Gap Analysis Against ISO 134852003

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                                               Gap Analysis Against ISO 13485:2003
               BS EN ISO 13485:2003         Medical devices. Quality management systems. Requirements for regulatory purposes.
               This harmonised standard was issued as a British Standard on 24th July 2003. It supersedes BS EN ISO 13485:2001 and BS
               EN ISO 13488:2001 which remain current and are to be withdrawn in July 2006.
               Where the ‘Action Required’ Column of the table refers to other sections, this is because the requirements stated would be
               managed by other processes. See subsequent sections as indicated for action points:
               Reference numbers match exactly those used within the standard. Where sub-paragraphs are not labelled within the standard
               itself the following table references the letters x, y, z etc in sequential order of the paragraphs quoted.
               The table has deliberately not been formatted against page lengths as it will change when the ‘Action Required’ column is
               completed.
               Disclaimer: All information is provided on an "as is" basis, and we make no warranties regarding the accuracy or completeness
               of that information or its fitness for purpose and cannot be held liable for any use or reliance you may make of or put on it
               except as specifically agreed with us in any further written agreement we may enter into with you.

    Reference                    Requirement                                                 Action Required
    4.1                   a      Identify the processes needed for the QMS and their
    QMS General:                 application throughout the organisation. Determine the
    The organisation
    shall establish,      b      sequence and interaction of these processes.
    document,             c      Determine criteria and methods needed to ensure that        See 5.6 Management Review.
    implement and
    maintain a QMS               both the operation and control of these processes are       See 4.2.1 & 5.4.1 Quality Objectives.
    and maintain its
    effectiveness in
                                 effective.                                                  See 8.2.2 Internal Audit.
    accordance with       d      Ensure the availability of resources and information        See 6 Resources.
    the requirements of
    this International           necessary to support the operation and monitoring of
    Standard.                    these processes.
                          e      Monitor, measure and analyses these processes.              See 5.6 Management Review.
                                                                                             See 4.2.1 & 5.4.1 Quality Objectives.
                                                                                             See 8.2.2 Internal Audit.
                                                                                             See 8.5.2 Corrective Action

                          f      Implement actions necessary to achieve planned results      See 4.2.1 & 5.4.1 Quality Objectives.
                                 and maintain the effectiveness of these processes           See 8.5.2 Corrective Action.
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    Reference                     Requirement                                                  Action Required
                          x       Where an organisation chooses to outsource any process       See 7.4.1 Purchasing.
                                  that affects product conformity with requirements, the
                                  organisation shall ensure control over such processes.
                                  Control of such outsourced processes shall be identified
                                  within the QMS.
    4.2.1                 a       Documented statements of a Quality Policy and Quality
    Documentat-                   Objectives.
    ion General.
    The QMS
                          b       A Quality Manual                                             See 4.2.2 Quality Manual.
    documentation
    shall include:        c       Documented Procedures required by this International
                                  Standard.
                          d       Documents needed by the organisation to ensure the
                                  effective planning, operation and control of its processes
                          e       Records required by this International Standard.             See 4.2.4 Control of Records.
                          f       Any other documentation specified by national or regional
                                  regulations.
                          x       For each type or model of medical device, the
                                  organisation shall establish and maintain a file either
                                  containing or identifying documents defining product
                                  specifications and QMS requirements. These documents
                                  shall define the complete manufacturing process and, if
                                  applicable, installation and servicing.
    4.2.2                 a       The scope of the QMS, including details of and
    Quality                       justification for any exclusion and/or non-application
    Manual
    The organisation      b       The documented procedures established for the QMS, or
    shall establish and           reference to them.
    maintain a quality
    manual that           c       A description of the interaction between the processes of    See 4.1 a) and b) above.
    includes:
                                  the QMS
                          x       The Quality Manual shall outline the structure of the
                                  documentation used in the QMS.
    4.2.3                 a       To review and approve documents for adequacy prior to
    Control of                    issue
    Documents
                          b       To review and update as necessary and re-approve

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    Reference                     Requirement                                                    Action Required
    Documents
    required by the
                                  documents
    QMS shall be          c       To ensure that changes and the current revision status of
    controlled. Records
    are a special type            documents are identified
    of document and
    shall be controlled
                          d       To ensure that relevant versions of applicable documents
    according to the              are available at points of use
    requirements given
    in 4.2.4              e       To ensure that documents remain legible and readily
    A documented
                                  identifiable
    procedure shall be    f       To ensure that documents of external origin are identified
    established to
    define the controls           and their distribution controlled
    needed:               g       To prevent the unintended use of obsolete documents,
                                  and to apply suitable identification to them if they are
                                  retained for any purpose
                          x       The organisation shall ensure that changes to documents
                                  are reviewed and approved either by the original
                                  approving function or another designated function which
                                  has access to pertinent background information upon
                                  which to base its decisions.
                          y       The organisation shall define the period for which at least
                                  one copy of obsolete controlled documents shall be
                                  retained. This period shall ensure that documents to which
                                  medical devices have been manufactured and tested are
                                  available for at least the lifetime of the medical device as
                                  defined by the organisation , but not less than the
                                  retention period of any resulting record or as specified by
                                  relevant regulatory requirements.
    4.2.4                 x       Records shall be established and maintained to provide
    Control of                    evidence of conformity to requirements and of the
    Records                       effective operation of the QMS. Records shall remain
                                  legible, readily identifiable and retrievable. A documented
                                  procedure shall be established to define the controls
                                  needed for the identification, storage, retrieval, retention
                                  time and disposition of records.
                          y       The organisation shall retain the records for a period of

