Our PROMISE: Our ads will never cover up content.
Our children thank you.
Brittany Vogel
Published: Thursday, July 16, 2009 - 13:40 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: 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 Quality Digest does not charge readers for its content. We believe that industry news is important for you to do your job, and Quality Digest supports businesses of all types. However, someone has to pay for this content. And that’s where advertising comes in. Most people consider ads a nuisance, but they do serve a useful function besides allowing media companies to stay afloat. They keep you aware of new products and services relevant to your industry. All ads in Quality Digest apply directly to products and services that most of our readers need. You won’t see automobile or health supplement ads. So please consider turning off your ad blocker for our site. Thanks, Brittany Vogel is a reporter and editor for Quality Digest. QualiPedia: ISO 13485
The global medical device standard
• 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.
Our PROMISE: Quality Digest only displays static ads that never overlay or cover up content. They never get in your way. They are there for you to read, or not.
Quality Digest Discuss
About The Author
Brittany Vogel
© 2023 Quality Digest. Copyright on content held by Quality Digest or by individual authors. Contact Quality Digest for reprint information.
“Quality Digest" is a trademark owned by Quality Circle Institute, Inc.