Tag: Regulatory Compliance

Document Control – How to manage a Standards Collection

Quality and Compliance professionals know the importance of standards in the business setting.  But keeping a standards collection current and correct can be a challenge for any organization.

Here at Document Center Inc., we’ve been working with standards for over 28 years.  So we’ve got some experience in collecting and maintaining standards!

Managing standards is an essential function in any organization.  Standards can positively or negatively impact your reputation and cause regulatory and quality problems.   And regulatory and quality problems eventually create legal liabilities which are much cheaper to avoid than to repair.

We believe that by separating the documentation function into 5 easy pieces, any organization can have a reliable standards system.  Here’s our plan:

Rule 1 – Define

Rule 2 – Assess

Rule 3 – Control Usage

Rule 4 – Procure

Rule 5 – Monitor

I’ll be using subsequent blogs to review the 5 Rules.  Each requires some discussion so that you are able to institute good practices throughout the standards lifecycle.

Contact us any time with any questions or for assistance.  We can be reached at our website www.document-center.com and via email at info@document-center.com.  Of course, feel free to call us at 650-591-7600 or fax 650-591-7617.

Out of Sync — Why EN-ISO’s are changing and the core ISO’s are not…

There’s been a lot of confusion in the standards-using community over recent EN-ISO revisions just issued on some very popular ISO titles.  Some examples?  The EN- ISO-10993 series is out in 2009 Editions, while the ISO-10993 series itself hasn’t changed.  Another?  EN-ISO-11607-1 was upgraded to a 2009 Edition replacing the 2006 Edition, yet still remains identical to the ISO-11607-1 1st Edition from 2006.

How can the EN adoption of the ISO come out in a new edition and still be identical to the original ISO document?

Here’s the reason — The EN (European Union) administrative information has been modified, which has prompted the revision of the document even though the ISO document which it adopts remains the same.

So for the EN-ISO-11607-1, the change is the addition of Annex ZA, which is an informative annex only.  This 1 page addition to the document has a table which identifies the relationship between the EN-ISO-11607-1 and the essential requirements of EU Directive 93/42/EEC.

How about the EN-ISO-10993-1?  It has the insertion of 2 Annexes, both informative:  ZA, again on the relationship between this standard and the EU Directive 93/42/EEC, and ZB, on the relationship of EN-ISO-10993-1 to Directive 90/385/EEC.

The rest of the EN-ISO-10993 series has been revised for the very same insertions.

If you reference the EN-ISO documents in your documentation, you are required to purchase the new revisions or risk being out of compliance.

If you reference the source ISO standards instead, no revisions are necessary, as the underlying ISO documentation remains stable.

More questions?  Contact us at info@document-center.com or check out the website at www.document-center.com.