Q
QualitySysISOAdmin
Hello,
My company is registering for ISO 13485 and we need some help on how to interpret section 5.5.1. It mentions that managment establishes the interrelation of personnel who manage, perform, and verify work affecting quality. It also states that management shall ensure the independence and authority necessary to perform these tasks.
Our question is, do we have to document this? I know the section does not mentioned that it has to be documented but we are afraid that when we get audited that we will not be able to prove the independence and authorities.
Is there any other suggestions other than documenting?
We would like not to document because we feel that if we were to do this that we would be tieing ourselves down and anytime any authorities change we have to update the document. If the change is not communicated to those who control that document then it will never get changed as appropriate.
Please help, we're open to all ideas at this point.
My company is registering for ISO 13485 and we need some help on how to interpret section 5.5.1. It mentions that managment establishes the interrelation of personnel who manage, perform, and verify work affecting quality. It also states that management shall ensure the independence and authority necessary to perform these tasks.
Our question is, do we have to document this? I know the section does not mentioned that it has to be documented but we are afraid that when we get audited that we will not be able to prove the independence and authorities.
Is there any other suggestions other than documenting?
We would like not to document because we feel that if we were to do this that we would be tieing ourselves down and anytime any authorities change we have to update the document. If the change is not communicated to those who control that document then it will never get changed as appropriate.
Please help, we're open to all ideas at this point.