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  • MATRIZ RACI ISO 27001

    In order to establish the responsibilities of ICT and Information Security, I would like to know if perhaps you have already prepared this type of document, please. Thank you very much.

    From your question is not clear the role of the ICT regarding information security (it leads the process or if it is an interested party). Anyway, you can use the template in this article:
    - RACI matrix for ISO 27001 implementation project https://advisera.com/27001academy/blog/2018/11/05/raci-matrix-for-iso-27001-implementation-project/

    https://www.screencast.com/t/GxZxpDfMhaJ

    In case ICT leads the project, you can change the term "Project team" to "ICT" in the related Role Column. On the other hand, if ICT is one interested party, you do not need to do any adjustments regarding this.

  • SAR REQUEST UNDER GDPR

    To perform the Subject Access Request (SAR), you may need Google Takeout which helps users to deal with their rights: https://takeout.google.com/Otherwise, if you need to ask for removing some information or content with your personal data, you can send a request to Google through this form: https://www.google.com/webmasters/tools/legal-removal-request?complaint_type=rtbf&hl=en&rd=1&pli=1

    ICO (the UK Data Protection Authority) developed a guide on how to file a Subject Access Requesthttps://ico.org.uk/your-data-matters/your-right-to-get-copies-of-your-data/preparing-and-submitting-your-subject-access-request/

    If you need more information about GDPR in general, you may consider to follow our free Foundation course:EU GDPR Foundations Course: https://advisera.com/training/eu-gdpr-foundations-course//

  • Medical Device Family

    According to both the MDD and MDR, you have a case of medical devices group or family. You can have one Technical documentation for the group of the medical devices with a description of a complete list of the various configurations/variants.

    To see how to structure the Technical file according to MDR, see this Technical file template: https://advisera.com/13485academy/documentation/technical-file-template/

  • TPM implementation

    Our Toolkit documents do not contain details about the TPM application. But according to my knowledge and experience, I can provide some details about TPM activities.

    There are 16 types of loss in GEMBA (production area). These losses are:

  • Machine failure
  • Set up and adjusting
  • Tool change
  • Start-up
  • Minor stoppage
  • Speed
  • Defect and rework
  • Shutdown
  • Management
  • Motion
  • Line organization
  • Logistic
  • Adjustments
  • Loss of energy
  • Die and tool
  • Yield

    • You can make improvements for these losses by creating 8 pillars from the organization.The eight pillars of TPM are mostly focused on proactive and preventative techniques for improving equipment reliability.

    These pillars and duties are: 

  • Autonomous Maintenance: Places responsibility for routine maintenance, such as cleaning, lubricating, and inspection, in the hands of operators.

  • Planned Maintenance: Schedules maintenance tasks based on predicted and/or measured failure rates.Quality Maintenance: Design error detection and prevention into production processes. Apply Root Cause Analysis to eliminate recurring sources of quality defects.

  • Focused Improvement: Have small groups of employees work together proactively to achieve regular, incremental improvements in equipment operation.

  • Early Equipment Management: Directs practical knowledge and understanding of manufacturing equipment gained through TPM towards improving the design of new equipment.

  • Training and Education: Fill in knowledge gaps necessary to achieve TPM goals. Applies to operators, maintenance personnel and managers.

  • Safety, Health, Environment: Maintain a safe and healthy working environment.

  • TPM in Administration: Apply TPM techniques to administrative functions.

    • My advice is instead of installing these 8 pillars at the same time; starting TPM studies with Autonomous Maintenance and Planned Maintenance activities and you choose pilot machines or lines. For more information, I recommend you review TPM books or get training on TPM.

     

  • Auditing Biomedical service providers

    If I understand correctly, you are asking about biomedical equipment that are used in production and/or service of medical devices. If that is so, the minimum and mandatory criteria according to both Medical device directive (MDD 93/442/EEC) and Medical device regulation (MDR 2017/745) are that any laboratory used to prove compliance of the medical device to a certain requirement must be accredited. So, you need to ask for an accreditation certificate of that company and check is your equipment test is on the method list.

    For more information what is EU MDR (EU MDR – Easy-to-understand basics), please read the following article: https://advisera.com/13485academy/what-is-eu-mdr/

    According to the ISO 134985:2016, companies that provide service of medical devices also need to be certified according to the ISO 13485:2016.

    On this link you can find Clause-by-clause explanation of ISO 13485:2016: https://info.advisera.com/13485academy/free-download/clause-by-clause-explanation-of-iso-13485

    Qualification of the personel who performed and signed the calibration certificate is covered and reviewed during the accreditation audit.  Usually, companies that perform calibration services are accredited by ISO 17025:2017 for a particular method, so a Certificate of accreditation is also necessary as proof that the calibration process is done properly. 

    What is ISO 17025? you can find on the following link: https://advisera.com/17025academy/what-is-iso-17025/

    Each equipment has its own standard under which they should be calibrated. There are different standards for scales, for thermometers, for hygrometers, pressure and so on. Standard under which calibration equipment needs to be calibrated must be stated on the calibration certificate. Annex to each calibration certificate is a certificate of the standard gauge with which calibration is done.

    For more information about calibration requirements in ISO 13485, please read the following article:
    Calibration requirements in ISO 13485 https://advisera.com/13485academy/blog/2019/03/08/calibration-requirements-in-iso-13485/

     

  • Annex A

     It is not mandatory to implement all 114 controls of Annex A of ISO 27001:2013, you only need to implement those that you need to reduce risks identified during the risk assessment (or those that are related to law, contractual requirements, etc.).

    This article will provide you further explanation about the selection of controls:

    These materials will also help you regarding ISO 27001:

  • Internal Audit

    I'm assuming that by AVP you mean "Assitant Vice President".

    Considering that, the person to approve the Internal audit must be the one in the highest position in the ISMS scope (i.e., the person most interested in the ISMS results). It should not be the person with responsibilities for the operation of information security (e.g., CSO or CISO) because this would be a situation of conflict of interest.

  • Logical return to work process

    The return to normal operations is covered in the Business Continuity Plan, in section "4. Restoring and resuming business activities from temporary measures". This template is located in folder 07 Business Continuity Plan.

    Regarding pandemic, we still do not have it covered in the templates, but next week we will announce a webinar on the topic: "How to use ISO 22301 to continue operations during the pandemic".
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