revisions to a document or standard

  1. L

    Document Control Procedure - Revision Control

    Hi, i hope you experts can help me sort out a little confusion here :-) we have a document control procedure that is revision controlled and kept in our quality management system where it is being verified by QC, checked and approved in the system before it is ready for use. This process can...
  2. L

    Keeping current on new/revised MEDDEVs

    Hi all, I'm looking for suggestions on a system that would help us keep current on new and revised MEDDEVs. We use a document center service for ISO, ASTM, BS, EN, ANSI, etc documents and receive an email from that service any time a document we have purchased from them has a new revision...
  3. E

    Will EN ISO 13485:2012 be revised when ISO 13485 is reviewed??

    Hi all, very happy New Year... I know the topic on BS EN ISO 13485:2012 has been clarified by many Gurus in elsmar. However, just wondering since ISO 13485 is also undergoing it's systematic review by ISO TC 210 WG1, will CEN revise their 2012 version once ISO has released the version...
  4. drgnrider

    Pro's & Con's for revision number AND revision date?

    I have been assigned as our Company's QMR since the previous QMR is now the Facility Director (FD). When he made all the ISO documents he had all of them given a revision number and a date. When I went to my Lead-Auditor class in July, it was recommended to not have a revision number, but...
  5. C

    Any news about IEC 62304 2nd edition

    Hello guys, Do you have any news about IEC 62304 2nd edition? I've read that a draft version was reviewed internally and that comments should be sent by january 11th 2013. Regards, Mitch.
  6. Q

    Has the update to MDD 93/42/EEC been released yet?

    Hi, Any one know if the update to MDD 93/42/EEC, has been released yet? Cant seem to find any update. Thanks
  7. B

    ISO 9001:2015 Draft - Status

    Does anyone have a draft copy of ISO 9001:2015 that they would be willing to share?
  8. S

    Previewing changes to revised Standards

    Hi, We recently submitted our 510(k) application. It included a Sterilization Validation report and other documents created a number of years ago and some of the standards referenced are now out of date. The FDA has asked we provide information as to whether the documents are still valid...
  9. P

    Amendment 1 to 60601-1, 3rd Edition Medical Electrical Equipment Standard

    The much anticipated amendment 1 of 60601-1 is reported to be just days away from publication. See here: http :// www. mddionline. com/blog/devicetalk/iec-issue-draft-amendment-1-60601-1-3rd-edition-medical-electrical-equipment - OBSOLETE BROKEN 404 LINK(s) UNLINKED
  10. M

    Proposed EU MDD (Medical Device Directive) Revision(s) - 2012 - 2013

    All, The MDD is being revisied again. What are the main proposed changes? Thanks, Ray
  11. S

    Control of the Content in the Master Calibration Equipment form

    Hello everyone. I am implementing ISO13485 in a small contract manufacturing company that works mainly for medical manufacturers, we receive their (final) product and we do a process on them. My question is regarding records control, more precisely its content. I have my Master Calibration...
  12. S

    Numbering of Pages in a Revised Procedure

    Dear Friends For QMS Documentation requirement At our procedures updating when we update documents and add new pages to the procedure the numbering will changed so we re-print the whole procedure As the procedure is 20 page and at the footer of every page we wrote (number of...
  13. N

    IEC 60601-1 3rd ed vs. IEC 60601-1 2nd ed Gap Analysis

    Hi All, For some reason I need to perform a gap analysis of the 60601-1 for 2nd to 3rd edition. Due to the enormous changes in the two edition I am struggle to do so. Is there a ready template or any guidance how to perform the gap? thanks in advance
  14. N

    ISO 14971:2007 vs. 2009 - Which Risk Management Standard is still accepted in the EU

    Hello All, Can someone advise whether the 2007 version of the risk management standard is still accepted in the EU, or must the 2009 version be used? Is there an easy way to determine what the changes are between the two? Thanks much for any response.
  15. T

    IEC 60601-2-27 - Comparison of 2nd to 3rd edition

    Does anyone out there have a comparison of The "Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment" IEC-60601-2-27 2nd edition (2005) to the 3rd edition (2011)? I am working on a gap analysis and dont want to re-invent the wheel...
  16. A

    Current Control Periodic Document Reviews - Process Updates in the FMEA

    Hi, I have question about the current process update in the FMEA during the periodic document review. If, for example, an action already taken has decreased the detection of a FM by introducing a more effective control, am I supposed to move this new control from the Action Results Section to...
  17. S

    Is it required to upgrade an AS9100 B Procedure Manual to AS9100 Rev. C

    This may sound like a real dumb question, but here it goes.... If you have recently upgraded from a AS9100 Rev. B QMS to Rev. C is it required to upgrade your AS9100 Procedure Manual to Rev. C as well? (example Rev. B has no mention of Risk Management) Can I just incorporate procedures to my...
  18. V

    What is the criteria for assigning the new-revision number for an FMEA?

    I understand that FMEA is a document which evolves through out product development and through product life-cycle. During product development, there could be at-least couple of sessions in identifying the "failure modes - respective controls - action points" and finally ""executing action...
  19. M

    Document Control (with Revisions Control) Management Database

    I have found many excellent database programs on Elsmar. Anyone have a database (mdb) to organize Document management,Document revision?
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