Rhino said:
Thank you everyone for your help and ideas. Let me give a little more in depth breakdown of what we currently have and my thoughts on improving it. Please feel free to critique my ideas all you want. I need some healthy objective view points.
Our company designs, manufactures and sells medical devices. We are currently registered to 13485 1996. We had our audit back in Ocotober of 2004 and are scheduled for another in June I believe. We are growing company with currently just under 50 employees, but forsee a rather substantial growth phase in the next 2-3 years which will at least double the size of the company in personnel.
The current system was creataed about 8 years ago I believe and has worked, but is just very cumbersome. It does work with 13485 1996, but it is not the most streamlined system out there.
After reading some more and going to a couple of seminars, I have gained a better understanding of how our current system relates with 13485 1996 and 2003.
We have a Quality Manual Document which outlines very basically what is required by the 13485 1996, but it also contains alot of information about other areas of the company as well. It is more like a business manual than a quality manual I guess you could say. It is about 20 pages long. We also have what we call procedures which are basically the requirements of 13485 and some other company procedures that are laid out more like incomplete work instructions which also reference other documents we call work instructions. Our Quality Manual (business manual) and our Procedures make-up what should effectively be called the Quality Manual as whole. So, this document is more like 100 pages. It is fairly large when it is put together.
The way I am viewing things now is that the Quality Manual should just be the basics saying that you are compliant with 13485. I need a little clarification as to how much information this should entail. Should it just be a flow-chart or an organizational chart. I guess is the basically just a visual or I suppose a written document that shows the process flow of a product through the company, from conception?
What we are calling procedures and work instructions are actually SOP's if I am not mistaken. Clarify me if I am wrong here. There should remain as such, but be written so that we have just one type of document rather than having procedures and work instructions both.
Now, is it enough to have a simple reference line in the Quality Manual that references the appropriate work instruction/procedure which actually tells how something is done. For example, the Quality Manual will mention that we we have a CAPA system and it will mention how a CAPA is determined and then it will reference the Work Instruction/Procedure which will actually explain how the CAPA system works.
Should there be a written Quality Manual and a Process flowchart or are they basically one in the same?
I hope this clarifies my problems a little better for everyone to understand. I may not have worded everything correctly and I may have missed a few things.
Please ask me questions and give me advice and anything else. I want to know if my basic thinking is correct on this.
Our company designs, manufactures and sells medical devices. We are currently registered to 13485 1996. We had our audit back in Ocotober of 2004 and are scheduled for another in June I believe. We are growing company with currently just under 50 employees, but forsee a rather substantial growth phase in the next 2-3 years which will at least double the size of the company in personnel.
The current system was creataed about 8 years ago I believe and has worked, but is just very cumbersome. It does work with 13485 1996, but it is not the most streamlined system out there.
After reading some more and going to a couple of seminars, I have gained a better understanding of how our current system relates with 13485 1996 and 2003.
We have a Quality Manual Document which outlines very basically what is required by the 13485 1996, but it also contains alot of information about other areas of the company as well. It is more like a business manual than a quality manual I guess you could say. It is about 20 pages long. We also have what we call procedures which are basically the requirements of 13485 and some other company procedures that are laid out more like incomplete work instructions which also reference other documents we call work instructions. Our Quality Manual (business manual) and our Procedures make-up what should effectively be called the Quality Manual as whole. So, this document is more like 100 pages. It is fairly large when it is put together.
The way I am viewing things now is that the Quality Manual should just be the basics saying that you are compliant with 13485. I need a little clarification as to how much information this should entail. Should it just be a flow-chart or an organizational chart. I guess is the basically just a visual or I suppose a written document that shows the process flow of a product through the company, from conception?
What we are calling procedures and work instructions are actually SOP's if I am not mistaken. Clarify me if I am wrong here. There should remain as such, but be written so that we have just one type of document rather than having procedures and work instructions both.
Now, is it enough to have a simple reference line in the Quality Manual that references the appropriate work instruction/procedure which actually tells how something is done. For example, the Quality Manual will mention that we we have a CAPA system and it will mention how a CAPA is determined and then it will reference the Work Instruction/Procedure which will actually explain how the CAPA system works.
Should there be a written Quality Manual and a Process flowchart or are they basically one in the same?
I hope this clarifies my problems a little better for everyone to understand. I may not have worded everything correctly and I may have missed a few things.
Please ask me questions and give me advice and anything else. I want to know if my basic thinking is correct on this.