January, 2004 Newsletter Articles

New ISO Website for ISO 9001:2000 Interpretations

Jan 11, 2004 in Newsletter | 0 comments

ISO Technical Committee 176 has established a new website for ISO 9001:2000 interpretations at<http://www.tc176.org/Interpre.asp>. The initial set of 14 interpretations are shown below. You can submit a request for interpretation at the same site. ISO 9001:2000 Interpretation RFI – 029 Request: ISO 9001:2000 Clause: 4.1 a) Does the _expression “needed for the QMS” in Clause 4.1 a) require the organization to identify the QMS processes related to product realization only? Interpretation: No Rationale: The processes needed for the...

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Survey on Most Difficult ISO 9001:2000 Clauses

Jan 11, 2004 in Newsletter | 0 comments

A report on the user experience with ISO 9001:2000 is available at: <http://standardsgroup.asq.org/news/psi/IMS06-2002E-Implementing_ISO_9001-BD.pdf>. The 227 survey responses included a ranking of the most difficult ISO 9001:2000 clauses for which to develop a process, document, and/or implement: Most Difficult ISO 9001:2000 Clauses 1. Customer satisfaction (8.2.1) 2. Competence, awareness, and training (6.2.2) 3. Analysis of data (8.4) 4. Preventive action (8.4) 5. Quality objectives (5.4.1) 6. Continual improvement (8.5.1) 7. Design...

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ISO 9001:2000 Guide for Design and Construction

Jan 11, 2004 in Newsletter | 0 comments

The “ISO 9001:2000 Interpretive Guide for the Design and Construction Project Team” was written by the ASQ Design and Construction Division. Effectively implementing a quality management system to conform to ISO 9001:2000 can be challenge, especially for organizations that are not in the manufacturing sector. This Interpretive Guide was written to assist project management teams (owners, designers, and constructors) in understanding the ISO 9001:2000 requirements and developing the appropriate policies and procedures. The...

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Guidance Document N630 on Outsourced Processes

Jan 11, 2004 in Newsletter | 0 comments

In support of ISO 9001:2000 and ISO 9004:2000, ISO Technical Committee 176/SC 2 has published the following guidance documents: N524 – Guidance on ISO 9001:2000 clause 1.2 ‘Application’ N525 – Guidance on the Documentation requirements of ISO 9001:2000 N526 – Guidance on the Terminology used in ISO 9001:2000 and ISO 9004:2000 N544 – Guidance on the Process Approach to quality management systems N630 – Guidance on ‘Outsourced Processes’ Document N630 was recently published and provides guidance on the intent of...

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ISO Guidance on Self-Declaration of Conformity

Jan 11, 2004 in Newsletter | 0 comments

If your organization doesn’t need an ISO 9001 or ISO 14001 certificate to satisfy customer, regulatory, or internal requirements, then the new ISO 17050 guidance on self-declaration may be of interest. ISO Guide 22 was issued in 1996 to provide general criteria for a supplier’s declaration of conformity. However, it has been used primarily for self-declaration on product standards. ISO 17050 is being drafted to replace Guide 22 and will explicitly state self-declaration of conformity applies equally to management systems. An ANSI...

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The Continued Transition to ISO 9001:2000

Jan 11, 2004 in Newsletter | 0 comments

Although ISO 9001:1994 was withdrawn on December 15, 2003, some organizations have not completed the transition to ISO 9001:2000. Some may have let the certificates expire on purpose. However, many were just late in making the transition. As a result, most registrars have announced plans to issue letters of conformity or unaccredited certificates to extend the transition period for a limited period of time. The IAF, comprised of the larger and better known registrars, has stated the delayed companies will not have to undergo a full...

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