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Brittany Vogel

FDA Compliance

QualiPedia: ISO 13485

The global medical device standard

Published: Thursday, July 16, 2009 - 12:40

ISO 13485 is an international standard that ensures that medical device organizations meet global quality management system regulations. Its aim is to provide consumers with safer medical devices and services.

Based on the eight quality management system regulations of ISO 9001 and its goal of conformity, this standard was created with the purpose of synchronizing all medical quality management systems across the globe. ISO 13485 is created for all organizations in the medical device industry (production, design, etc) and its related fields.

The eight quality management principles are:
• Principle 1: Customer focus. Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations. 
• Principle 2: Leadership. Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization's objectives.
• Principle 3: Involvement of people. People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization's benefit.
• Principle 4: Process approach. A desired result is achieved more efficiently when activities and related resources are managed as a process.
• Principle 5: System approach to management. Identifying, understanding and managing interrelated processes as a system contributes to the organization's effectiveness and efficiency in achieving its objectives.
• Principle 6: Continual improvement. Continual improvement of the organization's overall performance should be a permanent objective of the organization.
• Principle 7: Factual approach to decision making. Effective decisions are based on the analysis of data and information.
• Principle 8: Mutually beneficial supplier relationships. An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.

When implemented completely and correctly, these standards increase an organization’s overall performance. Organizations can develop a more cost-effective practice, improve intra-office communication, and improve the quality of all products and/or services provided. This is turn maintains a positive relationship with customers because, not only are organizations meeting regulatory requirements, they are improving business and thus customer satisfaction as well.

References:

www.iso.org/iso/pressrelease.htm?refid=Ref872

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Brittany Vogel

Brittany Vogel is a reporter and editor for Quality Digest.