ISO 9001 2000(1) by pptfiles

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									                  ISO 9001:2000                           ISO/FDIS 9001:2008 w/Markups                                     Comments                      Clarity
                                                                                                                                                         Consistency
                                                                                                                                                         Emphasis

0.1      The adoption of a quality               The adoption of a quality management system should         Added concept of business environment
         management system should be a           be a strategic decision of an organization. The design     and risk. Adds emphasis to the
         strategic decision of an                and implementation of an organization„s quality            integration of the QMS within the
         organization. The design and            management system is influenced by: its business           business as a whole. Leads to controls
         implementation of an organization„s     environment, changes in that environment, or risks         the QMS can provide to mitigate risks or
         quality management system is            associated with that environment; its varying needs;       processes that can support business
         influenced by varying needs,            its particular objectives; the products it provides; the   goals. As realized through a strategic       Emphasis
         particular objectives, the products     processes it employs; its size and organizational          deployment of 4.1. The organization
         provided, the processes employed        structure. It is not the intent of this International      should consider the risks pertinent to its
         and the size and structure of the       Standard to imply uniformity in the structure of quality   situation. Does its management system
         organization.                           management systems or uniformity of documentation.         effectively account for these?
         …                                       …
                                                                                                            Added the concept of Statutory and
         This International Standard can be      This International Standard can be used by internal        Regulatory Requirements as a
         used by internal and external           and external parties, including certification bodies, to   consistent theme throughout the
         parties, including certification        assess the organization„s ability to meet customer,        standard. Adds emphasis to ensure
         bodies, to assess the organization„s    statutory and regulatory requirements applicable to        conformance; organizations should            Consistency/
         ability to meet customer, regulatory,   the product, and the organization„s own requirements.      consider current statutory and               Emphasis
         and the organization„s own                                                                         regulatory requirements and how they
         requirements.                                                                                      are addressed.
0.2      For an organization to function         For an organization to function effectively, it has to     Ties back to 0.1 (strategy) where an
         effectively, it has to identify and     determine and manage numerous linked activities. An        organization should be managing
         manage numerous linked activities.      activity or set of activities using resources, and         (determining) its processes vs. simply       Clarity
         An activity using resources, and        managed…                                                   identifying what’s occurring (for better
         managed…                                                                                           or for worse). Further notes that a
                                                                                                            process may be made up of several
                                                                                                            activities.
0.2      The application of a system of          The application of a system of processes within an         Emphasizes the importance of
         processes within an organization,       organization, together with the identification and         processes being capable of achieving
         together with the identification and    interactions of these processes, and their                 desired outputs. Simply said, Output         Emphasis
         interactions of these processes,        management to produce the desired outcome, can be          Matters. Does it create the desired
         can be referred to as the “process      referred to as the “process approach“.                     output (product)? Is the system
         approach“.                                                                                         effective?




      Rev. 1.1                                                                                                                            Page 1 of 18
0.3      The present editions of ISO 9001       ISO 9001 and ISO 9004 are quality management              Updates verbiage to connect 9001 and         Clarity
         and ISO 9004 have been                 system standards which have been designed to              9004. Elimination of “consistent pair”
         developed as a consistent pair of      complement each other, but can also be used               moniker.
         quality management system              independently.
         standards which have been
         designed to complement each            …
         other, but can also be used
         independently. Although the two        NOTE At the time of publication of this International     Updated to account for status of 9004.
         International Standards have           Standard, ISO 9004 is under revision.
         different scopes, they have similar
         structures in order to assist their
         application as a consistent pair.

