to outputs can be considered a process. The output from one process may become the input to the next process. To function well, organizations have to identify and manage numerous interacting processes. The Process Approach involves the systematic identification and management of these...

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Ten Tips for Selecting and Using a Consultant – 5. Focus on new and changed requirements

Oct 10, 2001 in Newsletter | 0 comments

Market research firms often track the use of certain key words in newspapers and trade magazines to determine the general level of interest and acceptance of new topics. If we look at the word counts in ISO 9001:2000 compared to ISO 9001:1994, we see a dramatic shift in emphasis for some important areas: 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, and Planning occur 32 times versus 20 times Quality Objective can be found 11 times instead of...

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Survey Shows Strong Growth in ISO Registrations

Oct 10, 2001 in Newsletter | 0 comments

The International Organization for Standardization publishes an annual survey of worldwide registrations for ISO 9000 and ISO 14000. The most recent survey is available for free at: http://www.iso.ch/iso/en/commcentre/pressreleases/2001/Ref798.html ISO 9000 registrations at YE 2000 had increased by nearly 65,000 to 408,631 in 158 countries. ISO 14000 registrations increased by almost 9,000 to 22,897 in 98 countries. The top six countries for new ISO 9000 registrations last year were: 1. China, increase, 10 548 (total: 25 657) 2. Italy,...

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ISO 9001:2000 Guidance for Food and Drink Industry

Oct 10, 2001 in Newsletter | 0 comments

ISO/FDIS 15161, “Guidelines on the application of ISO 9001:2000 for the food and drink industry”, is expected to be published as an international standard by the end of this year. The guidance document is for organizations involved in all aspects of the industry, including sourcing, processing, and packaging of food and drink products. ISO/FDIS 15161 takes into account food safety systems such as Hazard Analysis and Critical Control Points (HACCP) for analyzing food processing for foreign, undesirable, or hazardous agents to ensure...

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Ways to Show Management Commitment

Oct 10, 2001 in Newsletter | 0 comments

How can top management demonstrate their commitment to the quality management system as required by clause 5.1 of the ISO 9001:2000 standard? Some suggested actions for top management are: 1. Learn Determine your customer needs and expectations. Understand the ISO 9001 requirements. 2. Imagine Envision the policy and objectives needed to meet requirements and achieve your vision. 3. Plan Formulate your strategy to achieve the quality objectives and manage change along the way. 4. Share Communicate your direction and values regarding quality....

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Quick Reference and Tips

Sep 12, 2001 in Newsletter | 0 comments

We have a two-page quick reference for all the ISO 9001:2000 sub-clauses with simple one line descriptions of the requirements. You can refer to our “Ten Tips for Moving to ISO 9001:2000” in the June, 2001 newsletter Next month, we will publish the first part of our new “Ten Tips for Auditing to ISO 9001:2000” guidance...

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Frequently Asked Questions

Sep 12, 2001 in Newsletter | 0 comments

The guidance document on Frequently Asked Questions includes 48 questions and answers. This list was developed from experts and users based on seminars and presentations around the world. These questions are reviewed and updated on a regular basis to maintain their accuracy and to include new questions as appropriate. A sampling of questions that may be of interest are: 10. Will we have to rewrite all our documentation? 13. What are the benefits of the revised standards? 14. What are the main changes to the standards? 15. What new requirements...

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Transition Planning

Sep 12, 2001 in Newsletter | 0 comments

The Transition Planning Guidance document explains that we are now in phase 2, the co-existence period for the 1994 and 2000 standards. Guidance is provided for current users of the ISO 9001:1994 and ISO 9002:1994 standards, as well as, new users of ISO 9001:2000. The document also shares guidance for registrars, training companies, and consultants. A large part of the guidance is devoted to summarizing the key ISO 9001:2000 enhancements compared to ISO 9001:1994. To see the transition planning guidance, go to:...

