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Head of Production as Management Representative
Would there be any contradiction or compromise in quality if the head of production is made a management representative? and what does ISO 9001 say about this? In reference to the 2008 version, does it talk about head of production to be made a management rep? -
Implementation of ISO 9001:2015 quality management system
Ours is the Fabrication unit manufacturing of Light, Medium & Heavy engineering equipment for earth moving equipment manufacturer. We have planned to go for ISO 9001: 2015 new standard requirements. Preparation of Q.M.S. & Implementation of new standard. -
Implementing ISO 9001 in hospitals
We're on the phase of preparation for implementing ISO 9001:2015 in our hospital. How can I apply the followed procedures in a healthcare field not industrial field: -
Getting support for ISO 9001 implementation
But you did not tell how to convince company peers to follow the new ISO 9001 process in your write-up. My Managing Director kept asking me why must they change a system that is working for us? The reasons I gave however good, did not convince him. I expected to see a good reason that I can use from you. This write up was short of it. -
Control of external documents
On the issue of 3.5 Documents of external origin (9001:2015) it discusses keeping an "incoming mail register" for all external documents. In doing a little research I found a list of examples of external documents and found customer drawings as one of them. We receive hundreds of drawings a week from clients that go to multiple people. Having to maintain a "incoming mail register" would be a big problem for us. Is there a way to work around this or exclude customer drawings. Could email storage be the record? -
Scope of the QMS
In 4.3_Appendix_3 Scope of the QMS section 3 the scope is defined in all the areas listed i.e. 3.1 - 3.6, do these definitions then combined together make up the Scope as a whole? Is there a place we document the entire scope? What is the expected length of the scope. Our current scope is one paragraph (4 lines) with more emphasis being put on the Scope whats the expected length? -
Processes and activities
I need some help distinguishing between process and activity/action on the quality objectives template. I see process as things being done that directly affect the objective? Activities or actions as defining the objective in terms outcome? Any direction would be greatly appreciated. -
Performance Evaluation for ISO 9001:2015
We have been ISO 9001:2008 certified for many years. We are currently working on the conversion to ISO 9001:2015. I would like to know what documentation is needed for 9.1.1 and 9.1.3? -
Warehousing Procedure
We don't really warehouse anything. We are a service but we do maintain a hard file for each of our clients that contains documents and records produced internally or externally. Would it be necessary for us to document the storage of the hard file with the warehousing procedure? Do we have to use every procedure in the tool kit? -
Relations with subcontractor and ISO 9001
I want to confirm about the documentation of QMS for subcontractor. If both the main and subcontractor are implementing ISO, then both of them must have records for activities such as material inspection and product inspection.