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I am deep in the throws of writing procedures based on our currently undocumented processes. Maybe I am just at the point of procedure paralysis, but I am stuck regardless.
8.4 talks in terms of procedures to determine, collect, and analyze appropriate data
8.2.3 says that we shall apply suitable methods for monitoring and measuring the quality management system processes
8.2.4 says that we shall monitor and measure the characteristics of the product and evidence of conformity with acceptance criteria shall be maintained
So ... I am thinking that a procedure for 8.2.3 and 8.2.4 would focus on the measurement piece and how we collect data. 8.4 then would be more along the lines of what we do with the data (SPC, statistical sampling, root cause analysis, etc...)
Am I thinking correctly? Does anyone have any examples of the two procedure or at least how other companies approach these sections?
8.4 talks in terms of procedures to determine, collect, and analyze appropriate data
8.2.3 says that we shall apply suitable methods for monitoring and measuring the quality management system processes
8.2.4 says that we shall monitor and measure the characteristics of the product and evidence of conformity with acceptance criteria shall be maintained
So ... I am thinking that a procedure for 8.2.3 and 8.2.4 would focus on the measurement piece and how we collect data. 8.4 then would be more along the lines of what we do with the data (SPC, statistical sampling, root cause analysis, etc...)
Am I thinking correctly? Does anyone have any examples of the two procedure or at least how other companies approach these sections?
First let's clarify the requirements. ISO 13485:2003 DOES NOT require a documented procedure for 8.2.3 or 8.2.4 clauses, so it is up to your organization to decide if you need aprocedure. My guess is that you already identify what product data are collecting in your control plans and what process data are collecting in your performance metrics. So, do you still need a procedure?!? Your call. Anyway, the intent if 8.2.3 and 8.2.4 is to require the collection of data related to the product and processes.
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