0.4      This International Standard has        During the development of this International Standard,    Slight wording change to show efforts to     Clarity
         been aligned with ISO 14001:1996       due consideration was given to the provisions of ISO      enhance compatibility.
         in order to enhance the                14001:2004 to enhance the compatibility of the two
         compatibility of the two standards     standards for the benefit of the user community.
         for benefit of the user community.     Annex A shows the correspondence between ISO
                                                9001:2008 and ISO 14001:2004.
1.1      This International Standard            This International Standard specifies requirements for
         specifies requirements for a quality   a quality management system where an organization         Added the concept of Statutory
         management system where an             a) needs to demonstrate its ability to consistently       Requirements to Regulatory                   Consistency/
         organization                               provide product that meets customer and               Requirements; see 0.1. This change will      Emphasis
         a) needs to demonstrate its ability        applicable statutory and regulatory requirements,     be seen throughout the standard.
         to consistently provide product that       and
         meets customer and applicable
         regulatory requirements, and           b) aims to enhance customer satisfaction through
         b) aims to enhance customer               the effective application of the system, including
         satisfaction through the effective        processes for continual improvement of the
         application of the system, including      system and the assurance of conformity to              same
         processes for continual                   customer and applicable statutory and regulatory
         improvement of the system and the         requirements.
         assurance of conformity to
         customer and applicable regulatory     NOTE 1 In this International Standard, the term
         requirements.                          “product” only applies to
                                                -the product intended for, or required by, a customer     Expands the term product to include          Emphasis
         NOTE In this International             -any intended output resulting from product realization   intermediate or purchased product. All
         Standard, the term “product”           processes.                                                inputs need to be effective to achieve the
         applies only to the product intended                                                             desired outcome.
         for, or required by, a customer.       NOTE 2           Statutory and regulatory requirements
                                                may be expressed as legal requirements                    Generally termed legal requirements.         Clarity
1.2      Where exclusions are made, claims      Where exclusions are made, claims of conformity to        Added the concept of Statutory               Consistency/
         of conformity to this International    this International Standard are not acceptable unless     Requirements to Regulatory                   Emphasis
         Standard are not acceptable unless     these exclusions are limited to requirements within       Requirements; see 0.1
      Rev. 1.1                                                                                                                         Page 2 of 18
         these exclusions are limited to         clause 7, and such exclusions do not affect the
         requirements within clause 7, and       organizations ability, or responsibility, to provide
         such exclusions do not affect the       product that meets customer and applicable statutory
         organizations ability, or               and regulatory requirements.
         responsibility, to provide product
         that meets customer and applicable
         regulatory requirements.
2.0      ISO 9000:2000 Quality                   9000: 2005 Quality management systems —                Updated Revision of Definition              Consistency
         management systems —                    Fundamentals and vocabulary.                           Document.
         Fundamentals and vocabulary.
3.0      The following terms, used in this       Dropped Supplier-Organization description              This wording was used to explain            Clarity
         edition of ISO 9001 to describe the                                                            differences between terminology from
         supply chain, have been changed                                                                the ISO 9001:1994 version and the ISO
         to reflect the vocabulary currently                                                            9001:2000 standards. The ISO 9001:2000
         used:                                                                                          terminology still is consistent with the
         Supplier            organization                                                              ISO 9001:2008 Draft Standard
                 customer
         The term “organization“ replaces
         the term “supplier“ used in ISO
         9001 :1994, and refers to the unit to
         which this International Standard
         applies. Also, the term “supplier“
         now replaces the term
         “subcontractor“.

4       QUALITY MANAGEMENT                                ISO/DIS 9001:2008 w/Markups                                   Comments                    Clarity
        SYSTEM                                                                                                                                      Consistency
                                                                                                                                                    Emphasis

4.1     The organization shall                   The organization shall                                 Determine vs. Identify. Ties back to 0.2,   Clarity
         a) identify the processes needed        a) determine the processes needed for the quality      where an organization should be
             for the quality management          management system and their application throughout     managing (determining) its processes
             system and their application        the organization (see 1.2),                            vs. simply identifying what’s occurring
             throughout the organization                                                                (for better or for worse).
             (see 1.2),                          ….
         ….

          e) monitor, measure and analyze        e) monitor, measure (where applicable), and analyse    Added caveat.                               Clarity
             these processes, and                these processes, and
          ….                                     ….

        Where an organization chooses to
                                                 Where an organization chooses to outsource any
        outsource any process that affects
      Rev. 1.1                                                                                                                       Page 3 of 18
  product conformity with                process that affects product conformity to                For outsourced processes the type and        Emphasis
  requirements, the organization shall   requirements, the organization shall ensure control       extent of control applied must be
  ensure control over such               over such processes. The type and extent of control to    defined. Reinforces awareness of
  processes. Control of such             be applied to these outsourced processes shall be         responsibility of the organization for
  outsourced processes shall be          defined within the quality management system.             process/product integrity.
  identified within the quality
  management system.                     NOTE 1 Processes needed for the quality
                                         management system referred to above should include
  NOTE Processes needed for the
                                         processes for management
  quality management system
                                         activities, provision of resources, product realization
  referred to above should include
                                         and measurement, analysis and improvement.
  processes for management
  activities, provision of resources,
                                         NOTE 2 An outsourced process is identified as one         Note 2 provides clarity on what an           Clarity
  product realization and
                                         being needed for the organization‟s quality               outsourced process is. Organizations
  measurement.
                                         management system but chosen to be performed by a         should evaluate what processes are
                                         party external to the organization.                       considered outsourced.

                                         NOTE 3 Ensuring control over outsourced processes
                                         does not absolve the organization of the responsibility   Note 3 further reinforces responsibility     Emphasis
                                         of conformity to all customer, statutory and regulatory   of the organization. Provides additional
                                         requirements. The type and extent of control to be        clarity on factors that will influence the
                                         applied to the outsourced process can be influenced       type and nature of controls.
                                         by factors such as:                                       Organizations should evaluate their
                                         a) the potential impact of the outsourced process on      controls for outsourced processes. Are
                                         the organization‟s capability to provide product that     they effective?
                                         conforms to requirements;
                                         b) the degree to which the control for the process is     Ultimately, the organization maintains
                                         shared;                                                   the responsibility for the fulfillment of
                                         c) the capability of achieving the necessary control      requirements performed by outsourcing.
                                         through the application of clause 7.4.




