ISO 9001:2000 Supply Chain Confidence

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Performance Improvement Solutions for Your Business Needs September 2008
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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.

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ISO 9001:2000 Supply Chain Confidence
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The objective of ISO 9001:2000 is to provide a set of requirements if effectively implemented, will provide you with confidence that your supplier can consistently provide goods and services that:

  • Meet your needs and expectations
  • Comply with acceptable regulations

ISO 9001:2000 does not specify requirements for the goods or services you are purchasing. That is up to you to define, by making clear your own needs and expectations for the product. You might, for example, refer to product specifications, drawings, national or international product standards, supplier’s catalogues or other documents as appropriate.

What does “Conformity to ISO 9001:2000” mean?
This means that your supplier has established a systematic approach to quality management, and is managing its business to ensure that your needs are clearly understood, agreed and fulfilled. A statement of conformity to ISO 9001:2000:2000 should not, however, be considered as a substitute for a declaration or statement of product conformity.

How does ISO 9001:2000 help you in selecting a supplier? ISO 9001:2000 provides some requirements for the purchasing process that include you as the customer. These requirements address the following topics:

  • requirements regarding the purchasing information that should be provided so that suppliers clearly understand their customers’ needs
  • the ways in which supplied products can be verified as meeting the requirements of the customer

You have an important role to play, by specifying to your supplier what you actually want. You may need to consult with your own internal technical staff (the actual users) in this process. If you don’t do this, you might find that you receive a product that meets all your stated requirements and the applicable regulatory requirements, but which is absolutely wrong for your intended application. So, first of all, you should concentrate on specifying your needs related to the intended use of the product.

To help in this task you may consider the following:

  • What is the specific product (goods or service) you are buying?
  • What impact does this product have on your own business?
  • What are the risks to your business if you experience problems with this product?
  • How can you be sure that the product you receive will actually meet your requirements?
  • What do you know about the reputation and historical performance of your supplier?
  • What level of confidence do you need in your supplier’s ability to provide you with conforming product on a consistent basis?
  • If you decide that conformity to ISO 9001:2000 is important, (based on your assessment of the risks associated with the goods and services you are buying) how can you be sure that your supplier does have a QMS that meets ISO 9001:2000 requirements?
  • Are the goods and services you require covered by your supplier’s QMS? (You may need to ask for a copy of your supplier’s actual certificate or declaration of conformity to find this out!)

ISO 9001:2000 is a useful basis for organizations to be able to demonstrate that they are managing their business so as to achieve consistent (good!) quality goods and services.

If you are not satisfied with the performance of your supplier, you must provide them with the appropriate feedback. Learning from complaints helps organizations to improve their future performance – that is what ISO 9001:2000 is about.

For More Information

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Accredited Certification to ISO 9001:2008
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ISO (International Organization for Standardization) and the IAF (International Accreditation Forum) have agreed an implementation plan to ensure a smooth migration of accredited certification to ISO 9001:2008, after consultation with international groupings representing quality system or auditor certification bodies, and industry users of ISO 9001 certification services.

ISO 9001:2008 does not contain any new requirements.

They have recognized that ISO 9001:2008 introduces no new requirements. ISO 9001:2008 only introduces clarifications to the existing requirements of ISO 9001:2000 based on eight years of experience of implementing the standard world wide with about one million certificates issued in 170 countries to date. It also introduces changes intended to improve consistency with ISO14001:2004

Accredited certification to the ISO 9001:2008 shall not be granted until the publication of ISO 9001:2008 as an International Standard.

Certification of conformity to ISO 9001:2008 and/or national equivalents shall only be issued after official publication of ISO 9001:2008 (which should take place before the end of 2008) and after a routine surveillance or recertification audit against ISO 9001:2008.

Validity of certifications to ISO 9001:2000

One year after publication of ISO 9001:2008 all accredited certifications issued (new certifications or recertifications) shall be to ISO 9001:2008. Twenty four months after publication by ISO of ISO 9001:2008, any existing certification issued to ISO 9001:2000 shall not be valid.

