ISO 9001 Implementation: Clarifications on Interpretation


Question:

We are in the process of implementing ISO 9001 for our Organization and have several questions regarding clarifications on the interpretation.

1.  We have an Engineer Requirements Document (ERD) that is written for every single feature for the product.  Sometimes it is just one ERD for a product.  What should this be classified under?  Currently we are classifying it as a Quality Record as this is generated every time we have a product or a feature.  Initially we wanted to classify it as a Level 2 document, however it is not static and happens every time we come up with feature or a product.  Is this the right way of classifying?  This applies to the Marketing Requirements Document, drawings, specification etc.

2.  Can a Quality record be amended, changed, or it should not be changed?  If we follow the above process, the ERD will keep changing during the entire product realization process.  Is this ok?

3.  For control of External documents, is it sufficient that we have all the standards under one location in a server and have authorized personnel access it?  Also, could you suggest how could be notified when any of the standards are changed or updated for a newer version?  Is it a manual process to check the standards periodically or is there a way to have this automated using any service?

Response:

Thank you for contacting ASQ’s Ask the Experts program.

With regard to your first question, based upon the information provided, your Engineering Requirement Document (ERD) should be classified as a form.  It is important to know that the purpose of a form is to provide a standard format for documenting information that may be related to in-house, customer or industry requirements.  The completed form will then serve as a record to provide evidence that requirements have been met. Consider assigning a form number to your standard ERD format.  Once this is accomplished, each ERD should be assigned a unique number such as a product, job, sales or contract number to facilitate tracking.

In response to the second question, a record is normally considered to be a static document and should not be changed or amended.  In most cases where changes are made, revised inputs should be signed/initialed and dated along with an explanation for the change.  As mentioned earlier, a record provides objective evidence that requirements have been met.  Most companies use a work order, shop traveler or other similar form to document and communicate product requirements that will be needed by the process owners during product realization.  This form may be updated as each process step is completed.  At the end of the product realization process, the completed form (work order, shop traveler or other) serves as evidence that all requirements have been met.

Regarding question number three, please be aware that the method selected to store external documents is strictly an in-house decision.  However, external documents must be identified and their distribution controlled (see ISO 9001:2008, clause 4.2.3, sub f).  One of the best ways to ensure that your organization is kept informed about the availability of the most current edition of external documents such as industry standards, is to sign up for “Standards Alert”.  This is a free service provided by the TECHSTREET Store at www.techstreet.com.

I hope this helps.

Best regards,

Bill Aston, Managing Director
Aston Technical Consulting Services
www.astontechconsult.com
Kingwood Texas

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