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    Quality Management System

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    meredil2023

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    Quality Management System

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    meredil2023
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    6 views2 pages

    Quality Management System

    Uploaded by

    meredil2023

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
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    Quality Management System (QMS) requirements are typically outlined in the ISO 9001

    standard, which provides a framework for managing and improving an organization’s processes.
    Below is an overview of the main requirements for a QMS as per ISO 9001:2015:

    1. Context of the Organization

     Understanding the organization and its context: Identify internal and external issues
    that affect the ability to achieve the intended results of the QMS.
     Understanding the needs and expectations of interested parties: Determine who the
    stakeholders are and what their requirements are.
     Determining the scope of the QMS: Define the boundaries and applicability of the
    QMS within the organization.
     QMS and its processes: Establish and implement processes to meet the QMS objectives.

    2. Leadership

     Leadership and commitment: Top management must demonstrate leadership by taking


    responsibility for the effectiveness of the QMS.
     Customer focus: Ensure that customer requirements are understood and met.
     Quality policy: Establish a quality policy aligned with the organization’s goals.
     Organizational roles, responsibilities, and authorities: Assign clear roles to ensure
    accountability.

    3. Planning

     Actions to address risks and opportunities: Identify risks and opportunities that could
    impact the QMS.
     Quality objectives and planning to achieve them: Set measurable objectives that
    support the quality policy.
     Planning of changes: When changes to the QMS are planned, they must be controlled
    and communicated effectively.

    4. Support

     Resources: Determine and provide the necessary resources (people, infrastructure, and
    environment) for the QMS.
     Competence: Ensure employees are competent based on education, training, and
    experience.
     Awareness: Make sure staff are aware of their contributions to the QMS.
     Communication: Establish internal and external communication relevant to the QMS.
     Documented information: Maintain documentation to support the QMS and ensure it's
    controlled and updated.
    5. Operation

     Operational planning and control: Plan and control processes to meet QMS
    requirements.
     Requirements for products and services: Determine and review customer requirements
    before offering products or services.
     Design and development of products and services: Implement a structured process for
    design and development.
     Control of externally provided processes, products, and services: Ensure that
    suppliers meet required standards.
     Production and service provision: Control production processes to ensure conformity.
     Release of products and services: Ensure products meet quality requirements before
    release.
     Control of nonconforming outputs: Identify and manage nonconforming products or
    services.

    6. Performance Evaluation

     Monitoring, measurement, analysis, and evaluation: Continuously monitor and


    measure performance to ensure the QMS is effective.
     Internal audit: Conduct periodic internal audits to check compliance with the QMS.
     Management review: Top management must review the QMS regularly to ensure its
    continuing suitability and effectiveness.

    7. Improvement

     Nonconformity and corrective action: Take action to eliminate the cause of


    nonconformities and prevent recurrence.
     Continual improvement: Continuously improve the QMS through corrective actions,
    audits, and management reviews.

    These requirements are designed to create a systematic and process-driven approach to ensuring
    quality in products and services. Adhering to them can help organizations achieve customer
    satisfaction and continuous improvement.

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