ISO Archives

CAPA – time for a rethink?

by Dominic Parry | Oct 16, 2022

All manufacturing sites have a CAPA system, usually a mechanism to deal with things that have gone wrong. Despite the fact that a lot of focus has been given to CAPA in recent years, there is a great deal of misunderstanding and a clear lack of clarity on what CAPA...

ISO 9001 versus GMP – Part 2

by Dominic Parry | Oct 8, 2022

A lot has been said about ISO 9001 in the pharmaceutical industry. This article tries to compare the two fairly. You should read Part 1 first to get some idea of the differences. One of the main problems of comparing GMP and ISO is that the two standards are not...

ISO 9001 versus GMP – Part 1

by Dominic Parry | Oct 8, 2022

A lot has been said about ISO 9001 in the pharmaceutical industry. With pros and cons and comparisons to GMP made all the time. This will be discussed more in a later article, but as a starter I have listed the clauses of ISO 9001:2015 below. Those in green text...

Non-conformity – not following a procedure

by Dominic Parry | Oct 17, 2012

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?

by Dominic Parry | Sep 25, 2012

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...