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    Reference                       Requirement                                                 Action Required
                                    time at least equivalent to the lifetime of the medical
                                    device as defined by the organisation, but not less than
                                    two years from the date of product release by the
                                    organisation or as specified by relevant regulatory
                                    requirements.
    5.1                   a         Communicating to the organisation the importance of
    Management                      meeting customer as well as statutory and regulatory
    Commitment                      requirements.
    Top Management
    shall provide         b         Establishing the Quality Policy
    evidence of its
    commitment to the     c         Ensuring that Quality Objectives are established
    development &
    implementation of     d         Conducting Management Reviews
    the QMS and
    maintaining its       e         Ensuring the availability of resources                      See 6 Resources.
    effectiveness by:
    5.2                   General Top Management shall ensure that customer                     See 7.2.1 Determination of Requirements
    Customer                      requirements are determined and met.                          See 8.2.1 Feedback.
    Focus
    5.3                   a         Is appropriate to the purpose of the organisation
    Quality Policy
    Top Management        b         Includes a commitment to comply with requirements and
    shall ensure that
    the Quality Policy:             to maintain the effectiveness of the QMS
                          c         Provides a framework for establishing and reviewing
                                    Quality Objectives.
                          d         Is communicated and understood within the organisation
                          e         Is reviewed for continuing suitability.
    5.4.1                 General Top management shall ensure that Quality Objectives,
    Quality                       including those needed to meet requirements for product,
    Objectives                    are established at relevant functions and levels within the
                                  organisation. The Quality Objectives shall be measurable
                                  and consistent with the Quality Policy..
    5.4.2                 a       The planning of the QMS is carried out in order to meet
    QMS Planning                  the requirements given in 4.1, as well as the quality
    Top Management
                                  objectives, and


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    Reference                        Requirement                                                     Action Required
    shall ensure that
                            b        The integrity of the QMS is maintained when changes to
                                     the QMS are planned and implemented.
    5.5.1                   x        Top Management shall ensure that responsibilities and
    Responsibility                   authorities are defined, documented and communicated
    & Authority                      within the organisation.
                            y        Top Management shall establish the interrelation of all
                                     personnel who manage, perform and verify work affecting
                                     quality, and shall ensure the independence and authority
                                     to perform these tasks.
                            z        Note: National or regional regulations might require
                                     nomination of specific persons as responsible for activities
                                     related to monitoring experience from the post-production
                                     stage and reporting adverse events
    5.5.2                   a        Ensuring that processes needed for the QMS are
    Management                       established, implemented and maintained,
    Representa-
    tive
                            b        Reporting to Top Management on the performance of the
    Top Management                   QMS and any need for improvement, and
    shall appoint a
    member of
                            c        Ensuring the promotion of awareness of regulatory and
    management who,                  customer requirements throughout the organisation.
    irrespective of other
    responsibilities,       x        Note: The responsibility of a Management Representative
    shall have                       can include liaison with external parties on matters relating
    responsibility and
    authority that                   to the QMS.
    includes:
    5.5.3                   General Top Management shall ensure that appropriate
    Internal                        communication processes are established within the
    Communica-                      organisation and that communication takes place
    tion
                                    regarding the effectiveness of the QMS.
    5.6.1                   General Top Management shall review the organisations QMS at
    Management                      planned intervals to ensure its continuing suitability,
    Review                          adequacy and effectiveness. This review shall include
    General
                                    assessing the opportunities for improvement and the need
                                    for changes to the QMS, including the Quality Policy and
                                    Quality Objectives. Records from Management Review
                                    shall be maintained