Certification to ISO 9001:2008 cannot be issued until after a surveillance or recertification audit based on ISO 9001:2008, and the decision to issue a certification is made following a CB’s normal practice including independent review (ISO/IEC 17021:2006, 9.1.14 and 9.1.15).

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New ISO/IEC Standard IT & Software Life Cycle
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Organizations wanting to apply the quality management requirements of ISO 9001:2000 to the acquisition, supply, development, operation and maintenance of IT systems and related support services now have a valuable tool in ISO/IEC TR 90005:2008, Systems engineering – Guidelines for the application of ISO 9001 to system life cycle processes.

ISO/IEC TR 90005 identifies the issues that should be addressed independent of technology, life cycle models, development processes, sequence of activities or organizational structure. It discusses each activity in ISO/IEC 15288 in terms of how it relates to sections of ISO 9001:2000. The tables enable quick comparison of the different treatment of systems in ISO/IEC 15288 and ISO 9001 and explanatory texts help the user to understand why a particular relationship is cited.

The guidelines provided do not in any way add or change the requirements of ISO 9001:2000 and are not intended to be used as assessment criteria in quality management system registration or certification.

ISO/IEC TR 90005:2008 is appropriate to systems that are:

  • part of a commercial contract with another organization
  • a product available for a market sector
  • used to support the processes of an organization
  • embedded in a hardware product, or
  • related to software services.

The guidance provided by ISO/IEC TR 90005 is intended for software-intensive systems. According to Fran├žois Coallier, Chair of ISO/IEC JTC1/SC 7, “Most of the systems that our society depends upon are either software-intensive or software-critical, i.e. they cannot work without one or many functional software component(s). Automobile systems, for instance, are now in such a category.”

Further details see iso.org press release

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Do Standards Make A Difference?
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September is the final month for the nomination of documents that will be included in this year’s survey of Standards That Make a Difference.

First organized by the American National Standards Institute (ANSI) in 2002, the survey compiles information about standards that are “making a difference” in today’s ever-changing global marketplace.

“Standards play a major role in many aspects of our daily lives – from decisions consumers make when purchasing products for the home to societal issues such as environmental protection, and from the competitive concerns of business in today’s marketplace to the government’s role in protecting the public interest,” said Stacy Leistner, ANSI director of communications and public relations. “ANSI invites those who develop standards – and those who use them – to identify the documents that they believe are having the greatest impact on business, government or society.”

Each entry should clearly identify the standard (or family of standards) selected and explain why the document(s) is/are important (e.g., how it relates to and focuses on business or consumer issues). Qualifying entries will be displayed publicly during the World Standards Week 2008 activities; entries will also be featured on ANSI Online.

Nominations may include American National Standards, standards developed by the International Organization for Standardization (ISO) or the International Electrotechnical Commission (IEC), or any other domestic, regional or international body – including consortia. Each entry must refer to a standard that is already published and in use in the marketplace; standards that are still a work in progress will be excluded from this survey.

Every eligible entry will be entered into a random drawing for one of three $100 American Express Gift Cards. The drawing will be held at the conclusion of the ANSI Annual Business Meeting during World Standards Week 2008, in Bethesda, MD. Entries will be published on ANSI Online and displayed during World Standards Week.

The deadline for submission is Friday, September 19, 2008. For more information, contact ANSI’s communications team at pr@ansi.org

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Training Courses
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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

ISO 9001:2000 Process Based Internal Auditor
Documenting Your Quality Management System

Understanding & Implementing AS9100B:2004
AS9100B: 2004 Process Based Internal Auditor
Documenting Your Quality Management System

Understanding and Implementing ISO/TS16949:2002
ISO/TS16949:2002 Process Based Internal Auditor
Documenting Your Quality Management System

Understanding and Implementing ISO14001:2004
ISO14001:2004 Process Based Internal Auditor

The Five Pillars of a Lean Workplace Organization
Continuous Process Improvement
Lean Six Sigma

All courses can be delivered at your company. Don’t see a course, location, or date that fits your needs?

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