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ISO 9001:2008Whats New for 2008

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Rationale for updates .

ISO Review process: Requires continual review to keep standards up to date.

Must be initiated within 5 years of publication of the standard.

User inputs:

Global user questionnaire/survey

Market justification study

Suggestions arising from the ISO/TC 176 interpretations process

Opportunities for increased compatibility with ISO 14001

Current trends:

Keeping up with recent developments in management systempractices

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Next generation of ISO 9000

Summary: ISO 9001:2008 already published no major changes expected for

2009.

A Final Draft International Standard (FDIS) has been drafted with smallchanges to ISO 9001 with the target of issuing ISO 9001:2008 by theend of the year. (Publication: 15 November 2008).

More significant changes are planned for ISO 9004 (revision) to bepublished in 2009 at the earliest.

Design specifications for ISO 9001 and ISO 9004 approved byISO/TC176/SC2 in 2005 and revised for ISO 9001 in 2007.

ISO 9004 DIS is currently being circulated for comments.

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ISO 9001

Main objectives of ISO 9001:2008

To provide greater clarity and ease of use

Incorporate improvements to address the

interpretations and clarifications requested by

users through the ISO/TC178 interpretations

process.

To improve compatibility with ISO 14001:2004

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What do we mean by Amendment

to ISO 9001?

Aim is to emphasize that no MAJOR changes to therequirements are being made to ISO 9001.

Focus is on changes that improve clarity, translatability,and ease of use; address ambiguities that resulted inrequests for interpretations; improve consistency with theISO 9000 family, and improve compatibility with ISO14001:2004.

No formal ISO distinction between a revision and an

amendment. Amendment is something used to address known issues,

but not to create new or delete existing requirements.

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High-benefit and Low-impact Changes

Only minimal or marginal

changes of an organizations

documentation needed.

No need for additional

education or training for users.

Improves translation into other languages.

No impact on most users.Is consistent within the ISO 9000 family of

standards, including ISO 9001.

No changes in intent of

requirement.

Corrects an error in existing standard.

No increased or reduced

requirement.

Address a widely expressed specific user

need by improving clarity and eliminating

confusion (for example, improve

compatibility with ISO 14001, reduce the

need for official interpretation).

Low-impactHigh benefit

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Key strategies for ISO 9001:2008

ISO 9001:2008 Process Approach model will be

maintained.

The standard will remain generic and be

applicable to all sizes and types of organization

operating in any sector.

Compatibility with ISO 14001:2004 to be

maintained and if possible enhanced. Changes will be restricted to limit impact on users.

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Compatibility with ISO 14001

Compatibility means that common elments of the

standards can be implemented by organizations in a

shared manner, in whole or in part, without unnecessary

duplication or the imposition of conflicting requirements. When maintaining compatibility with ISO 14001:2004 the

following do not necessarily represent potential conflicts:

Different text in common elements or terminology

Different numbering of the clauses. Different models and structure.

Inclusion of guidance, notes or annexes.

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Compatibility with Sector specific

and other standards

Sector standards based on ISO 9001:2000.

Example ISO/TS 16949; AS 9100; TL 9000;

ISO/TS 29001

Other management system standards that are

based on ISO 9001:2000 and use its structure and

text.

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Other decisions already made for

ISO 9001:2008

The current scope, purpose, title and field of application of

the standard will be unchanged.

No new requirements included.

The eight Quality Management Principles (as contained inISO 9000:2005) will be applied, unchanged.

Certification to ISO 9001:2008 is not an upgrade, and

organizations that are certified to ISO 9001:2000 should

be afforded the same status as those who have alreadyreceived a new certificate to ISO 9001:2008.

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Implementation

ISO 9001:2008 changes have a limited impact on

users. Some arrangements regarding

implementation are needed.

To reflect the limited scope of changes the termimplementation is used to make a clear

distinction with the former transition.

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Joint IAF-ISO communiqu

The agreed implementation plan for ISO 9001:2008 inrelation to accredited certification is therefore thefollowing:

2) Certification to ISO 9001:2008 will only be issued after

publication of ISO 9001:2008 (expected before the endof 2008) and after a routine surveillance or recertificationaudit against ISO 9001:2008.

2) One year after publication of ISO 9001:2008, allcertification issue (new certificate and recertification)

must be to ISO 9001:2008.3) Two years after publication of ISO 9001:2008, existing

ISO 9001:2000 certification will not be valid.

