How does the FDA's SMG 2020 compare to ISO/TR 10013:2001?

[Pataha]

The FDA has adopted the "SMG 2020 - FDA QUALITY SYSTEM FRAMEWORK FOR INTERNAL ACTIVITIES". Can be reviewed at http://www.fda.gov/smg/vol3/2000/2020.html
just wondering how it compared to the ISO/TR 10013:2001

[RCBeyette]

I've moved this thread to this location anticipating more of a response than what you would obtain in the forum where you orginally posted.

[Al Rosen]

Originally Posted by patahaconsulting

The FDA has adopted the "SMG 2020 - FDA QUALITY SYSTEM FRAMEWORK FOR INTERNAL ACTIVITIES". Can be reviewed at http://www.fda.gov/smg/vol3/2000/2020.html
just wondering how it compared to the ISO/TR 10013:2001

Apples & Oranges.

ISO 10013
Scope
This Technical Report provides guidelines for the development and maintenance of the documentation necessary to ensure an effective quality management system, tailored to the specific needs of the organization. The use of these guidelines will aid in establishing a documented system as required by the applicable quality management system standard.
This Technical Report may be used to document management systems other than that of the ISO 9000 family, for example environmental management systems and safety management systems.
NOTE When a procedure is documented, the term “written procedure ” or “documented procedure” is frequently used.
Abstract
Specifies guidelines for the development and maintenance of the documentation necessary to ensure an effective quality management system, tailored to the specific needs of the organization. This Standard is identical with and reproduced from ISO/TR 10013:2001.

SMG 2020
PURPOSE.

The FDA uses quality systems to control, assure, and improve the effectiveness of the processes used to deliver a quality product or service. This Guide defines the essential quality elements for management to address in any quality system that controls an internal FDA regulatory activity and relevant management, facility, purchasing, and information technology support.

This document is intended to assist FDA management and staff to

* review their current quality activities,
* identify quality system elements that may already exist, and
* identify additional elements needed to implement a quality system.