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  • MDR/ISO 13485 risk management of "SYSTEM"

    It should be done for its individual parts. 

  • Which ISO standards are mandatory to purchase as an official version?

    Yes, you are right, ISO 13485 and ISO 14971 are mandatory. As for other standards, it depends on what your medical device is.

    For all medical devices are also applicable following standards:

    • ISO 20417:2021 Information from the manufacturer
    • ISO 10993-1:2018 Biocompatibility
    • ISO 15223-1:2021 Labelling
    • IEC 62366-1:2015 Usability

    There are also a lot of different technical standards. For example, if your medical device is sterile, then you need to have ISO standards relating to your type of sterilization. If your device requires electricity, then it has to be electromagnetic compatible.

    List of all harmonized standards are published on several links as follows:

    • https://health.ec.europa.eu/medical-devices-topics-interest/harmonised-standards_en
    • https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.LI.2020.090.01.0001.01.ENG&toc=OJ:L:2020:090I:TOC
    • https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2021.129.01.0153.01.ENG

    • ISO 27001:2022 Documentation Toolkit

      Dear All,

      Trust all is well

      The advisera document toolkit for ISO 27001, ISO 9001& ISO 14001 has been a great help to our organization. We have a partnership with Advisera..


      The much-awaited ISO 27001:2022 is finally here. Just want to ask the following questions:-

      1. Whether ISO 27001:2013 version documentation toolkit can used in the transition of ISO 27001:2022 version. If yes, How can it be done and If no, please provide the reason also?
      2. When will be Advisera ISO 27001:2022 documentation toolkit will be available? Any timelines for that
      3. Can u please provide the quotes for Advisera ISO 27001:2022 Documentation toolkit?

      Looking forward to hearing from you

    • Query Related to ISO 27001

      From your scenario, I’m understanding that your customer is a solution provider that does not own the operational infrastructure.

      Considering that, ISO 27001 certification is possible for this customer considering the protection of the information in the process it controls (i.e., sales marketing).

      Since the IT solutions provided are outsourced, these are out of the scope (these could be handled by means of contracts/services agreements signed with such providers).

      For further information, see:

    • ISO 27001:2013 Certification

      Please note that ISO 27001 provides a systematic way to implement Information Security management, and its sequence is a bit different from what you proposed:

      1. getting management buy-in for the project
      2. defining ISMS basic framework (e.g., scope, objectives, organizational structure), by understanding the organizational and the requirements of interested parties
      3. development of risk assessment and treatment methodology
      4. perform a risk assessment and define a risk treatment plan
      5. controls implementation (e.g., policies and procedures documentation, acquisitions, etc.)
      6. people training and awareness
      7. controls operation
      8. performance monitoring and measurement
      9. perform internal audit
      10. perform management critical review
      11. address nonconformities, corrective actions, and opportunities for improvement.

      In short:

      • part of the mandatory documents and records are created before risk assessment and treatment processes (e.g., scope, objectives, organizational structure), and the other part after it (e.g., policies and procedures documentation related to implemented controls, internal audit report, management review, etc.)
      • controls are implemented after the approval of the Statement of Applicability, not before

      This article will provide you with further explanation about ISO 27001 implementation:

    • A.8.11 Data Masking

      The implementation of data masking as a good practice or to fulfill a requirement will depend on the results of risk assessment (i.e., relevant risks), and the existence of applicable legal requirements (e.g., laws, regulations, or contracts).

      In case you have relevant risks or legal requirements demanding the implementation of data masking, implementing control A.8.1.1 control would be a requirement, otherwise, its implementation could be seen as a good practice.

      Regarding its balance with the business day to day operation, you should evaluate the positive impact of its implementation (e.g., reduction of costs due to information security incidents) against negative effects (e.g., reduction in processes performance or productivity), so you can evaluate the extension on ho implement the control.

      For example, for some processes, you may implement heavy masking practices and still have acceptable operational results, and for others, even the slighted practices won’t be worth it (and for these cases you may have to accept the risk, since applying the control will bring more problems than solving them).

      This article will provide you with further explanation about applying controls:

    • Sample document

      Thank you Rhand.

    • ISO 27001 - Enquiry

      1 - Can you confirm if during stage 1 of a certification process, does an organisation certified Lead Implementer or Auditors within the organisation before the organisation is certified and which clause demands this.

      I’m assuming you are asking if certified Lead Implementers or auditors need to be present in the organization as certification criteria.

      Considering that ISO 27001 does not prescribe the role of lead implementer so the presence of a lead implementer is not a requirement for certification. Regarding the auditor role, the standard defines it in clause 9.2, but only requires that the internal audit needs to be performed by a person with proper competency (clause 7.2 competence), so the presence of auditors is not a requirement for certification (the certification auditor will only check if audits were performed by auditors with proper competencies).

      For further information, see:

      2 - Secondly, can an organisation outsource the roles of ISO 27001 LA and LI and be successfully certified?

      I will be grateful to have your feedback.

      ISO 27001 does not prescribe that auditors and implementers need to be employees of the organization, so it is acceptable to outsource these roles.

      For further information, see:

      • How to prepare for an ISO 27001 internal audit https://advisera.com/27001academy/blog/2016/07/11/how-to-prepare-for-an-iso-27001-internal-audit/

      • Free ISO 27001:2013 to 2022 Conversion Tool – find out what has changed

        Please note that this tool does not provide deep insights or gap analysis on the changes brought by the 2022 revision of ISO 27001. It only shows how previous controls from the 2013 version are now mapped. For Example:  

        ISO 27001:2013 controls:

        • A.8.1.1 Inventory of assets, and

        • A.8.1.2 Ownership of assets

        ... have merged into ISO 27001:2022 control: 

        • A.5.9 Inventory of information and other associated assets

        This is an example right from the tool.

        For further information about new controls introduced by ISO 27001:2022, please read:

        • ISO 27001 2013 vs. 2022 revision – What has changed? https://advisera.com/27001academy/blog/2022/02/09/iso-27001-iso-27002/

        • External auditor for contamination for warehouse environment

          It is usually inspected for pests - rodents, flies, and cockroaches. Therefore, it is checked whether the traps are installed and whether they are inspected regularly. The external auditor looks at how the finished goods are arranged, whether the boxes are damaged, and whether the product itself may be damaged. And the third is to check whether the defined storage conditions are ensured - whether the temperature/humidity is measured, whether temperature mapping has been done in the case of a high-shelf warehouse, and whether the products are placed somewhere so that they are directly exposed to the sun.

          All these situations can lead to contamination of the finished product.
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