Quality Is Not An Organization

By Author: Susanne Manz
Total Articles: 13
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What is one characteristic that can be considered the soul of an organization? It has to be the quality of its products and services. So, what then is Quality, if it is this very critical and vital to an organization?
It can mean different things. As with most concepts of management, it is fluid and subjective and hence evades a single definition. It can be understood as being any or all of these:
• The ability of a product or service to meet its performance expectations
• A measurement against a set standard or customer requirement
• A state in which a product is free from defects
• A department within the organization that is responsible for creating inspection standards or a Quality System
• Most importantly perhaps, a culture of excellence that pervades the organization and is rooted into its outlook.
A webinar from Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, will explain these and other popular meanings and interpretations of Quality from the perspective of the medical device industry.
Susanne Manz, a highly ...
... accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma, will be the speaker at this ninety-minute webinar, which is being organized on January 28.
Please visit Compliance4all to register for this webinar and gain core understanding of the concept of Quality.
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An organization has to put various processes and steps at many stages to establish Quality into its products, because Quality does not happen by chance. A series of deliberate, proven and well-established steps constitutes Quality. It is indispensable to assuring an organization’s stakeholders that the product or service they are consuming meets the set performance and regulatory requirements,
The challenge for any organization is to match its resources with customer expectations to meet Quality standards through efficient and effective processes to manage scarce resources. At this session, Susanne will show how participating organizations can balance and meet all of those expectations. She will explain how to create the foundation and framework for ensuring Quality-by establishing a culture of Quality, which is the only means by which organizations can gain the competitive advantage needed to survive and flourish in the market.
Participants will learn the following objectives at this session:
• Warning signals that indicate quality problems within your organization
• Changing your organization form reactive to proactive
• How a culture of quality and compliance can impact your company success
• The risks your company faces from quality and compliance issues
• Creating a culture of quality and compliance at all levels of your organization
Susanne will cover the following areas at this webinar:
• FDA and NB expectations for Quality Systems
• Lessons Learned from 483s and warning letters
• How culture can impact quality and compliance risk
• Management commitment and responsibility
• Maturity levels to understand your culture of quality
• Roles and responsibilities
• The case for quality
• Stages of quality and compliance culture
• Tools and techniques for improvement
• Best Practices
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About the expert: Black Belt, Master Black Belt, Regulatory Affairs Certification (RAC) and Certified Quality Auditor (CQA) Susanne Manz brings an extensive background in quality and compliance for medical devices, which spans all areas from new product development, to operations, to post-market activities. Her consulting business provides services to help medical device companies achieve world-class quality and compliance.