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AS9100 Rev. C should be ready for organizations to be certified to it by May 2010

ISO 13485 - Medical devices - Quality management systems - Requirements for regulatory purposes

ISO 13485 is an international standard designed to provide medical device suppliers with a common approach to applying a Quality Management System that addresses most FDA requirements.  The ISO 13485 standard is based on the ISO 9001 standard (and includes the old ISO 13488).

The main change is that there are 8 sections in the new standard, which describe the intent and the requirements biased on a process approach.  As opposed to the 20 elements in the 1996 version; another change is that the ISO 9001 standard has, with a few exceptions, been incorporated into the new standard.

*Unlike ISO 9001 Continuous Improvement and Customer Satisfaction are not as stressed in ISO 13485 instead more emphasis is placed on regulatory requirements.

Intent

The intent of ISO 13485 is to provide for the development of a Quality Management System that ensures to prospective customers and regulatory bodies that the goods and services offered by the organization will meet customer and regulatory requirements.  

Note: You are not required to renumber or realign your Quality Manual or Procedures to the new numbering scheme utilized in ISO 13485 or to the 21CFR820.  A map of your documentation showing where the requirements are addressed should be created to show the auditors where the requirements have been addressed, where appropriate.

Applicability

ISO 13485 can be applied to any type or size of organization that designs, develops, produces, installs or services medical devices.

 

Training Offered

ISO 13485 Overview

Internal Auditor Training 

Advanced Internal Quality Auditor Training

Business Operating System (BOS)

Customer Satisfaction

Implementation Workshop

Process Flowcharting Workshop

Team Oriented Problem Solving (8D)

Document Writing

Online Training Courses

 

Services Offered

Initial System Evaluation ("Gap Analysis")

Documentation Development

Implementation Assistance and Guidance

Final System Evaluation ("Dress Rehearsal")

Hands-on Auditing

Contract Internal Auditing Program

Compliance Auditing

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