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?
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...
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...
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...
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?
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...
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?
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.
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...
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?
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?
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...
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)
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
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...