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Process Approach

Sep 12, 2001 in Newsletter | 0 comments

The process approach is one of the eight quality management principles incorporated by the ISO 9001:2000 family of standards. Since a process is simply a set of interrelated or interacting activities which transform inputs to outputs, the process approach refers to the systematic identification and management of these processes. The Process Approach guidance describes the concept and intent of the process approach. It also explains the difference between efficiency (results achieved versus resources used) and effectiveness (ability to achieve...

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Terminology Guidance

Sep 12, 2001 in Newsletter | 0 comments

The Terminology guidance document lists 164 important words and terms. In 77 cases, it refers you to the ISO 9000:2000 Fundamentals and Vocabulary document for the official definitions. However, it repeats the ISO 9000:2000 definitions for four “difficult” entries: Continual Improvement, Customer Satisfaction, Quality Improvement, and Requirement. The guidance includes dictionary definitions for 83 entries that are not covered in ISO 9000:2000. For example, the word “integrity” is used in ISO 9001:2000 and is defined by...

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Documentation Requirements

Sep 12, 2001 in Newsletter | 0 comments

The Guidance on the Documentation Requirements of ISO 9001:2000 explains why there has been a reduction in the required documentation with the new standard. The primary reason is to allow more flexibility in the way an organization chooses to document its quality management system. This means you can develop the minimum amount of documentation needed to show effective planning, operation, and control of your processes, as well as, the continual improvement of the system. The guidance points out that ISO 9001 has always required a...

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Clause 1.2, Application

Sep 12, 2001 in Newsletter | 0 comments

The scope of your quality management system should be based on the nature of your products and realization processes, as well as, the result of risk assessment, commercial considerations, and contractual, statutory, and regulatory requirements. If you choose to implement a system with limited scope, this should be clearly defined in your quality manual and other publicly available documents to avoid confusing or misleading customers. If you have overall responsibility for product realization, the fact that a specific process such as design or...

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Quality Management Principles

Sep 12, 2001 in Newsletter | 0 comments

The Quality Management Principles document introduces the eight principles upon which the ISO 9000:2000 family of standards were based: 1. Customer focus 2. Leadership 3. Involvement of people 4. Process approach 5. System approach to management 6. Continual improvement 7. Factual approach to decision making 8. Mutually beneficial supplier relationships The guidance describes the benefits of adopting these principles and the management actions necessary to apply them for improved organizational performance. To read about the eight quality...

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Selection and Use

Sep 12, 2001 in Newsletter | 0 comments

The brochure on Selection and Use of the ISO 9000:2000 Family of Standards is actually a collection of several documents at the ISO web site. The first part of the brochure explains its purpose and identifies the contents of the rest of the sections. You can see the opening section of the brochure at: <http://www.iso.ch/iso/en/iso9000-14000/iso9000/selection_use/selection_use.html>. The ISO 9000 Family portion of the brochure lists the standards, guidelines, and technical reports that make up the family. Go...

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EPA Issues Report on ISO 14001 Auditing

Aug 12, 2001 in Newsletter | 0 comments

The U.S. Environmental Protection Agency has completed a year-long, independent study of the third-party registration process for environmental management systems. Their analysis and recommendations were recently issued in a 142 page report. They concluded that the ISO 14001 accreditation, registration, and auditing systems are developing well at this “early stage”. Most registered organizations contacted for the study are satisfied with the results. These organizations report that third-party registration and auditing have...

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Free Subscriptions to Trade Magazines

Aug 12, 2001 in Newsletter | 0 comments

The Business News Publishing Company offers free subscriptions to 38 trade industry magazines to qualifying subscribers through their <http://www.renewforfree.com> site. Although it is set up for online renewals, the site can also be used by new accounts to sign up for free magazines. “Quality” is one of the magazines they offer at the site. Canon Communications publishes 13 trade magazines covering the medical manufacturing, general design, microelectronics, pharmaceutical, and packaging industries. You can request free...

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New QS-9000 Sanctioned Interpretations

Aug 12, 2001 in Newsletter | 0 comments

New QS-9000 Sanctioned Interpretations dated July 1, 2001 have been issued by the Supplier Quality Requirements Task Force of DaimlerChrysler, Ford, and General Motors. A letter to their global suppliers said the document had been updated with three new interpretations as part of their continued effort to support quality performance in the automotive supply chain. The three new interpretations are: 1. Entry C9 for QS-9000 3rd Edition, clause 4.6.2.1, now defines the goal of subcontractor development as compliance within 18 months after the...

