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Quality policy in healthcare organization
Can the Quality Policy for a healthcare organization be a statement or it needs to be descriptive? -
Documenting training and awareness
I am starting to prepare the documents for the training module of each position in the particular department. I would like to clarify that competence training and awareness is necessary to have documentation or give some sample of documents that need to prepare. -
Interpretation of risks and opportunities
We are currently 9001-2008 registered and just had our surveillance audit for upgrading to 9001-2015. In reading/digesting the new Standard, it’s my opinion that each element is a matter of interpretation. It’s not black or white, it’s gray. Example: Risks and Opportunities. I was looking for additional input to help solidify my opinion of “interpretation”. -
Demonstrating competence for ISO 9001:2015
I am working as Quality Assurance manager. We are a ISO 9001: 2008 certified organization. We are hoping to upgrade to ISO 9001: 2015 version by the end of this year. Related to this I have some queries: -
Nonconformity in production process
We are a manufacturing company and sometimes when we manufacturing the parts. The parts get made incorrectly and have to be redone. -
Where to start with ISO 9001 transition
How to initiate in our company 2015 start with which document Quality Manual is mandatory or not? -
Nonconformity and related clauses
In the ISO 9001:2015 standard, if our Fabrication shop drills holes in the wrong place on a part and it has to be redone (the problem was caught before the part left our facility), should I cite Clause 8.7.1? We would do an NCR but on my NCR’s, I also cite clauses from the standard and I want to be sure I am using the best one. -
Qualification of Quality Management Representative
Could you please advise the qualifications or eligibility criteria to be a Quality Management Representative (QMR) for ISO 9001. -
Do changes in top management require changes in the documentation?
If the Top management of company is change (i.e. Vice president or authorized person, whose sign is on policy) then what to do in "change of document" section and "Obsoleted Documents" and how? The policy and name of company Head is changed everywhere. -
Determining interested parties
We have our ISO auditor who says what I have is on the right track where I just mentioned stakeholders suppliers regulators etc and stated if their needs where power/interest our objectives towards them and rate high medium low priority to deal with these parties, my problem is how much more info is needed? do I have to name the parties individually.