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  • The Statement of Acceptance of ISMS System Documents


    Answer:

    First is important to understand that this Statement:
    - is necessary only if they have found risks or some other reason to use it
    - is not necessary if you have some other way to prove that the documents were read by employees (e.g., through a document management system)

    Considering that, the auditor's role is to verify if documents comply with the standard's requirements and if people's activities and process comply with what was documented, so the auditor will not require employees to sign this or that policy, but will check if they understand the policies, procedures and documents that are listed in the Statement of Acceptance of ISMS System Documents.

    As for which documents to include in the statement, you have to include all documents from the toolkit you implemented.

    This article may provide you further information:
    - Which questions will the ISO 27001 certificatio n auditor ask? https://advisera.com/27001academy/blog/2015/07/20/which-questions-will-the-iso-27001-certification-auditor-ask/

  • Different standard for sampling?


    Answer:

    ISO 13485 does not state any specific standard for sampling. It is the company’s responsibility to ensure compliance to relevant sampling standard according to local regulatory requirements.

  • ISO 45001:2018 external communication


    Answer:
    Remember, the external communication is anything that you send to an outside organization about your OH&S activities. So, if you need to send anything to the municipalities that you work for this should be kept as a record. This could include such things as incident reports, back to work report, or anything else that is mandated for you to report on in your organization. If you need to send out information to anyone about the OH&S processes or performance, you need to keep a record of what you sent.
    For a better understanding of the ISO 45001:2018 stan dard, see the whitepaper: Clause-by-clause explanation of ISO 45001:2018, https://info.advisera.com/45001academy/free-download/clause-by-clause-explanation-of-iso-45001

  • AS9100 Rev D Requirement Clarifications

    While AS9100 does not dictate how the QMS will be assessed and does not dictate how long customer production processes need to be functioning, it might b possible to assess if the processes are in place without this (although this is not easy nor preferable). It is also worth noting that AS9100 does not talk about KPIs either. In ISO 19011, the standard which gives guidance on how to audit ISO management systems, these guidelines identify three methods of collecting audit evidence; observation, interview, and review of records. So, it could be possible to verify through interviews and observation that the processes are in place and functioning even if the records do not exist because no customer production has taken place.

    I am not suggesting this is preferable, nor will it be easily done, but it could be possible. As for certification auditors, I also do not know what their opinion would be on auditing a system that is not currently in use to meet customer requirements, so you would have to ask your certification body directly. The question I would ask is why are you maintaining a QMS that you are not using? If the company does not produce products for aerospace, then why are you certifying to AS9100?

    You can read more on how ISO 19011 works in the article:

Page 605-vs-13485 of 1128 pages

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