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ISO 9001:2008


ISO 9001:2008 Key Changes Example - the type and extent of control to be applied to these outsources processes shall be defined with the QMS Where an ... – PowerPoint PPT presentation

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Title: ISO 9001:2008

ISO 90012008 Key Changes
Key Changes to ISO 9001
  • This presentation is intended to identify the
    changes to ISO 90012008 that will have the
    greatest impact in terms of organisations
    quality management systems.
  • After completing this course you should be able
  • Understand and explain the key changes to ISO
  • Conduct ISO 9001 2008 audits (provided that you
    are qualified ISO 9001 2000 auditor / lead

The ISO 9000 Series of Standards
ISO 9001
ISO 9004
ISO 9000
  • The aim is improvement of the performance of the
    organization and satisfaction of customer and
    other interested parties.
  • This standard is currently under revision and
    expected to be released with major changes in
  • Specifies terminology and describes quality
    management systems
  • Was initially released in 2000 along with ISO
    9001, but was updated in 2005 per the normal 5
    year ISO review period
  • Specifies requirements for a quality management
  • Was expected to be updated in 2005, but because
    of a 3 year transition period from the 1994
    version to the 2000 version, revision was delayed
    until 2008

Overview of Changes introduced by ISO 90012008
Changes to ISO 9001
  • The committee responsible for ISO 9001 notes
  • ISO 90012008 has been developed in order to
    introduce clarifications to the existing
    requirements of ISO 90012000 and changes that
    are intended to improve compatibility with ISO
    140012004. ISO 90012008 does NOT introduce
    additional requirements nor does it change the
    intent of the ISO 90012000 standard.
  • Many new notes have been included in the 2008
    version of the standard to provide further
  • Cross-references have been added between clauses
    in the standard to show relationships between

  • The introduction now includes a reference to
    business environment and risk
  • The update is sowing the seeds for future
  • that QMS should be applied to the entire business
    and should extend past provision of product or
  • introduces risk to the business includes
    unsatisfied customers

  • Clarification of regulatory requirements added
    for consistency within the standard and with
    other management system standards
  • The term statutory added along with regulatory
    requirements throughout the whole of the 2008
  • The standard now expects that both local and
    national laws that are applicable to the
    organization in providing products and services
    to their customers' requirements should be

Outsourcing (4.1)
  • Enhanced control required for outsourcing to
    cover the type and extent of control to be
  • Clause now highlights that organisations should
    clarify what controls they have in place for any
    outsourced products or services

Example - the type and extent of control to be
applied to these outsources processes shall be
defined with the QMS
  • Where an organization outsources Training to be
    delivered, they may write specific details within
    the Outsourcing process procedures ( which form
    part of the QMS) such as 
  • the trainer must attend the organizations
    train-the-trainer process. The organization then
    requires feedback from the course to evaluate the
    competency of the trainer.
  • In this example, they have defined within the
    process the types of controls they have over
    their outsourced training provision.

Documentation (4.2)
  • A record is now officially a document
  • All documentation requirements also apply to
  • Records are just as much a part of the management
    system documentation as procedures, work
    instructions and other documents
  • The revised statement also now covers any record
    that falls within the scope of the management

Management Representative (5.5.2)
  • The management representative must now be a
    member of the organizations management team
  • The management representative position should not
    be an outsourced position
  • The management system is the responsibility of
    the top management of the organization and
    therefore the management representative should
    come from the top management team in the

Human Resources (6.2.1-6.2.2)
  • The Human Resources clause has been extended to
    now apply to all staff who can affect conformity
    to product requirements which extends beyond
    just product quality as in the previous version
    of the standard
  • The clause now requires competence of any
    employee that could affect conformity to product

  • Example
  • A delivery driver would not have a direct effect
    on the quality of the product he is transporting,
    but would be responsible for the requirement of a
    safe and/or timely delivery of the product to the
    customer. This way, this employee is also
    included in the requirement for competence
    because his actions could affect product
    requirements even if it does not affect physical
    product quality.

Infrastructure (6.3)
  • Supporting services expanded to include
    information systems
  • Information systems should be included as part of
    the infrastructure to ensure the agreement for
    the product/service to be delivered is achieved

  • If an organization includes any sort of order
    processing system, it should now be included as
    part of the infrastructure the organization
    controls within the management system as it is
    key to conformity to product requirements.

Identification and Traceability(7.5.3)
  • Identification of product status should be kept
    throughout product realization
  • A process should be in place at each stage of
    product realization that ensures the
    identification and status of the product is known

  • During a chemical treatment to be performed on
    an item, the paper labeling must be removed but
    the organization may use a color classification
    system to ensure identification is maintained
    during the chemical treatment process.

Internal Audit (8.2.2)
  • Addition of a requirement that the management
    team in the area being audited is responsible for
    necessary corrections and corrective actions.
  • The previous version of the standard only stated
    actions but did not specify the types of
    actions required of the management in response to
    internal audit findings
  • Now, not only do you have to correct the problem
    by making a correction you also have to ensure
    that the problem does not recur by initiating a
    corrective action

  • During an audit it was observed that Mary Smith
    did not have the proper competence to perform her
    job. The correction to the nonconformity is to
    train her and the corrective action is to develop
    a process to assess competencies for new

Control of Nonconforming Product (8.3)
  • Changes include addition of
  • where applicable in reference to methods for
    dealing with nonconforming product and
  • bullet d) which was previously the last sentence
    of the clause
  • The addition of where applicable now permits
    flexibility for solutions for dealing with
    nonconforming product
  • Allows for consideration of other ways and other
    actions that may be taken to deal with
    nonconforming product

Corrective and Preventive Action (8.5.2 - 8.5.3)
  • Addition of a requirement to review the
    effectiveness of corrective and preventive
    actions taken
  • Now, you must ensure any action taken is

  • A nonconformity was raised on a process for
    scanning documents. Two sided documents were only
    being scanned on the front side.
  • The corrective action was to implement a
    checklist to confirm the requirements for
    scanning the document. Reviews were later carried
    out to show that implementation of the checklist
    improved the scanning process in other ways than
    just ensuring both sides were scanned and the new
    process was considered more effective.

  • ISO 90012008 introduces no new requirements, but
    introduces clarifications to the existing
    requirements of ISO 90012000 based on eight
    years of experience of implementing the standard
    world wide 
  • Changes have been made to clarify interpretations
    and existing requirements based upon feedback
    from users 
  • Using the eight management principles that
    underpin ISO 9001, an organization can improve
    the way they view and use their management


Thank you!