Documents required by EU GMP
There are many activities that you do that are “procedures”, such as how you get in the car in the morning (unlock the door, adjust the seat, fasten seat-belt, start the engine, and so on), but this is (hopefully) not a “documented procedure”! “Documented procedures”...
Non-conformity – not following a procedure
A common finding when auditing is discovering that the organisation or department that you are auditing is not following their own internal procedure or policy. This is a non-conformity, and should be raised as such. The problem is – what clause of the...
Procedure or documented procedure?
In many standards that exist there are often statements such as “there must be a procedure to control training records”. Whilst I am sure that none of you will disagree with a statement such as this there is an element of unclarity in the statement itself. It...
Documents required by ISO 9001
PLEASE NOTE: THIS ARTICLE IS NO LONGER RELEVANT AS THE 2015 VERSION DOES NOT INCLUDE ANY SPECIFIC REQUIREMENTS FOR DOCUMENTATION The ISO 9001 standard is the international standard for Quality Management Systems. During its review in the late 1990 they removed its...
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