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  • How comprehensive and specific should we describe the implementation methods in SoA?

    Thank you for your question.

    We answered it through Experta - you can find the answer here: https://experta.com/shared-post/076e2772-3efb-4557-8a6d-9558333d7e5d

  • Non-mandatory documents

    Most of the non-mandatory documents on our website come from our experience in helping organizations comply with ISO 22301. These non-mandatory documents were identified by organizations as being helpful in implementing and operating their BCMS.

    For example, ISO 22301 does not require organizations to document how they control documents and records, but having a procedure for that can facilitate communication and keep documents in a default format.   

    This article can provide you with further information:

  • What do we do when our existing policies do not match Conformio's policies?

    In terms of the standard, the question here would be: 
     
    "What do we do if our guidelines and Conformio's do not match?"
     
    In this case, the customer should choose the document that best complies with the standard. Sometimes the user's document is more strict than the one provided by Conformio, and this is not a problem as the user can upload the PDF version of their own document to Conformio and use it instead of the Conformio template. 
     
    An alternative can be that the user includes the link to the page where the document is published in the Conformio template and explains to the customer that if he fulfills the requirements for document management in their Wiki platform it wouldn't be a problem. However, this means they would have to manage updating two different documents (the Wiki page, and the Conformio document), so it might be too complicated.

  • Teleworking Policy and IT Security Policy

    Thank you for your question!

    You can do that, but it is advisable that you mark the control that lists the Teleworking Policy as inapplicable in the Statement of Applicability so the step for Teleworking Policy is then hidden.

  • Risk treatment plan

    Thank you for your question.

    We answered it through Experta - you can find the answer here: https://experta.com/shared-post/356983f7-e736-474d-b864-81cb855154a8

  • CQI 17

    For reference informed

  • 3.4. Handling classified information

    Thank you for your question.

    We answered it through Experta - you can find the answer here: https://experta.com/shared-post/fdc70116-07a2-4725-b1ab-b81cd698870c

  • Custom Edit Documents

    Thank you for your question.

    We answered it through Experta - you can find the answer here: https://experta.com/shared-post/a195a94d-9059-4e02-ab72-90480d32fce6

  • Multiple scope in one certification

    Our company is certified for meeting ISO 13485 requirements for the scope of design, development, manuafcture and sales of product for brand A. Our Parent company has requested to get certified for their brand (i.e Brand B) with the scope of manufacture aand sales of products. Would this be treated as a spearate certification and would require both stages of audits? or can be integrated with existing one as an extension of scope

  • Recovery

    ISO 22301 does not prescribe how recovery needs to be performed, so organizations can implement recovery as best fits their needs.

    The preference for fully automated recovery versus human intervention step by step would depend on various factors such as the criticality of the systems or data being recovered, the complexity of the recovery process, and the resources available.

    Fully automated recovery processes can be faster and more efficient in certain situations, especially for routine or well-defined recovery scenarios where human intervention may introduce delays or errors. Automation can also help ensure consistency and reduce the risk of human error during the recovery process.

    However, in some cases, human intervention may be necessary to make critical decisions, assess the situation, or address unforeseen issues that automated systems may not be able to handle. Human intervention can also provide a level of oversight and control that may be necessary for certain recovery scenarios.

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