Hello all,
Have a (possibly quick!) question that will help me in my quest to manage our Essential Requirement/Principles Checklists more effectively:

When EN 1441:1998 was replaced by BS EN ISO 14971:2001, what did you all do with regard to keeping your ER's up to date, and living, as the Notified Bodies want?!

In a nutshell, when an updated harmonized standard comes along, how do you manage its impact on your organizations?


:thanx:
James

Hello all,
Have a (possibly quick!) question that will help me in my quest to manage our Essential Requirement/Principles Checklists more effectively:

When EN 1441:1998 was replaced by BS EN ISO 14971:2001, what did you all do with regard to keeping your ER's up to date, and living, as the Notified Bodies want?!

In a nutshell, when an updated harmonized standard comes along, how do you manage its impact on your organizations?


:thanx:
JamesWe review the standard, revise our procedures, implement, and then verify the implementation.

We do an annual review of both the essential requirements and risk assessments for our products. They are amended accordingly. The results are also reported at one of our management reviews - any further actions are minuted.

Microbe:)

Hello forum,
I have found that with annual review of the internal documents regarding the MDD and the associated directives that one must keep up to date with all the revisions. At times I have seen organizations who claim to be compliant with directives that are not as they have only been reviewing annually against the original version of the specifc directive. There was recently a revision of the MDD this year and although companies have until 2010 to get up to speed many have not even addressed the new changes. Many of the device manufacturers may not be affected by the changes but to review against the MDD without KNOWING what the changes are, how do they truly know? document review, especially where the documents are related to standards and regulations, the CURRENT revisions must be reviewed as well. For instance, the company I am presently contracting for was reviewing their internal risk assessments against the original in house version of the ISO standard. They missed the changes and had not reviewed or updated their internal documentation per the changes to the standard and frankly had no idea that these changes were in draft guidance documents prior to the revision becoming effective. It is imparative that all quality people stay current on all their guidances, standards and regulations as applicable to their industry.
Thank You for the opportunity to share.
Katherine McKay