Search the Elsmar Cove!
**Search ALL of Elsmar.com** with DuckDuckGo including content not in the forum - Search results with No ads.

Do standards have performance reviews?

Ed Panek

VP QA RA Small Med Dev Company FDA and ISO13485:16
Trusted
#1
For example, when a new ISO standard is released, does that process go through a Management Review with CAPAs? If a new standard is released, how does the committee prove it is effective to improve/control performance? What metrics are used?
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#2
For example, when a new ISO standard is released, does that process go through a Management Review with CAPAs? If a new standard is released, how does the committee prove it is effective to improve/control performance? What metrics are used?
I believe a few committees plan for “validation” during the standard development/revision process. For example, during the period 2012-2015, the ISO TC 176 SC2 had a project timeline that called for some validation in 2014. I am sure I posted about that here.

full?d=1538053359.jpg

The problem was: the scope and results of the validation were as transparent as a brick wall. The leadership of the TC’s deliberately keep any negative info close to their chest, especially if that can negatively impact the timeline of the release of the document. After all, commercial interests are large.

If you want to become familiar with the ISO Standards development process, search for the ISO/IEC Directives Parts 1 & 2; they are available for free download online.
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#3
There's no requirement in the ISO/IEC directives that a standard needs to specifically "prove" anything. However, it's expected that that it does reflect best practices at the time (as a standard is simply a collection of good practices of the time as created by a group of experts), and the standard development process is performed in a way to guarantee that problems are caught before publication (and any standard has to go thru a systematic review each 5 years) - you can see the process here: ISO/IEC Directives Part 1 and Consolidated ISO Supplement

Sometimes committees create a design specification for a standard that is verified at the end, but this is generally a high level document, and do not focus on the general outcome of the application of the document.
 
Top Bottom