D
danirenee
Hi! My company is in the process of implementing an eQMS/ERP system and cranking out the work instructions for how the systems are used. I am trying to categorize the work instructions relevant to our QMS processes (ISO 13485) as opposed to those that are considered "business documents."
I would appreciate any insight you may have regarding the categorization of WIs specific to a system administrator, such as creating/modifying/maintaining sites, domains, users, roles, permissions, etc. within the system. Would you categorize these activities as business-related or QMS documents? If QMS, under what aspect would they best fit?
For example, our QMS documents follow a hierarchy starting at a policy level, where the policies are "buckets" structured after 13485. So, would you bucket these system admin WIs under "infrastructure", "resource management", or would you place them under their own policy bucket?
Thanks in advance for your thoughts!
I would appreciate any insight you may have regarding the categorization of WIs specific to a system administrator, such as creating/modifying/maintaining sites, domains, users, roles, permissions, etc. within the system. Would you categorize these activities as business-related or QMS documents? If QMS, under what aspect would they best fit?
For example, our QMS documents follow a hierarchy starting at a policy level, where the policies are "buckets" structured after 13485. So, would you bucket these system admin WIs under "infrastructure", "resource management", or would you place them under their own policy bucket?
Thanks in advance for your thoughts!