Rev. 1.1                                                                                                                         Page 4 of 18
4.2.1   The quality management system            The quality management system documentation shall
        documentation shall include              include
        ….                                       ….
        c) documented procedures required
            by this International Standard,      c) documented procedures and records required by
        d) documents, needed by the              this International Standard, and                            Rearranged wording to flow better and        Clarity
        organization to ensure the effective     d) documents, including records, determined by the          be more grammatically correct.
        planning, operation and control of       organization to be necessary to ensure the effective
        its processes, and                       planning, operation and control of its processes.
        e) records required by this
        International Standard (see 4.2.4)       NOTE 1 Where the term “documented procedure“
                                                 appears within this International Standard, this means      Added information to Note 1 to indicate
        NOTE 1 Where the term                    that the procedure is established, documented,              an allowance that requirements can be        Clarity
        “documented procedure“ appears           implemented and maintained. A single document may           covered in multiple procedures and that
        within this International Standard,      include the requirements for one or more procedures.        a single procedure can cover multiple
        this means that the procedure is         A requirement for a documented procedure may be             requirements.
        established, documented,                 covered by more than one document.
        implemented and maintained.
4.2.3   A documented procedure shall be          A documented procedure shall be established to              Wording clarifies scope of the control of
        established to define the controls       define the controls needed                                  external documents to those that are
        needed                                   ….                                                          necessary for QMS planning and
        ….                                                                                                   operation.
                                                 f) to ensure that documents of external origin
        f) to ensure that documents of           determined by the organization to be necessary for          Customers may wish to re-evaluate their
        external origin are identified and       the planning and operation of the quality management        approach to external document control        Clarity
        their distribution controlled, and       system are identified and their distribution controlled,    and may only control appropriate
        .                                        and                                                         external documents pertinent to the
                                                                                                             QMS.

4.2.4   Quality records shall be established     Records established to provide evidence of conformity       Rearranged wording to flow better and        Clarity
        and maintained to provide evidence       to requirements and of the effective operation of the       be more grammatically correct.
        of conformity to requirements and of     quality management system shall be controlled.
        the effective operation of the quality
        management system. Quality               The organization shall establish a documented
        records shall remain legible, readily    procedure to define the controls needed for the
        identifiable and retrievable. A          identification, storage, protection, retrieval, retention   Strike of “time” does not eliminate
        documented procedure shall be            and disposition of records.                                 contractual, legal or regulatory retention
        established to define the controls                                                                   requirements.
        needed for the identification,           Records shall remain legible, readily identifiable and
        storage, protection, retrieval,          retrievable.
        retention time and disposition of
        quality records.

    Rev. 1.1                                                                                                                               Page 5 of 18
5       MANAGEMENT                                          ISO/DIS 9001:2008 w/Markups                                     Comments                      Clarity
        RESPONSIBILITY                                                                                                                                    Consistency
                                                                                                                                                          Emphasis

5.5.2   Top management shall appoint a            Top management shall appoint a member of the                Management Representative must be a         Clarity
        member of management who,                 organization’s management who, irrespective of other        part of management of the organization.
        irrespective of other responsibilities,   responsibilities, shall have responsibility and authority   Emphasizes need of the MR to be
        shall have Responsibility and             that includes:                                              internally involved with organization.
        authority that includes                   a) ensuring that processes needed for the quality           Organization should ensure that the
        a) ensuring that processes needed         management system are established, implemented              Management Representative is a
            for the quality management            and maintained,                                             member of their organization having
            system are established,               b) reporting to top management on the performance of        objective evidence to support (e.g. Org
            implemented and maintained,           the quality management system and any need for              Chart, Job Description, Contract). Most
        b) reporting to top management on         improvement, and                                            of all, is s/he effective in this role?
            the performance of the quality        c) ensuring the promotion of awareness of customer
            management system and any             requirements throughout the organization.                   Data Collection, Analysis, etc. may be
            need for improvement, and                                                                         outsourced to consultant, but the
        c) ensuring the promotion of              NOTE The responsibility of a management                     Management Representative “buck”
            awareness of customer                 representative can include liaison with external parties    must stop with someone internal.
            requirements throughout the           on matters relating to
            organization.                         the quality management system.

        NOTE The responsibility of a
        management representative can
        include liaison with external parties
        on matters relating to the quality
        management system.




    Rev. 1.1                                                                                                                               Page 6 of 18
6       RESOURCE MANAGEMENT                              ISO/DIS 9001:2008 w/Markups                                   Comments                      Consistency
                                                                                                                                                     Clarity
                                                                                                                                                     Emphasis

6.2.1   Personnel performing work affecting    Personnel performing work affecting conformity to         Using term “product requirements”           Consistency
        product quality shall be competent     product requirements shall be competent on the basis      supports theme throughout revision.
        on the basis of appropriate            of                                                        Also see 8.1, 8.2.3.
        education, training, skills and        appropriate education, training, skills and experience.
        experience.                                                                                      Emphasizes conformity to requirements;
        .                                      NOTE Conformity to product requirements may be            that may extend to all individuals in the
                                               affected directly or indirectly by personnel performing   organization, directly or indirectly.       Emphasis
                                               any task within the quality management system.            Organizations should re-assess
                                                                                                         individuals who may have been
                                                                                                         previously overlooked (e.g. contracts,
                                                                                                         administration, etc).
6.2.2   Competence, awareness and              Competence, training and awareness                        Shifted order of title components
        training

