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Greetings! Welcome to Sustaining Edge Solutions E- Newsletter Our newsletters provide guidance on operational and quality systems ISO 9001, AS9100, ISO/TS 16949, TL 9000, ISO 13485, ISO 14001, and others. This includes process improvement methods Six Sigma, Lean Enterprise, and other topics of interest to our readers. If you have any questions about the articles appearing in this issue, or you want to suggest topics for future issues, please let us know. The Best of the New Year to You!
The Draft International Standard version is now being circulated for review and comment. The new publication date is expected to be late 2008, so I will refer to the revised standard as ISO 9001:2008.
Please note that only the new or changed sections are discussed. Unaffected text has not been included. To begin, under 4.1 General Requirements, sub-clause (a), the word “Identify” has been replaced with “Determine”: 4.1 General Requirements a) Determine the processes needed for the quality management system and their application throughout the organization (see 1.2), Although similar, the words “Identify” and “Determine” have slightly different meanings. To identify is to recognize or establish something as being a particular thing. To determine is to apply reason and reach a conclusive decision. Therefore, to determine the processes implies more analysis and judgment than merely identifying them. e) monitor, measure (where applicable) and analyze these processes, and … Processes are monitored, but may not need to be measured. Therefore, the requirement change indicates processes are only measured where applicable. 4.2.3 Control of DocumentsThe first sentence of this clause in the draft standard still states that documents required by the quality management system are to be controlled. The only suggested change to clause 4.2.3 is shown below: f) to ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled, and The change in sub-clause (f) clarifies that not all external documents have to be identified and controlled; only those necessary for the planning and operation of the quality management system. 4.2.4 Control of Records The opening sentence for clause 4.2.4 has expanded from records being “maintained” to having them “controlled”. Maintaining the records would be to simply keep them in good condition. Controlling the records means to regulate their use. The organization shall establish a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention, and disposition of records. The requirement for a documented Record Control procedure was rewritten as shown above, but the content is basically the same. Note that “retention time” has been reduced to “retention”. Records must still remain legible, readily identifiable, and retrievable. This text was just moved to the end of clause 4.2.4. 5.5.2 Management Representative Top management shall appoint a member of the organization’s management who, irrespective of other responsibilities, shall have responsibility and authority that includes: I’ve encountered a few small companies that have outsourced the Management Representative role to a consultant or non-managerial personnel. I wonder if this clarification is aimed at that practice? 7.1 Planning of Product Realization The only change to the text of clause 7.1 is the addition of “measurement” as one of the required activities to be determined during the planning of product realization. In planning product realization, the organization shall determine the following, as appropriate: c) required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance; 7.2.1 Determination of Requirements Related to the Product The slight change below from “for delivery and post-delivery activities” to “for delivery, and for post-delivery activities” adds emphasis to post-delivery activities. In addition, a Note has been added with examples of post-delivery activities. NOTE: Post delivery activities include, for example, actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal. Look for more proposed changes in Next Month’s Issue!
Another new year. Will it be more of the same for you?
Think big for a change! The really positive thinker sees the invisible, feels the intangibles, and achieves the impossible. It’s called a quantum leap. Give the following some thought…
Ask yourself: What were some of the things I did last year that were non-productive; things that, given another chance, I wouldn’t do? What will I commit to doing differently this year? Thanks to Sam Williams, New View Group for the insights.
The ISO 28000 series of standards on supply chain security management systems have been upgraded from their status as Publicly Available Specifications to that of full International Standards. They are expected to help reduce risks to people and cargo by addressing potential security issues such as terrorism, fraud, and piracy.
The ISO 28000 standards specify the requirements for a security management system to ensure safety in the supply chain. They can be applied by organizations of all sizes involved in manufacturing, service, storage, or transportation by air, rail, road, and sea at any stage of the production or supply process. The standards include provisions to:
The ISO 28000 series consists of:
Organizations can then continually assess their security measures to protect their business interests and ensure compliance with international regulatory requirements. By encouraging the implementation of these standards by the various organizations in the supply chains, countries will be able to maximize the use of government’s resources, while maintaining a level of optimal security. ISO 28000, ISO 28001, ISO 28003 and ISO 28004 are available from the ANSI Web Store.
Have your customers quit responding to your lengthy satisfaction surveys? Are your response rates too low for adequate analysis and action? Well, you know you can’t just give up. You need to know what your customers are thinking. And, for example, meeting the requirements expressed in ISO 9001:2000, clause 8.2.2, Customer Satisfaction. Fortunately, there is a simpler way of surveying your customers. A measurement tool, called Net Promoter Score (NPS), uses only one question: On a scale of 1 to 10, how likely is it that you would recommend our company to a friend or colleague? A study by Satmetrix Systems, in partnership with Fred Reichheld of Bain & Company, determined this single loyalty question can judge individual customer purchase and referral patterns across seemingly disparate industries. If customers reported they were likely to recommend a particular company to a friend or colleague, then these same customers were also likely to actually repurchase from the company, as well as, generate new business by referring the company by word-of mouth. If customers reported they were not likely to recommend a company, they were also less likely to engage in actual repurchase or referral behaviors. Ultimate Question Promoters Passives Detractors
Our 2008 1st Quarter course schedule is now posted on our website.
To see the course description, schedule, and on-line registration click on the course title below. Courses are awarded Continuing Education Units. Understanding & Implementing ISO9001:2000 Understanding & Implementing AS9100B:2004 Understanding and Implementing ISO/TS16949:2002 Understanding and Implementing ISO14001:2004 The Five Pillars of a Lean Workplace Organization All courses can be delivered at your company. Don’t see a course, location, or date that fits your needs?
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email: wtighe@sustainingedge.com
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Proposed Changes to ISO 9001:2008
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