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Academe's suppliers
"Are criteria for evaluation of suppliers a required document in applying ISO 9001-2015 in the academe? If yes, how can it be applied if we declare that our products are graduated?”
Design and development topics
"I am working as QMS M.R., facing difficulties in design and development clause as it was not in my previous working organization. Need help in the same for developing records, conducting reviews and risk analysis. additionally, will you be able to provide new work instruction formats content (points to be mentioned in WI format).”
SWOT and risk analysis
"I am looking for information on what of the SWOT is to be measured into the risk analysis. Only the opportunities?”
Possible risks found in ICU
Can you please give me one event with corresponding cause and consequence in Intensive care unit so i can start making our risk register. This is a requirement in ISO 2015.
Risk mitigation as quality objectives
"Can risk mitigation be taken as a quality objective?”
Changing quality objectives
"How to change a quality objective?”
Documentation required
"I would like to know what components are needed to acquire a complete QMH according to ISO 9001: 2015 with document management, management reports, instructions etc ...”
Writing a good quality policy and objectives
We have a big quality policy which need to be reduced in a good shape. Pls give your suggestion. Also we do not have concrete objective so ISO remains useless. Pls help us to improve.
Interpretation of audit report
"When the auditor says: “The organization has not defined the “type & extent of control” for purchasing. Special processes such as NDE are not controlled for sub–suppliers, there are no documented requirements for such.
Documenting risks and opportunities in ISO 9001:2015
Internal & External Issues - We have broadline Internal & External Issues, however, the auditor does not approve and ask for a risk register and risk assessment document. Please advise.