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Welcome to the Whittington & Associates e-Newsletter! Visit and bookmark our web site today: http://www.WhittingtonAssociates.com This e-Newsletter
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Now is the time for US organizations to register their experiences, comments, and concerns on the use of ISO 9001:2000 and ISO 9004:2000. It is critical that ISO gets feedback on actual user experiences on the application of these two standards. Since US organizations will be providing feedback along with other ISO member countries, it is essential that our experience with the use of these standards be recorded so that US interests are represented and protected. To be included, your comments must be submitted through the ISO survey located at: http://isotc.iso.ch/webquest/tc176/index.html It should only take about 15 minutes to complete the survey. Anyone with some knowledge or experience with the standards may participate. Where you indicate concerns, participants will be prompted to suggest improved wording of the clauses (if interested). Since there is no limit to the number of people who may respond from any one organization, it is imperative that actual US users of the standards take the time to participate in order that all US experiences are adequately represented in the evaluation. Your participation is vital and your feedback goes directly to ISO! When the survey is completed, the results of the survey will be widely disseminated, e.g., through the ISO/TC 176/SC 2 web site at www.bsi.org.uk/ios-tx176-sc2. The results of the survey will play a major role in guiding the revisions of these standards.
Manufacturing is a cornerstone of the American economy. The United States is the world’s largest producer of manufactured goods and leads the world in innovation. Simply put, manufacturing matters -- to jobs, rising productivity, and higher standards of living. Manufacturers improve our quality of life. To help identify the challenges facing our manufacturing sector, the Department of Commerce held many public roundtables over the past year. These discussions included representatives from small, medium, and large companies from a broad range of industries, including auto parts, aerospace, biotechnology, and semiconductors. Through this dialogue, they heard the challenges facing US manufacturers. The feedback from manufacturers fell within the following six categories: 1. Focusing On Manufacturing and Its CompetitivenessTheir report included recommendations for each of these six areas. For example, the recommendations for "Strengthening Education, Retraining, and Economic Diversification" are:
How should internal auditors determine if their organization is conforming to regulatory requirements? Before answering this question, lets review the references to "regulatory" requirements in ISO 9001:2000:0.1, Introduction - General: This International Standard can be used ... to assess the organization's ability to meet customer, regulatory, and the organization's own requirements. 1.1, Scope - General: This International Standard specifies requirements for a quality management system where an organization ... b) aims to enhance customer satisfaction through ... and the assurance of conformity to customer and applicable regulatory requirements. 1.2, Application: Where exclusions are made, claims of conformity to this International Standard are not acceptable, unless ... and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements. 5.1, Management Responsibility - Management Commitment: Top management shall provide evidence of its commitment ... by: a) communicating to the organization the importance of meeting customer, as well as, statutory and regulatory requirements, ... 7.2.1, Determination of Requirements Related to the Product: The organization shall determine ... c) statutory and regulatory requirements related to the product, and ... 7.3.2, Design and Development Inputs: These inputs shall include ... b) applicable statutory and regulatory requirements, ... What is the difference between "statutory" and "regulatory" requirements? A statute is a law enacted by the legislative branch of a government. A regulation is a rule or order issued by an executive authority or regulatory agency of a government that has the force of law. If audits evaluate the conformity of a quality management system to the requirements of ISO 9001:2000, then clauses 5.1.a, 7.2.1.c, and 7.3.2.b indicate audits must also address statutory and regulatory requirements. Among the regulation sources are the Food and Drug Administration (FDA), Federal Aviation Administration (FAA), Occupational Health and Safety Administration (OHSA), and Environmental Protection Agency (EPA). Requirement examples are: Safety-related, e.g., Federal Motor Vehicle Safety Standards; Environment-related, e.g., recycling permits for waste oil; and Medical-related, e.g., Quality System Regulation -Title 21 part 820 - Code of Federal Regulations. Legal requirements are extremely important. If they are violated, your products could be recalled, fines levied, facilities closed, and criminal penalties imposed. Unfortunately, many auditors are unaware of these legal requirements. They may be the most important requirements to be met, yet many internal audits ignore them. However, someone must know about these requirements, because clause 7.2.1.c requires the organization to determine them. Auditors must ask the appropriate people, "What regulatory requirements are applicable to our products and organization?" And, it all begins with management, since clause 5.1.a states top management must communicate the importance of meeting these legal requirements. Remember, we're not just talking about federal regulations. There may also be state or local regulations that apply to your products. If your organization is involved with international business, there will be foreign laws and regulations to consider, as well as, the permits and clearances needed to import and export products. Auditors should identify the statutory and regulatory requirements that are recognized by the organization. Then, find out how these requirements are addressed by the quality management system.
ISO has published new guidelines for organizations in the education sector wishing to benefit from the implementation of ISO 9001:2000. The guidelines are intended for organizations at all levels, providing all types of education: elementary, medium and higher; special and adult education; and distance and e-learning. ISO/IWA 2: Quality management systems - Guidelines for the application of ISO 9001:2000 in education, contains the full text of ISO 9001:2000, clause-by-clause, followed by specific text making the standard easier to understand and implement by the education sector. In addition, IWA 2 includes the full text of ISO 9004:2000, which gives organizations guidelines for achieving further benefits from their quality management systems through the pursuit of continual performance improvement. The IWA 2 guidelines do not add
to, change, or modify the requirements of ISO 9001:2000. It is not intended
that organizations be certified to the document. However, IWA 2 can be
used to assess the organization's ability to meet customer, regulatory,
and its own quality requirements. As a result, it will be useful to both
internal and external parties (including registrars) when the user organization
is seeking ISO 9001:2000 registration. IWA 2 is ISO's second International
Workshop Agreement (IWA 1 provided guidelines for process improvements
in health service organizations). An IWA is one of several ISO alternatives
to International Standards where swift development and publication takes
priority. Compared to the usual ISO process of developing International
Standards through its technical committee structure, the IWA is developed
in open workshops and organized by a national standards institute. IWA 1 is available from ASQ, so
I expect that you will be able to order IWA 2 soon at <http://qualitypress.asq.org>.
Several readers questioned my use of "certification"
in an article last month about publicizing an ISO 9001:2000 certificate.
They felt the term should have been "registration". My article was based
on an official ISO press release dated 12/15/03.
We’ll begin with a box, and the plural is boxes,
But the plural of ox became oxen, not oxes.
And the plural of cat is cats, not cose. Source: AAA Going Places: November – December 2002
To enroll in these public classes, go to Class Schedule at our web site, or call us at 800-404-7585. The classes taught by Larry Whittington are shown in gold. ISO 9001:2000 Lead Auditor (RAB Accredited)
- BSI Management Systems
ISO 9001:2000 Internal Auditor (RAB Accredited) - BSI Management Systems
ISO 9001:2000 Auditor Update - The Process Approach - Course developed by Larry Whittington
Implementing ISO 9001:2000 -
Course developed by Larry Whittington
Understanding ISO 9001:2000
Understanding ISO 9001:2000 Requirements
(Atlanta Only - $295) - Course
developed by Larry Whittington
Quality System Documentation (ISO 9001:2000)
- Course developed by Larry Whittington
The above public courses can be offered on-site at your
facility. In addition, we offer these on-site courses:
To arrange an economical on-site class, please call us at 800-404-7585.
© 2000-2004 Whittington & Associates, LLC. All rights reserved. You may copy this e-Newsletter provided you copy it completely, do not change it, and include this copyright notice. |
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