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Hello Members,
I am new to the Cove and also to a start-up medical device company. I am trying to implement a Quality System based on ISO 13485.
I have proposed a 3 tier quality system for our company
Tier 1 -- Quality Manual
Tier 2 -- Quality Assurance Procedures (QAP)
Tier 3 -- Standard Operating Procedures (SOP) & Forms
The QAPs include procedures for purchasing, customer complaints, reworks, inspections and testing etc..(you get the idea) and the SOPs include procedures for passivating, anodizing, laser etching, calibrations etc..
I wanted to know is it conflicting that both the QAPs and SOPs are telling me WHAT and HOW to do things. Is it ok to follow this way or is it better to plug all HOW and WHAT things together in a SOPs. I am a bit confused
Your comments and inputs
Thanks
I am new to the Cove and also to a start-up medical device company. I am trying to implement a Quality System based on ISO 13485.
I have proposed a 3 tier quality system for our company
Tier 1 -- Quality Manual
Tier 2 -- Quality Assurance Procedures (QAP)
Tier 3 -- Standard Operating Procedures (SOP) & Forms
The QAPs include procedures for purchasing, customer complaints, reworks, inspections and testing etc..(you get the idea) and the SOPs include procedures for passivating, anodizing, laser etching, calibrations etc..
I wanted to know is it conflicting that both the QAPs and SOPs are telling me WHAT and HOW to do things. Is it ok to follow this way or is it better to plug all HOW and WHAT things together in a SOPs. I am a bit confused
Your comments and inputs
Thanks

Hope you find this helpful.

