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Welcome to the Whittington & Associates e-Newsletter! Visit and bookmark our web site today: http://www.WhittingtonAssociates.comThis e-newsletter is in HTML
format and may not be displayed properly by some email programs.
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 intensity of the demand for the standards is illustrated by the fact that the first download by a national standards institute took place only three minutes after access to the documents on the ISO server was opened. The ISO 9000 series of International Standards for quality management is among the most widely known and successful of the 13,000 standards published by ISO since it began operations in 1947. The ISO 9000 standards have become an international reference for quality requirements in business-to-business dealings and form the basis of more than 350,000 certified quality management systems within private and public sector organizations in at least 150 countries. Current ISO 9000 certificate holders will have up to three years to make the transition to the new versions. ISO rules demand that its standards be reviewed periodically in the light of technological and market developments. The 2000 revisions of the ISO 9000 series represent the most thorough overhaul of these standards since they were first published in 1987. The new versions take account of developments in the field of quality and the considerable experience that now exists with implementing ISO 9000. Among the changes are:
"The new versions of the standards will provide organizations with an opportunity to improve their existing quality management systems with a view to adding value both for the organization and its customers. In addition to wider acceptance and implementation in current user sectors, the new editions will attract many new users from less traditional fields, thereby contributing to ISO’s goals of facilitating trade, increasing global prosperity, and contributing to social well-being." Dr. Caillibot paid tribute to the national delegations of quality experts from 63 countries which participated in the development of the revised standards, in collaboration with 22 liaison organizations representing key business or economic groupings. He added: "The publication of the ISO 9000:2000 series represents the culmination of years of development in which full use has been made of the experience gained from the previous editions and of the valuable input from users via the ISO consensus process. In addition to these customary ways of working, ISO/TC 176 has brought innovation to the development of standards by introducing business techniques such as user surveys and field validations – while the whole has been tied together by rigorous project management. We are proud of our product and deliver the ISO 9000:2000 series with confidence to users." In parallel with the standards, ISO/TC 176 has developed explanatory and guidance documents to help ensure a smooth transition to the ISO 9000:2000 series. This material, which is free of charge, is available on the ISO web site: (www.iso.ch). The revised ISO 9000, ISO 9001 and ISO
9004 standards can be purchased from the American Society for Quality (ASQ) web
site. To order the hard copy versions, go their Quality
Press page. To order the electronic versions, go to their e-Standards
page.
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: infrastructure, dependability, preventive action, corrective action, correction, rework, repair, scrap, audit, criteria, audit evidence, audit findings, audit conclusion, auditor, audit team, metrological confirmation, measuring equipment, and metrological function. Numerous definitions had NOTEs revised for improved explanations or because of the changed reference numbers. If your organization prepared a draft glossary document based on ISO/FDIS 9000:2000, you should verify your definitions are still appropriate by checking the modified terms in the published Standard. We have prepared a list of ISO 9000:2000 FDIS to IS Changes that can be viewed at our web site. ISO 9001:2000 The word "fulfil" and its variations were replaced by "meet" and its variations throughout the standard. Interestingly, ISO 9004 also made the same changes, but ISO 9000 went the other direction and changed from "meet" to "fulfil". The title of clause 4.2.4 was changed from "Control of Quality Records" to just "Control of Records". This change makes sense because clause 4.2.3 is merely "Control of Documents. All references to "quality records" were changed to "records" within the Standard. Clause 7.2.1, Determination of Requirements Related to the Product, revised "specified use or known and intended use" to more clearly say "specified or intended use, where known". Similarly, clause 7.3.5, Design and Development Validation, changed "specified or known intended use or application" to "specified application or intended use, where known". Clause 7.3.4 (Review) and 7.3.5 (Verification) both added "performed in accordance with planned arrangements (see 7.3.1)". This phrase was already in clause 7.3.5 (Validation). Although it should have been clear in clause 7.5.1 (due to "as applicable") that work instructions are not a requirement, the Standard now has "as necessary" at the end of sub-clause b) about the availability of work instructions. Four cross-references in Annex B.1 (1994 to 2000) were added and twenty-two cross-references were dropped. Annex B.2 (2000 to 1994) had eight cross-reference added and twenty-six cross-references dropped. If you included cross-references in your draft ISO 9001:2000 quality manual, you may need to revise them to reflect the published cross-references. We have prepared a list of ISO 9001:2000 FDIS to IS Changes that can be viewed at our web site. ISO 9004:2000 Most of the changes in ISO 9004 were slight wording differences, but in a few cases the modifications resulted in quite different meanings. For example, the phrase "transparent manner" was replaced by "visible manner" in clause 4.3 on the use of the quality management principles. The clause numbers in ISO 9004 are still different from ISO 9001 in parts of clauses 7.5 and 8.2. For example, ISO 9004 does not include guidance for Process Validation (7.5.2) and uses that reference number for its guidance on Identification and Traceability, which is actually clause 7.5.3 in ISO 9001. As a result, the guidance clause numbers are offset for the remainder of that section. If you were wondering about the plans for ISO 9000-4 (Dependability Management), a reference to IEC 60300-1 was added to the bibliography and this new entry is described as the replacement for ISO 9000-4. We have prepared a list of ISO
9004:2000 FDIS to IS Changes that can be viewed at our web site.
