what is it?

If you want custom-made ISO 9001 quality system documentation, then I can help you.

Remember, you want a system that works!  So that means you must have a procedure to audit so that you can identify where a procedure is not working.

I will require you to complete the questionnaire as the starting point.  That will give me some sort of idea about your business, and from that, I will develop your custom-made procedures as outlined below:

• Organogram
• scope and description of the quality management system
• management responsibility & resources
• human resources and training
• document control
• records
• purchasing and material/ service control
• internal auditing
• corrective action
• analysis of risk and opportunities for improvement
• control of non-conforming product
• (marketing and) sales

Then if you really benefit from the procedures, then I can be called on to do the balance which require an on-the-job analysis before I start:

• planning & production/ manufacturing/ assembly/ servicing

• inspection & testing (intermediate & final product/ service)

• packaging & dispatch

Plus, I will give you the following forms, if you do not have them, and analysis:

• PIR (Performance improvement report), not the electronic form, which is like the CAR (corrective action report) or NCR (non-conformance report).  It is a report that documents when something goes wrong, be it a customer complaint, or your supplier delivering the wrong material, or during an audit you find that the procedure is wrong, etc, you then fill out the PIR to take corrective action, and from the root cause identification, you take action to prevent it from occurring again.  (For the electronic form, see the last item – PIR demo – on the menu.)

• PIR analysis for capturing the pertinent details, giving an statistical analysis of them for action, and also for showing which PIR's are due for follow-up or close-out

• Audit report (that single page that describes your quality system audit)

• Audit checklist (to identify what you will ask during an audit)

• Documentation record (who has a copy and which revision)

• Risk Assessment form (Similar to the PIR’s but more for analyzing the risk and identifying process improvements to minimize the risk of a non-conformance)

• Risk Assessment  Report (as per the PIR analysis)

• Management review agenda

• Basic Quality Awareness

Plus, I will make your system electronic (with a detailed, hyperlinked menu)  OR a hard copy.

For the electronic system, I will give you the electronic directories already filled with the documentation so that it is possible for you just to maintain it, and I will give you the Webmenu so that you can add to it using the likes of Microsoft Frontpage or Dreamweaver.  (Of course you can employ me to maintain it)

For the hard copy, I will give you the electronic directories already filled with the documentation, and a hard copy that will be your master from which you will make your “controlled copy” manuals