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Audits of Registrars as Aerospace Suppliers

Aug 12, 2001 in Newsletter | 0 comments

Registrars that perform audits of aerospace suppliers to the revised AS9100 requirements will be considered as suppliers and audited by companies in the aerospace industry. Frank Paskiewicz of the Federal Aviation Administration (FAA) was quoted as saying any use of third-party quality system surveillance is considered a supplier activity and must be appropriately controlled. Dale Gordon, chairman of the Americas Aerospace Quality Group (AAQG) and director of quality and business improvement for Defense North America at Rolls Royce, stated in...

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New ISO Guidance for Health Care Industry

Aug 12, 2001 in Newsletter | 0 comments

The ISO 9004:2000-based guidance document for hospitals and other health care organizations has been approved for publication as an ISO Industry Workshop Agreement. This is the same document referred to in an earlier newsletter as an International Technical Agreement. The name for the ISO document category has changed from ITA to IWA. An IWA is an alternative to full-fledged International Standards when swift development and publication takes priority. An ITA is developed in open workshops rather than through the ISO technical committee...

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Revision for ISO 9000-3 Software Guidelines

Aug 12, 2001 in Newsletter | 0 comments

The ISO 9000-3:1997 Guidelines for the Application of ISO 9001 to the Development, Supply, and Maintenance of Software will be revised to incorporate the verbatim text of ISO 9001:2000. The revised ISO 9000-3 is expected to be published in 2002. The software guidance document will include references to these related (existing or developing) standards: ISO 12207 Information Technology — Software Life Cycle Processes ISO 15504 Information Technology — Software Process Assessment ISO 15939 Information Technology – Software...

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Use of Audit Checklists with ISO 9001:2000

Aug 12, 2001 in Newsletter | 0 comments

Although audit checklists have never been required by ISO 9001, most organizations use them to ensure their internal audits address all the documented requirements. Auditing courses promote the use of checklists and provide practice in creating them. However, audits to ISO 9001:2000 should cause us to rethink our use of checklists. As interview tools, they should help us audit effectively and provide valuable feedback on the results of the quality management system. If not, why are we still using them? Well, there are good reasons to use them....

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Data, Information, Knowledge, and Wisdom

Jul 12, 2001 in Newsletter | 0 comments

The May 2001 Project Management Institute (PMI) newsletter offered these explanations on the differences between data, information, knowledge, and wisdom: Data: Factual material such as measurements and statistics, frequently quantifiable. Information: Data endowed with meaning and purpose, which may differ according to individual interpretation. Knowledge: Understanding of a science, art, or technique, which is gained from study, experience, or association. Wisdom: Use of knowledge, with ability to discern inner qualities and relationships...

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The Importance of Analyzing Correct Data

Jul 12, 2001 in Newsletter | 0 comments

Clause 8.4 of ISO 9001:2000 requires an organization to determine, collect, and analyze data to demonstrate the suitability and effectiveness of its quality management system, as well as, to evaluate where continual improvements can be made. Guidance in ISO 9004:2000 states that data should be analyzed to assess performance against plans and objectives. Analysis of data can help determine the cause of existing or potential problems and, therefore, guide decisions about corrective and preventive actions. To effectively evaluate the performance...

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ISO 13485 for Medical Devices to be Revised

Jul 12, 2001 in Newsletter | 0 comments

More than 70 delegates from 19 countries and international organizations gathered in Tokyo in April to attend the eighth meeting of ISO/TC 210, Quality management and corresponding general aspects for medical devices, which was hosted by the Japan Federation of Medical Devices Associations (JFMDA). The US delegation included 12 representatives of the Association for the Advancement of Medical Instrumentation (AAMI) member companies and the Food and Drug Administration (FDA). One of the most significant developments in Tokyo was agreement to...

