differences (general)

  1. M

    Authorized Rep (AR), competent authority, NCA and notified body - Differences

    Hi Everyone, I am a little confused as to what the difference between these terms. People interchangeably use them and I just wanted to understand it. Authorized Rep (AR) - Also known as Competent authority/ European representative? Notified Body - Regulatory Body in EU - Certification...
  2. P

    HVAC System vs Air Handling Unit (AHU) - Differences

    Does any one know the difference between HVAC and AHU please assist
  3. G

    Differences - Nonconformances vs CAPA, Corrections vs Corrective Actions

    I'd appreciate people's thoughts on the following regarding how/what system our medical device company uses for NMRs, CAPAs, corrections, corrective/preventive actions... As the head of Quality for my company, I hold regular meetings with influential members of my organization to discuss...
  4. M

    What are the differences between "Process Flowchart form" and "Process Flow Diagram form"?

    Hello all, In AIAG core tools forms, there are two forms entitled Process flowchart and Process flow diagram as follows: As you see they include different symbols specially Process flow diagram which include diamond for fabrication. My questions are: What are the differences between these...
  5. P

    What is the exact difference between Risk and Opportunity in context of ISO 27001?

    Hi All, ISO 27001:2013 defines planning for Risks and Opportunities. It's bit confusing to understand Opportunity as a positive risk. Unfortunately there's no documented definition of Opportunity available in ISO 27000 vocabulary. Can someone help me understand the exact difference between...
  6. S

    Difference between Surface Finish (Ra) and Flatness (GD&T)

    These both seem like they would be very similar measures.. Can anyone shed some light- preferably with a drawing example on the difference between them? Is it an obvious difference or are these terms used somewhat incorrectly in practice?
  7. K

    Differences between EN ISO 11607-1:2009 vs. 2017

    Hi Everyone Has anyone made a comparison of what changes EN ISO 11607-1:2017 introduces over the 2009 version it replaces? I have 2017 version and 2006 version, it seems no difference between them. I cannot get the 2009 version now, it seems a little rich to me.:sick: Regards Kwak2
  8. I

    "Method" vs "Process" - Differences

    I've been considering addressing some of my processes with the concept of "method" as opposed to "process" - I've been advised that a method does not need to be in a document - BUT - the burden of proof for a method is more difficult for an internal audit team to verify as EACH member of the...
  9. S

    What the difference is between Stub Acme & Acme thread?

    Hello Everyone, Can someone tell me briefly what the difference is between Stub Acme & Acme thread? I'm asking because I just molded a internal thread that has a flat root but a rounded crest. (The print is calling out a Acme thread) Now I haven't been dealing with Acme threads long at all, but...
  10. TarKEpa

    The difference between SOP and Kaizen Standardization

    Hello Guys; I would like to ask about the difference between SOP and Kaizen standardization, and is it important to replace or gather SOPs & standardization in one place (eg. Warehouse), and is there a template or a structure to use Kaizen standardization?
  11. H

    Differences between CQI 15 and CQI 17

    greetings to all I am reading the CQi 15 and 17 but I can not understand the difference, could you guide me what is the difference between cqi 15 and cqi 17? Tanks
  12. xfngrs

    How similar or different are IATF 16949 Vs. ISO 13485

    Has anyone worked in or is familiar with both the automotive and the medical quality management systems? I am familiar with the automotive and am wondering how similar or different they are? Also who has to be certified to the medical standard? And are there government standards you would...
  13. K

    Difference between intended purpose and intended use of the device

    Hi, I'm working on IVDR. gone through Annex-XIII, in which it is mentioned that "specification of the intended purpose of the device; and specification of the intended use of the device" to be mentioned in performance evaluation. Whether intended purpose and intended use is different...
  14. 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...
  15. 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...
  16. S

    EASA Part 145 - The difference between non-certifying staff and Certifying staff

    Hi - can someone explain the difference between non-certifying staff and Certifying staff within a EASA Part 145 repair station - thanks in advance
  17. M

    FOD Standards - NAS412 & AS9146

    Does anyone have any info on the differences/similarities between NAS412 and the newer AS9146 FOD Prevention standards?
  18. S

    The difference between a Medical Device Accessory and Component

    I would like to know what the difference is between a component and an accessory. For example, can a piece of software be classified as a component of a system or an accessory, which is outside the system?
  19. S

    What is the difference between a service request and a complaint?

    Hi everyone, What is the difference between a service request and a complaint? For example, I work at a manufacturer where we receive service requests. For example, damage to a cable not within the intended use. It's not framed as a complaint in the service request. Is this still considered...
  20. R

    Difference Process Objective/Opportunity for improvement

    Hi all Just wondering what would be the main difference between process quality objectives and opportunities of improvement? I mean if i say "Increase on time delivery to 95%" isn't that an opportunity for improvement of the Delivery process? Please clarify
Top Bottom