The Problems

The ability for a company to say "ISO 9001 certified" is a requirement for many industries, and has become important for more and more industries where products include services as well as manufactured products.

The ISO 9001:2000 standard contains the requirements for a quality management system designed to insure that a company's products meet its customer's expectations, however successfully implementing the standard brings challenges.

Do these problem sound familiar ?

I am not ready to pass an ISO 9001 audit.
I can’t find the correct documentation.
It is too difficult to develop the right document.
My document does not meet the requirements of the ISO 9001standard.
My company spends too much money on compliance efforts.
My company is not able to keep up with changes to documents.
I need to bring my documentation up to the current version of the standard.

The Needs

Organizations seeking registration to ISO 9001 must be able to must successfully execute the following:

Development of “audit ready” documentation – Solid documentation must include a policy manual, procedures and instructions covering the requirements in the standards with traceability to the stated requirements and objective evidence to support that the documentation is being followed.
Enforce document control – Successful document control means that you can do the following things well: Revision control, document access, routing, approval and change impact analysis. Besides control, a document must be easy to find and retrieve by the intended user of its contents.

ISO 9001 News

ISO 9001:2008 Overview

The 2008 revision of the ISO 9001 International Standard has been released and Powerway has released the ISO 9001:2008 Template pack in suport of this revision (read more about the new Template Pack). What is the likely impact to your organization? Read below.

Impact

Q: How will this impact my organization?

A: Not very much

Our conclusion is that it will likely have very little impact on any currently registered organization. Overall, it would appear that this is a minor revision to the standard and it has been stated by many analysts at industry events that there are no new requirements. The revision is more of a clarification as a couple of headers have changed, a few requirements have changed position within their section and some flexibility has been incorporated to allow organizations more latitude in the application of some requirements.

Change Summary

Standard Content

The clarifications impact less than 35 of the 240+ requirements contained in the International Standard. Most of the changes are nothing more than a subtle rephrasing where the new wording has no real effect upon the original intent of the previous version requirement.

Existing Documents

We do not see the need for any new documents to be created, and if your organization is already registered to the standard, very minor changes will likely be necessary to any existing documents, if any at all. Organizations that have implemented ISO 9001-based quality management systems for the right reasons will likely find themselves in the enviable position of having a system in place that already exceeds the requirements of the standard. Perhaps a simple updating of the reference documents to the new standard will be all that is required to get you ready for registration to this new revision.

Announcements

Suite 2000 v3.00 is now available

Features include Vista support and the ISO 9001:2008 Template Pack.