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Introduction ISO 9001:2008

On November 14, 2008, the InternationalOrganization for Standardization (ISO)

published ISO 9001:2008, Quality ManagementSystems.

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ISO 9001:2008 has been developed in order tointroduce clarifications to the existing requirements ofISO 9001:2000 and to improve compatibility with ISO

14000:2004.

ISO 9001:2008 does not introduce additional

requirements nor does it change the intent of the ISO9001:2000 standard.

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The key focuses of the ISO 9001:2008 amendmentswere to enhance the clarity of ISO 9001:2000 and to

enhance its compatibility with ISO 14001:2004.

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The benefits identified for the ISO 9001:2008 editionfall into the following categories:

- Provides clarity to ISO 9001:2000

- Increases compatibility with ISO 14001

- Maintains consistency with ISO 9000 family of

standards

- Improves translatability

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The important changes

in ISO 9001:2008 are

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Clause No Clause Change

0.2 Process Approach Wording changedfrom identify todetermine to

emphasize theimportance ofprocesses beingcapable of

achieving desired

outputs.

1.1 Scope Some clarification thatproduct can also be

intermediate productand an explanation that

statutory

and regulatoryrequirements can bereferred to as legal

requirements.

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Clause No Clause Change

4.1 General

requirements

A note has been added thatclarifies requirementsregarding outsourcing andthe types of control thatmay

be applied to suchprocesses.

4.2.1 GeneralDocumentation

Requirements

Acknowledgement thatdocumentation can alsoinclude

records, and that themandatory procedures maybe

combined in one documentor that the requirements of

one procedure may becovered in more than one

document.

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Clause No Clause Change

4.2.3 DocumentControl

Useful clarification that onlydocuments of external origin that

affect the quality management systemhave to be controlled.

5.5.2

6.2.2

Management

Representative

Competence ,Training,Awareness

Inclusion of a statement that this

person must be a member of theorganizations own management.

Requires organizations to ensure necessary

competencies have been achieved

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Clause No Clause Change

6.3 Infrastructure Clarification that informationsystems are included as a

part of the companys

infrastructure, and thereforethe management system

6.4 WorkEnvironment

Some examples shown ofwhat constitutes the Work

Environment.

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Clause No Clause Change

7.2.1 Determination of

Requirements

related to theProduct

Explanations of the sortsof post delivery activities

should be covered, suchas warranties, aintenance,

recycling and so on.

7.3.1 Design andDevelopment

Planning

Clarification that review,verification and validationhave distinct purposes butmay be conducted andrecorded separately or in any

combination as appropriateto the product and theorganization

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Clause No Clause Change

7.3.3 Design and

Development

Outputs

Clarifies that productpreservation (such as

packaging)may beincluded for productionand service provision.

7.5.4 Customer

Property

Clarification thatintellectual property andpersonal data are to beconsidered as customer

property.

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Clause No Clause Change

7.6 Control of

Monitoring &

MeasuringDevices

Clause has been re-titledand the term devices

has been replaced byequipment. A note hasbeen added relating tochecking the conformityof software used formonitoring and measuringpurposes

8.2.1 Customer

Satisfaction

A note has been addedshowing examples of how

customer satisfaction data

may be gathered.

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Clause No Clause Change

8.2.3 Monitoring &

Measurement of

Processes

A clarification note hasbeen added that methods

of monitoring andmeasuring of processesare determined based onproduct conformity andthe quality managementsystem effectiveness.

8.2.4 Monitoring &

Measuring of

Product

A clarification has beenincluded, indicating thatrelease

of the product means tothe customer, not just thenext

in-process stage.

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Validity of certifications to ISO9001:2000

One year after the publication of ISO9001:2008 all accredited certifications

issued (new certifications or re-certifications) shall be to ISO 9001:2008.

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Twenty four months after publicationby ISO of ISO 9001:2008, any

existing certification issued to ISO

9001:2000 shall not be valid.