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  • Toolkit content

    ISO 27001 does not require each control in Annex A to be implemented, only those deemed necessary as a result of risk assessments, legal requirements, or organizational decisions. To see the required documents by the standard, and the most common documents implemented to support an ISMS, please see this article:  
    - List of mandatory documents required by ISO 27001 (2013 revision) https://advisera.com/27001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-27001-2013-revision/

    Our toolkits focus on small and mid-size companies, and that's the reason we do not write documents to cover each control – for those companies this large number of documents would result in overkill for many of them. Instead of that, a single template may cover multiple controls. In the root folder of the toolkit, you'll find a document called “List of Documents” that explains which control is covered by which document.

    A.6.1.1 - Information security roles and responsibilities are embedded in every document in the toolkit (you can identify its application on the field which requires a job title to be defined).

    For further information, see:  
    - How to document roles and responsibilities according to ISO 27001 https://advisera.com/27001academy/blog/2016/06/20/how-to-document-roles-and-responsibilities-according-to-iso-27001/

    A.6.1.2 - Segregation of duties is included in templates where such control is deemed applicable (e.g., in change management policy roles for request a change and approve one can be different), and the Statement of Applicability document provides a short guidance on how to implement this control. 

    For further information, see:
    - Segregation of duties in your ISMS according to ISO 27001 A.6.1.2 https://advisera.com/27001academy/blog/2016/11/21/segregation-of-duties-in-your-isms-according-to-iso-27001-a-6-1-2/

    A.6.1.3 - Keeping in contact with authorities, A.6.1.4 - Keeping in contact with special interest groups, and A.6.1.5 - Information security in project management are not commonly used controls, so they do not have a specific application in the templates. Likewise for A.6.1.2, the Statement of Applicability document provides a short guidance on how to implement these controls.

    For further information, see:
    - Special interest groups: A useful resource to support your ISMS https://advisera.com/27001academy/blog/2015/04/06/special-interest-groups-a-useful-resource-to-support-your-isms/
    - How to manage security in project management according to ISO 27001 A.6.1.5 https://advisera.com/27001academy/what-is-iso-27001/

  • Consent for processing children's data in the EU

    From the user experience that you described in this survey, the withdrawal of consent has a narrow timeframe which is fine, it can be also shorter, you can decide to erase data after reaching the purpose of processing which is to verify the identity of the teenage participant to the survey. So you can also implement a system that lets you a small amount of personal data for a limited period and develop only anonymous data. In this case, withdrawal of consent will be possible for a short period of time, but it is fine until you state it in the privacy notice.You can set different data retention periods, i.e., you may say that you are going to process localization data for 24 hours, IP address for 2 days, etc., and that at the end of processing you will keep anonymous data, removing all personally identifiable information.

    If you need more information about how to implement data subjects rights, these articles may help:

    If you need to understand how to process consent under GDPR, you can consider enrolling in our free online training EU GDPR Foundations Course: https://advisera.com/training/eu-gdpr-foundations-course//

  • Knowing ISO 27001 and ISO 22301

    Good morning, a question, I would like to know about the information security standards ISO 27001 and ISO 22301, can it be done for free or free and then certified?

    First is important to note that only ISO 27001 is about information security. ISO 22301 is about business continuity.

    Considering that, to know about these standards you can find many useful information in our blog posts and free downloadable material:

    Regarding certification, I’m assuming that you are asking about personal certifications.

    Considering that, some training providers offer courses for free, but for certification, you have to pay. 

    To see how our free-to-enroll ISO 27001 courses look like, please access these links:

  • Symbol MD in the label of Medical Devices Class I (no sterile)

    Thank you, Kristina for the detailed response. 

  • End of life and ISO 27001

    Using third parties with a physical presence in remote locations to manage corporate equipment is an acceptable solution for ISO 27001. In this situation, you also need to consider signing contracts or service level agreements including information security clauses to increase information protection (specifically how to dispose or re-use equipment).

    In case hiring third parties to collect or receive the equipment is not a viable solution, an alternative you can consider is the use of BYOD, where employees use their own devices to work, implementing software that either forbids the storage of corporate information locally in the device (e.g., employees can only access corporate resources through a virtual machine) or that allows a remote full reset of the device.

