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    Iso 9001 Audit Part B

    Uploaded by

    Mr. Chiragwile Bita
    This document provides an internal audit checklist for ISO 9001 regarding quality manuals and document control. It outlines key requirements such as having a quality policy and objectives documented, a quality manual, documented procedures, and sufficient documentation to ensure quality processes are efficiently planned, operated and controlled. The checklist also evaluates whether the quality manual contains information like the quality management system scope and references to documented procedures. It asks whether the organization has a document control procedure that defines how documents are authorized, reviewed, revised and re-authorized.

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    Iso 9001 Audit Part B

    Uploaded by

    Mr. Chiragwile Bita
    15 views2 pages
    This document provides an internal audit checklist for ISO 9001 regarding quality manuals and document control. It outlines key requirements such as having a quality policy and objectives documented, a quality manual, documented procedures, and sufficient documentation to ensure quality processes are efficiently planned, operated and controlled. The checklist also evaluates whether the quality manual contains information like the quality management system scope and references to documented procedures. It asks whether the organization has a document control procedure that defines how documents are authorized, reviewed, revised and re-authorized.

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    iso-9001-audit-part-b

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    This document provides an internal audit checklist for ISO 9001 regarding quality manuals and document control. It outlines key requirements such as having a quality policy and objectives documented, a quality manual, documented procedures, and sufficient documentation to ensure quality processes are efficiently planned, operated and controlled. The checklist also evaluates whether the quality manual contains information like the quality management system scope and references to documented procedures. It asks whether the organization has a document control procedure that defines how documents are authorized, reviewed, revised and re-authorized.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    15 views2 pages

    Iso 9001 Audit Part B

    Uploaded by

    Mr. Chiragwile Bita
    This document provides an internal audit checklist for ISO 9001 regarding quality manuals and document control. It outlines key requirements such as having a quality policy and objectives documented, a quality manual, documented procedures, and sufficient documentation to ensure quality processes are efficiently planned, operated and controlled. The checklist also evaluates whether the quality manual contains information like the quality management system scope and references to documented procedures. It asks whether the organization has a document control procedure that defines how documents are authorized, reviewed, revised and re-authorized.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    ComplianceQuest Inc.

    www.compliancequest.com

    ISO 9001 Internal Audit Checklist – Part B (Quality Manual, Document Control)

    ISO standards are globally recognized, which allows for a consistent framework for quality management
    regardless of where your company is located. Following a framework for your quality management can
    streamline the process and eliminate confusion about expectations.

    Utilize the checklist to evaluate your current management system against the standard's requirements. Each
    question pertains to a condition that must be fulfilled to adhere to ISO 9001.

    This is Part B of this checklist. To get the full details, please refer to Part A as well.

    S. No. Documentation - General Yes No NA

    Is there a quality policy that has been officially


    1
    documented by the organization?

    Has the organization established a collection of quality


    2
    objectives that are documented?

    3 Does the organization have a quality manual?

    Does the organization operate a set of documented


    4
    procedures as required by the standard?

    Has the organization established sufficient documentation


    5 to guarantee the efficient planning, operation and control
    of its processes?

    Does documentation include the records required by ISO


    6
    9001:2008?

    Documentation - Quality Manual

    Does the quality manual contain a QMS scope that


    7 outlines the specifics of any exclusions and provides a
    rationale for them?

    Is there a reference or inclusion in the quality manual of


    8 the documented procedures that have been developed for
    the QMS?

    Is there a depiction or written account in the quality


    manual that explains the interaction between the
    9
    processes within the QMS, either in the form of a process
    map or written description?

    Documentation - Document Control


    e
    Does
    r the organization operate a document control
    c
    10
    procedure?
    d
    n
    Does the procedure define the controls to authorize
    11
    documents for adequacy before they are released?

    Does the procedure specify the required measures for


    12 reviewing, revising, and re-authorizing documents as
    needed?

    © 2022 ComplianceQuest. All rights reserved. Confidential and Proprietary. Publishing of this content is not allowed without express permission from ComplianceQuest Page 1 of 2
    ComplianceQuest Inc.
    www.compliancequest.com

    Wouldn’t it be wonderful to automatically classify all findings from an ISO 9001 audit? What about the ability to
    automatically prioritize key quality risks in your enterprise? As per the requirement of ISO 9001, does your QMS
    workflow offer the ability to perform integrated risk management? What about the ability to track the status of all
    risk control action items?

    With ComplianceQuest EQMS, each of these becomes simple and efficient. It’s time to implement a truly next-
    generation, connected, holistic EQMS solution like ComplianceQuest, and meeting ISO 9001 requirements with
    efficiency.

    Request A Demo

    Doc. CQEQMS-108Ver1.0, eff. May 9th, 2023

    About ComplianceQuest
    Transform to a fully connected business with a next-generation AI-Powered Quality and Safety management platform, built on Salesforce. Our
    connected suite of solutions helps businesses of all sizes increase quality, safety and efficiency as they bring their products from concept to
    customer success. Our intelligent data-driven platform comes with best-in-class integrated processes to mitigate risks, protecting your employees,
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    For more information, or to request a demo with a ComplianceQuest expert, contact ComplianceQuest today:

    Visit www.compliancequest.com • Email us at [email protected] • Call us at 408-458-8343

    © 2023 ComplianceQuest. All rights reserved. Confidential and Proprietary. Publishing of this content is not allowed without express permission from ComplianceQuest.
    © 2022 ComplianceQuest. All rights reserved. Confidential and Proprietary. Publishing of this content is not allowed without express permission from ComplianceQuest Page 2 of 2

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