Preparing for your ISO9001-2015 Audit

The focus of ISO9001-2015 is the adoption of a quality management system.  Compliance with ISO9001-2015 is a strategic decision for a manufacturing organization that can help to improve its overall performance and provide a sound basis for sustainable development initiatives.  It can also help increase sales.

ISO9001-2015 calls for roughly 40 procedures to be written and followed.  Your company may already be following some of these, the others will need to be written.  There are no standard procedures.  Each company is different either by company, culture or because of a different set of employees.

Companies will write procedures that fit their culture and fit with their employees within their environment.  As you might imagine, this is not a simple task.

When you have written a procedure, it is best to have the people that will need to follow the procedure walk through it to make sure that it is accurate and that it works in your environment.  This will be an iterative process.

You will need to do this with each of your 40 or so procedures.  As you work through these, you will be updating your quality manual.

It is important for companies to perform an internal audit.  It is not likely that you will have covered everything in your first [or more] attempt.  An internal audit will provide the input you need to pass an audit.

The Audit

The Auditor will want to see the written procedure.  They will want to see that you follow that procedure.  They may want to speak with the person following the procedure.  They will want to see documents used to start the procedure and they will want to see documents produced as a result of the procedure.  They will need to see the signatures that prove the procedure was followed.

The Objective of Compliance

Continually improve the effectiveness of a company’s quality management system so that it can provide the ultimate in customer satisfaction.  Compliance should contribute to increased revenues and higher profits.

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