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  • Justification and control objectives

    Please note that justifications in the Statement of Applicability need to be based on applicable legal requirements, relevant risks, or management decisions (in general because management considers the implementation of control as a good practice).

    Considering that, the fact that you operate on a remote structure wouldn’t be enough. Since you stated that you do not have legal or contractual reasons for justifying some controls, you should review the results of the risk assessment to see if any identified risk can be used as a justification. If there are no relevant risks, you do not need to implement any controls.

    In case you decide to implement a control regardless of the lack of legal requirements and relevant risks, you can state as justification that the control implementation is considered good practice management.

    For further information, see:

  • MDR article 120 significant changes

    Yes, it is, because you need to prove that the new company that provides sterilization is just as good as the previous one (so that it has a valid ISO 13485 certificate for its type of sterilization, that you have sterilization validation results with the new provider, that you have done biological indicator tests with the new provider, etc.). Also, in your risk analysis, you should check whether any new risks have appeared with the change of sterilization provider: for example, how long is the transport from you to the new provider, is it longer or shorter, has the responsibility for transport changed.

  • Regarding safety precautions in IATF 16949:2016 QMS standard

    The subject of product safety is specified in article 4.4.1.2 in the IATF 16949:2016 standard.

    At the same time, safety issues are mentioned in articles 8.2.2.1, 8.3.3.1, 8.5.1.2, 8.5.2.1, and 9.3.2.1 of the same standards.

  • Evidence of InfoSec Awareness Training

    ISO 27001 does not prescribe a format to document evidence of InfoSec Awareness Training, so organizations can adopt the format that best fits their needs (e.g., certificates, attendance lists, exam results, etc.).  

    This article will provide you with a further explanation of competence evidence for ISO 27001:

    For an example of a document that can be used as evidence, please take a look at this template: Training and Awareness Plan https://advisera.com/27001academy/documentation/training-and-awareness-plan/

    This material may also help you regarding InfoSec Awareness Training:

  • Secure system engineering principles (clause A.14.2.5)

    ISO 27001 does not specify how to document secure system engineering principles, so organizations are free to document them as best fit their needs.To see a document covering secure system engineering principles compliant with ISO 27001, please see this demo template: https://advisera.com/27001academy/documentation/secure-development-policy/In its section 3.3 Secure engineering principles you can document the principles you have in place (e.g., adoption of user authentication techniques, secure session control, data validation, etc.), or refer to the documents where they are explained (e.g., documents about guidance on secure programming techniques).

    These articles will provide you with further explanation:

    • What are secure engineering principles in ISO 27001:2013 control A.14.2.5? https://advisera.com/27001academy/blog/2015/08/31/what-are-secure-engineering-principles-in-iso-270012013-control-a-14-2-5/
    • How to integrate ISO 27001 A.14controls into the system/software development life cycle (SDLC) https://advisera.com/27001academy/how-to-integrate-iso-27001-controls-into-the-system-software-development-life-cycle-sdlc/

    • Do we need an incident management procedure?

      ISO 27001 does not require an incident management procedure to be documented, so you only need to document one in case you have a legal requirement (e.g., law, regulation, or contract) demanding such procedure to be documented.

      Only response plans require documentation, in case-control A.16.1.5 (Response to information security incidents) is stated as applicable in the Statement of Applicability.

    • ISO 45001 - Interdependencies in the components of an OHS system

      While ISO 45001 does not require an analysis of these interdependencies, clause 4.4 does ask that you identify the processes of the OHSMS and understand their interactions. One way that many companies do this is through a flowchart that includes the OPH&S processes and their linkages so that you understand exactly what is included in the OHSMS, and how they interact so that you can understand where inputs come from and where outputs go so that you can better plan and manage the processes. It is not required to align this with the clauses of the standard, but some companies will also do this.

      To learn more about the requirements of ISO 45001 in more plain language, 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

      • Incidents

        Please note that the incident registers are records, and as such, they should not be deleted and should be evaluated in the context when they were created.

        Considering that, for the first case, you need to document which incidents were created only for testing purposes and store this document as a management decision.

        For the second case, you need to show to the auditor the incident procedure that was valid at the time the incidents were recorded. The auditor needs to evaluate the processes at that time considering that procedure, not the current one.

      • Costumer Satisfaction Sheet

        I’m not an expert in ISO 45001. However, I recommend looking into clause 4.2 in each standard. If you consider the customer as a relevant interested party, then determine what are their relevant requirements in terms of quality, environment and health, and safety. Then, you can create a customer satisfaction sheet where you ask customers to assess the extent to which the company meets their expectations and needs.

      • TIME CLOCK POLICY AND PROCEDURES

        I knew that it wasn't required but just took a shot that there is a clause for it...Thank you for the help!
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