Changes in FDIS 9001:2000

[dbulak]

I have a copy of dis 2000. Can anyone tell me what changes were made when it became fdis 2000.

[Marc]

You might want to take a read through Kyoto Communique and Status for some info. As I understand it nothing 'significant' has changed.

[Al the Elf]

I'm trying to discover if the remaining requirements for "documented procedures" in the DIS have been removed at the FDIS e.g 8.2.2, 8.3, etc. Does anyone know ?

Cheers, Al.

[Marc]

From: ISO Standards Discussion
Date: Tue, 29 Aug 2000 09:14:26 -0500
Subject: Re: Qualified vs. Certified /Ensell/Robinson

From: Ralph Robinson

"Ken Ensell" enquired:
<snip>
> Q: I have been told that for the 2000 version of 9001 only 6 procedures are
> required. Can anyone verify this ? How would the 20 elements be
> consolidated.
>
> I would really appreciate any help. Thanks in advance
<snip>

In ISO\DIS 9001:2000 there are, in fact, only 6 specific call outs
for documentation. These are:

a) Clause 5.5.6 - Control of Documents:
"A documented procedure shall be established:" This is followed by 7 requirements for the procedure.

b) Clause 5.5.7 - Control of Quality Records:
"A documented procedure shall be established for the identification, storage, retrieval, protection, retention time, and disposition of quality records.

c) Clause 8.2.2 - Internal Audit
"A documented procedure shall include the responsibilities and requirements for conducting audits, ensuring their independence, recording results, and reporting to management."

d) Clause 8.3 - Control of Nonconformity
"These activities shall be defined in a documented procedure."

e) Clause 8.5.2 - Corrective Action
"The documented procedure for corrective action shall define requirements for:" This is followed by 6 requirements for the procedure.

f) Clause 8.5.3 - Preventive Action
"The documented procedure for preventive action shall define requirements for:" This is followed by 4 requirements for the procedure.

Now the gray areas.

There are a number of requirements that require outcomes, outputs, reviews, actions, etc. to be recorded. These are:

a) The output of quality planning activity must be documented.

b) Results of management reviews must be recorded.

c) Planning of realization processes must be documented.

d) Results of contract reviews and subsequent follow-up actions must be recorded.

e) Results of design/development reviews and subsequent follow-up actions must be recorded.

f) Results of design/development verification and validation activities and subsequent follow-up actions must be recorded.

g) Results of supplier evaluations and subsequent follow-up actions must be recorded.

h) Occurrences of loss, damage, or other damage conditions to customer property must be recorded and reported to the customer.

j) Where no standard for the calibration of measuring and monitoring devices exists, the basis used for calibration must be recorded.

Do these requirements suggest documented procedures may be needed? In some cases it would be difficult to satisfy the requirements of the standard without a documented procedure.

And, finally, the really vague guidance found in Clauses 4.1 - General Requirements and 4.2 - General Documentation Requirements.

Clause 4.1 states, "The organization shall establish, document, implement, maintain, and continually improve a quality management system in accordance with the requirements of this Internation Standard."

Clause 4.2 states, "The quality system documentation shall include:" This is followed by 2 requirements, which are then followed by 3 conditions that could affect the presence of documentation.

However, Section 4 of the standards is OUTSIDE that portion to which companies will be audited for compliance!

ARE YOU CONFUSED YET?

Hopefully the FDIS, which is due out in the very near future, will clear up this mess. If it doesn't, I can see many disputes between companies and their registrars over just what documentation is really needed.

Ralph E. Robinson

[rrramirez]

http://www.bulltek.com - Link was: /Spanish_Site/ISO_9000_INTRODUCCION/ISO_9000-2000_Spanish/iso_9000-2000_spanish.html has all the changes in the ISO/FDIS 9001:2000 but Spanish Language.

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

------------------
Senior Member ASQ (1986)

just use a translator web page such as http://babelfish.altavista.digital.c...bin/translate/

[Marc]

Cambios para la versión final de ISO 9001:2000 (Spanish)
Changes made in the ISO/FDIS 9001:2000 (English))

La versión FDIS de ISO 9001:2000 hace ajustes menores y cambia el numero de
cláusulas, igualmente añade 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.
________________________________________________
Numeración de cláusulas

Manual de calidad (5.5.5), control de documentos (5.5.6) y control de registros (5.5.7) bajo la Sección 5 esta ahora bajo los requerimientos de documentación y respectivamente 4.2.2, 4.2.3 y 4.2.4. La sección 5.5, Administración, ahora se llama Responsabilidad, Autoridad y Comunicación.

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.
________________________________________
Otro ajuste de cláusulas es proceso de validación (7.5.5) se convierte en 7.5.2 y se revisa y cambia su titulo por "Validación de los Procesos para Producción y (Provisión 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 PROVISIÓN OF SERVICES.
____________________________________________
Procesos "Outsourced"

Se añade 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.
____________________________________________
Evaluación/Revisión del Sistema

Bajo 5.6.2, Evaluación del Sistema, ahora incluye "recomendaciones para mejora" como ítem 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.
_________________________________________________
Desarrollo de Proceso

Una nueva nota se agrega bajo 7.1, Planificación para la Realización del Producto indica que "una organización también puede aplicar los requerimientos de diseño y desarrollo de 7.3 para el desarrollo de procesos para realización 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.
______________________________________________
Ventas Internet

Una nueva nota bajo 7.2.2, Revisión de Requerimientos Relacionados al Producto ahora indica "que en algunas situaciones, tal como en ventas por internet, una revisión no es práctica para cada orden. En estos casos revisar puede implicar información 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.
________________________________________________
Información de Compras

Los requerimientos de salida 7.3.3, parte de Diseño y Desarrollo, ahora requieren información para Compras además a la información requerida para producción y servicio.

Purchasing Information

The requirements of output 7.3.3, now requires information regarding the purchasing and the information for production and service.
__________________________________________________
Administración de Configuración

Una nota bajo la nueva 7.5.3, Identificación y Trazabilidad, indica "para algunos rubros, administración de configuración se usa para mantener identificación 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.
________________________________________________
Identificación de Equipo

Una nueva cláusula, 7.6.c, bajo Control de Vigilancia y Medición, requiere que el equipo de medición sea identificado tal que se puede reconocer y determinar el estado de calibración.

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.
__________________________________________________
Independencia de Auditores

Los auditores no tienen que ser independientes de la actividad a auditar. 8.2.2, Auditoría 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.
_____________________________________________________
Acción Preventiva

Un nuevo requerimiento bajo 8.5.3, Acción Preventiva, requiere que una organización re evalúe la "necesidad" de tomar acción 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.
______________________________________________________

I apologize my bad English.

Reinaldo R.

[This message has been edited by Marc Smith (edited 04 October 2000).]

[Marc]

From: ISO Standards Discussion
Date: Mon, 9 Oct 2000 13:28:10 -0500
Subject: Re: Q: ISO 9000:2000 FDIS /Schuchmann/Green

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)

Old Joe