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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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