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  • ISO 27001 Lead Implementor - need to maintain certification

    Thank you for this question, Lee!
    After obtaining the certificate, the certificate is valid until the standard itself changes its version officially. Specifically for ISO 27001, minor changes have been made to the standard in 2017, but the current version of the standard remains ISO 27001:2013. From this, we conclude that the standard will not change very soon.

  • Procedure on personnel

    The ISO 17025:2017 clause on personnel is one of the most stringent in terms of mandatory requirements for a procedure and retaining records. The procedure must explain firstly how the personnel needs of the laboratory are determined (6.2.5a). Then the recruitment, training, supervision and authorisation process must be explained (6.2.5 b to e).  You need evidence (records) for each step, including evidence of competence. Only once personnel have the required competence level, can they work on their own.

    For further assistance, have  a look at the Advisera Expert Advice Community answers on personnel training (https://community.advisera.com/topic/personnel-training/) and deeming someone competent for more information (https://community.advisera.com/topic/how-training-should-someone-have-before-they-are-deemed-competent-for-a-specific-task/)

    The whitepaper Clause-by-clause explanation of ISO 17025:2017 will assist you with overall ISO 17025 awareness for Personnel requirements. It is available at https://info.advisera.com/17025academy/free-download/clause-by-clause-explanation-of-iso-17025/

    For more information on competence, have a look at the article How to manage competence in a laboratory according to ISO 17025, available at https://advisera.com/17025academy/blog/2021/05/20/how-to-manage-competence-in-a-laboratory-according-to-iso-17025/.

    The Advisera ISO 17025 toolkit includes the mandatory personnel procedure as ISO 17025 document template: Competence, Training and Awareness Procedure along with 4 appendices: Training Program, Training Record and Performance Monitoring, Record of Attendance and Competence. You can preview the template at https://advisera.com/17025academy/documentation/competence-training-and-awareness-procedure/

  • Article 1÷

    Thank you very much.  Your advice and your service here is priceless.  I will check with the UK Commissioner.  I guess as it is not a Data Breach I will not be entitled to any compensation.

    I think the Data Processor should also have told me that they were processing my sensitive data or at least checked that the Data Controller had informed me.

  • Text source about obligation to have IT Security Structure in place on premises

    The GDPR only states that the data controller must ensure that data are “processed in a manner that ensures appropriate security of the personal data, including protection against unauthorized or unlawful processing and against accidental loss, destruction, or damage, using appropriate technical or organizational measures (‘integrity and confidentiality).” (Article 5 paragraph 1, f) GDPR)Article 32 GDPR, among the obligation of the data controller, states that:“Taking into account the state of the art, the costs of implementation and the nature, scope, context, and purposes of the processing, as well as the risk of varying likelihood and severity for the rights and freedoms of natural persons, the controller, and the processor, shall implement appropriate technical and organizational measures to ensure a level of security appropriate to the risk, including inter alia as appropriate:

    A) the pseudonymization and encryption of personal data;

    B) the ability to ensure the ongoing confidentiality, integrity, availability, and resilience of processing systems and services;

    C) the ability to restore the availability and access to personal data in a timely manner in the event of a physical or technical incident;

    D) a process for regularly testing, assessing, and evaluating the effectiveness of technical and organizational measures for ensuring the security of the processing. In assessing the appropriate level of security account shall be taken in particular of the risks that are presented by processing, in particular from an accidental or unlawful destruction, loss, alteration, unauthorized disclosure of, or access to personal data transmitted, stored, or otherwise processed.

    Setting access policies and determining roles and responsibilities is considered an organizational security measure and of course there is no indication of what technical security measures must be applied, the aim of GDPR is to be technological neutral but ISO27001 standard on the security of information can be a good guide.

    Here you can find some information on security aspects and GDPR:

    If you want to know more about the EU GDPR compliance, you can consider enrolling in our free online training EU GDPR Foundations Course: https://advisera.com/training/eu-gdpr-foundations-course//

  • Email marketing

    It depends on the country you are located in. I would choose a consultant from where I'm based in order to have an idea of the privacy legislation which applies to my current situation.

  • MDR - difference between configurable device and device with accessories

    If I understand it correctly, your device will be a system. According to the Definitions in the MDR system (point 10) is a combination of products, either packaged together or not, which are intended to be interconnected or combined to achieve a specific medical purpose.

    The question here is: are parts separately certified as medical devices?

    For systems that consist of parts that are medical devices, according to Article 22, you need to prepare the statement that will have the following information:

    • verified the mutual compatibility of the devices and, if applicable other products, in accordance with the manu­ lecturer's instructions and have carried out their activities in accordance with those instructions
    • packaged the system or procedure pack and supplied relevant information to users incorporating the information to be supplied by the manufacturers of the devices or other products which have been put together
    • the activity of combining devices and, if applicable, other products as a system or procedure pack was subject to appropriate methods of internal monitoring, verification, and validation.

    However, if your parts are not a medical device, that it needs to be certified as a system separately. In that case, you need the involvement of the Notify body, you need to prepare applicable technical documentation according to Annex 2 and 3 of the MDR, and in that case, you will put a CE mark on that system.

    For more information, see:

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