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  • Enforcing the quality management system requirements

    Mark hit it on the head. While QA really has no power to enforce requirements for leadership, you can always remind them that corrective action requirements, including obviously internal audit findings and/or 2nd and 3rd party audit findings that drive CARS/SCARS/RCA and follow up audits to ensure the corrective actions that were initiated are effective, are the ONLY requirments of AS9100 that a CB 3rd party auditor can pull your cert immediately. I've witnessed this in action. The CB auditor physically pulled the framed cert off the wall on his way out and after reporting to the CB, the cert was revoked within 3 days. This means this info is available on the IAQG website and your basically out of business. So, if they like the fat paychecks executives tend to receive, it's in their best interest to support the QMS to their fullest extent, it's a requirement of the standard. So, the 3rd party auditor would write up Majors on leadership as well as lack of continuous improvement through the methods I mentioned. Hope this helps!

  • Applicable exclusion from standard

    In our documentation toolkit, in 03_Quality_Manual_Premium_EN, in section 2.1 you can state all requirements that are not applicable for your company, with proper justification.

     

  • Need of explicit consent

    Tecnically, your client is the data controller who should acquire consent before sharing its clients' data with third parties. You could send a cold email under legitimate interest and acquire consent acting as a data controller.

  • Quality manual & Procedure under the ISO 13485:2016

    That's a really great post describes all the important points which are very useful to get ISO 13485 Manual. Get more information about ISO 13485 Manual on 

  • ISO2 7001 / 2 website changes

    ISO 27001:2013 was confirmed by its responsible committee on 2019 review, and it will not undergo a new review for some years. No changes were required in our material.

    Regarding ISO 27002:2013, it is under review at this moment (current DIS is available at https://www.iso.org/obp/ui/#iso:std:iso-iec:27002:dis:ed-3:v1:en) and the new ISO 27002 will be published in 2022, and by then we will of course make all necessary changes.

  • Admin verification checks and physical verification checks

    No, we do not have such a checklist. But, maybe you can explain to us what do you need from that kind of list, what will be the purpose of that checklist, so maybe we have it in our toolkit under a different form.

  • EU GDPR breach

    Google is committed to complying with GDPR requirements in offering services to its Clients, so along you set up correctly your privacy and cookies notice in your website and ask consent to visitors for targeting/marketing purposes you should be ok with GDPR requirements offering to the services offered by Google Analytics.

    Here you can find more information about how to comply with GDPR in online marketing

    If you want to learn how to comply with EU GDPR requirements you may consider enrolling in our free training EU GDPR Foundations course: https://advisera.com/training/eu-gdpr-foundations-course//

  • Environmental aspects/impact criteria

    You determine a set of environmental aspects. Then, you evaluate and segregate the significant from the nonsignificant environmental aspects:

    https://www.screencast.com/users/ccruz5284/folders/Default/media/945f7731-f09e-4718-9d47-cec7449bdfdb

    Organizations do not have enough resources to act upon every environmental aspect. Each organization has the authority to determine its own method to evaluate significant from nonsignificant aspects. Many organizations use, as criteria, the frequency or probability of the environmental aspect, the severity of its impact and the time needed to recover from impact.

    Please check this information below with more detailed answers:

  • Nature of impact

    While implementing an environmental management system an organization determine its environmental aspects:

    https://www.screencast.com/users/ccruz5284/folders/Default/media/20cafdff-0f68-4782-a621-3faa6ec58ce0

    Environmental aspects are the ways an organization interacts with the environment.

    For example, consider from the example above the environmental aspect related with wastewater discharge.

    Organization A discharges wastewater in a river, after treatment in a wastewater treatment facility, and the wastewater quality is according to legislation and permit.

    Organization B discharges wastewater in a river, without treatment in a wastewater treatment facility, and the wastewater quality is not according to legislation and permit.

    Same environmental aspect, different consequences for the environment. An environmental impact considers the consequences of a particular aspect for the environment.

    You can find more information below:

  • Security of information that pertains to computers only

    ISO 27001 aims to protect information wherever it is, and in any format, so it covers all media where information can be.

    These articles will provide you a further explanation about ISO 27001:

    These materials will also help you regarding ISO 27001:
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