Quality system
I build and reorganise quality systems so that they support the work instead of blocking it, while still holding up to a customer audit. Documentation has to describe the process that actually runs — otherwise you end up with a second set of rules for the auditor.
The procedures exist, but people work differently and everyone knows it.
A customer or certification audit is coming and nobody knows where the weak spots are.
Documentation has grown to a size where nobody reads it.
Internal audits happen to tick a box, not to find anything.
Every site does the same thing differently, so results cannot be compared.
A quality system documented to match how the work actually happens
Tidied controlled documentation with a clear owner for every document
An internal audit plan and trained auditors
A nonconformity list with actions and confirmed effectiveness
Talking to the team and management, mapping the constraints: people, systems, deadlines and budget.
Mapping how the process actually runs, not how the procedure describes it.
What gives the largest effect for the smallest cost, in what order, and who owns what.
Working with users, piloting, training, correcting based on what practice shows.
Checking whether the change actually worked, then locking it into the standard.
Yes. As an ISO 9001 internal auditor I prepare the system and the team for the audit. I do not carry out certification itself — that is the certification body's job, and it is right that those roles are separate. My work ends when the system is ready and the team knows how to talk about it.
That is the most common case. It usually means the documentation describes a process invented for the audit rather than the one performed on the floor. I start by putting the two side by side and deciding which one changes — sometimes the process, sometimes the description. What matters is that one set of rules is left afterwards, not two.
Usually yes. The standard requires control over documented information, not volume. Most of the growth comes from documents added after every nonconformity and never removed. A review asking who uses each document and for what typically shortens things considerably.
Yes, and that is where the lack of standardisation usually surfaces: the same process described three different ways at three sites, so the results cannot be compared. Fixing that typically delivers more than the audit itself.
Describe what is happening in the process and what you have already tried. I reply within one business day.
