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What will an auditor look for?

ISO 9001 is often summarized as "Say what you do, and do what you say". (See 12/5/07 post: "Explaining your project...) Auditors are looking to make sure that you are doing what you say. Everyone should be on the same page so that an auditor can walk into your facility and ask anyone"WHY they are doing a particular task, and HOW they know to do it this way".

An employee should be able to say: I was trained on this procedure/task/work instruction (and there should be a record of it) on 4/11/06 (for example) I have a document (that the employee can quickly reference) that outlines the procedure/task/work instruction next to me/in my filing cabinet/on my PC

And, the procedure should be clearly marked with the current revision when compared to the master list in the QMS.  These may seem nit picky, but it takes complete alignment to keep your company working as a system of interlinked processes.

ISO 9001 is also about being consistent – if your processes are designed to meet certain goals/objectives, then if followed they should meet them every time. By making sure everyone is following the same recipe each time, then the company will realize consistent results.  This is what an auditor will look for.

Explaining your Project to Co-workers...in simple terms

It is important to have people on your side as you implement the project, and there is a balance between not enough info and too much when you’re informing employees.  Anxiety is often caused by a lack of knowing (“will my job be affected?”) yet too many details can confuse them.  So as you prepare to implement ISO 9000:2000, try to get people engaged without giving them the nitty-gritty details. We’ve all seen an ISO implementation broken down into any number of steps, our site even gives some examples. But depending on the context of the conversation it may be too much. Here is a simple look which may help translate the project into very concise terms that anyone can understand:

  1. Documentation = Say what you do – document your processes/procedures
  2. Implementation = Do what you say – follow procedures as documented
  3. Training – Ensure that everyone knows how to perform their procedures/tasks.
  4. Improve – Continually look for ways to improve your processes. 

And all of the above must be customer driven…you must be meeting or exceeding customer expectations.  This is the big advantage of ISO 9001:2000 over the 1994 version.  You could follow #1-4 above, but it is said that if you are designing CONCRETE life jackets you won’t have many customers, even though you are making them consistently to the specification.

Everyone needs to be informed. So keeping it in simple terms might just help you win some employees and keep them from becoming cynical detractors.