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    Reference                       Requirement                                                   Action Required
    5.6.2                  a        results of audits
    Management             b        customer feedback
    Review
    Inputs                 c        Process performance and product conformity
    The input to
    management
                           d        status of preventive and corrective actions
    review shall include
    information on:
                           e        follow-up actions from previous management reviews
                           f        changes that could affect the QMS
                           g        recommendations for improvement
                           h        new or revised regulatory requirements
    5.6.3                  a        improvements needed to maintain the effectiveness of the
    Management                      QMS and its processes
    Review
    Outputs
                           b        improvement of product related to customer requirements,
    The output from the             and
    management
    review shall include
                           c        Resource needs.
    any decisions and
    actions related to:
    6.1 Provision          a        To implement the QMS and to maintain its effectiveness,
    of Resources                    and
    The organisation
    shall determine and    b        To meet regulatory and customer requirements
    provide the
    resources needed:
    6.2.1                  General Personnel performing work affecting product quality shall
    Human                          be competent on the basis of appropriate education,
    Resources                      training, skills and experience.
    General
    6.2.2                  a        determine the necessary competence for personnel
    Competence                      performing work affecting product quality
    Awareness &
                           b        provide training or take other actions to satisfy these
    Training
    The organisation                needs
    shall:
                           c        evaluate the effectiveness of the actions taken
                           d        ensure that its personnel are aware of the relevance and
                                    importance of their activities and how they contribute to
                                    the achievement of the quality objectives, and
                           e        maintain appropriate records of education, training, skills
                                    and experience.

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    Reference                    Requirement                                                    Action Required
    6.3                  a       Buildings, workspace and associated utilities
    Infrastructure       b       Process equipment (both hardware and software), and
    The organisation
    shall determine,     c       Supporting services (such as transport or communication)
    provide and
    maintain the         x       The organisation shall establish documented requirements
    infrastructure
    needed to achieve            for maintenance activities, including their frequency, when
    conformity to                such activities or lack thereof can affect product quality.
    product
    requirements.        y       Records of such maintenance shall be maintained             See 4.2.4 Control of Records
    Infrastructure
    includes, as
    applicable:
    6.4                  a       The organisation shall establish documented requirements
    Work Environ-                for health, cleanliness and clothing of personnel if contact
    ment                         between such personnel and the product or work
    The organisation
    shall determine,             environment could adversely affect the quality of product.
    and manage the
    work environment     b       If work environment conditions can have an adverse effect
    needed to achieve            on product quality, the organisation shall establish
    conformity to
    product                      documented requirements for the work environment
    requirements.                conditions and documented procedures or work
    The following
    requirements shall           instructions to monitor and control these work environment
    apply.
                                 conditions.
                         c       The organisation shall ensure that all personnel who are
                                 required to work temporarily under special environmental
                                 conditions within the work environment are appropriately
                                 trained or supervised by a trained person.
                         d       If appropriate, special arrangements shall be established
                                 and documented for the control of contaminated or
                                 potentially contaminated product in order to prevent
                                 contamination of other product, the work environment or
                                 personnel.
    7.1                  a       Quality Objectives and requirements for the product          See 5.4.1
    Planning of
    Product              b       The need to establish processes, documents, and provide
    Realisation                  resources specific to the product
    The Organisation
    shall plan and       c       Required verification, validation, monitoring, inspection
    develop the                  and test activities specific to the product and the criteria
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    Reference                       Requirement                                                   Action Required
    processes needed
    for product
                                    for product acceptance.
    realisation.
    Planning of product    d        Records needed to provide evidence that the realisation
    realisation shall be
    consistent with the
                                    process and resulting product meet the requirements
    requirements of the
    other processes of
    the QMS.               x        The output of this planning shall be in a form suitable for
    In Planning product
    realisation, the
                                    the organisation’s method of operations
    organisation shall
    determine the          y        The organisation shall establish documented requirements
    following as                    for Risk Management throughout product realisation.
    appropriate:
                                    Records arising from Risk Management shall be
                                    maintained.
                           Note 1   A document specifying the processes of the QMS            See x above
                                    (including product realisation processes) and the
                                    resources to be applied to a specific product, project or
                                    contract, can be referred to as a quality plan.
                           Note 2   The organisation may also apply the requirements given in
                                    7.3 (Design & Development) to the development of
                                    product realisation processes.
                           Note 3   See ISO 14971 for guidance related to Risk Management See y above

