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    Audit Check List-9001

    Uploaded by

    akash batra
    The document is an audit checklist for various processes according to AS 9100 Rev. B quality standard. It lists various check points for processes like document control, maintenance, purchasing, production, etc. and columns to record observations and remarks from auditing those check points for conformance to the standard. The purpose is to conduct a thorough audit of the organization's quality management system and processes to ensure compliance.

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    © All Rights Reserved
    Download as XLS, PDF, TXT or read online from Scribd

    Audit Check List-9001

    Uploaded by

    akash batra
    85 views9 pages
    The document is an audit checklist for various processes according to AS 9100 Rev. B quality standard. It lists various check points for processes like document control, maintenance, purchasing, production, etc. and columns to record observations and remarks from auditing those check points for conformance to the standard. The purpose is to conduct a thorough audit of the organization's quality management system and processes to ensure compliance.

    Original Description:

    audit check list ISO 9001

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    The document is an audit checklist for various processes according to AS 9100 Rev. B quality standard. It lists various check points for processes like document control, maintenance, purchasing, production, etc. and columns to record observations and remarks from auditing those check points for conformance to the standard. The purpose is to conduct a thorough audit of the organization's quality management system and processes to ensure compliance.

    Copyright:

    © All Rights Reserved
    Download as XLS, PDF, TXT or read online from Scribd
    Download as xls, pdf, or txt
    85 views9 pages

    Audit Check List-9001

    Uploaded by

    akash batra
    The document is an audit checklist for various processes according to AS 9100 Rev. B quality standard. It lists various check points for processes like document control, maintenance, purchasing, production, etc. and columns to record observations and remarks from auditing those check points for conformance to the standard. The purpose is to conduct a thorough audit of the organization's quality management system and processes to ensure compliance.

    Copyright:

    © All Rights Reserved
    Download as XLS, PDF, TXT or read online from Scribd
    Download as xls, pdf, or txt
    of 9

    AUDIT CHECK LIST-AS 9100 Rev.

    Prosess MR

    Sr. No. Check Point. Observation Remark

    1 All documents in use are under document control.

    2 Master list of documents availablility.

    3 Understanding of documention.
    5 Records are maintained as per record matrix.

    6 Audit plan.

    7 Audit schedule availability.

    8 Audit NC availabe closed as defined.

    10 Quality objective monitoring.exist.

    11 Process performance record available.

    12 Manegement review is conducted against alll specified points.

    13 Decisions are implimented

    14 CAPA are implimented.

    15 All documents are issued as per issue& removal advice.

    16 Documents in use are legeble and appropriate.

    17 No obsolete document should be available.


    AUDIT CHECK LIST-AS 9100 Rev.B

    Prosess STORE

    Sr. No. Check Point. Observation Remark

    Material are identified with respect to MRN


    1
    & Qty. & item.

    2 FIFO is implimented.

    3 House keeping
    5 Work envoirnment.

    6 Use of PPE.

    8 Shelf life list is available

    10 Issue slip is available.

    11 GRN is available

    12 Gate pass challan are available

    13 MSDS are available.


    AUDIT CHECK LIST-AS 9100 Rev.B

    Prosess DEVELOPMENT

    Sr. No. Check Point. Observation Remark

    1 Development plan is available.

    2 Development inputs are adequatly define.


    Responsibilities and target dates are
    3 defined for development input,
    output,review,verification &validation.
    Development verification & validation record
    4
    are available.
    5 All related comunication are available.
    In output key characteristicsare identified (if
    6
    any)

    In input functional & performance


    7 requirments, statutary& regulatory
    requirments are identified

    All relvent drawing, specification are


    8
    generated

    9 Review evidence available.

    10 Authorasation for next phase is available.

    11 Control development changes are available.

    12 training record available.


    AUDIT CHECK LIST-AS 9100 Rev.B

    Prosess MAINTINANCE

    Sr. No. Check Point. Observation Remark

    1 Master list of machine availability

    2 Maintinance log book is available

    Preventive maintinance records are


    3
    available.

    4 History Card is available

    5 Work envoirnment is adequatly monitored


    AUDIT CHECK LIST-AS 9100 Rev.B

    Prosess HRD

    Sr. No. Check Point. Observation Remark

    1 Training plan is available.

    2 Training records are available

    3 Competence is evaluated.
    4 Competence matrix is available.
    AUDIT CHECK LIST-AS 9100 Rev.B

    Prosess PERCHASE

    Sr. No. Check Point. Observation Remark

    Approved supplier list is available have


    1
    scope of approval status.
    P.O. have clear discription of products &
    2
    terms& condition.
    5 Supplier performance is monitored.

    6 Training records are available.


    AUDIT CHECK LIST-AS 9100 Rev.B

    Prosess QUALITY ASSURANCE

    Sr. No. Check Point. Observation Remark

    1 Inspection plan is defined

    2 Sampling plan is available.


    4 Test methods are available.
    5 External origin documents are available.
    6 Only calibrated equipments are used.
    Inspection records are available &
    7
    maintained as per inspection plan.

    8 House keeping.

    10 House keeping is satisfactory

    11 Poeples are trained on test method.


    AUDIT CHECK LIST-AS 9100 Rev.B

    Prosess MARKETING
    Evidence
    Sr. No. Check Point. Status
    Remark

    Statutory & regulatory is assesed while


    1
    submitting the offer & reciept of order.

    4 Product requirments adequality.

    Terms and condition are agreed with


    5
    customer.

    6 delivery performance is monitored

    Customer feedback is assesed & action are


    7
    taken.

    Customer Complaints are handled in timely


    8 manner and corrective action are taken
    accordingly
    Customer satiafaction improvement plan is
    9
    available.
    AUDIT CHECK LIST-AS 9100 Rev.B

    Prosess Production

    Sr. No. Check Point. Observation Remark

    1 Each product is identified with unique no.

    Status of each product with respect


    2
    accepted, rejected or hold is available.

    3 Treacibility record is available.

    4 MSDS of all chemicals used is available.

    5 Work instruction are available.

    Only calibrated monitaring &measurement


    6
    equipment are in use

    People are trained on propcedure,work


    7
    instruction.

    9 Improsses inspectionis carried out.

    10 Contral plan is available.

    12 Master samples are displyed (if any)

    15 People are trained on work.

    List of authorised person for release of


    16
    product is available.

    For all chemical MSDS is available Process


    17
    noncomformatly

    19 Process nonconformity report is available.


    Key characteristics are identified &
    20
    displayed & people are aware about it.
    Storage requiement for production
    21
    equipments are identified &maintained.
    Accountibility for all product manufacured is
    22
    defined.
    If any change in requirment , save is being
    23 approved by customer /ragulatory
    requirment.
    Special process are identified & parameters
    24
    are followed.

    Non conforming products are adequatly


    25
    identified & sarggregated from ok material.

    CAPA are taken Trainning record are


    26
    available.
    27 Training records are available

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