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 Planning Clause 5.4.1 covers the planning necessary to establish measurable quality objectives that are consistent with the quality policy. This planning must ensure the objectives include those needed to meet product requirements and are established at the relevant functions and levels within the organization. Guidance from ISO 9004 suggests that management consider current product and process performance, as well as, relevant findings from management reviews, in establishing the objectives. This planning should also cover how the objectives will be communicated to ensure their understanding and achievement. Clause 5.4.2 addresses the system-level planning necessary to meet the overall requirements expressed in clause 4.1. Therefore, planning must be carried out to establish, document, implement, and maintain the quality management system. The system planning must include:
ISO 9004 summarizes this planning by suggesting it focus on defining the processes needed to effectively and efficiently meet the quality objectives and requirements in a manner consistent with the strategies of the organization. 7.1 Planning of Product Realization Clause 7.1 requires the organization to plan and develop its processes for product realization. This planning must be consistent with other process requirements defined for the system in clause 4.1 and, therefore, compatible with the planning covered in clause 5.4. The product realization planning must determine:
According to ISO 9004, the product realization plan, or operating plan, should consider topics such as the desired outputs, process steps, activities, flows, control measures, training needs, equipment, methods, information, resources, and support processes. 8.1 General Clause 8.1 requires an organization to plan and implement the monitoring, measurement, analysis, and improvement processes necessary to:
According to clause 8.1.1 of ISO 9004, this planning should cover the processes for recording, collecting, analyzing, summarizing, and communicating the relevant data needed to monitor and improve organizational performance. It goes on to say the measurement criteria and objectives should be identified. Clause 8.1.2 provides a list of issues to be considered when planning for measurement, analysis, and improvement. Planning Evidence Since system-level planning also includes planning for product realization and measurement processes, an organization could devise a checklist to address most, if not all, of these related planning requirements. The checklist itself would be evidence of system planning. The completed checklist, along with actions, would be evidence of product realization and measurement planning. Since ISO 9001 states the planning
output can be in any form suitable for the organization, the evidence could also
be in planning documents, such as a quality plan, or even meeting minutes. The
key is to recognize the related planning activities and determine if multiple
requirements can be addressed in a single, comprehensive approach.
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 (for interfaces between groups) and in purchasing (for communications with suppliers). 5.1.a) Management Commitment 5.3.d) Quality Policy 5.5.1 Responsibility and Authority 5.5.3 Internal Communication 6.3.c) Infrastructure 7.2.3 Customer Communication 7.3.1 Design and Development Planning 7.4.2 Purchasing Information Develop a comprehensive communications
approach by considering the overall requirements for communicating with
customers, with suppliers, and within the organization.
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. The classes scheduled for the first half of 2001 are listed below: The Auditor Refresher course will be taught in Atlanta on:
Our last e-newsletter included information on:
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other questions or comments, please e-mail us at Larry@WhittingtonAssociates.com |
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