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Non-conformity – not following a procedure

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?

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

Documents required by ISO 9001

The ISO 9001 standard is the international standard for Quality Management Systems.  During its review in the late 1990 they removed its “obsession” of needing a documented procedure to cover most tasks.  This is because organisations vary in size and...
Audit preparation

Audit preparation

I perform a number of audits throughout the year.  Most are supplier audits but some are internal audits.  In order to make the audits as efficient as possible I recommend good planning for the audit – rather than just turning up on the day and “going with...
ISO 9001 versus GMP – Part 2

ISO 9001 versus GMP – Part 2

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...