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  • ISO 14001 benefits

    Start by reading these articles - 6 Key Benefits of ISO 14001 - https://advisera.com/14001academy/blog/2019/08/27/key-iso-14001-benefits-to-customers/nowledgebase/6-key-benefits-of-iso-14001/ and - ISO 14001: The benefits for customers - https://advisera.com/14001academy/blog/2019/08/27/key-iso-14001-benefits-to-customers/ - can you use one or more topics from the articles to support your proposal. Can your organization win new clients that demand ISO 14001 certification? Can your organization reduce costs due to a systematic improvement of environmental issues? For example, while implementing an environmental management system I was able to reduce costs and improve productivity by changing to water-based adhesives instead of solvent-based ones.

    You can find more information below with more detailed answers:

  • SCC

    It is the adopted version (the old one) because the draft of new Standard Contractual Clauses (SCC) is not officially adopted. 

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

  • Is explicit consent request necessary?

    According to Article 8 GDPR, the processing of children’s data requires consent from their parents or from the person holding parental responsibility over them. Even if the legal ground is a contract, the child cannot enter into a contract without parental consent.Recently, some social networks had been fined by Surveillance Authorities because it was not implemented a system to verify the age of the user and require parental consent. 

  • LIMS validation

    The Toolkit includes a Laboratory Information Management System (LIMS) Validation Register and generic template for a LIMS record. These are associated with the Quality Assurance Procedure. The record guides the user to record the purpose and type of test planned. Then the Test case and Procedure , Acceptance criteria and Comments / Action required can be recorded. All the other felds are provided, for example for additional comments / monitoring of risk, record of person performing the validation and approving the validation.

    It is the laboratory’s role to identify the criteria and list them in the record. This reinforces the awareness and consideration of the needs. The latest Part 11, Electronic Records; Electronic Signatures - Scope and Application is available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application 
    To view a preview of the Advisera 17025 toolkit and the LIMS register and record, you can go to https://advisera.com/17025academy/iso-17025-documentation-toolkit/

  • Retaining documented information

    AS9100 Clause 8.2.3 is about the review of requirements for products and services, and clause 8.2.3.2 is a subclause to this. So in clause 8.2.3.1 you review if you are able to meet all of the requirements for your products and services (customer, legal, other), and clause 8.2.3.2 is telling you that you need to keep records on what you found in your review (the results of the review). For example, could you meet everything, did you change requirements due to customer agreement, etc.

    As this is common to ISO 9001, you can read mor in this related 9001Academt article: How Product Requirements work in ISO 9001, https://advisera.com/9001academy/blog/2014/04/08/product-requirements-work-iso-9001/

  • What is perceived as a risk from production control?

    Following questions can be asked when analyzing risks from production control:

    • Are all checkpoints correctly identified and set?
    • If you use any measuring equipment for the control, is that equipment properly maintained and calibrated (if applicable)?
    • What is the sample size for control, whether the sample quantity is correctly defined with respect to the batch size?

    It is not important what your prediction is that something will happen, but how much such a risk can have negative consequences for the user of the medical device (harm). Usually, if the prediction is very small, it just means that you keep that risk under very good control. The point is that the risk is there, that you have to recognize it and that you have to take all possible measures to reduce it to a minimum.

    For more information regarding the risk in medical devices please see the following article:

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