Well, we are a group of students doing our project to develop this combined ISO 9001/ISO 13485 QMS for a very small company (15 people). We have already done gap analysis for the existing company processes, now in the process of process mapping for the most important processes. Our approach is to prepare the process mapping on a full scale (I mean incorporating everything possible) and then point the missing parts to the company. Is it alright as a way forward?? Comments/feedback/suggestions from experienced people here will be welcome.
With regards to the number of important processes, is there any definite amount? or can anyone provide some sort of list of such processes? Another confusion is difference between flow chart and process map, which one to follow??
There is so much information in Cove that sometimes I feel lost

. But I am sure that this is the only place which I can resort to for reaching our goal!
srb10139,
DEVELOPING A PROCESS-BASED MANAGEMENT SYSTEM
Please study and understand clauses 4.1 and 4.2.1d. First analyze the core process that runs from determining customer needs and ends with cash in the bank for having fulfilled those needs.
From this you will have determined the key processes in the system. Those that are part of the core process and those that are essential for sustaining the core process.
I hope that you are working with the designated process owner (starting with the process objective - see 4.1c) in mapping or analyzing each process as they should stop you from writing idealistic procedures.
4.2.1d tells you not "to incorporate everything possible".
Process mapping results in flowcharts. If these are deployment flowcharts they can also act as your documented procedures.
Have you devised a means of uniquely identifying each procedure before it exists? This enables you to include the cross-references as you go.
Lastly, at least 90% of the system documentation will reflect what the organization already does. Bring nonconformities to the attention of the process owner as you go and record these on the relevant flowchart.
Failure to correct the process by the time of system launch should result in your system's first corrective actions.
Try not to improve the processes as you go however interesting this may be. This is the job of the management system as it is used and improved. So, get through the grind of developing the system as quickly as you can.
Copying another organization's documents is a distraction.
Good luck,
John