    7.2.1                  a        Requirements specified by the customer, including the
    Determination                   requirements for delivery and post-delivery activities,
    of
                           b        Requirements not stated by the customer but necessary
    requirements
    related to the                  for specified or intended use, where known,
    product                c        Statutory and regulatory requirements related to the
    The Organisation
    shall determine:
                                    product, and
                           d        Any additional requirements determined by the
                                    organisation.
    7.2.2                  a        Product requirements are defined and documented
    Review of                       Contract or order requirements differing from those
    requirements           b
    related to the                  previously expressed are resolved, and
    product                         The organisation has the ability to meet the defined
                           c
    The Organisation                requirements.
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    Reference                      Requirement                                                   Action Required
    shall review the
                                   Records of the review and actions arising from the review     See 4.2.4 Control of Records
    requirements           x
    related to the                 shall be maintained
    product. The review
    shall be conducted             Where the customer provides no documented statement
    prior to the           y       of requirement, the customer requirements shall be
    organisation’s
    commitment to                  confirmed by the organisation before acceptance
    supply a product to
    the customer (e.g.
                                   Where product requirements are changed, the
    submission of                  organisation shall ensure that relevant documents are
    tenders,               z       amended and that relevant personnel are made aware of
    acceptance of
    contracts or orders,           the changed requirements.
    acceptance of
    changes to             Note:   In some situations, such as internet sales, a formal review
    contracts or orders)
    and shall ensure               is impractical for each order. Instead the review can cover
    that:                          relevant product information such as catalogues or
                                   advertising information.
    7.2.3                  a       Product information
    Customer               b       Enquiries, contracts or order handling, including             See 7.2.1 a) above
    Communica-
    tion                           amendments
    The Organisation       c       Customer feedback, including customer complaints              See 8.2.1 (Feedback) below
    shall determine and
    implement effective    d       Advisory notices
    arrangements for
    communicating with
    customers in
    relation to:
    7.3.1                  a       The design and development stages.
    Design &               b       The review, verification, validation and design transfer
    Development
    Planning                       activities (see Note) that are appropriate at each design
    The Organisation               and development stage, and
    shall establish
    documented             c       The responsibilities and authorities for design and
    procedures for                 development
    design and
    development.           x       The organisation shall manage the interfaces between
    The organisation               different groups involved in design and development to
    shall plan and
    control the design             ensure effective communication and clear assignment of
    and development of
    product.                       responsibility.
    During the design      y       Planning output shall be documented, and updated as
    and development
                                   appropriate, as the design and development progresses

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    Reference                       Requirement                                                     Action Required
    planning, the
    organisation shall
                                    (see 4.2.3).
    determine:              Note:   Design transfer activities during the design and
                                    development process ensure that design and
                                    development outputs are verified as suitable for
                                    manufacturing before becoming final production
                                    specifications.
    7.3.2                   a       Functional, performance and safety requirements,
    Design &                        according to intended use,
    Development
    Inputs
                            b       Applicable statutory and regulatory requirements,
    Inputs relating to      c       Where applicable, information derived from previous
    product
    requirements shall              similar designs,
    be determined and       d       Other requirements essential for design and development,
    records maintained
    (see 4.2.4). These              and
    inputs shall include:
                            e       Output(s) of risk management (see 7.1)
                            x       These inputs shall be reviewed for adequacy and
                                    approved.
                            y       Requirements shall be complete, unambiguous and not in
                                    conflict with each other.
    7.3.3                   a       Meet the input requirements for design and development,
    Design &                b       Provide appropriate information for purchasing, production
    Development
    Outputs                         and for service provision,
    The outputs of          c       Contain or reference product acceptance criteria, and
    design and
    development shall       d       Specify the characteristics of the product that are essential
    be provided in a
    form that enables
                                    for its safe and proper use.
    verification against    x       Records of the design and development outputs shall be
    the design and
    development input               maintained (see 4.2.4).
    and shall be            Note:   Records of design and development outputs can include
    approved prior to
    release.                        specifications, manufacturing procedures, engineering
    Design and
    development
                                    drawings, and engineering or research logbooks.
    outputs shall:
    7.3.4                   a       To evaluate the ability of the results of design and
    Design &                        development to meet requirements, and
    Development
                            b       To identify any problems and propose necessary actions.
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    Reference                       Requirement                                                  Action Required
    Review                x         Participants in such reviews shall include representatives
    At suitable stages,
    systematic reviews              of functions concerned with the design and development
    of design and
    development shall
                                    stage(s) being reviewed, as well as other specialist
    be performed in                 personnel (see 5.5.1 and 6.2.1).
    accordance with
    planned
                          y         Records of the results of the reviews and any necessary
    arrangements (see               actions shall be maintained (see 4.2.4).
    7.3.1):
    7.3.5                 General Verification shall be performed in accordance with planned
    Design &                      arrangements (see 7.3.1) to ensure that the design and
    Development                   development outputs have met the design and
    Verification
                                  development input requirements. Records of the results of
                                  the verification and any necessary actions shall be
                                  maintained (see 4.2.4)
    7.3.6                 x       Design and development validation shall be performed in
    Design &                      accordance with planned arrangements (see 7.3.1) to
    Development                   ensure that the resulting product is capable of meeting the
    Validation
                                  requirements for the specified application or intended use.
                                  Validation shall be completed prior to the delivery or
                                  implementation of the product (see Note 1).
                          y       Records of the results of validation and any necessary
                                  actions shall be maintained (see 4.2.4).
                          z       As part of design and development validation, the
                                  organisation shall perform clinical evaluations and/or
                                  evaluation of performance of the medical device, as
                                  required by national or regional regulations (see Note 2)
                          Note 1: If a medical device can only be validated following
                                  assembly and installation at point of use, delivery is not
                                  considered to be complete until the product has been
                                  formally transferred to the customer.
                          Note 2: Provision of the medical device for purposes of clinical
                                  evaluations and/or evaluation of performance is not
                                  considered to be delivery.



