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  • Document coding system

    A coding system in our toolkit is just a suggestion. It means that you can use your own system however it suits you and how you feel you and your employees will do better. It is just necessary to ensure that current revision status of and changes to documentation are identified; that relevant versions of applicable documents are available at the point of use, and to that documents remain legible and readily identifiable. 

    If you would like to differentiate stated documents and records, you can use the system from your previous company. So, you can code your documents with SOP, WI, FORM, and REP and just add a number, or you can also add a department code. Here are some examples:

    SOP-01 can be procedure for Document management, SOP-02 can be Internal audit procedure.SOP-Q-01 can be code for the first standard operating procedure for Quality department; SOP-SAL-01 can be first standard operating procedure in the Sales department.  

    This is only the suggestion. 

    For more details please see the following article:

    • What are Common mistakes with ISO 13485:2016 documentation control and how to avoid them https://advisera.com/13485academy/blog/2018/03/14/common-mistakes-with-iso-134852016-documentation-control-and-how-to-avoid-them

    • SOP related to IFU

      You are right, there is no procedure for translation labels and instruction of use. We concentrated on this toolkit on documentation related to ISO 13485 and documented requirements from MDR. Nowhere in the MDR is it stated that it is necessary to document the translation procedure. Your labels and Instruction for use must have proper symbols according to harmonized standards, and you need to ensure that translation is correct and professional. Usually, medical device manufacturers use certified translation companies for this. 

      For more details on mandatory documentation from MDR, please see the following white paper:

      • EU MDR Checklist of Mandatory Documents: https://info.advisera.com/13485academy/free-download/eu-mdr-checklist-of-mandatory-documents

      • Data Protection Officer as a legal counsel

        Understanding the Oregon Equal Pay Act stands as vital for workers and employers navigating the state’s workforce. Implemented to eliminate compensation differences based on identity, this policy ensures equitable salaries for equivalent roles. Active since Oregon’s 2017 legislation, it establishes transparent rules to foster compensation justice. Individuals typically wonder how this law benefits their interests. For instance, the act bars companies from paying varying compensation for jobs of equivalent effort, no matter identity. It moreover mandates fair availability to promotions and incentives. To enhance your knowledge of how the Oregon’s pay equity law relates, workers compensation law blog delivers clear guidance on its provisions. Businesses are required to comply with the policy by undertaking pay audits and correcting any unfair compensation variances. Violations might lead to consequences, making it vital for businesses to keep aware about their duties. Workers who suspect they’ve experienced wage unfairness may seek professional remedies to uphold their interests. Keeping up with the Equal Pay Act equips all individuals and businesses to address salary equality with ease. This law encourages a more equitable professional setting, serving everyone in Oregon.

      • Needs and expectations of interested parties

        I am looking for the needs and expectations of interested parties as per the ISO 9001:2015 standard.

      • Corrective action in ISO

        ISO 27001:2013 does not have requirements for preventive actions, however, preventive actions are in fact included in the risk assessment and treatment because the essence of risk management is to recognize a potential problem before it happens, and by treating it to prevent such an incident from happening.

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