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ISO/DIS 19011 Ready for Download as E-Standard

Jul 12, 2001 in Newsletter | 0 comments

The draft of the new ISO 19011 standard for auditing both ISO 9000 (quality) and ISO 14000 (environmental) management systems is now publicly available. Benefiting from the considerable body of experience from audits of ISO management systems, the standard will replace six existing ones in the ISO 9000 and ISO 14000 families. The new combined standard will help user organizations to optimize their management systems, ease the integration of quality and environmental management, and, in allowing single audits of both systems, should save money...

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Revised AS9100 to be Available in August

Jul 12, 2001 in Newsletter | 0 comments

The AS9100 quality standard for the aerospace industry has been revised for ISO 9001:2000 and will be available from the Society for Automotive Engineers (SAE) in early August. The revised AS9100 uses the ISO 9001:2000 clause structure and contains no new requirements (beyond those of ISO 9001:2000). However, AS9100 reinstates some language on inspection and test that was dropped from ISO 9001:1994. According to one of the document authors, this is a sensitive area for the Federal Aviation Administration and civil air authorities. Although...

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New Information About QS-9000 Certificates

Jul 12, 2001 in Newsletter | 0 comments

An earlier article said organizations would have to move from QS-9000 to ISO/TS 16949:2002 to continue their automotive scheme registrations. This information was based on ISO 9001:1994 being withdrawn in December, 2003 and there being no plans to revise QS-9000 for ISO 9001:2000. However, based on my conversation with Randy Dougherty, RAB Director of Registrar Programs, I have learned that a company registered to QS-9000:1998 could continue its registration indefinitely with a reference ISO 9001:1994 or ISO 9002:1994 on its certificate. The...

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Ten Tips for Moving to ISO 9001:2000 – 1. Understand New and Changed Requirements

Jun 30, 2001 in Newsletter | 0 comments

When you are planning a trip, you must know your starting point and ultimate destination to decide on the most efficient and effective route. Similarly, you need to understand the new and changed ISO 9001:2000 requirements before plotting your transition path. Start by ordering the ISO 9001:2000, ISO 9000:2000, and ISO 9004:2000 family of standards. Copies can be purchased at http://qualitypress.asq.org. Before opening the ISO 9001:2000 Requirements standard, review the quality concepts described in the ISO 9000:2000 Fundamentals and...

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Ten Tips for Moving to ISO 9001:2000 – 2. Determine Scope and Permissible Exclusions

Jun 29, 2001 in Newsletter | 0 comments

ISO 9001:2000 is intended to be generic and applicable to all organizations, regardless of type, size, and product category. However, not all requirements in the new standard will necessarily be relevant to all organizations. Under certain circumstances, an organization may exclude some specific requirements. Clause 1.2, Application, in ISO 9001:2000 states that requirements can be excluded only if they are limited to clause 7, Product Realization. Exclusions are acceptable only if they do not affect the organization’s ability, or...

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Ten Tips for Moving to ISO 9001:2000 – 3. Adopt the Process Approach

Jun 28, 2001 in Newsletter | 0 comments

A “process” is a system of activities that uses resources to transform inputs into outputs. The “process approach” promoted by ISO 9001:2000 systematically identifies and manages these processes and their interaction within a quality management system. As mentioned in an earlier tip, the process model illustrates the linkage of ISO 9001:2000 clauses (4-8) based on the plan-do-check-act approach. This PDCA methodology can be applied to all processes. In the Plan step, you establish the objectives and processes necessary to deliver...

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Ten Tips for Moving to ISO 9001:2000 – 4. Revise Quality Manual and Procedures

Jun 27, 2001 in Newsletter | 0 comments

The documentation for a compliant quality management system must include the quality policy, quality objectives, quality manual, required procedures, and other documents deemed necessary for its effective planning, operation, and control. These requirements are covered in clause 4.2.1 of ISO 9001:2000. You may already have the necessary documentation in place for the new standard. However, check your current documents to ensure they adequately address the new and changed ISO 9001:2000 requirements. For organizations registered to ISO 9001:1994...

