4.1.1 requires an entity that can be held legally responsible.....
I have seen incorporation, LLC, even a business license.....laws differ some so what may work in one spot may not work in another......
4.1.2 requires the organization to carry out its work in a way that satifies the requirements of the standard, customers, regulaory authorities, and/or those providing recognition.....
That is to me an open door for lots of interpretation.....basically i appears to me that if the lab meets the requirements of the standard and any additional regulators, generally they meet customer requirements.....but I suspect that may not always be true.....
4.1.3 requires tht the management system cover work at the lab, away from the lab, and so on.....what is covered has to be defined.....
usually everything gets covered, but I believe it is OK to cover specific locations and not others too, so long as the other locations are not on the scope.....
4.1.4 requires responsibilities of key people to be defined to prevent conflict of interest.....
There are numerous other clauses that go with this one, including 5.2.5, 4.1.5 (all sub-clauses), and 4.2.6 among others.....it is best to address all the requirements at one time in one section rather than all over, in my opinion.....
I have seen incorporation, LLC, even a business license.....laws differ some so what may work in one spot may not work in another......
4.1.2 requires the organization to carry out its work in a way that satifies the requirements of the standard, customers, regulaory authorities, and/or those providing recognition.....
That is to me an open door for lots of interpretation.....basically i appears to me that if the lab meets the requirements of the standard and any additional regulators, generally they meet customer requirements.....but I suspect that may not always be true.....
4.1.3 requires tht the management system cover work at the lab, away from the lab, and so on.....what is covered has to be defined.....
usually everything gets covered, but I believe it is OK to cover specific locations and not others too, so long as the other locations are not on the scope.....
4.1.4 requires responsibilities of key people to be defined to prevent conflict of interest.....
There are numerous other clauses that go with this one, including 5.2.5, 4.1.5 (all sub-clauses), and 4.2.6 among others.....it is best to address all the requirements at one time in one section rather than all over, in my opinion.....
