Risk Management for medical devices

While no medical device is entirely free of risk, what's the best way to minimize it?
By complying with ISO 14971:2007, the international standard in device risk management, and by developing a solid risk management plan. But understanding the recently expanded ISO and effectively implementing it is not the same thing.
The three biggest additions to the newest version of ISO 14971 are: six new terms, better integration with ISO 13485 and the addition of Annex (J)
For detailed guidance on how to :
• apply risk management in a straightforward easy manner
• ensure compliance with the FDA's QSR and the EU's Medical Device Directives ,
adhering to ISO 14971:2007

Contact: willyg@tqas.co.il

What are the key management principles of the ISO 9000 standards and most performance excellence models?

ISO 9000 standards and performance excellence models are based on management principles that reflect the fundamental ideas of a good management. This section lists the principles of each key methodology and provides hyperlinks to their websites for further explanation.

The principles of the standards and performance excellence models are as follows:

ISO 9001 and ISO 9004 - Quality management principles:
 Customer focus
 Leadership
 Involvement of people
 Process approach
 System approach to management
 Continual improvement
 Factual approach to decision making
 Mutually beneficial supplier relationships

Malcolm Baldrige National Quality Award - Core values and concepts:

 Visionary leadership
 Customer-driven excellence
 Organizational and personal learning
 Valuing employees and partners
 Agility
 Focus on the future
 Managing for innovation
 Management by fact
 Social responsibility
 Focus on results and creating value
 Systems perspective

European Foundation for Quality Management - Fundamental concepts of excellence:

 Results orientation
 Customer focus
 Leadership and constancy of purpose
 Management by processes and facts
 People development and involvement
 Continuous learning, innovation and improvement
 Partnership development
 Corporate social responsibility


Deming Application Prize – TQM Principles:

 Distinctive performance improvement through the application of TQM
o Challenging and customer-oriented business objectives and strategies under management leadership,
o Proper implementation of TQM to achieve the business objectives, and
o Outstanding results obtained for the business objectives.
 TQM understanding and enthusiasm
o Aiming at long-term success through benefits to customers and other interested parties
o Managing the organization putting 'quality' in its core,
o Top management leadership, vision, strategies, and policies
o Participation of all the organization’s members based on human resource development
o Developing and applying effective quality management methods
o Improving and transforming organization's constitution for sustainable success