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ISO 9001:2015 requirements and clasues
I hope you can help me as I have been studying the standard for quite some time now. -
What % of companies have already transitioned to ISO 9001:2015?
I was trying to do research to understand what % of companies have already transitioned to the 2015 standard? Top management is asking because we have completed the transition in the US but still need to do so in Europe. I would love some educated guesses or data that I could supply to them. -
Certification audit findings
In stage one Audit what we should find as auditor ? Some say just write a report on observation but do not address it as a non-conformity. -
Document control
In regards to Document Control, can people check out native copies of the documents from the document library? My way of thinking is that the library is the controlled environment, and it is only the re-submissions and revisions that needs to be controlled again. People checking out natives, does not have a negative impact, unless changes are made and the document does not become controlled. I think my organisation is a lot more mature than our staff to do that. -
Evidencing organizational knowledge
Regarding organizational knowledge evidence. What evidence of org knowledge will be checked by auditor? -
FMEA and addressing opportunities in ISO 9001
Failure Mode Effect Analysis and Control Plan are used in automotive world, in order to control the risks, however the opportunities how can we addressed, is it enough to do with a continuous improvement? your comments will be appreciated, thanks. -
HACCP and hierarchy of documents
Pls let me know in 4 levels of documents, where does HACCP manual falls.. -
Excluding engineering process from ISO 9001 scope
The company I work for is a 3rd party manufacturing company. We currently don't have Engineering, Service dept.....all we currently have is procurement, production line and a CFO. For sections of ISO that talk about Engineering how will we fulfill those during an audit. -
PPAP and occurrence, severity and detection
How severity, occurrence and detection number should be given in PPAP ? -
Process capability and Process Capability Index
Process capability is the ability of a process to produce output within specification limits. In process improvement efforts, the process capability index or process capability ratio is a statistical measure of process capability. The concept of process capability only holds meaning for processes that are in a state of statistical control. Process capability indices measure how much "natural variation" a process experiences relative to its specification limits and allows different processes to be compared with respect to how well an organization controls them.