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Ten Tips for Moving to ISO 9001:2000 – 5. Focus on Expanded Top Management Role

Jun 26, 2001 in Newsletter | 0 comments

ISO 9000:2000 defines top management as the person or group of people who directs and controls an organization at the highest level. Top management leadership, commitment, and active involvement are essential for an effective quality management system. Every sub-clause in clause 5, Management Responsibility, begins with the phrase “Top management shall”. Top management must provide evidence of their commitment to the development and implementation of the quality management system, as well as, the continual improvement of its...

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Ten Tips for Moving to ISO 9001:2000 – 6. Establish Measurable Quality Objectives

Jun 25, 2001 in Newsletter | 0 comments

When you drive down the road, you can glance at the indicators on the dashboard to see how your car is performing. In a similar fashion, your organization needs to identify the key quality measures for evaluating the performance of your quality management system. First, use the quality policy statement as the framework for establishing your process and product goals. Then set specific, measurable targets on the path to attaining these goals. The product objectives will be largely determined by your product specifications. Focus your attention...

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Ten Tips for Moving to ISO 9001:2000 – 7. Prepare Your Transition Plan

Jun 24, 2001 in Newsletter | 0 comments

We began these tips by talking about planning a trip. To know your starting point, you should assess your current system against the requirements of the new standard (your destination). This gap analysis will identify any missing documentation and practices. Knowing the needed deliverables, you can determine the appropriate activities and assignments to enhance your current system for compliance with ISO 9001:2000. Develop the transition schedule in consultation with your registrar. Depending on your system status and business needs, you may...

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Ten Tips for Moving to ISO 9001:2000 – 8. Inform Organization of Changes and Plans

Jun 23, 2001 in Newsletter | 0 comments

It is important to keep everyone within the scope of your quality management system informed of your plans and progress. Clause 5.5.3 of ISO 9001:2000 requires internal communication channels be established to share information about the effectiveness of your quality management system. Top management will rely on internal communications to convey the importance of meeting customer requirements. The organization must also make employees aware of the relevance and importance of their activities and how they contribute to achieving the quality...

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Ten Tips for Moving to ISO 9001:2000 – 9. Update Your Internal Audit Program

Jun 22, 2001 in Newsletter | 0 comments

Clause 8.2.2, Internal Audit, requires an organization to consider the process status and importance when planning an audit program. Since the quality management system will be revised to comply with ISO 9001:2000, your internal audit schedule should focus on the areas of new and changed practices. In addition, the internal audit procedure must be updated to comply with the requirements of clause 8.2.2. Don’t overlook training your internal auditors on ISO 9001:2000. The auditors need to understand how the new clause structure and...

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Ten Tips for Moving to ISO 9001:2000 – 10. Identify Areas for Continual Improvement

Jun 20, 2001 in Newsletter | 0 comments

According to clause 8.5.1, the organization must 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 preventive actions, and management review. Management should continually seek to improve process effectiveness rather than wait for problems to reveal opportunities for improvement. When a problem does occur, the cause must be determined and a corrective action taken to prevent its recurrence. The new standard emphasizes...

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RAB-Approved ISO 9001:2000 Transition Classes

May 12, 2001 in Newsletter | 0 comments

Our Auditor Refresher course is approved by the RAB, and accepted by IRCA, for the required transition training for certified auditors and lead auditors. The course is also valuable for previously trained internal auditors that need to understand the new ISO 9001:2000 requirements and consider the possible effects on audit approaches. Our transition training course has been taught more than 20 times over the past three months. It was selected by a major registrar to train nearly 100 of their auditors. The Auditor Refresher course will be...

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ISO 9001:2000 Quick Reference

May 12, 2001 in Newsletter | 0 comments

This article includes part of a reference document available on our web site under Resources. It is a quick clause-by-clause summary of the ISO 9001:2000 requirements. See the standard for a complete description of the actual requirements. ISO 9001:2000 Clauses Summary of Requirements     5. Management Responsibility     5.1 Management Commitment  Show evidence of top management commitment     5.2 Customer Focus  Meet the requirements and satisfy your customers     5.3 Quality Policy  Have top management express quality...