        The organization shall                 The organization shall
         a) determine the necessary            a) determine the necessary competence for personnel       Greater focus on the relationship of        Emphasis
             competence for personnel          performing work affecting conformity to product           product conformity and competence.
             performing work affecting         requirements,                                             Ensuring product integrity.
             product quality,                  b) where applicable, provide training or take other
         b) provide training or take other     actions to achieve the necessary competence,              Organizations should ensure that            Clarity
             actions to satisfy these needs,   c) evaluate the effectiveness of the actions taken,       necessary competence has been
         c) evaluate the effectiveness of      d) ensure that its personnel are aware of the             achieved.
             the actions taken,                relevance and importance of their activities and how
         d) ensure that its personnel are      they contribute to the achievement of the quality
             aware of the relevance and        objectives, and
             importance of their activities    e) maintain appropriate records of education, training,
             and how they contribute to the    skills and experience (see 4.2.4).
             achievement of the quality
             objectives, and
         e) maintain appropriate records of
             education, training, skills and
             experience (see 4.2.4).




    Rev. 1.1                                                                                                                          Page 7 of 18
6.3     The organization shall determine,          The organization shall determine, provide and
        provide and maintain the                   maintain the infrastructure needed to achieve
        infrastructure needed to achieve           conformity to product requirements. Infrastructure
        conformity to product requirements.        includes, as applicable
        Infrastructure includes, as
        applicable                                 a) buildings, workspace and associated utilities,

          a) buildings, workspace and              b) process equipment (both hardware and software),        Added “Information Systems” as a key
              associated utilities,                and                                                       example of the type of support services      Clarity
                                                                                                             that may impact conformity to product
          b) process equipment (both               c) supporting services (such as transport,                requirements. Organizations should
              hardware and software), and          communication or information systems).                    ensure that all applicable supporting
                                                                                                             services have been considered (e.g.
          c) supporting services (such as                                                                    security, cleaning, etc.)
              transport or communication).

6.4     The organization shall determine           The organization shall determine and manage the
        and manage the work environment            work environment needed to achieve conformity to
        needed to achieve conformity to            product requirements.
        product requirements.
                                                   NOTE The term "work environment" relates to               Organizations should ensure that all         Clarity
                                                   conditions under which work is performed including        applicable conditions have been
                                                   physical, environmental and other factors (such as        considered.
                                                   noise, temperature, humidity, lighting, or weather).

7       PRODUCT REALIZATION                                  ISO/DIS 9001:2008 w/Markups                                    Comments                      Clarity
                                                                                                                                                          Consistency
                                                                                                                                                          Emphasis

7.1
        In planning product realization, the       In planning product realization, the organization shall
        organization shall determine the           determine the following, as appropriate:
        following, as appropriate:
          a) quality objectives and                a) quality objectives and requirements for the product;
              requirements for the product;        b) the need to establish processes and documents,
          b) the need to establish                 and to provide resources specific to the product;
              processes, documents, and            c) required verification, validation, monitoring,
              provide resources specific to        measurement, inspection and test activities specific to   Added the word “Measurement” as              Consistency
              the product;                         the product and the criteria for product acceptance;      additional option to product verification
          c) required verification, validation,    d) records needed to provide evidence that the            activities.
              monitoring, inspection and test      realization processes and resulting product meet
              activities specific to the product   requirements (see 4.2.4).

      Rev. 1.1                                                                                                                             Page 8 of 18
             and the criteria for product
             acceptance;                       The output of this planning shall be in a form suitable
         d) records needed to provide          for the organization„s method of operations.
             evidence that the realization
             processes and resulting
             product meet requirements
             (see 4.2.4).

        The output of this planning shall be
        in a form suitable for the
        organization's method of
        operations.

7.2.1   The organization shall determine       The organization shall determine                          a), c), d) - Slight wording changes .         Clarity
        a) requirements specified by the       a) requirements specified by the customer, including
            customer, including the            the requirements for delivery, and for post-delivery
            requirements for delivery and      activities,
            post-delivery activities,          b) requirements not stated by the customer but
        b) requirements not stated by the      necessary for specified or intended use, where
        customer but necessary for             known,
        specified use or and intended use,     c) statutory and regulatory requirements applicable to
        where known,                           the product, and
                                               d) any additional requirements considered necessary
        c) statutory and regulatory
                                               by the organization.
            requirements related to the
            product, and
                                               NOTE Post delivery activities include, for example,       Note provides examples that give a            Clarity
        d) any additional requirements
                                               actions under warranty provisions, contractual            broader definition of “Post Delivery
        determined by the organization.
                                               obligations such as maintenance services, and             Activities” to emphasize characteristics
                                               supplementary services such as recycling or final         of product life cycle. Organizations
                                               disposal.                                                 should evaluate the applicability of such
                                                                                                         post-delivery requirements.

