Hello, I pretty much got thrown in the deep end here. I took over the quality department in our machine shop when our quality tech left for another job and our quality manager got laid off. I had no previous experience in quality and now we have an ISO 9001:2015 surveillance audit coming up. I'm struggling to wrap my head around a few of the requirements and I would love some direction from those of you more experienced and knowledgeable than I am in this so I can hopefully salvage this situation.
8.5.6 Control of changes:
Does this apply to all changes to all controlled documents? If no, what does it apply to? If it is not all controlled documents then my interpretation would be anything directly related to the process like work instructions. Is any documentation required for the change outside of a log with the specifics mentioned in the clause? For example, do we need a "document change request form" to be filed and kept? Or just a log of the results?
7.5.3 Control of documented information
Specifically the retention part. Do we need a document retention log of sorts to show what documents we're retaining and for how long?
I would really appreciate any input. Trying to learn this stuff on the fly on such a short time frame is frying my brain.
8.5.6 Control of changes:
Does this apply to all changes to all controlled documents? If no, what does it apply to? If it is not all controlled documents then my interpretation would be anything directly related to the process like work instructions. Is any documentation required for the change outside of a log with the specifics mentioned in the clause? For example, do we need a "document change request form" to be filed and kept? Or just a log of the results?
7.5.3 Control of documented information
Specifically the retention part. Do we need a document retention log of sorts to show what documents we're retaining and for how long?
I would really appreciate any input. Trying to learn this stuff on the fly on such a short time frame is frying my brain.