ISO 9001:2008

The Truth
about the
Changes

Joint IAF / ISO Communique

They have recognized that ISO 9001:2008 introduces no new requirements.

ISO 9001:2008 only introduces clarifications to the existing requirements of ISO
9001:2000 based on eight years of experience of implementing the standard
world wide with about one million certificates issued in 170 countries to date. It
also introduces changes intended to improve consistency with ISO14001:2004

Joint IAF / ISO Communique

They have recognized that ISO 9001:2008 introduces no new requirements.

ISO 9001:2008 only introduces clarifications to the existing requirements
of ISO 9001:2000 based on eight years of experience of implementing the
standard world wide with about one million certificates issued in 170 countries to
date. It also introduces changes intended to improve consistency with
ISO14001:2004

Joint IAF / ISO Communique

They have recognized that ISO 9001:2008 introduces no new requirements.

ISO 9001:2008 only introduces clarifications to the existing requirements
of ISO 9001:2000 based on eight years of experience of implementing the
standard world wide with about one million certificates issued in 170 countries to
date. It also introduces changes intended to improve consistency with

ISO14001:2004.

Joint IAF / ISO Communique

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ISO 9001:2008 introduces no new requirements.
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ISO 9001:2008 only introduces
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of ISO 9001:2000ebased
standard world
Thwide with about one million certificates issued in 170 countries to
date. It also introduces changes

intended to improve consistency with

ISO14001:2004.

ISO 9001:2008

The Truth about

the Changes

The Truth about the Changes

1.1 General
a) needs to demonstrate its ability to consistently provide product that meets
customer and applicable statutory and regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the
system, including processes for continual improvement of the system and the
assurance of conformity to customer and applicable statutory and regulatory
requirements.
NOTE 2 Statutory and regulatory requirements can be expressed as legal
requirements.

The Truth about the Changes

4.1 General requirements

NOTE 2 An outsourced process is identified as one needed for the organizations
quality management system but chosen to be performed by a party
external to the organisation.
NOTE 3 Ensuring control over outsourced processes does not absolve the
organization of the responsibility of conformity to all customer, statutory and
regulatory requirements.

The Truth about the Changes

4.2 Documentation requirements
4.2.1 General
NOTE 1 Where the term documented procedure appears within this International
Standard, this means that the procedure is established, documented,
implemented and maintained. A single document may address the requirements
for one or more procedures. A requirement for a documented procedure may be
covered by more than one document.

4.2.3 Control of documents

f) to ensure that documents of external origin determined by the organization to be
necessary for the planning and operation of the quality management system are
identified and their distribution controlled

The Truth about the Changes

4.2 Documentation requirements
4.2.1 General
NOTE 1 Where the term documented procedure appears within this International
Standard, this means that the procedure is established, documented,
implemented and maintained. A single document may address the requirements
for one or more procedures. A requirement for a documented procedure may be
covered by more than one document.

4.2.3 Control of documents

f) to ensure that documents of external origin determined by the organization to be
necessary for the planning and operation of the quality management system are
identified and their distribution controlled

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The Truth about the Changes

5.5.2 Management representative

Top management shall appoint a member of the organizations management
who, irrespective of other responsibilities, shall have responsibility and authority
that includes

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The Truth about the Changes

6.2.2 Competence, training and awareness

The organization shall
a) determine the necessary competence for personnel performing work affecting
conformity to product requirements,
b) where applicable, provide training or take other actions to achieve the necessary
competence

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The Truth about the Changes

6.3 Infrastructure
c) supporting services (such as transport, communication or information systems)

6.4 Work environment

NOTE The term work environment relates to those conditions under which work
is performed including physical, environmental and other factors (such as noise,
temperature, humidity, lighting, or weather)

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The Truth about the Changes

6.3 Infrastructure
c) supporting services (such as transport, communication or information systems)

6.4 Work environment

NOTE The term work environment relates to those conditions under which work
is performed including physical, environmental and other factors (such as noise,
temperature, humidity, lighting, or weather)

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The Truth about the Changes

7.2.1 Determination of requirements related to the product

NOTE Post-delivery activities include, for example, actions under warranty
provisions, contractual obligations such as maintenance services, and
supplementary services such as recycling or final disposal

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The Truth about the Changes

7.3.1 Design and development planning

NOTE Design and development review, verification and validation have distinct
purposes. They can be conducted and recorded separately or in any
combination, as suitable for the product and the organization

7.3.3 Design and development outputs

NOTE Information for production and service provision can include details for the
preservation of product

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The Truth about the Changes

7.3.1 Design and development planning

NOTE Design and development review, verification and validation have distinct
purposes. They can be conducted and recorded separately or in any
combination, as suitable for the product and the organization

7.3.3 Design and development outputs

NOTE Information for production and service provision can include details for the
preservation of product

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The Truth about the Changes

7.6 Control of monitoring and measuring equipment

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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The Truth about the Changes

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

8.2.2 Internal audit

Records of the audits and their results shall be maintained

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The Truth about the Changes

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

8.2.2 Internal audit

Records of the audits and their results shall be maintained

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The Truth about the Changes

8.2.3 Monitoring and measurement of processes

NOTE When determining suitable methods, it is advisable that the organisation
consider the type and extent of monitoring or measurement appropriate to each
of its processes in relation to their impact on the conformity to product
requirements and on the effectiveness of the quality management system

8.2.4 Monitoring and measurement of product

Records shall indicate the person(s) authorising release of product for delivery to the
customer

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The Truth about the Changes

8.2.3 Monitoring and measurement of processes

NOTE When determining suitable methods, it is advisable that the organisation
consider the type and extent of monitoring or measurement appropriate to each
of its processes in relation to their impact on the conformity to product
requirements and on the effectiveness of the quality management system

8.2.4 Monitoring and measurement of product

Records shall indicate the person(s) authorising release of product for delivery to the
customer

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ISO 9001:2008

The Truth about

the Changes

23

The Truth about the Changes - Transition

Certification of conformity to ISO 9001:2008 and/or national equivalents

shall only be issued after official publication of ISO 9001:2008 (which has
now taken place) and after a routine surveillance or recertification audit
against ISO 9001:2008.

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The Truth about the Changes - Transition

Validity of certifications to ISO 9001:2000

One year after publication of ISO 9001:2008 all accredited certifications
issued (new certifications or recertifications) shall be to ISO 9001:2008.
Twenty four months after publication by ISO of ISO 9001:2008, any
existing certification issued to ISO 9001:2000 shall not be valid.

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The Truth about the Changes - Transition

Validity of certifications to ISO 9001:2000

One year after publication of ISO 9001:2008 all accredited certifications
issued (new certifications or recertifications) shall be to ISO 9001:2008.
Twenty four months after publication by ISO of ISO 9001:2008, any
existing certification issued to ISO 9001:2000 shall not be valid.

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ISO 9001:2008

The Truth about

the Changes

End of presentation - thank you for your participation

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Implementation issues
What do you, as an organisation, have to do in relation to these changes?

Familiarise yourself with the changes to the standard.

Assess the impact on each function, department, process, area within your
organisations current Quality Management System.
Where applicable, take appropriate action (implementation) to ensure that
your organisation complies with the amendments in ISO 9001:2008.
Monitor and measure your processes and product against policies,
objectives and requirements for the product and report the results.
Take further actions to continually improve the performance of the
processes.

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Implementation issues

DO
PLAN

CHECK
ACT

We cannot stand still or slip backwards. We must go forward now together.

Gerald R. Ford
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Implementation issues
Add local contact details here

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