7.3.1   [no note]                              NOTE Design and development review, verification
                                               and validation have distinct purposes. They may be        Provides flexibility on how these             Clarity
                                               conducted and recorded separately or in any               requirements may be achieved.
                                               combination as suitable for the product and the           Organizations should ensure that the
                                               organization.                                             distinct requirements are met even if
                                                                                                         conducted simultaneously.
7.3.2   Inputs relating to product             Inputs relating to product requirements shall be
        requirements shall be determined       determined and records maintained (See 4.2.4).
        and records maintained (see 4.2.4).    These inputs shall include
        These inputs shall include             a) functional and performance requirements,
          a) functional and performance        b) applicable statutory and regulatory requirements,
              requirements,                    c) where applicable, information derived from previous
    Rev. 1.1                                                                                                                            Page 9 of 18
         b) applicable statutory and           similar designs, and
             regulatory requirements,          d) other requirements essential for design and
         c) where applicable, information      development.
             derived from previous similar
             designs, and                      The inputs shall be reviewed for adequacy.               Slight wording change.                     Consistency
         d) other requirements essential for   Requirements shall be complete, unambiguous and
             design and development.           not in conflict with each other.

        These inputs shall be reviewed for
        adequacy. Requirements shall be
        complete, unambiguous and not in
        conflict with each other.

7.3.3                                          The outputs of design and development shall be in a      Slight wording change.                     Clarity
        The outputs of design and
                                               form suitable for verification against the design and
        development shall be provided in a
                                               development input and shall be approved prior to
        form that enables verification
                                               release.
        against the design and
        development input and shall be
                                               Design and development outputs shall
        approved prior to release.
                                               a) meet the input requirements for design and
                                               development,
        Design and development outputs
                                               b) provide appropriate information for purchasing,
        shall
                                               production and for service provision,
         a) meet the input requirements for
                                               c) contain or reference product acceptance criteria,
              design and development,
                                               and
         b) provide appropriate information
                                               d) specify the characteristics of the product that are
              for purchasing, production and
                                               essential for its safe and proper use.
              for service provision,
         c) contain or reference product
                                               NOTE Information for production and service provision    Organizations should consider
              acceptance criteria, and
                                               can include details for the preservation of product.     preservation of product (e.g.              Clarity
         d) specify the characteristics of
                                                                                                        packaging/labeling requirements) during
              the product that are essential
                                                                                                        the design process. Ensuring Product
              for its safe and proper use.
                                                                                                        Integrity.




    Rev. 1.1                                                                                                                       Page 10 of 18
7.5.1   The organization shall plan and          The organization shall plan and carry out production
        carry out production and service         and service provision under controlled conditions.
        provision under controlled               Controlled conditions shall include, as applicable,
        conditions. Controlled conditions        …
        shall include, as applicable,            d) the availability and use of monitoring and            “Devices” used throughout the standard.    Consistency
                                                     measuring equipment,…
        d) the availability and use of
            monitoring   and   measuring         f)   the implementation of product release, delivery     “Product” added for consistency with
            devices,…                            and post-delivery activities.                            remainder of clause.

        f)   the implementation of release,
        delivery and post-delivery activities.


7.5.2   The organization shall validate any      The organization shall validate any processes for
        processes for production and             production and service provision where the resulting
        service provision where the              output cannot be verified by subsequent monitoring or
        resulting output cannot be verified      measurement and, as a consequence, deficiencies          Slight wording change.                     Clarity
        by subsequent monitoring or              become apparent only after the product is in use or
        measurement. This includes any           the service has been delivered.
        processes where deficiencies
        become apparent only after the           Validation shall demonstrate the ability of these
        product is in use or the service has     processes to achieve planned results.
        been delivered.                          The organization shall establish arrangements for
                                                 these processes including, as applicable
        Validation shall demonstrate the         a) defined criteria for review and approval of the
        ability of these processes to            processes,
        achieve planned results.                 b) approval of equipment and qualification of
        The organization shall establish         personnel,
        arrangements for these processes         c) use of specific methods and procedures,
        including, as applicable                 d) requirements for records (see 4.2.4), and
          a) defined criteria for review and     e) revalidation.
              approval of the processes,
          b) approval of equipment and
              qualification of personnel,
          c) use of specific methods and
              procedures,
          d) requirements for records (see
              4.2.4), and
          e) revalidation.
7.5.3   Where appropriate, the organization      Where appropriate, the organization shall identify the
        shall identify the product by suitable   product by suitable means throughout product
        means throughout product                 realization.

    Rev. 1.1                                                                                                                         Page 11 of 18
        realization.

        The organization shall identify the      The organization shall identify the product status with    Added wording to ensure that product          Consistency
        product status with respect to           respect to monitoring and measurement requirements         and ID are maintained during the entire
        monitoring and measurement               throughout product realization.                            product realization process.
        requirements.
                                                 Where traceability is a requirement, the organization      Changed from recording unique
        Where traceability is a requirement,     shall control the unique identification of the product     identification to maintaining records of      Consistency
        the organization shall control and       and maintain records (see 4.2.4).                          traceability to align with Control of
        record the unique identification of                                                                 Records.
        the product (see 4.2.4).

