I often get asked this as sites get close to bringing in the auditor so I put together this summary of what I would expect to see in relation to the five main paragraphs so it is possible for anyone to gauge if they are ready.

How much of the system?
The QMS should have been operational for at least 4 – 6 months with quality records created in every section of the system.  A full set of controlled procedures, work instructions and forms should be in use backed by an effective record retention system.  Evidence of controlled issue of such documents either electronically or as hard copy needs to be visible.

Clearly at least one Management Review meeting needs to have been undertaken with minutes on file and adequate resources in place – especially the Management Representative! An effective Quality Policy and objectives should in place and understood by staff.  The scope needs to be adequately declared with a note of exceptions from Section 7 and the company should be able to demonstrate an effective means of communication to the staff, perhaps a newsletter, notice board items or briefing sessions.

A full set of training records need to be on file for employees plus a means to determine training needs and requirements e.g. a skills matrix. The relevant aspects of infrastructure and environment would be addressed as appropriate and a current Organisational chart visible for all to see how they fit into the structure.

Where it really counts
Operational procedures should be complied with in Sales, Purchasing, Design, Calibration and Production and control of identification and status evident throughout the company. You need to be adhering to your Approved Suppliers and Subcontractors List with adequate inspection from Goods Inwards, In process through to Despatch.  Customer property needs effective control if relevant along with preservation of product in stock, in process and on despatch.

All internal audits have to be completed in accordance with your schedule by a qualified auditor and corrective action reports documented and action in a timely manner. Evidence of Quality Objectives and their measurement is required so as to demonstrate continuous improvement and you must have effective control and analysis of non-conforming product.  Finally, clear evidence of customer satisfaction data collection and evaluation should be present.

Help is at hand
After all that if the Management Representative wants some moral support then he can subscribe to the free 9001 Training Guides. You can find a full set of samples on Utube on the QualityAuthority channel or click on this link to go to the web site to take up the free subscription for the full series of ISO 9001 Training Guides.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s