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ISO 13485 & EU MDR - Expert Advice Community



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  • Would becoming ISO 13485 compliant benefit customers more than ISO 9001?

    We manufacture machines that are not subject to FDA oversight. However, our customers use them in an FDA regulated environment. Would our becoming ISO 13485 compliant benefit our customers more than an ISO 9001 certification?
  • Production data in 8.2.1 Feedback

    Sec. 8.2.1 feedback- contains a requirement to document the requirement for the feedback process. "This feedback process shall include provisions to gather data from production as well as post-production activities." While customer feedback of post-production activity is well understood, my question is related to the production data. what is expected from production data with regards to the feedback process? Dose is related to how the company react and respond to feedback and trends
  • What is the role of the process owner?

    Document Management - what is the role of the process owner?
  • Product recall requirements and Drinking water standard in Cambodia

    "I want to know the regulatory requirements for Product recall in Cambodia. Kindly include Standard plant water requirements for Cambodia and treatment water requirements in Cambodia. Thank you."
  • How to mark and identify Company Policies?

    New to QA Manager. Previous QA Manager made it mandatory for Position Descriptions in HR department, as well as Company Policies i.e Health & Safety, Social Media Policy to be version & document ID controlled. It is mandatory for those types of documents to have a document ID, version number and review date?
  • Documents within the Quality Manual Handbook

    Hi may I ask you for advice, is it possible and wise to have all documents related to system in Quality manual handbook?
  • Complaints handling and corrective actions

    Does a formal CAPA is always needed when complaints investigation results with corrective action task? or can it be included as part of the complaint activity and follow up? also if CAPA was assigned, can Complaint be closed?
  • Method for recording inspection activities

    We are looking at ways to reduce workload. One topic brought up was the recording of dimensional measurement. Some of the senior employees have mentioned that at previous companies they've worked at, they did not record dimensions at Incoming Inspection. Rather, after the completion of dimensional activities, a checkbox was checked that said something like "All dimensions were found to be within tolerance". This was sufficient for the auditors at those companies.
  • Paper-based or electronic records?

    What is the best practice with regards to records management? Do you suggest paper-based (physical) or electronic records? For now, I only have electronic records. Do you suggest we create physical records in addition?
  • Report writing for certification

    I would like to get an explanation of the report writing for this certification. Whether it is in international practice or has its own set of requirements requires two auditors, one viewing the scope of the quality management system and other one for the technical scope (by the technical expert). Is it provided by two auditors or is it just an auditor?
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