7.5.4   The organization shall exercise care     The organization shall exercise care with customer
        with customer property while it is       property while it is under the organization„s control or
        under the organization's control or      being used by the organization. The organization shall
        being used by the organization. The      identify, verify, protect and safeguard customer
        organization shall identify, verify,     property provided for use or incorporation into the
        protect and safeguard customer           product. If any customer property is lost, damaged or
        property provided for use or             otherwise found to be unsuitable for use, the
        incorporation into the product. If any   organization shall report this to the customer and         Slight wording change.                        Clarity
        customer property is lost, damaged       maintain records (see 4.2.4).
        or otherwise found to be unsuitable
        for use, this shall be reported to the   NOTE Customer property can include intellectual            Adds personal data as a key example of
        customer and records maintained          property and personal data.                                a type of customer property.                  Clarity
        (see 4.2.4).                                                                                        Organizations should ensure that all
                                                                                                            forms of customer property have been
        NOTE Customer property can                                                                          considered.

        include intellectual property


7.5.5   The organization shall preserve the      The organization shall preserve the product during
        conformity of product during internal    internal processing and delivery to the intended           Slight wording change. Brings theme of        Consistency
        processing and delivery to the           destination in order to maintain conformity to             conformity to requirements.
        intended destination. This               requirements. As applicable, preservation shall
        preservation shall include               include identification,                                    “As applicable”: it depends on the type       Clarity
        identification, handling, packaging,     handling, packaging, storage and protection.               of product provided.
        storage and protection.                  Preservation shall also apply to the constituent parts
        Preservation shall also apply to the     of a product.
        constituent parts of a product.


7.6     Control of monitoring and                Control of monitoring and measuring equipment              Slight wording change.                        Consistency
        measuring devices

      Rev. 1.1                                                                                                                            Page 12 of 18
                                           The organization shall determine the monitoring and
  The organization shall determine         measurement to be undertaken and the monitoring
  the monitoring and measurement to        and
  be undertaken and the monitoring         measuring equipment needed to provide evidence of
  and measuring devices needed to          conformity of product to determined requirements.         Slight wording change.                       Consistency
  provide evidence of conformity of
  product to determined requirements       The organization shall establish processes to ensure
  (see 7.2.1).                             that monitoring and measurement can be carried out
                                           and
  The organization shall establish         are carried out in a manner that is consistent with the
  processes to ensure that monitoring      monitoring and measurement requirements.
  and measurement can be carried
  out and are carried out in a manner      Where necessary to ensure valid results, measuring
  that is consistent with the              equipment shall
  monitoring and measurement               a) be calibrated or verified, or both, at specified       Added wording change that both may           Clarity
  requirements.                            intervals, or prior to use, against measurement           apply.
                                           standards traceable to international or national
  Where necessary to ensure valid          measurement standards; where no such standards
  results, measuring equipment shall:      exist,
    a) be calibrated or verified at        the basis used for calibration or verification shall be
        specified intervals, or prior to   recorded (see 4.2.4);
        use, against measurement           b) be adjusted or re-adjusted as necessary;               Clarifies that calibration status
        standards traceable to             c) have identification in order to determine its          identification may not be physically on      Clarity
        international or national          calibration status;                                       equipment.
        measurement standards;             d) be safeguarded from adjustments that would
        where no such standards exist,     invalidate the measurement result;
        the basis used for calibration     e) be protected from damage and deterioration during
        or verification shall be           handling, maintenance and storage.
        recorded;
    b) be adjusted or re-adjusted as
        necessary;
    c) be identified to enable the
        calibration status to be
        determined;
    d) be safeguarded from
        adjustments that would
        invalidate the measurement
        result;
    e) be protected from damage and        In addition, the organization shall assess and record
        deterioration during handling,     the validity of the previous measuring results when the
        maintenance and storage.           equipment is found not to conform to requirements.
                                           The organization shall take appropriate action on the
  In addition, the organization shall      equipment and any product affected.
  assess and record the validity of the
Rev. 1.1                                                                                                                          Page 13 of 18
        previous measuring results when
        the equipment is found not to
        conform to requirements. The                                                                       Same verbiage, moved to separate
        organization shall take appropriate                                                                paragraph.
        action on the equipment and any           Records of the results of calibration and verification
        product affected. Records of the          shall be maintained (see 4.2.4).
        results of calibration and verification
        shall be maintained (see 4.2.4).          When used in the monitoring and measurement of
                                                  specified requirements, the ability of computer
        When used in the monitoring and           software to
        measurement of specified                  satisfy the intended application shall be confirmed.
        requirements, the ability of              This shall be undertaken prior to initial use and
        computer software to satisfy the          reconfirmed as necessary.
        intended application shall be
        confirmed. This shall be undertaken       NOTE See ISO 10012-1 and ISO 10012-2 for
        prior to initial use and reconfirmed      guidance.                                                Clarifies that software being used for       Clarity
        as necessary.                                                                                      measurement and monitoring may not
                                                  NOTE Confirmation of the ability of computer software    have traditional “calibration” but may be
                                                  to satisfy the intended application would typically      focused on verification and
        NOTE See ISO 10012-1 and ISO              include its verification and configuration management    configuration (revision) management.
        10012-2 for guidance.                     to maintain its suitability for use.

