revisions to a document or standard

  1. F

    Device Standards - Managing Changes to existing standards that apply to our devices

    After having spent the better part of the last 20 years working for large device companies with oodles of resources, systems, and processes, I am now with a very small company with few resources, so I'm the lucky person responsible for standards compliance and maintenance. My team of standards...
  2. Sidney Vianna

    ISO 19011:2018 Released - July 2018

    The 2018 Edition of ISO 19011 is now released. For the ISO article, point your browsers to: Auditing standard for management system standards now updated
  3. 2

    First Article Requirements for Revision Changes of Engineering

    Hello Everyone, I couldn't find an answer in older threads so I figured I would ask. I work in an Aerospace Manufacturing and Finish house and I am the SME for First Articles. I have been receiving a lot of push back from our upfront process on how to handle revision changes to engineering...
  4. Q

    AS 9100 C and D Purchasing requirements difference

    Hello QA Pros: What are the differences in the AS 9100 C and AS 9100 D purchasing requirements. Do I need to make changes to my current AS 9100 C Purchasing Procedure, to meet Purchasing requirements under AS 9100 D? is it required? necessary? Appreciate your input
  5. M

    ISO 13485:2016 Cl. 5.1 - Management commitment verbiage change

    I would like to know why the ISO 13485:2016 standard changed the verbiage in 5.1 Management Commitment from Top management shall provide evidence of its commitment to the development and implementation...and maintaining its effectiveness to maintenance of its effectiveness. Sounds like...
  6. M

    User Interface of Unknown Provenance (UOUP) applicability

    Looking to understand timing of when UOUP actually applies. This is my understanding of the timing of events. IEC62366-1:2007 released- initial version IEC62366-1:2007 Am1 released in 2014- includes UOUP IEC62366-1:2015- updated for clarity Can you confirm the timing of these events is...
  7. T

    External Standard Update Notification

    An internal audit found our company to not have the most recent ASTM standard. My question is how or what tools are there out there in the internet world that can email a contact here to notify them there was an update released? (not just for ASTM but for other Aerospace/Defense related...
  8. B

    Standards Needed In House - Determining what standards are applicable

    Dear all, I hope this post finds you doing well. I have been tasked with purchasing the newest version of the standards we have in house. When looking to the ones we have, I am not able to determine why we purchased some of the standards in the first place or where they are used. Is anyone...
  9. Brizilla

    Knowledge of the upcoming ISO 17025 Revision

    So, second day in my new quality manager role. We have to transition to ISO 2015 by February, fine. Oh and next after that IATF16949, maybe next year and oh yeah, we want our gage lab to be accredited to ISO 17025. Hmmm, I do have a copy of that standard and I'm just starting to look into it. I...
  10. H

    Drowning in ECR/ECO/ECN Document Changes

    :bigwave: Hello Covers! I am working on implementing a quality system in a small, custom manufacturing medical device company and I am falling down a rabbit hole when it comes to change requests. Since every device is custom (we have nothing off the shelf) the current ECR in place is being...
  11. P

    Are we an outlier for so many variations of Change Management?

    While conducting a desk audit of our change management procedure, I realized we do not have a MOC form for quality system changes...I.E. If I were to revise a procedure. We have separate MOC forms for Machinery Moves/Purchases, Process Deviation Requests for our machining processes, Personnel...
  12. M

    IEC 60601-1 Ed2 vs Ed3 - Does a product that conforms to Ed3 also fulfill Ed2?

    Is it safe to say that a product that conforms to Ed3 also fulfills Ed2 of 60601-1? (EU)
  13. W

    Update of SOPs for ISO 13485:2016 / MDSAP

    Hi, :bigwave: I wonder how others are updating their SOPs/QSPs for the transition to ISO 13485:2016 (and/or MDSAP), regarding the risk management aspect(s). I heard, that some people (1) just add a new chapter "Risk Management" to all SOPs and (2) update all other parts as necessary...
  14. howste

    AS9110 Rev C has been released and is available for purchase - November 2016

    The new AS9110 Rev C standard has been published as of today: Deployment support materials are here.
  15. howste

    AS9120 Rev B has been released and is available for purchase - November 2016

    It looks like the new AS9120 Rev B standard has been published: Deployment support materials are here.
  16. I

    Curious if a List of Current Standards Revisions Exsists

    Not sure if this exists and I cannot find it but is is time for the annual review of the current standards before the ISO audit and I was curios if somewhere out there, there is a spreadsheet or list of the the standards and the current rev and effective date. I'm going on the web and searching...
  17. E

    Challenges in document control, revisional control, and change control

    Hello everyone :bigwave: First of all, so glad that the Elsmar Cove is back! :D I wonder if anyone can share their experience how BOMs, drawings, manufacturing instructions, and inspection procedures are linked and controlled in their company...? My company makes active medical devices. At...
  18. Marcelo Antunes

    Updates on proposed EU Medical Device Regulations - June 2016

    Some recent developments on the proposal medical devices regulations in Europe. Announcement from last week: Medical devices: deal reached on new EU rules Official Journal 10-06-16 - Amendments on the proposal for revision of the directives - Revised Medical...
  19. V

    What are the changes in ISO 14001:2015?

    HEY ALL, Can you please guide me on the changes to be implemented as per new standard (ISO14001-2015), and are there any new mandatory requirements?
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