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    ISO 9001:2008

    The Truth

    about theChanges

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    2

    Presentation Host:

    Paul Stock ISO 9001 Product Manager

    Question and Answer Host:

    Peter Crack International Training Manager

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    3

    Introduction to webinar Systems

    Youw

    illsee

    only

    Youw

    illsee

    only

    you

    rnam

    ehere

    your

    name

    here

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    4

    QUESTIONS?

    There will be a question and answer session at

    the end of the presentation. Please utilise the

    question box to submit a question.

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    5

    ISO 9001:2008 The Truth aboutthe Changes

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    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

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    8

    Joint IAF / ISO Communique

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

    ISO 9001:2008 only introduces clarifications to the existing requirementsof ISO 9001:2000 based on eight years of experience of implementing the

    standard world wide with about one million certificates issued in 170 countries todate. It also introduces changes intended to improve consistency with

    ISO14001:2004

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    9

    Joint IAF / ISO Communique

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

    ISO 9001:2008 only introduces clarifications to the existing requirementsof ISO 9001:2000 based on eight years of experience of implementing the

    standard world wide with about one million certificates issued in 170 countries todate. It also introduces changes intended to improve consistency with

    ISO14001:2004.

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    10

    Joint IAF / ISO Communique

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

    ISO 9001:2008 only introduces clarifications to the existing requirementsof ISO 9001:2000 based on eight years of experience of implementing the

    standard world wide with about one million certificates issued in 170 countries todate. It also introduces changes intended to improve consistency with

    ISO14001:2004.The

    Trut

    haboutth

    eChan

    ges

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    ISO 9001:2008 The Truth aboutthe Changes

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    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.

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    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.

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    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

    forone 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 areidentified and their distribution controlled

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    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 areidentified 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 authoritythat 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 affectingconformity 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 orinformation systems)

    6.4 Work environmentNOTE 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 environmentNOTE The term work environment relates to those conditions under which work

    is performed including physical, environmental and otherfactors (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 managementto 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 theirimpact 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 aboutthe Changes

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    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 hasnow 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 aboutthe Changes

    End of presentation - thank you for your participation

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    QUESTIONS?

    There will now be a question and answer

    session. Please utilise the question box to

    submit any questions.

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    Implementation issues

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

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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.

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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.

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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 thatyour organisation complies with the amendments in ISO 9001:2008.

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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 thatyour 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.

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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 thatyour 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 theprocesses.

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    Implementation issues

    DO

    CHECK

    ACT

    PLAN

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

    Gerald R. Ford

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    Any further questions or request for information can

    be obtained by contacting:

    SGS United Kingdom Ltd

    Systems & Services Certification

    SGS House

    217/221 London Road

    Camberley

    Surrey GU15 3EY

    United Kingdom

    Tel: +44(0) 1276 697999Fax: +44(0) 1276 697696

    Email: [email protected]