8       MEASUREMENT,                                        ISO/DIS 9001:2008 w/Markups                                  Comments                       Clarity
        ANALYSIS AND                                                                                                                                    Consistency
                                                                                                                                                        Emphasis
        IMPROVEMENT
8.1     The organization shall plan and           The organization shall plan and implement the
        implement the monitoring,                 monitoring, measurement, analysis and improvement
        measurement, analysis and                 processes needed                                         Slight wording change to address
        improvement processes needed              a) to demonstrate conformity to product requirements,    conformance to product conformity            Consistency/
          a) to demonstrate conformity of         b) to ensure conformity of the quality management        theme. Recurring emphasis theme on           Emphasis
              the product,                        system, and                                              product integrity.
          b) to ensure conformity of the          c) to continually improve the effectiveness of the
              quality management system,          quality management system.
              and
          c) to continually improve the           This shall include determination of applicable
              effectiveness of the quality        methods, including statistical techniques, and the
              management system.                  extent of their use.

        This shall include determination of
        applicable methods, including
        statistical techniques, and the
        extent of their use.

      Rev. 1.1                                                                                                                          Page 14 of 18
8.2.1   As one of the measurements of the      As one of the measurements of the performance of
        performance of the quality             the quality management system, the organization
        management system, the                 shall monitor information relating to customer
        organization shall monitor             perception as to whether the organization has met
        information relating to customer       customer requirements. The methods for obtaining
        perception as to whether the           and using this information shall be determined.
        organization has met customer
        requirements. The methods for          NOTE Monitoring customer perception may include
        obtaining and using this information   obtaining input from sources such as customer              This note provides additional examples
        shall be determined.                   satisfaction surveys, customer data on delivered           to above indicators or customer             Clarity
                                               product quality, user opinion surveys, lost business       perception (beyond typical customer
                                               analysis, compliments, warranty claims, dealer             survey).
                                               reports.
8.2.2   The organization shall conduct         The organization shall conduct internal audits at
        internal audits at planned intervals   planned intervals to determine whether the quality
        to determine whether the quality       management system
        management system                      a) conforms to the planned arrangements (see 7.1), to
          a) conforms to the planned           the requirements of this International Standard and to
              arrangements (see 7.1), to the   the quality management system requirements
              requirements of this             established by the organization, and
              International Standard and to    b) is effectively implemented and maintained.
              the quality management
              system requirements              A documented procedure shall be established to
              established by the               define the responsibilities and requirements for           Re-structured to separate the
              organization, and                planning and conducting audits, establishing records       requirement for having a documented         Consistency
          b) is effectively implemented and    and reporting results.                                     procedure from the requirement to
              maintained.                                                                                 maintain records.
                                               Records of the audits and their results shall be
                                               maintained (see 4.2.4).

        An audit programme shall be            An audit programme shall be planned, taking into
        planned, taking into consideration     consideration the status and importance of the
        the status and importance of the       processes
        processes and areas to be audited,     and areas to be audited, as well as the results of
        as well as the results of previous     previous audits. The audit criteria, scope, frequency
        audits. The audit criteria, scope,     and
        frequency and methods shall be         methods shall be defined. Selection of auditors and
        defined. Selection of auditors and     conduct of audits shall ensure objectivity and
        conduct of audits shall ensure         impartiality
        objectivity and impartiality of the    of the audit process. Auditors shall not audit their own
        audit process. Auditors shall not      work.
        audit their own work.

        The responsibilities and
    Rev. 1.1                                                                                                                          Page 15 of 18
        requirements for planning and
        conducting audits, and for reporting
        results and maintaining records
        (see 4.2.4) shall be defined in a
        documented procedure.

        The management responsible for           The management responsible for the area being                “Actions” is expanded to corrections
        the area being audited shall ensure      audited shall ensure that any necessary corrections          and corrective actions. “Correction”
        that actions are taken without           and corrective actions are taken without undue delay         equates to the immediate action to          Clarity
        undue delay to eliminate detected        to eliminate detected nonconformities and their              eliminate the detected nonconformity
        nonconformities and their causes.        causes.                                                      whereas “corrective action” equates to
        Follow-up activities shall include the   Follow-up activities shall include the verification of the   the elimination of the cause of the
        verification of the actions taken and    actions taken and the reporting of verification results      detected nonconformity. Both are part
        the reporting of verification results    (see 8.5.2).                                                 of an effective CA system.
        (see 8.5.2).
                                                 NOTE See ISO 19011 for guidance.                             Dropped references to ISO 10011 series      Consistency
        NOTE See ISO 10011-1, ISO                                                                             as these documents have been
        10011-2 and ISO 10011-3 for                                                                           deactivated in lieu of ISO 19011.
        guidance.
8.2.3   The organization shall apply             The organization shall apply suitable methods for
        suitable methods for monitoring          monitoring and, where applicable, measurement of
        and, where applicable,                   the quality management system processes. These
        measurement of the quality               methods shall demonstrate the ability of the
        management system processes.             processes to achieve planned results. When planned
        These methods shall demonstrate          results are not achieved, correction and corrective          Struck direct reference to product          Clarity
        the ability of the processes to          action shall be taken, as appropriate.                       related processes to broaden emphasis.
        achieve planned results. When
        planned results are not achieved,        NOTE When determining suitable methods, the                  Organizations should consider:
        correction and corrective action         organization should consider the type and extent of          - processes key to product conformity or    Emphasis
        shall be taken, as appropriate, to       monitoring or measurement appropriate to each of its         management system effectiveness
        ensure conformity of the product.        processes in relation to their impact on the conformity      -the potential impact a process has on
                                                 to product requirements and on the effectiveness of          conformity to product requirements and
                                                 the quality management system.                               to the effectiveness of the Management
                                                                                                              System, and
                                                                                                              - the type and extent of monitoring and
                                                                                                              measurement as related to the
                                                                                                              importance of the process.
8.2.4   The organization shall monitor and       The organization shall monitor and measure the
        measure the characteristics of the       characteristics of the product to verify that product
        product to verify that product           requirements have been met. This shall be carried out
        requirements have been met. This         at appropriate stages of the product realization
        shall be carried out at appropriate      process in accordance with the planned arrangements
        stages of the product realization        (see 7.1). Evidence of conformity with the acceptance
        process in accordance with the           criteria shall be maintained.
    Rev. 1.1                                                                                                                              Page 16 of 18
        planned arrangements (see 7.1).

