1. A

    Where are the rules for when a repeat minor nonconformance becomes a major?

    Can someone answer a question I have had for some time? If a CB auditor issues a "minor" non-conformity and a year later at a subsequent visit discovers a similar "minor", (same clause or part of the QMS) the "minor" automatically becomes a "major"? I have reviewed the Rules and I can only find...
  2. S

    MDR Annex II Design & Manufacturing info - 'Adjuvants' definition

    Hi, Please could someone help me to understand what is meant by the phrasing of the word 'adjuvants' used in MDR - Annex II - Design and Manufacturing Information. (b) complete information and specifications, including the manufacturing processes and their validation, their adjuvants, the...
  3. sonflowerinwales

    Anodyze - what is it?

    Good evening all In our requirement to our supplier it states - The following materials shall be avoided: - 1. Anodyze - 2. Fiberglass material - 3. Paint (white) (others listed also...) Then at the end fo the paragraph - Note: The reason is that they have a known association with ESD risks. I...
  4. M

    IEC 62304 - Develop an Architecture for the Interfaces of Software Items

    What does IEC 62304 cl 5.3.2 - Develop an ARCHITECTURE for the interfaces of SOFTWARE ITEMS refers to? What does ARCHITECTURE of the interfaces means? Is it expecting descriptions of the methods instead of defining the actual interfaces? For examples, there are two MCUs and one SOFTWARE ITEM...
  5. S

    How to Define Importers under EU MDR / Brexit

    I have a few questions about how to define importers under the new MDR. Currently, our importers are UK based businesses and we ship our products from outside the EU to 3PL warehouses located within the EU (not in UK). Following Brexit, the UK businesses can no longer be our importers and we...
  6. R

    Endless doubts and questions concerning procedure vs process.

    Reading some articles about the differences between Procedures and Processes, I usually find that Processes are "what" and procedures are "how" things are done. This White Paper...
  7. C

    CFR 21 Definition for Data or Raw Data

    Hello, I'm having trouble finding a definition for data per CFR 21. Specifically in regards to nonclinical studies or cGMP manufacture. For context, I'm working on a risk assessment of a dissolution instrument. Best regards, Chemist
  8. S

    Labelling in Medical Device Software

    What is the meaning of labelling a medical device software? There is "version" of the software. Does this satisfy the needs of labelling? There are user-guides for use of software. Do such user-guides need to be labelled? Are there any other pieces of medical device software that need to...
  9. W

    EU GMP Annex XI - What is an "appropriate QMS"?

    Hi, I wonder if someone can give me advice about EU GMP Annex XI: 4.5 The regulated user should take all reasonable steps, to ensure that the system has been developed in accordance with an appropriate quality management system. The supplier should be assessed appropriately. We get an ERP...
  10. V

    Discussion of ISO 9001:2015 - "Quality Objectives" term

    My customers have been embarrassed with the "quality objectives" term. It is not difficult to do, but it is boring and inefficient to do with this term. Did you encounter this problem?
  11. P

    Is throughput yield the same as FPY or FTY? Rolled Throughput Yield

    I understand that First Pass Yield (FPY) does not include reworked units in the calculation, but First time Yield (FTY) does. What I am confused from the internet is that some people are saying Throughput yield is the same as FPY, while others are linking throughput yield to FTY instead...
  12. Q

    Auditing Product and Services doubts

    Hello everybody In your opinion how important is to take care into an ISO 9001 System P and S? In this sense, we know that, which is manufactured, fabricated, built, is PRODUCT. If I have a business which sell training, it could be SERVICE. But in both options exist in my point of...
  13. D

    How to ensure independence and authority necessary to perform QM tasks

    Hi all, The management has to document and ensure the independence and authority necessary to perform QM tasks. Can someone please explain what does "independence" here mean and how can we show/document it? Thank you Daliane
  14. M

    IEC 60601 - Limits of agreement as Essential Performance

    Hi All, Supposedly I have a medical device that measures and logs respiratory rate (it is not defined as an Alarm Monitor). The efficacy of the device in clinical testing is determined with respect to a gold standard measurement (i.e by comparing the respiratory rate measured by the test...
  15. L

    Mini Builds - Quality Assurance Terms and Definitions

    Can anyone explain what performing mini builds in Quality Assurance means? Thanks in advance.:notangel:
  16. M

    Vernier Calibrations & more

    Hi, We recently had an ISO 13485 2016 change audit. The NB auditor pointed out that we should increase the calibration frequency of verniers that we use daily from once in a year to once every quarter . There was no proper justification given . He just stated that for daily use instruments...
  17. S

    Difference between an Advisory Notice (ISO 13485) and a Field Safety Notice?

    What is the difference between an Advisory Notice (ISO 13485) and a Field Safety Notice? Is there a document that tells me what goes into an Advisory Notice? Thank you in advance for the help/
  18. Mikishots

    Defined - Definition and meaning of "defined"

    With respect to AS9100D Clause, there is a requirement to define data protection processes. While our IT group is very much included in our audit that contains review of document and record control (as we almost exclusively have a paperless system), this requirement has them asking...
  19. D

    User Needs - Concrete definition for "User Needs" as required by the FDA

    Hello, I don't suppose someone would be able to give me a concrete definition for "User Needs" as required by the FDA. What I ideally want is to screen user needs requirements to see if they are really a user need and hence require validation. For example, I would argue there is a difference...
  20. T

    Difference between "data analysis" and "management review"

    I'm a little confused about how "data analysis" and "management review" are related, or possibly, redundant? Both say they "do" something in order to ensure or demonstrate that the QMS is "suitable, adequate, and effective" Several inputs are listed for both, "feedback" and "audits" are...