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    Reference                     Requirement                                                    Action Required
    7.3.7               x         Design and development changes shall be identified and
    Control of                    records maintained. The changes shall be reviewed,
    Design &                      verified and validated, as appropriate, and approved
    Development
    Changes                       before implementation. The review of the design and
                                  development changes shall include evaluation of the effect
                                  of the changes on constituent parts and product already
                                  delivered.
                        y         Records of the results of the review of changes and any
                                  necessary actions shall be maintained (see 4.2.4)
    7.4.1               x         The organisation shall establish documented procedures
    Purchasing                    to ensure that purchased product conforms to specified
    Process                       purchase requirements.
                        y         The type and extent of control applied to the supplier and
                                  the purchased product shall be dependant upon the effect
                                  of the purchased product on subsequent product
                                  realisation or the final product
                        z         The organisation shall evaluate and select suppliers
                                  based on their ability to supply product in accordance with
                                  the organisation’s requirements. Criteria for selection,
                                  evaluation and re-evaluation shall be established. Records
                                  of the results of the evaluations and any necessary
                                  actions arising from the evaluation shall be maintained.
    7.4.2               a         Requirements for approval of product, procedures,
    Purchasing                    processes and equipment
    Information
    Purchasing
                        b         Requirements for qualification of personnel, and
    Information shall
    describe the        c         QMS requirements
    product to be
    purchased,
    including where
                        x         The organisation shall ensure the adequacy of specified
    appropriate:                  purchase requirements prior to their communication to the
                                  supplier.
                        y         To the extent required for traceability given in 7.5.3.2 the   See 4.2.4 Control of Records
                                  organisation shall maintain relevant purchasing
                                  information i.e. documents and records.

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    Reference                     Requirement                                                  Action Required
    7.4.3                  x      The organisation shall establish and implement the
    Verification of               inspection or other activities necessary for ensuring that
    Purchased                     purchased product meets specified purchase
    Product
                                  requirements
                           y      Where the organisation or its customer intends to perform
                                  verification at the supplier’s premises, the organisation
                                  shall state the intended verification arrangements and
                                  method of product release in the purchasing information
                           z      Records of the verification shall be maintained.             See 4.2.4 Control of Records
    7.5.1.1                a      The availability of information that describes the
    Production &                  characteristics of the product
    Service
    Provision
                           b      The availability of documented procedures, documented
    General                       requirements, work instructions, and reference materials
    Requirements                  and reference measurement procedures as necessary
    The Organisation
    shall plan and carry
                           c      The use of suitable equipment
    out production and
    service provision      d      The availability and use of monitoring and measuring
    under controlled
    conditions.
                                  devices
    Controlled             e      The implementation of monitoring and measurement
    conditions shall
    include as
    applicable:            f      The implementation of release, delivery and post-delivery
                                  activities, and
                           g      The implementation of defined operations for labelling and
                                  packaging
                           x      The organisation shall maintain a record for each batch of   See 7.1 d) above and also 4.2.4 Control of Records
                                  medical devices that provides traceability to the extent
                                  specified in 7.5.3 and identifies the amount manufactured
                                  and amount approved for distribution. The batch record
                                  shall be verified and approved
                           Note   A batch can be a single medical device
    7.5.1.2.1              a      Product is cleaned by the organisation prior to its
    Cleanliness of                sterilisation and/or its use, or


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    Reference                    Requirement                                               Action Required
    product &          b       Product is supplied non-sterile to be subject to a cleaning
    contamination              process prior to sterilisation and/or its use, or
    control
    The Organisation   c       Product is supplied to be used non-sterile and its
    shall establish            cleanliness is of significance in use, or
    documented
    requirements for   d       Process agents are to be removed from product during         See 7.5.1.2.1 a) above
    cleanliness of
    product if:                manufacture
                       x       If product is cleaned in accordance with a) or b) above the
                               requirements in 6.4 a) and 6.4 b) do not apply prior to the
                               cleaning process.
    7.5.1.2.2          x       If appropriate, the organisation shall establish documented
    Installation               requirements which contain acceptance criteria for
                               installing and verifying the installation of the medical
                               device
                       y       If the agreed customer requirements allow installation to
                               be performed other than buy the organisation or its
                               authorised agent, the organisation shall provide
                               documented requirements for installation and verification.
                       z       Records of installation and verification performed by the
                               organisation or its authorised agent shall be maintained
    7.5.1.2.3          x       If servicing is a specified requirement, the organisation
    Servicing                  shall establish documented procedures, work instructions
                               and reference materials and reference measurement
                               procedures, as necessary, for performing servicing
                               activities and verifying that they meet the specified
                               requirements
                       y       Records of servicing activities carried out by the
                                                                                            See 4.2.4 Control of Records
                               organisation shall be maintained
                       Note    Servicing can include, for example, repair and
                               maintenance
    7.5.1.3            General The organisation shall maintain records of the process       See 4.2.4 Control of Records
    Requirements               parameters for the sterilisation process which was used
    for Sterile                for each sterilisation batch. Sterilisation records shall be
    Medical
    Devices                    traceable to each production batch of medical devices.

