ATCS – Q-BLOG, ASK THE EXPERT – July 2010

QUESTION:

From: Craig W.
Sent: Tuesday, July 13, 2010 8:52 AM
To: ATCS
Subject: ISO 9000 standard question – ECM process

Hello,
We are a small company with very few well structured procedures and need to adopt a procedure for our ECO process.  We have decided to follow the ISO 9000 procedure for engineering change management.  I am unsure which particular standard we need to buy.  I am pretty sure if we just purchase the ISO 9000 – Quality Management (12th Edition Compendium) documentation from the ANSI website, it will contain this, but I was wondering if there was a specific standard we could purchase which just contains the ECM procedure (at this time we are not interested in adopting all of the ISO 9000 procedures).  If not, can you confirm this information is included in the ISO 9000 – Quality Management (12th Edition Compendium) documentation?

RESPONSE:

From: Bill Aston, ATCS –Q-Blog, Ask The Expert
Sent: Monday, July 26, 2010 6:26 PM
To: ‘Craig W.
Subject: ISO 9000 standard question – ECM process

Dear Craig,

ISO 9000 only provides information regarding QMS vocabulary and terminology.

If you are interested in applying ISO quality management system requirements for engineering change management (ECM), I suggest that you obtain a copy of  ISO 9001:2008 “Quality Management System Requirements”.  This standard speaks specifically to change management in clause 7.3.7 “Control of design and development changes”.

It must be noted that none of the ISO standards provide procedures.  ISO 9001:2008 like other ISO management system standards (i.e., ISO TS 29001/API Q1 and ISO 14001) will only state the requirements that must be addressed/referenced by the procedure to achieve conformity to that standard.  I hope this helps.

Best regards,

Bill