    Normally, these rules are implemented through a BYOD policy, which you can see how it looks like at this link: https://advisera.com/27001academy/documentation/bring-your-own-device-byod-policy/


    This article will provide you a further explanation about the supplier relationship:

    This article will provide you a further explanation about BYOD policy:

    These materials will also help you regarding supplier management and BYOD:

  • Standard for chlorine dioxide sterilization of medical devices

    To my knowledge, there is no ISO standard for performing chlorine dioxide sterilization. However, besides that kind of standard, each sterilization process and sterile medical device must correspond to the following harmonized and state-fo.the-art standards:

    ISO 18472:2018 Sterilization of health care products — Biological and chemical indicators — Test equipment
    EN ISO 11737-2:2020 Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation, and maintenance of a sterilization process (ISO 11737-2:2019)’
    EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
    EN ISO 11140-1: 2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements
    EN ISO 11140-3:2009 Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and ****-type steam penetration test
    EN ISO 11737-1: 2018 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
    EN ISO 11737-2:2019 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation, and maintenance of a sterilization process
    EN ISO 14937:2009 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process for medical devices

  • BIA and Risk Assessement

    1 - Thanks for the reply. I will highly appreciate if you can give me one example of risk which has been done for a BIA process.

    Answer: First is important to note that risks are not identified as part of a BIA process. Risk assessment and BIA are different processes. From risk assessment you can identify risks that can help you prioritize on which business process to perform BIA first. For BIA it is irrelevant which risks might materialize - the only relevant thing is the duration of the outage (irrespective of the incident).

    Examples of risks that can be identified and used to prioritize business processes to apply on BIA are fire, earthquake, bomb threat, and interruption of power supply.

    To see how such risks can help understand which business processes a BIA should cover first, I suggest you take a look at the demo of this template: https://advisera.com/27001academy/documentation/examples-of-disruptive-incident-scenarios/

    For further information, see:
    - Risk assessment vs. business impact analysis https://advisera.com/27001academy/knowledgebase/risk-assessment-vs-business-impact-analysis/
    - How to implement business impact analysis (BIA) according to ISO 22301 https://advisera.com/27001academy/knowledgebase/how-to-implement-business-impact-analysis-bia-according-to-iso-22301/

    2 - Also as per you answer, should I perform RA only for the process which I have in BIA? If that’s the case, should I consider RA w.r.t People , process and technologies boundaries? or should I consider operational and business risks as well?

    Thanks

    Answer: In case your purpose is to ensure business continuity, considering the ISO 22301 standard, which provides requirements for business continuity management, then you should apply RA only for the process which you have in BIA (which are all the processes included in the Business Continuity Management System scope).

    Regarding risk categories, ISO 22301 does not prescribe which ones to apply, so you can define the ones that better fit your needs.

    To see how documents compliant with ISO 22301 BIA and RA looks like, please take a look at the free demos of these toolkits:
    - ISO 22301 Business Impact Analysis Toolkit https://advisera.com/27001academy/iso22301-business-impact-analysis-documentation-toolkit/
    - ISO 27001/ISO 22301 Risk Assessment Toolkit https://advisera.com/27001academy/iso-27001-22301-risk-assessment-toolkit/

  • Question about requirements

    No, everything is covered there. So for the periodic audits after 26th May 2021, you need to have in place the following elements for the MDR (point 17.-4 in the document that you referred to):

    a) Registration of economic operators and of devices (see Art. 31 MDR and Art. 29 MDR)
    b) Post market surveillance (PMS) (see Art. 83-86, 92 MDR including Annex III but without the PMS having to be an integral part of the QMS)
    c) Market surveillance (see Art. 93 – 100 MDR, but device standards to be met = Directives)
    d) Vigilance (see Art- 87-92 MDR)

  • Storing data on Google Suite/Drive

    We wondered if you could help us regarding the following. We would like to know:

    When collating our list of client emails when sending out a seasonal greeting (our annual Christmas email) we store the list on Google Suite/Drive, and also CETA - our facilities managing database. Is this permitted?

    Yes, the data controller can choose the means and purpose of data processing and Google is a third-party processor which claims to be compliant with EU GDPR.

    I update an online excel sheet which tracks which clients attend for which jobs. This is also stored on G Suite and CETA. Is this permitted?"

    Yes, you need to verify if any particular category of data is stored and if it is protected (maybe you can add a password to access the sheet in order to increase security).Remember to verify the Google G Suite privacy notice because the personal profile gives fewer security options compared to the business account.

    Here you can find some information on cybersecurity:

    If you need to have an overview on the EU GDPR compliance you can consider enrolling to our free EU GDPR Foundations Course: https://advisera.com/training/eu-gdpr-foundations-course//
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