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Will Quality Objectives Help or Hurt?

May 12, 2001 in Newsletter | 0 comments

Clause 5.4.1 of ISO 9001:2000 requires top management to ensure measurable quality objectives are established at relevant levels and functions within the organization. However, be careful how you set these objectives and how you communicate them. You might find people actually manipulating processes to achieve the desired results, especially if the numbers are used to evaluate employee performance. When handled poorly, performance targets can result in internal competition and a lack of cooperation. In fact, a specific process objective can be...

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FS 9000 in Financial Services Future?

May 12, 2001 in Newsletter | 0 comments

The automotive industry has QS-9000, the aerospace industry has AS 9100, and the telecommunications industry has TL 9000. Will the financial services industry be next with FS 9000? KPMG and Productivity Resources recently sponsored an ISO/FS 9000 Quality Awareness Conference at Citigroup’s corporate facility in New York for more than 80 executives from more than 30 top financial services firms. For more information about the proposed FS 9000 association and standard, go to:...

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TL 9000 Handbooks Revised for ISO 9001:2000

May 12, 2001 in Newsletter | 0 comments

The Quality Excellence for Suppliers of Telecommunications (QuEST) Forum is a unique partnership of telecommunications suppliers and service providers. It was founded by Bell Atlantic, Bell South, Pacific Bell and Southwestern Bell and now has more than 110 members. The QuEST Forum has released their new TL 9000 Quality Management System Requirements Handbook (Release 3.0) that incorporates the recently released ISO 9001:2000 standard. The handbook promotes consistency and efficiency, as well as, improved customer satisfaction in the...

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TickIT Guide 5.0 Aligned with ISO 9001:2000

May 12, 2001 in Newsletter | 0 comments

Issue 5.0 of the TickIT Guide has been released to align with ISO 9001:2000. It includes improved clause-by-clause guidance for software developers and provides detailed cross-references to the ISO 12207 software life cycle processes. Use of the Guide can help software companies adopt a process-based approach to quality systems management. The guide also provides guidance for customers of computerized systems with a focus on the key role that customers play in achieving quality. Of special interest is the revised guidance for auditors of...

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How will ISO 9001:2000 Change your Procedures?

May 12, 2001 in Newsletter | 0 comments

Only six documented procedures are specifically required by the new ISO 9001:2000 standard. Although these same procedures are also required by ISO 9001:1994, you need to ensure they address the new and changed requirements. 1. Control of Documents (4.2.3) – A key difference is that documents must be reviewed, updated as necessary, and re-approved. This implies a periodic review of controlled documents to find out if they need to be updated. In addition, changes must always be identified, not just “where practical”. Your current...

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RAB-Approved ISO 9001:2000 Transition Classes

Apr 12, 2001 in Newsletter | 0 comments

Our Auditor Refresher course is approved by the RAB, and accepted by IRCA, for the required transition training for certified auditors and lead auditors. The course is also valuable for previously trained internal auditors that need to understand the new ISO 9001:2000 requirements and consider the possible effects on audit approaches. Our transition training course has been taught 20 times over the past three months. It was selected by a major registrar to train nearly 100 of their auditors. The Auditor Refresher course will be taught...

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Scope Statements on Registration Certificates

Apr 12, 2001 in Newsletter | 0 comments

The International Accreditation Forum (IAF) has issued the following guidance for registration certificates: Certificates issued to ISO 9001:2000 shall state clearly in words the scope of the quality management system in a way that will not mislead customers, and shall ensure that information is available for the user to determine which categories of product and product realization processes are included within the scope of registration. In particular, scope statements shall be explicit in stating the responsibility for product design and...

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Application of Clause 7.3 – Design and Development

Apr 12, 2001 in Newsletter | 0 comments

Since ISO 9001:2000 replaces the 1994 editions of ISO 9001, ISO 9002, and ISO 9003, it will no longer be clear from the standard title if the registered system includes design and development. As a result, the International Accreditation Forum (IAF) has issued the following guidance: If an organization has responsibility for, and performs or outsources the design and development of products that are within the scope of its certification, then clause 7.3 of ISO 9001:2000 shall be included in the quality management system. When assessing the...

