Mixed Use of Corporate and Site Level Procedures and Forms in the Quality System

M

Med Devices

#1
#1
Help! Has anyone else inherited a quality system where procedures and forms that are released at the "corporate" level were utilized, but not released at the site level?

To be very clear, these are two distinct sites, with different products, CE mark certs, and establishment registrations.

The practice of using forms and procedures for convenience / lack of corresponding site level procedure / whatever reason was started some years ago, and there are no site level approvals in the Doc Control system for their use.

Any suggestions on how to unravel this mess???
 
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#2
#2
Med Devices said:
Help! Has anyone else inherited a quality system where procedures and forms that are released at the "corporate" level were utilized, but not released at the site level?

To be very clear, these are two distinct sites, with different products, CE mark certs, and establishment registrations.

The practice of using forms and procedures for convenience / lack of corresponding site level procedure / whatever reason was started some years ago, and there are no site level approvals in the Doc Control system for their use.

Any suggestions on how to unravel this mess???
Click to expand...
According to waht you said, it seems that the pyramid of Documentation control is not so effective. You can have site procedures but they shall be as addendum of Corporate ones or Corporate quality manual, otherwise we are in presence of a clear violation of 4.2.3 clause of ISO 9001.
Local procedures and related forms shall be approved as well and so they shall be controlled.:bigwave:
 
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