ISO9001 Requirements

The objective of ISO9001 compliance is quality.  Companies are continually looking for ways to improve quality.

The ISO9001-2015 starts by addressing your QMS – quality management system.  The adoption of a QMS is a strategic decision to improve performance and build a long term development strategy.  A few goals include:

  • Provide products and services that meet customer requirements.
  • Enhance customer satisfaction.
  • Manage all kinds of potential risks.
  • Demonstrate that you adhere to your QMS.

Some of the requirements follow…

Quality Manual

It starts with your goals and objectives and goes on to explain how you will achieve those.

Your quality manual explains how your company conducts business.  It explains how you will manage your business.  It explains all of the procedures that will be followed.  It explains how they will be followed.

It explains how you will measure your success.  It explains how you will measure your quality improvements.

Procedures

All of the work in your company follows a process [procedure].  As you might imagine, there are a lot of procedures to be documented.  These procedures exist in your quality manual.  They are documented in writing and in flow charts.  There should be no doubt as to how your company does business.

Documents

Beyond the quality manual, your company needs to securely store and retrieve information related to the many procedures that are being followed.  These documents must not be over-written; they must be versioned and saved for reference.

The Audit

All of this effort is in support of your company becoming ISO9001 compliant.  The ultimate objective is to pass an audit and become ISO certified.  You should perform several internal audits to be sure that you can pass the certification audit.  This is a lot of work but well worth the effort.

It can be useful to enlist help from someone that has done this before.  Contact me if you would like some help…

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