differences (general)

  1. 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?
  2. 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
  3. 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...
  4. 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...
  5. 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...
  6. 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...
  7. 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
  8. M

    FOD Standards - NAS412 & AS9146

    Does anyone have any info on the differences/similarities between NAS412 and the newer AS9146 FOD Prevention standards?
  9. 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?
  10. 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...
  11. 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
  12. Q

    Management control Procedures & Operational Control Procedures

    Hello , We are planning to implement ISO 14001:2015 & OHSAS 18001:2007 along with QMS in our organization. What is the difference between Management Control procedure & Operational control procedures. Can anyone share examples ? Thanks in advance.
  13. QMMike

    ISO (in search of) IATF 16949 vs. TS 16949 changes summed up

    Sorry if it's been asked before --- I've looked and didn't notice if it was -- Does a document exist - or does anyone have a document that simply breaks down exactly what the changes are? In all honesty, reading the entire specification and looking for changes is daunting and seems like...
  14. D

    AS9100D vs AS9120B differences

    I am looking for a document that lists the differences between the AS9100D and AS9120B. I have my internal audit checklist for 9100 and just want to add what is missing for the AS9120. Is there such a document?
  15. Q

    Difference between Monitor & Measurement

    Hello Members Just a basic question. What is the difference between Monitor and Measure ? We regularly use terms like monitoring & measurement of processe, monitoring frequency, measuring frequency etc.. What is the best example to understand the basic difference between these terms? Thanks
  16. kjoberk

    Nonconforming Output vs. Nonconformity vs. Nonconforming Product

    I'm trying to gain some insight. Currently certified to AS9110B (C is coming up this new year for us). My Management Rep and I are having a disagreement on the terms. In 9110B, it states in 8.3 that we have to have control of Nonconforming Product...then in 8.5.2 talks about...
  17. A

    ISO 13485:2003 vs ISO 13485:2016 - What are the differences between the two?

    Hello! What are the differences between the two? What is changing? Does anyone have a "gap analysis" showing the difference between them?
  18. M

    ASTM F 75-12 - Tensile properties Product castings ( 7.1 ) vs Casting alloys ( 7.2)

    With reference to the above standard can some body please explain the difference between Tensile properties for product castings ( 7.1 ) and tensile properties for casting alloys ( 7.2) Thanks michelle
  19. T

    QA vs. RA - The difference between QA and RA

    I post my question here because it become our favorite pastime during coffee breaks. It concerns the difference between QA and RA. Having often worked in small medical device structures where only one person occupies 2 functions QA / RA. Do you have an opinion on
  20. C

    Differences between IATF 16949 and AS9100

    Is there a gap analysis available on the differences between these two standards? We are MUCH more heavily automotive, but have some hardware parts that are supplied to an aircraft customer who is pushing us to become AS9100 certified. My hunch is that the new, more stringent IATF Standard...
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