checklist or check sheet

  1. R

    How to SHOW the importance of checklists, through some team gaming or play?

    Hope my topic fits here on TRAINING. My company has an annual "QUALITY Day", where we usually have some team buildings games, some talks, coffee break and some comedy show for the employees We recently decided we would scrap the external shows, and focus on gaming... specially, try to have a...
  2. C

    CMDR Essential (Safety & Effectiveness) Requirements Checklist?

    We recently completed our MDSAP audit with Canada, USA, Australia and Europe in scope. As part of the Country Specific requirements, we have the checklists/template for Essential Requirements for Europe and Australia. Our auditor asked me for one for Canada.(CMDR 10-20 S&E reqts) There is no...
  3. D

    Internal audit forms or checklists for a medical/veterinary laboratory

    I am new to this forum and I am looking for some examples on internal audit forms or checklists for a medical/veterinary laboratory.
  4. S

    Internal Audit Checklist for Application/Software development

    I am planning to do ISMS internal audit for software/application development team in my company. Is there any checklist available.
  5. Ed Panek

    Moving from Contract Manufacturing to Production In-House

    We use an ISO 13485:2016 manufacturing house to make our med device. Its a class 2 FDA 510 cleared and CE marked. We do not offer service or installation on our scope We are adding production. Is there a good checklist of objectives to allow me to communicate to our BoD what this change entails...
  6. D

    Essential Requirements Checklist for Standalone Software

    For standalone software that is being run on a piece of hardware I was under the impression the hardware does not need to be considered with regard to the essential requirements checklist? I was under the impression the hardware will be CE marked in its own right and if I were to incorporate it...
  7. P

    IATF checklist for External Supplier Audit

    Dear colleagues, do you have any good audit checklist form for IATF (for external supplier audit). Of course I tried to find some on the forum but unfortunately I can't find it. Can I kindly ask you to send the file to me? Thank you Best regards Piotr
  8. Q

    Any good Checklists for ensuring SOPs cover ISO 13485:2016 and 21CFR 820?

    Does anyone have a good spreadsheet or check list that compares ISO and 21CFR820? Something that would cover the ISO clause in one column the 820 reference in another and then space for notes and links to my documents? Any help would be useful. Thanks!
  9. CbusQAguy

    IATF 16949 - Contingency Plans Testing Checklist

    Does anybody have a Checklist that they utilize to schedule and capture (document) that Contingency Plans were tested in accordance with IATF 16949 similar to the (attached) Fire Drill Checklist?
  10. Ajit Basrur

    Looking for a Design Transfer Checklist

    I am looking for a Design Transfer Checklist especially for an OEM to transfer the design to a Contract Manufacturer. Thanks for your help!
  11. N

    Essential requirements checklist needed?

    Hello, We had the first day of our ISO 13485:2016 audit today. Our business is a very small company who primarily assembles IVD's for self test use under contract from the manufacturer from CE marked components. This is not OBL, the manufacturer is named as such on the products and IFU. The...
  12. R

    Anyone who can share a checklist for ISO 29134?

    Hi Everyone, Greetings in the name of Peace and Prosperity! I was wonderin' if there's any body who can share a checklist for ISO 29134? Thank you very much in advance. Best, Raffy
  13. V

    MAQMSR Checklist Wanted

    Does anyone have, or can direct me to an MAQMSR (Minimum Automotive Quality Management System Requirements for Sub-Tier Suppliers) checklist? I have the standard but am trying to not recreate a checklist if possible.
  14. R

    Mass production handover check sheet (IATF 16949)

    Please help for a Mass production handover check sheet needs to be defined and implemented to check preparedness of various functions (such as production, maintenance, quality, PPC etc.) prior to SOP of new models.
  15. A

    Essential Requirement Checklist For Medical Device

    Hello, Maybe I am asking you a very basic question about the CE Marking. But as I am new in this process, I have some doubt related to the Essential Requirement Checklist. I am preparing the Essential Requirement Checklist for the Medical Device Class IIb product. I have found the required...
  16. D

    VDA 6.4 Audit checklist - Production tool suppliers

    Dear all, I am looking for a VDA 6.4 checklist to assess our tooling equipment suppliers. Or a similar Audit checklist by the way (old TE 9000 audit checklist ...). Thanks in advance. Francois
  17. H

    EU Medical Device Regulations (MDR) Checklist

    Hi All, Does anyone have EU MDR (Medical Device Regulations) Checklist ?
  18. R

    AS 9100D internal audit checklist

    Can anyone please share AS 9100D Internal Audit checklist.
  19. B

    IEC 60601-1-11:2015 checklist

    I will plan to certificate medical device. but our report is old version, I hop to find IEC 60601-1-11:2015 checklist item. someone have a summary file for easy check . I really appricate for you
  20. R

    Please help me with attached copy of AS 9100D internal audit check sheet

    Can anyone please help me with attached copy of AS 9100D internal audit check sheet.
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