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    Reference                     Requirement                                                      Action Required
    7.5.2.1                a      Defined criteria for review and approval of the processes
    Validation             b      Approval of equipment and qualification of personnel
    General
    The organisation       c      Use of specific methods and procedures
    shall validate any     d      Requirements for records, and                                    See 4.2.4 Control of Records
    processes for
    production and         e      Revalidation                                                     See 7.1 c) above
    service provision
    where the resulting
                           x      The organisation shall establish documented procedures
    output cannot be              for the validation of the application of computer software
    verified by
    subsequent                    (and changes to such software and/or its application) for
    monitoring or                 production and service provision that affect the ability of
    measurement. This
    includes any                  the product to conform to specified requirements. Such
    processes where
    deficiencies
                                  software applications shall be validated prior to initial use.
    become apparent        y      Records of validation shall be maintained.                       See 4.2.4 Control of Records
    only after the
    product is in use or
    the service has
    been delivered.
    Validation shall
    demonstrate the
    ability of these
    processes to
    achieve planned
    results.
    The organisation
    shall establish
    arrangements for
    these processes
    including, as
    applicable:
    7.5.2.2                x      The organisation shall establish documented procedures
    Requirements                  for the validation of sterilisation processes. Sterilisation
    for Sterile                   processes shall be validated prior to initial use.
    Medical
    Devices                y      Records of validation of each sterilisation process shall be     See 4.2.4 Control of Records Control of Records
                                  maintained
    7.5.3.1                x      The organisation shall identify the product by suitable
    Identification                means throughout product realisation, and shall establish
    & Traceability                documented procedures for such product identification.
    Identification
                           y      The organisation shall establish documented procedures
                                  to ensure that medical devices returned to the
                                  organisation are identified and distinguished from

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    Reference                   Requirement                                                 Action Required
                                conforming product.
    7.5.3.2.1        x       The organisation shall establish documented procedures
    Identification           for traceability. Such procedures shall define the extent of
    & Traceability           product traceability and the records required.
    General
                     y       Where traceability is a requirement, the organisation shall
                             control and record the unique identification of the product.
                     Note    Configuration management is a means by which
                             identification and traceability can be maintained.
    7.5.3.2.2        x       In defining the records for traceability, the organisation
    Requirements             shall include records of all components, materials and
    for Active               work environment conditions, if these could cause the
    Implantable &
    Implantable              medical device not to satisfy its specified requirements.
    Medical          y       The organisation shall require that its agents or
    Devices                  distributors maintain records of the distribution of medical
                             devices to allow traceability and that such records are
                             available for inspection.
                     z       Records of the name and address of the shipping package
                             consignee shall be maintained.
    7.5.3.3          x       The organisation shall identify the product status with
    Status                   respect to monitoring and measurement requirements.
    Identification
                     y       The identification of product status shall be maintained
                             throughout production, storage, installation and servicing
                             of the product to ensure that only product that has passed
                             the required inspections and tests (or released under an
                             authorised concession) is dispatched, used or installed.
    7.5.4            General The organisation shall exercise care with customer
    Customer                 property while it is under the organisation’s control or
    Property                 being used by the organisation. The organisation shall
                             identify, verify, protect and safeguard customer property
                             provided for use or incorporation into the product. If any
                             customer property is lost, damaged or otherwise found to
                             be unsuitable for use, this shall be reported to the
                             customer and records maintained.

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    Reference                     Requirement                                                     Action Required
                          Note    Customer property can include intellectual property or
                                  confidential health information.
    7.5.5                 x       The organisation shall establish documented procedures
    Preservation                  or documented work instructions for preserving the
    of Product                    conformity of product during internal processing and
                                  delivery to the intended destination. This preservation
                                  shall include identification, handling, packaging, storage
                                  and protection. Preservation shall also apply to the
                                  constituent parts of a product.
                          y       The organisation shall establish documented procedures
                                  or documented work instructions for the control of product
                                  with a limited shelf-life or requiring special storage
                                  conditions. Such special storage conditions shall be
                                  controlled and recorded.
    7.6                   a       Be calibrated or verified at specified intervals, or prior to
    Control of                    use, against measurement standards traceable to
    Monitoring &                  international or national measurement standards; where
    Measuring
    Devices                       no such standards exist, the basis used for calibration or
    The organisation              verification shall be recorded.
    shall determine the
    monitoring and        b       Be adjusted or readjusted as necessary.
    measurement to be
    undertaken and the    c       Be identifiable to enable the calibration status to be
    monitoring and
    measuring devices             determined.
    needed to provide     d       Be safeguarded from adjustments that would invalidate
    evidence of
    conformity of                 the measurement result.
    product to
    determined            e       Be protected from damage and deterioration during
    requirements.                 handling, maintenance and storage.
    The organisation      x       In addition, the organisation shall assess and record the
    shall establish
    documented                    validity of the previous measuring results when the
    procedures to                 equipment is found not to conform to requirements. The
    ensure that
    monitoring and                organisation shall take appropriate action on the
    measurement can
    be carried out in a
                                  equipment and any product affected. Records of the
    manner that is                results of calibration and verification shall be maintained.