        Evidence of conformity with the         Records shall indicate the person(s) authorizing            Slight wording change to break up              Consistency/
        acceptance criteria shall be            release of product for delivery to the customer (see        paragraph. Clarifies intent of “released       Clarity
        maintained. Records shall indicate      4.2.4).                                                     product.”
        the person(s) authorizing release of
        product (see 4.2.4).

        Product release and service             The release of product and delivery of service to the
        delivery shall not proceed until all    customer shall not proceed until the planned                Clarifies distinction between internal         Clarity
        the planned arrangements (see 7.1)      arrangements (see 7.1) have been satisfactorily             release vs. release to the customer.
        have been satisfactorily completed,     completed, unless otherwise approved by a relevant
        unless otherwise approved by a          authority and, where applicable, by the customer.
        relevant authority, and where
        applicable by the customer.
8.3     The organization shall ensure that      The organization shall ensure that product which does
        product which does not conform to       not conform to product requirements is identified and
        product requirements is identified      controlled to prevent its unintended use or delivery. A
        and controlled to prevent its           documented procedure shall be established to define         Slight wording change to clarify the
        unintended use or delivery. The         the controls and related responsibilities and               requirement for documented procedure.          Consistency
        controls and related responsibilities   authorities for dealing with nonconforming product.
        and authorities for dealing with
        nonconforming product shall be
        defined in a documented procedure.

        The organization shall deal with        Where applicable, the organization shall deal with          Allows flexibility, especially for Service     Clarity
        nonconforming product by one or         nonconforming product by one or more of the                 Industries.
        more of the following ways:             following
         a) by taking action to eliminate the   ways:
             detected nonconformity;            a) by taking action to eliminate the detected
         b) by authorizing its use, release     nonconformity;
             or acceptance under                b) by authorizing its use, release or acceptance under
             concession by a relevant           concession by a relevant authority and, where
             authority and, where               applicable, by the customer;
             applicable, by the customer;       c) by taking action to preclude its original intended use
         c) by taking action to preclude its    or application.
             original intended use or           d) by taking action appropriate to the effects, or          Moved from end of paragraph to become          Clarity
             application.                       potential effects, of the nonconformity when                an additional optional method for dealing
                                                nonconforming product is detected after delivery or         with nonconformities.
        Records of the nature of                use has started.
        nonconformities and any
        subsequent actions taken, including     …
        concessions obtained, shall be
        maintained (see 4.2.4).                 When nonconforming product is corrected it shall be
      Rev. 1.1                                                                                                                             Page 17 of 18
        …                                       subject to re-verification to demonstrate conformity to
                                                the requirements.
        When nonconforming product is
        detected after delivery or use has      Records of the nature of nonconformities and any
        started, the organization shall take    subsequent actions taken, including concessions
        action appropriate to the effects, or   obtained, shall be maintained (see 4.2.4).
        potential effects, of the
        nonconformity.
8.4     The analysis of data shall provide      The analysis of data shall provide information relating
        information relating to                 to

             a) customer satisfaction (see          a) customer satisfaction (see 8.2.1)
                 8.2.1)                             b) conformity to product requirements (see 8.2.4)     Revised/Added references.                   Consistency
             b) conformity to product               c) characteristics and trends of processes and
                 requirements (see 7.2.1)              products including opportunities for preventive
             c) characteristics and trends             action (see 8.2.3 and 8.2.4), and
                 of processes and products          d) suppliers (see 7.4).
                 including opportunities for
                 preventive action, and
             d) suppliers.
8.5.2   The organization shall take action to   The organization shall take action to eliminate the       Slight change indicating more than one      Clarity
        eliminate the cause of                  causes of nonconformities in order to prevent             cause may be attributed to a
        nonconformities in order to prevent     recurrence.                                               nonconformity.
        recurrence.
        …                                       …
        f) reviewing corrective action taken    f) reviewing the effectiveness of the corrective action   Re-emphasizes that actions should be        Emphasis
                                                taken                                                     reviewed for effectiveness; were desired
                                                                                                          outputs achieved?
8.5.3   e) reviewing preventive action taken    f) reviewing the effectiveness of the preventive action   Re-emphasizes that actions should be        Emphasis
                                                taken                                                     reviewed for effectiveness; were desired
                                                                                                          outputs achieved?




      Rev. 1.1                                                                                                                        Page 18 of 18

								
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