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  • Internal Complaint

    Internal OH&S complaints in ISO 45001 should be addressed as with any other process nonconformity, with the corrective action system required per clause 10.2, Incident, nonconformity and corrective action. These identifications of OH&S problems by employees are a key improvement opportunity, and are common in the OHSMS (although not everyone would call them complaints).

    For more on corrective action in the OHSMS, see that article: Using corrective actions to eliminate nonconformities and drive health & safety improvements, https://advisera.com/45001academy/blog/2017/02/15/using-corrective-actions-to-eliminate-nonconformities-and-drive-health-safety-improvements/

  • MDR 2017/745

    Liability insurance is designed to protect your property as a whole from claims by third parties. Your property is not physically insured under this policy, but it is protected from being reduced, as the insurer will pay out compensation to a third party on your behalf. This insurance protects your economic interest. 

    In MDR, Article 10. General obligations of Manufacturers is stated that natural or legal persons may claim compensation for damage caused by a defective device in accordance with applicable Union and national law. Manufacturers must, in a manner that is proportionate to the risk class, type of device and the size of the enterprise, take measures to provide sufficient financial coverage in respect of their potential liability under Directive 85/374/EEC (on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products).

    A lot of different insurance companies can offer you this kind of insurance, so please look through the internet.

  • Certificate of calibration

    I understand from your question that a calibration certificate was not received. The answer is no, a receipt cannot be used in place of a calibration certificate. ISO 17025 has specific requirements for the suitability of equipment and its calibration. The laboratory must ensure that equipment conforms to specified requirements. Evidence that equipment can perform as required may, depending on the equipment, be a specific qualification or verification process which may be provided in some part by the provider. The laboratory needs to verify this post installation, on your site. If the use of your equipment is to establish the metrological traceability of reported results or if the validity of the reported results is affected by measurement accuracy and or uncertainty, then you need calibration and a calibration certificate which meets ISO 17025 requirements of for calibration reports.

    The following articles will provide further information related to equipment and calibration

    The relevant ISO 17025 document template, Equipment and Calibration Procedure, as well as a list of related documents, is available for download at https://advisera.com/17025academy/documentation/equipment-and-calibration-procedure//

  • Legal basis and contracts

    It depends on the purposes of data processing. If the data processing is related to give execution to the contract, article 6, paragraph 1, letter b GDPR, states that the processing is lawful under GDPR when "processing is necessary for the performance of a contract to which the data subject is party or in order to take steps at the request of the data subject prior to entering into a contract".

    Of course, this is limited only to the performance of the contract. You must inform the data subject about data processing by providing your privacy notice. You may need consent form even if you are working on the contractual legal basis if your data processing purposes go beyond the contract (i.e. marketing purposes).

    You may find some useful information here:

    You may also consider taking our free Foundation GDPR Course: https://advisera.com/training/eu-gdpr-foundations-course// 

  • ISO 9001 and remote audits

    Thanks

  • Bar codes under MDR

    In MDR, Chapter III - Requirements regarding the information supplied with the device it is stated that all labels for medical devices must be provided in a human-readable format and may be supplemented by machine-readable information, such as radio-frequency identification (‘RFID’) or bar codes.

    In ANNEX VI – Information to be submitted upon the registration of devices and economic operators, in Part C are guidelines on how to implement bar code in UDI number.

    There are also several guidelines from the Medical device coordination group (MDCG) showed in the table:

    MDCG 2018-1 v3                Guidance on basic UDI-DI and changes to UDI-DI

    MDCG 2019-1                     MDCG guiding principles for issuing entities rules on basic UDI-DI

    MDCG 2019-2                     Guidance on application of UDI rules to device-part of products referred to in article 1(8), 1(9) and                                                1(10) of Regulation 745/2017
    MDCG 2018-2                     Future EU medical device nomenclature - Description of requirements

    Link to this table and all guidelines is: https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en

     

    For more information, see the following article: 

    EU MDR – Easy-to-understand basics https://advisera.com/13485academy/what-is-eu-mdr/

  • FAI vs Design Validation?

    FAI is referenced in clause 8.5.1.3 of AS9100 Rev D as an equivalent to “production process verification”. That is because the FAI process does a lot more than just validate the design, it verifies that all the processes, documentation and tooling utilized to create the first product are working properly to meet the design requirements. The FAI gives you a “line in the sand” stating, when everything was set up in this manner the product created meets the requirements. Design validation is making one article to show that the design can work.

    In answer to your question, though, this greatly depends on how your customer has defined the FAI and design validation requirements. The FAI does show that the design works, but it also shows much more and a failure in FAI might be due to other situations in the processes and could give a false negative of your design validation. However, if your customer accepts this as a design validation then it could be acceptable.

    Find out more on FAI in the article: How does First Article Inspection fit into AS9100 Rev D?, https://advisera.com/9100academy/blog/2017/11/07/how-does-first-article-inspection-fit-into-as9100-rev-d/

  • Certification of IT Service Provider

    Thank you for the response

  • Data deletion request

    I have a question regarding a data deletion request -  once we delete all the data do we need to inform the data subject that the deletion has been done? Is there an official form that we need to send the data subject? Or anything we should do or be aware of?

    Yes, according to article 19 GDPR the data controller must inform the data subject of erasure of data, which must be carried out, according to article 17 GDPR, "without undue delay".

    The GDPR does not require a specific form for communication of erasure, however, we developed a template that you can find here.

    EU GDPR document template:Confirmation for Erasure of Data:  https://advisera.com/eugdpracademy/documentation/confirmation-for-erasure-of-data/

  • Classification policy

    ISO 27001 does not prescribe how to built the inventory of assets, so organizations are free to build them the best way to fulfill their needs. In cases like this, you can group files per type (i.e., files that share similar risks), and include only the type as an asset the inventory of assets. For example, you can have an asset called "customer contracts", and others like "project specifications".

    This article will provide you further explanation about inventory of assets:
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