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    Reference                     Requirement                                                      Action Required
    consistent with the
    monitoring and
                          y       When used in the monitoring and measurement of
    measurement                   specified requirements, the ability of computer software to
    requirements.
                                  satisfy the intended application shall be confirmed. This
    Where necessary
    to ensure valid
                                  shall be undertaken prior to initial use and reconfirmed as
    results, measuring            necessary.
    equipment shall:
                          Note    See ISO 10012 for guidance related to measurement
                                  management systems.
    8.1                   a       To demonstrate conformity of the product
    Measurement
    Analysis &            b       To ensure conformity of the QMS, and
    Improvement
    General               c       To maintain the effectiveness of the QMS.
    The organisation
    shall plan and
    implement the
                          x       This shall include determination of applicable methods,
    monitoring,                   including statistical techniques, and the extent of their use.
    measurement,
    analysis and
                          Note    National or regional regulations might require documented
    improvement                   procedures for implementation and control of the
    processes needed:
                                  application of statistical techniques.
    8.2.1                 w       As one of the measurements of the performance of the
    Feedback                      QMS, the organisation shall monitor information relating to
                                  whether the organisation has met customer requirements.
                          x       The methods for obtaining and using this information shall
                                  be determined
                          y       The organisation shall establish a documented procedure
                                  for a feedback system (see 7.2.3 c) to provide early
                                  warning of quality problems and for input into the CAPA
                                  processes (see 8.5.2 & 8.5.3)
                          z       If national or regional regulations require the organisation
                                  to gain experience from the post production phase the
                                  review of this experience shall form part of the feedback
                                  system (see 8.5.1)
    8.2.2                 a       Conforms to the planned arrangements (see 7.1), to the
    Internal Audit                requirements of this International Standard and to the
    The organisation
                                  QMS requirements established by the organisation, and


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    Reference                        Requirement                                                      Action Required
    shall conduct
    internal audits at
                           b         Is effectively implemented and maintained.
    planned intervals to
    determine whether      x         An audit programme shall be planned, taking into
    the QMS:
                                     consideration the status and importance of the processes
                                     and areas to be audited, as well as the results of previous
                                     audits. The audit criteria, scope, frequency and methods
                                     shall be defined. Selection of auditors and conduct of
                                     audits shall ensure objectivity and impartiality of the audit
                                     process. Auditors shall not audit their own work.
                           y         The responsibilities and requirements for planning and
                                     conducting audits, and for reporting results and
                                     maintaining records shall de defined in a documented
                                     procedure.
                           z         The management responsible for the area being audited
                                     shall ensure that actions are taken without undue delay to
                                     eliminate the non-conformities and their causes. Follow-up
                                     activities shall include the verification of the actions taken
                                     and the reporting of verification results (see 8.5.2)
                           Note      See ISO 19011 for guidance related to quality auditing
    8.2.3                  General The organisation shall apply suitable methods for                  See 5.6 Management Review.
    Monitoring &                   monitoring and, where applicable, measurement of the
    Measurement                    QMS processes. these methods shall demonstrate the
    of Processes
                                   ability of the processes to achieve planned results. When
                                   planned results are not achieved, correction and
                                   corrective action shall be taken, as appropriate, to ensure
                                   conformity of the product.
    8.2.4.1                x       The organisation shall monitor and measure the                     See 8.1 a) above
    Monitoring &                   characteristics of the product to verify that product
    Measurement                    requirements have been met. This shall be carried out at
    of Product
                                   appropriate stages of the product realisation process in
                                   accordance with the planned arrangements (see 7.1) and
                                   documented procedures (see 7.5.1.1)
                           y       Evidence of conformity with the acceptance criteria shall

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    Reference                        Requirement                                                   Action Required
                                   be maintained. Records shall indicate the person(s)
                                   authorising release of product.
                           z       Product release and service delivery shall not proceed
                                   until the planned arrangements (see 7.1) have been
                                   satisfactorily completed.
    8.2.4.2                General The organisation shall record (see 4.2.4) the identity of
    Requirements                   personnel performing any inspection or testing.
    for Active
    Implantable &
    Implantable
    Medical
    Devices
    8.3                    a         By taking action to eliminate the detected nonconformity.
    Control of
    Non-                   b         By authorising its use, release or acceptance under
    Conforming                       concession.
    Product                c         By taking action to preclude its original intended use or
    The organisation
    shall ensure that                application.
    product which does
    not conform to         v         The organisation shall ensure that nonconforming product
    product                          is accepted by concession only if regulatory requirements
    requirements is
    identified and                   are met. Records of the identity of the person(s)
    controlled to                    authorising the concession shall be maintained (see
    prevent its
    unintended use or                4.2.4).
    delivery. The
    controls and related   w         Records of the nature of nonconformities and any
    responsibilities and             subsequent actions taken, including concessions obtained
    authorities for
    dealing with                     shall be maintained (see 4.2.4).
    nonconforming          x         When nonconforming product is corrected it shall be
    product shall be
    defined in a                     subject to re-verification to demonstrate conformity to the
    documented
    procedure.
                                     requirements.
    The organisation
                           y         When nonconforming product is detected after delivery or
    shall deal with                  use has started, the organisation shall take action
    nonconforming
    product by one or
                                     appropriate to the effects, or potential effects of the
    more of the                      nonconformity.
    following ways
                           z         If product needs to be re-worked (one or more times), the
                                     organisation shall document the rework process in a work

