posted 03 October 2000 09:48 PM               

I«m in the process of translating for you to the English Language.
Regards
Reinaldo Ramirez
Caracas, Venezuela

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Senior Member ASQ (1986)

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EDITOR'S NOTE: Edited html error.

posted 04 October 2000 05:32 PM               

La versi—n FDIS de ISO 9001:2000 hace ajustes menores y cambia el numero de
cl‡usulas, igualmente a–ade y revisa varios de los requerimientos.

The FDIS version of ISO 9001:2000 made minor adjustment and changes some of the number of the elements; also it adds and review some of the requirements.
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Numeraci—n de cl‡usulas

Manual de calidad (5.5.5), control de documentos (5.5.6) y control de registros (5.5.7) bajo la Secci—n 5 esta ahora bajo los requerimientos de documentaci—n y respectivamente 4.2.2, 4.2.3 y 4.2.4. La secci—n 5.5, Administraci—n, ahora se llama Responsabilidad, Autoridad y Comunicaci—n.

Numbers of the elements:

Quality Manual (5.5.5), Document Control (5.5.6) and Control of Records (5.5.7) under Section 5, are now under the General Documents Requirements under 4.2.2, 4.2.3 and 4.2.4, respectively. The Section 5.5 was renamed as RESPONSIBILITY, AUTHORITY AND COMMUNICATION.
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Otro ajuste de cl‡usulas es proceso de validaci—n (7.5.5) se convierte en 7.5.2 y se revisa y cambia su titulo por "Validaci—n de los Procesos para Producci—n y (Provisi—n de) Servicio".

Another adjustment of elements is the validation process (7.5.5) was changed to 7.5.2 with a new title: VALIDATION OF PROCESES FOR THE PRODUCTION AND PROVISIîN OF SERVICES.
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Procesos "Outsourced"

Se a–ade bajo 4.1 que cualquier proceso contratado que afecten en la conformidad de la calidad se identifica y controla.

Outsourced Proceses:

It was added, under 4.1: any process contracted where the conformity to quality may be affected shall be identified and controlled.
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Evaluaci—n/Revisi—n del Sistema

Bajo 5.6.2, Evaluaci—n del Sistema, ahora incluye "recomendaciones para mejora" como ’tem en la agenda.

Evaluation/Revision of the System

Under 5.6.2, Evaluation of the System, now it was included "reccomendation for improvement" as an item in the agenda.
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Desarrollo de Proceso

Una nueva nota se agrega bajo 7.1, Planificaci—n para la Realizaci—n del Producto indica que "una organizaci—n tambiŽn puede aplicar los requerimientos de dise–o y desarrollo de 7.3 para el desarrollo de procesos para realizaci—n del producto.

Process Development

A new Note was added under 7.1: Planning of realization processes, indicating that " an organization also could apply the requirements of design and development of 7.3 to the development of processes for the realization of the product.
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Ventas Internet

Una nueva nota bajo 7.2.2, Revisi—n de Requerimientos Relacionados al Producto ahora indica "que en algunas situaciones, tal como en ventas por internet, una revisi—n no es pr‡ctica para cada orden. En estos casos revisar puede implicar informaci—n relevante al producto expresados en catalogos y publicaciones.

Selling in Internet

A new Note under 7.2.2: Review of products requirements, now indicates that "in some situations, like selling through Internet, a review is not practical for each order. In those cases the review could imply relevant information to the product expressed in catalog and publications.
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Informaci—n de Compras

Los requerimientos de salida 7.3.3, parte de Dise–o y Desarrollo, ahora requieren informaci—n para Compras adem‡s a la informaci—n requerida para producci—n y servicio.

Purchasing Information

The requirements of output 7.3.3, now requires information regarding the purchasing and the information for production and service.
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Administraci—n de Configuraci—n

Una nota bajo la nueva 7.5.3, Identificaci—n y Trazabilidad, indica "para algunos rubros, administraci—n de configuraci—n se usa para mantener identificaci—n y trazabilidad.

Configuration Management

A note under the new 7.5.3 Identification and Traceability, indicates "for some items, it«s possible to use the configuration management in order to maintain the Identification and Traceability.
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Identificaci—n de Equipo

Una nueva cl‡usula, 7.6.c, bajo Control de Vigilancia y Medici—n, requiere que el equipo de medici—n sea identificado tal que se puede reconocer y determinar el estado de calibraci—n.

Device Identification

A new element, 7.6.c, under Control of measuring and monitoring devices, requires the measuring device shall be identified in order to know and determine the calibration status.
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Independencia de Auditores

Los auditores no tienen que ser independientes de la actividad a auditar. 8.2.2, Auditor’a Interna, los auditores se seleccionan para asegurar objetividad e imparcialidad, aunque no auditan su propio trabajo.

Independence of the auditors

The auditors do not have to be independent in the activity to audit. 8.2.2 Internal Audit, the auditors are selected in order to maintain the objectivity and impartiality, but do not audit their own activity.
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Acci—n Preventiva

Un nuevo requerimiento bajo 8.5.3, Acci—n Preventiva, requiere que una organizaci—n re evalœe la "necesidad" de tomar acci—n para prevenir la ocurrencia de no conformidad

Preventive Action

A new requirement under 8.5.3 Preventive Action requires " an organization re-evaluate the necessity to take action in order to prevent the ocurrence of the no conformity.
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I apologize my bad English.

Reinaldo R.

posted 22 November 2000 04:55 PM               

From: Joseph & Susan Green

"Quality Assessoria Empresarial"
Asked;
> Does anyone have information about what changes have occurred
> from DIS version to FDIS in ISO 9001:2000
> Moacir Schuchmann

Joe Green; reply

Moacir,

The movement of "Documents" and "Records" from Management Responsibility to 4 QMS and the movement of "Validation of process" within section 7 created a minor change to the clause numbers.

The balance of the changes were sentence structure with no change to the base requirements. There will be some discussion over the use of the words "enhance customer perception" rather than "achieve customer satisfaction"; but, it's my opinion that enhancement leads to achievement and "achievement" broaches perfection....(perfection is a worthy goal but not realistic in this life).

Movement within some clauses made sense and improved understanding.

Records (4.2.x) are clearly defined (minimum) by the inclusion of the trusted method (see 4.16) which now reads (see 4.2.x)

DIS to FDIS
Anyway, everything that was in the DIS version is still there in the FDIS, and now we have clearly defined requirements for

Processes (yours)
System (your processes defined & working together)
Measurement (product and system processes)
Analysis (collect, analyze, and respond appropriately)
Improvement (demonstrate (trend) for product & process improvement)