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Key Changes in Documentation Requirements

Apr 12, 2001 in Newsletter | 0 comments

ISO 9001:2000 is less prescriptive than the 1994 version and allows an organization to be more flexible in the way it documents its quality management system. Organizations should develop the minimum amount of documentation needed to demonstrate the effective planning, operation, and control of its processes. The extent of the documentation will be based on process complexity, personnel competence, and organization size. Clause 4.2 of ISO 9001:2000 describes the documentation requirements for a quality management system. To see how these...

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The Future of QS-9000 and ISO/TS 16949

Apr 12, 2001 in Newsletter | 0 comments

The European and US original equipment manufacturers of the International Automotive Task Force (IATF) have said they: Will revise ISO/TS 16949:1999 for ISO 9001:2000 by March 2002 Have no plans to revise QS-9000, VDA6.1, EAQF94, or AVSQ94 for ISO 9001:2000 ISO/TS 16949:1999 certificates will remain valid until December 15, 2003, which corresponds to the end of the transition period for moving to ISO 9001:2000. What are your options as a QS-9000 registered organization? You can maintain your current QS-9000 registration until ISO/TS...

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How Well Do You Know ISO 9001:2000?

Apr 12, 2001 in Newsletter | 0 comments

How well do you know the new ISO 9001:2000 standard? Can you identify the clauses for these requirements? (See the answers at the end of the newsletter)    1. Reviewing the system at planned intervals: __________    2. Identifying the status of product measurements: __________    3. Maintaining process equipment: __________    4. Handling, packaging, and storing products: __________    5. Preventing the recurrence of nonconformities: __________    6. Maintaining evidence of conformity to acceptance criteria: _________    7....

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Answers for the ISO 9001:2000 Clause Quiz

Apr 12, 2001 in Newsletter | 0 comments

The correct clauses for the ten requirements are:    1. Reviewing the system at planned intervals = 5.6.1 [also 8.2.2 regarding audits]    2. Identifying the status of product measurements = 7.5.3    3. Maintaining process equipment = 6.3 (b)    4. Handling, packaging, and storing products = 7.5.5    5. Preventing the “recurrence” of nonconformities = 8.5.2 (not 8.5.3)    6. Maintaining evidence of conformity of acceptance criteria = 8.2.4    7. Ensuring requirements are complete and unambiguous = 7.3.2  [implied by...

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RAB-Approved ISO 9001:2000 Transition Classes

Mar 12, 2001 in Newsletter | 0 comments

Our Auditor Refresher course is approved by the RAB, and accepted by IRCA, for the required transition training for certified auditors and lead auditors. The course is also valuable for previously trained internal auditors that need to understand the new ISO 9001:2000 requirements and consider the possible effects on audit approaches. Our transition training course has been taught 20 times over the past three months. It was selected by a major registrar to train nearly 100 of their auditors. The classes scheduled for the first half of 2001 are...

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Free Copy of 2001 Baldrige Criteria

Mar 12, 2001 in Newsletter | 0 comments

You can receive a free paper copy of the 2001 Baldrige Criteria for Performance Excellence by requesting it from nqp@nist.gov or by calling the National Institute of Standards and Technology (NIST) at 302-975-2036. You can also download a free PDF version by connecting to: <http://www.quality.nist.gov/2001_Criteria.pdf.htm>. You can select to receive the Business Criteria, Education Criteria, or Health Care Criteria. The Baldrige Criteria for Performance Excellence provide a systems perspective for understanding performance management....

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EMS Audits Must Include Regulated Aspects

Mar 12, 2001 in Newsletter | 0 comments

The Registrar Accreditation Board (RAB) recently notified its EMS-accredited registrars that regulated aspects of an environmental management system must be included in audit plans for an organization. The registrars were told that efforts to exclude activities regulated under environmental law are in violation of the intent of ISO 14001 and the NAP EMS registrar accreditation criteria.