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    Reference                     Requirement                                                   Action Required
                                  instruction that has undergone the same authorisation and
                                  approval procedure as the original work instruction. Prior
                                  to authorisation and approval of the work instruction, a
                                  determination of any adverse effect of the rework upon
                                  product shall be made and documented (see 4.2.3 and
                                  7.5.1)
    8.4                    a      Feedback (see 8.2.1)                                          See 5.6 Management Review
    Analysis of
    Data                   b      Conformity to product requirements (see 7.2.1)
    The organisation
    shall establish        c      Characteristics and trends of processes and products
    documented
    procedures to                 including opportunities for preventive action, and
    determine, collect
    and analyse
                           d      Suppliers
    appropriate data to
    demonstrate the        x      Records of the results of the analysis shall be maintained    See 4.2.4 Control of records
    suitability and
    effectiveness of the          (see 4.2.4)
    QMS and to
    evaluate if
    improvement of the
    effectiveness of the
    QMS can be made.

    This shall include
    data generated as
    a result of
    monitoring and
    measurement and
    from other related
    sources.

    The analysis of
    data shall provide
    information relating
    to:
    8.5.1                  v      The organisation shall identify and implement any             See 5.6 Management Review
    Improvement                   changes necessary to ensure and maintain the continued
    General                       suitability and effectiveness of the QMS through the use of
                                  the Quality policy, Quality Objectives, audit results,
                                  analysis of data, CAPA and Management Review
                           w      The organisation shall establish documented procedures        See 7.2.3 d) Customer Communication (Advisory
                                  for the issue and implementation of Advisory Notices.         Notices)
                                  These procedures shall be capable of being implemented        and 8.2.1 Measurement Analysis & Improvement
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    Reference                     Requirement                                                    Action Required
                                  at any time.
                            x     Records of all customer complaint investigations shall be      See 8.2.1 Feedback (w.r.t. Customer Complaints SOP)
                                  maintained (see 4.2.4). If investigation determines that the
                                  activities outside the organisation contributed to the
                                  customer complaint, relevant information shall be
                                  exchanged between the organisations involved (see 4.1)
                            y     If any complaint is not followed by corrective and/or          See 8.2.1 Feedback (w.r.t. Customer Complaints SOP)
                                  preventive action, the reason shall be authorised (see
                                  5.5.1) and recorded (see 4.2.4)
                            z     If national or regional regulations require notification of    See 7.2.3 d) Customer Communication (Advisory
                                  adverse events that meet specified reporting criteria, the     Notices)
                                  organisation shall establish documented procedures to          and 8.2.1 Measurement Analysis & Improvement
                                  such notification to regulatory authorities.
    8.5.2                   a     Reviewing nonconformities (including customer
    Corrective                    complaints)
    Action
    The organisation
                            b     Determining the causes of nonconformities
    shall take action to
    eliminate the cause     c     Evaluating the need for action to ensure that
    of nonconformities
    in order to prevent           nonconformities do not recur
    recurrence.             d     Determining and implementing action needed, including, if
    Corrective actions
    shall be appropriate          appropriate, updating documentation (see 4.2)
    to the effects of the
    nonconformities
                            e     Recording the results of any investigation and of action
    encountered.                  taken (see 4.2.4); and
    A documented            f     Reviewing the corrective action for its effectiveness
    procedure shall be
    established to
    define the
    requirements for:
    8.5.3                   a     Determining potential nonconformities and their causes
    Preventive
    Action
    The organisation
                            b     Evaluating the need for action to prevent occurrence of
    shall determine               nonconformities.
    action to eliminate
    the cause of
    potential               c     Determining and implementing action needed
    nonconformities in




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    Reference                     Requirement                                                    Action Required
    order to prevent
    occurrence.
                            d     Recording of the results of any investigations and of action
    Preventive actions            taken (see 4.2.4); and
    shall be appropriate
    to the effects of the
    potential problems.     e     Reviewing preventive action taken and its effectiveness.
    A documented
    procedure shall be
    established to
    define the
    requirements for:




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Description: Gap Analysis Against ISO 134852003