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    Project Checklist for ISO 13485 Implementation En

    Uploaded by

    Lokesh

    Copyright:

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

    Project Checklist for ISO 13485 Implementation En

    Uploaded by

    Lokesh
    11 views3 pages

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    © © All Rights Reserved

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    DOCX, PDF, TXT or read online from Scribd

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    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    11 views3 pages

    Project Checklist for ISO 13485 Implementation En

    Uploaded by

    Lokesh

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    of 3

    [organization name]

    Project Checklist for ISO 13485:2016 Implementation

    Implementation phases Tasks Done

    Obtain management Research which benefits of ISO 13485:2016 would be


    support applicable to your company.

    Present the benefits to the management and get their


    commitment.

    Get formal approval for the project.

    Establish your project Decide whether you are going to use consultants, or if you will
    be using documentation templates.

    Purchase the ISO 13485:2016 standard.

    Educate your project team.

    Write the Project Plan, including the definition of the project


    manager, project team, project sponsor, required resources,
    and milestones.

    Define which stakeholders need to be informed about each


    step in the project.

    Organize a kick-off meeting.

    Identify requirements Identify requirements of the standard.

    Identify applicable legal requirements.

    Define the scope, Define the scope of the QMS (Quality Management System).
    management
    commitment, and Write the Quality Policy.
    responsibilities
    Decide on the Quality Objectives.

    Define processes and Identify all processes and procedures necessary for the QMS.

    Project Checklist for ISO 13485:2016 ver [version] from [date] Page 1 of 3

    ©2018 13485Academy https://www.advisera.com/13485academy/


    [organization name]

    procedures Write the Quality Manual.

    Write the Procedure for Document Control.

    Write the Procedure for Internal Audit.

    Write the Procedure for Corrective and Preventive Action.

    Establish risk Establish a risk management process.


    management process
    Define a risk assessment methodology.

    Conduct the risk assessment.

    Implement processes, Implement all the processes, procedures, and controls defined
    procedures, and for the QMS.
    controls
    Maintain records of the implementation.

    Perform training and Perform training for all employees who lack required skills.
    awareness programs
    Perform awareness programs for all employees and third
    parties who have a role in your QMS.

    Operate the QMS Maintain all the records required by your own policies and
    procedures.

    Perform corrective actions as needed.

    Make sure you monitor all your systems.

    Measure if you have achieved the objectives set for your QMS.

    Perform internal audit Develop the audit program.

    Perform the internal audit(s).

    Write an Internal Audit Report.

    Perform corrective actions.

    Project Checklist for ISO 13485:2016 ver [version] from [date] Page 2 of 3

    ©2018 13485Academy https://www.advisera.com/13485academy/


    [organization name]

    Perform management Perform the management review.


    review
    Maintain records from the management review.

    Perform corrective actions.

    Ensure continual improvement.

    Choose a certification Obtain proposals from several certification bodies.


    body
    Select the certification body.

    Certification audit Perform the Stage 1 certification audit.

    Perform the Stage 2 certification audit.

    Conduct surveillance visits.

    For all the documents needed to implement the standard, check out this ISO 13485:2016
    Documentation Toolkit.

    Project Checklist for ISO 13485:2016 ver [version] from [date] Page 3 of 3

    ©2018 13485Academy https://www.advisera.com/13485academy/

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