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Drawing the Line Between Safety and Quality

Mar 12, 2001 in Newsletter | 0 comments

This question was submitted by a newsletter reader. If you have a question for me, or want to comment on this response, please send a note to <Larry@WhittingtonAssociates.com>. Clause 6.4 requires an organization to determine and manage the work environment needed to achieve conformity to product requirements. Where do we draw the line between work environment requirements and health and safety (OHSA) requirements? Are there cases where a safety problem could be identified as a nonconformity? ISO 9004:2000 includes safety as a...

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Audit Trail Index for ISO 9001:2000

Mar 12, 2001 in Newsletter | 0 comments

  When developing an audit plan, you may need to look beyond the primary clause for a subject to fully evaluate it. For example, to assess compliance with the requirement for “quality objectives”, you would first look at clause 5.4.1:   5.4.1  Planning – Quality Objectives   Top management must ensure that quality objectives, including those needed to meet requirements, are established at relevant functions and levels within the organization. The quality objectives must be measurable and consistent with the...

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Suitability, Adequacy, and Effectiveness

Mar 12, 2001 in Newsletter | 0 comments

One of our readers asked for an explanation of the words suitability, adequacy, and effectiveness as used in ISO 9001:2000 clause 5.6.1: “Top management shall review the organization’s quality management system, at planned intervals, to ensure its continuing suitability, adequacy, and effectiveness.” Suitability is the fitness of the quality management system for its defined purpose. For example, is the system suitable to direct and control activities of the organization to achieve its quality policy and quality...

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RAB-Approved ISO 9001:2000 Transition Classes

Feb 12, 2001 in Newsletter | 0 comments

Our Auditor Refresher course is approved by the RAB, and accepted by IRCA, for the required transition training for certified auditors and lead auditors. However, the course is also valuable for previously trained internal auditors that need to understand the new ISO 9001:2000 requirements and recognize how it affects their current audit methods. The transition training course has been taught 15 times over the past three months. It was selected by a major Registrar to train nearly 100 of their auditors. The classes scheduled for the first...

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Monitoring Information on Customer Satisfaction

Feb 12, 2001 in Newsletter | 0 comments

Clause 8.2.1 of ISO 9001:2000 requires monitoring of information about the customer’s perception of how well the organization has met the customer’s requirements. In addition, the organization must determine the methods for obtaining and using this information. The second article in this newsletter interpreted the requirement. If we agree that determining customer satisfaction is more than reviewuating complaints, then what information is needed and how do organizations go about obtaining it? Capturing the “voice of the...

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Top 10 Ways To Reduce Software Defects

Feb 12, 2001 in Newsletter | 0 comments

Many organizations develop software applications in support of their quality management systems. However, software complexity and tight schedules often result in application defects that affect product quality. An article by Bohemia and Basil in the January, 2001 issue of Computer magazine identified the ten best techniques for reducing software defects. Their findings, based on objective and quantifiable data, should be shared with the software specialists in your organization. 1. Finding and fixing a software problem is often 100 times more...

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Evidence of Transition Planning

Feb 12, 2001 in Newsletter | 0 comments

Our last newsletter had an article on Requirements in ISO 9001:2000 for Planning. As organizations perform the system-level planning required by clause 5.4.2, they are to maintain the integrity of the system as changes are implemented. Note that the transition to the new ISO 9001:2000 standard is itself a significant change to the system and must be thoroughly planned. Clause 5.6 (f) requires that management reviews consider changes that could affect the quality management system. Ensure your transition activities are properly planned,...

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Do You Agree With These Interpretations?

Feb 12, 2001 in Newsletter | 0 comments

What is your opinion on how to interpret these new requirements? Are you now required to re-evaluate controlled documents on a periodic basis? Will compliance require more than analyzing complaints to judge customer satisfaction? Will the quality manual need to address every requirement in the standard? Is equipment maintenance no longer a specific requirement? Are you no longer required to evaluate the effectiveness of corrective actions? Clause 4.2.3 (b) on Reevaluating Documents Did you notice that clause 4.2.3 (b) states “to review...

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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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