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Changes made to standard using notes

New8.2.3

Revised8.2.2

New8.2.1Deleted 2000 note, added new note7.6

Revised7.5.4

New7.3.3

New7.3.1

New7.2.1

New6.4

New6.2.1

New4.2.1

Revised4.1

Two new notesClauses

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ISO 9001:2008

The Changes

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Overview

The changes of the ISO 9001:2008 do not contain

new requirements.

There are specifications and clarifications in the

text of the new standard.

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Principles

Process approached unchanged.

Eight quality management principles unchanged.

No major changes.

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Main modifications

Outsourcing process defined.

Training to achieve competence.

Work environment includes physical and

environmental factors.

Process measurement focused to effectiveness.

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4.1 General requirement outsourcing

Type and nature of control to the outsourcedprocesses shall ensure the conformity to

requirement.

Outsourcing has to be a well

managed part of the

quality management system.

Relationship to clause 7.4 (Purchasing)

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4.2.1 General documentation requirement

Notes included to emphasize that documentation

can also include records and that mandatory

procedures may be in the form of combined

documents, or that requirements may be coveredby more than one document.

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4.2.3 Document control

Note to clarify that only external documents

affecting the QMS need to be controlled.

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5.5.2 Management Representative

Top management shall appoint a member of the

organizations management.

Outsourcing of the Management

Representative (MR) is NOT conforming.

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6.2.1 General

Note: Conformity to product requirements can be

affected directly or indirectly by personnel

performing any task within the quality

management system.

Not just the core process. This include

the support processes.

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6.2.2 Competence, training and

awareness

Provide training to achieve the necessary

competence.

Ensure that the necessary competence has been

achieved.

Necessary competence affecting conformity to

product quality requirements.

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6.3 Infrastructure

Clarifies that this includes information systems.

Support services (such as transport,

communication or information systems)

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6.4 Work environment

Work environment includes physical,environmental and other factors.

Broader scope and not limited to product quality only.

The term work environment relates to conditions under which work is

performed including physical, environmental and other factors (such as

noise, temperature, humidity, lighting, or weather)

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7.2.1 Determination of requirements related to

product

Note: Post-delivery activities include, for example,

actions under warranty provision, contractual

obligations such as maintenance services, and

supplementary services such as recycling or finaldisposal.

Product requirements includes post-deliveryactivities.

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7.3.1 Design and development planning

Note: Design and development review, verification

and validation have distinct purposes but may be

conducted and recorded either separately or in

any combination, as suitable for the product andthe organization.

Clarification

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7.3.3 Design and development output

Note: Information for production and service

provision can include details for the preservation

of product.

Clarification

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7.5.4 Customer property

Note: Customer property can include intellectual

property and personal data.

Intellectual property and personal data

as useful part of customer property.

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7.6 Control of monitoring and measuring devices

Re-titled. Replace devices with equipment.

Explanation of its applicability to software.

Note: Confirmation of the ability of computer software to

satisfy the intended application would typically include

its verification and configuration management tomaintain its suitability for use.

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8.2.1 Customer satisfaction

Note: Monitoring customer perception can include

obtaining input from sources such as customer

satisfaction surveys, customer data on delivered

product quality, user opinion surveys, lostbusiness analysis, compliments, warranty claims,

dealer reports.

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8.2.2 Internal Audit

A documented procedure shall be established to define

the responsibilities and requirements for planning and

conducting audits, establishing records and reporting

results.

Records of the audits and their results shall be maintained

(see 4.2.4)

The management responsible for the area being audited

shall ensure that any necessary corrections and correctiveactions are taken without undue delay to eliminate

detected nonconformities and their causes.

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8.2.3 Monitoring and measurement of process

When planned results are not achieved, correction andcorrective action shall be taken, as appropriate.

Note: When determining suitable methods, it is advisable

that the organization consider the type and extent of

monitoring and measurement appropriate to each of its

processes in relation to their impact on the conforminity to

product requirements and on the effectiveness of the quality

management system.

Focus changed from product conformity to the

impact on the conformity and effectiveness.

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Implementation Guidance for ISO 9001:2008

To help with the move from ISO9001:2000 to the

ISO 9001:2008, you may analyse the clarifications

using the comparisons table, contained in annex B

of ISO 9001:2008 and see the ImplementationGuidance obtainable from www.iso.org or

www.iso.org/tc176/sc2.

THANK YOU

http://www.iso.org/http://www.iso.org/tc176/sc2http://www.iso.org/tc176/sc2http://www.iso.org/