ISO 9001:2008

What’s New for 2008

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 system
practices

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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 small
changes to ISO 9001 with the target of issuing ISO 9001:2008 by the
end of the year. (Publication: 15 November 2008).
 More significant changes are planned for ISO 9004 (“revision”) to be
published in 2009 at the earliest.
• Design specifications for ISO 9001 and ISO 9004 approved by
ISO/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 the

requirements are being made to ISO 9001.
 Focus is on changes that improve clarity, translatability,
and ease of use; address ambiguities that resulted in
requests for interpretations; improve consistency with the
ISO 9000 family, and improve compatibility with ISO
14001:2004.
• 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
High benefit Low-impact

Address a widely expressed specific user No increased or reduced

need by improving clarity and eliminating requirement.
confusion (for example, improve
compatibility with ISO 14001, reduce the
need for official interpretation).
Corrects an error in existing standard. No changes in intent of
requirement.

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

standards, including ISO 9001.

Improves translation into other languages. No need for additional

education or training for users.

Only minimal or marginal

changes of an organization’s
documentation needed.
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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 in
ISO 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 already
received 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 term
“implementation” is used to make a clear
distinction with the former “transition”.

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Joint IAF-ISO communiqué

• The agreed implementation plan for ISO 9001:2008 in

relation to accredited certification is therefore the
following:
2) Certification to ISO 9001:2008 will only be issued after
publication of ISO 9001:2008 (expected before the end
of 2008) and after a routine surveillance or recertification
audit against ISO 9001:2008.
2) One year after publication of ISO 9001:2008, all
certification 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

Clauses Two new notes

4.1 Revised
4.2.1 New
6.2.1 New
6.4 New
7.2.1 New
7.3.1 New
7.3.3 New
7.5.4 Revised
7.6 Deleted 2000 note, added new note
8.2.1 New
8.2.2 Revised
8.2.3 New

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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 outsourced

processes 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 covered
by 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

organization’s 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 final
disposal.

Product requirements includes post-delivery

activities.

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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 and
the 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 to
maintain 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, lost
business 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 corrective
actions 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 and

corrective 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 Implementation
Guidance obtainable from www.iso.org or
www.iso.org/tc176/sc2.

THANK YOU

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