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White Papers and Market Updates


The New ISO 13485: Major Changes Your Organization Must Address

ISO 13485:2016 was published on February 25, 2016.  This market update covers the major changes to the revised standard, and the impact and opportunity presented by these changes.


Preparing for the New EU Medical Device Regulations: A Look Ahead for IVD Manufacturers

This Market Update focuses on the key changes in the new EU IVD regulation and questions organizations should consider now.


Understanding the New Requirements of ISO 9001:2015 - Changes and Opportunities for Your Organization

Changes to ISO 9001 create significant ripple effects across many industries, and the 2015 issue is no exception.  This Market Update reviews and explains the major changes in the new standard, the opportunity to use these changes to make your quality management system a strategic driver of performance and sustainability, and the transition period for currently certified organizations.


Increasing the Value of Audit Programs with Performance Based Auditing

Think back to your last round of internal audits…Can your organization use the audit findings to improve overall performance and efficiency? For too many organizations, the answer is "no." Their audit programs focus on conformance and miss opportunities to improve organizational performance. In this White Paper, we explore four ways to increase the value of your audit program.


Are You Ready for the Changes to European CE Mark Requirements for Medical Devices?

What should you expect from the new EU Commission measures aimed at the medical device industry? Tougher audit requirements: more audits, random audits, and more stringent auditing of your suppliers. Find out how to prepare in our latest Market Update.


Leadership’s Role in Performance Improvement

Even in challenging economic times, smart business leaders invest in the future of their organizations. The best investment you can make is in quality: quality of workers and quality of processes leads to quality products and services that will delight your customers. In this riveting article, written especially for top management and business leaders, learn how implementing quality can transform your organization.


Tough Economic Times Call for Lean Six Sigma

In these difficult economic times, organizations are looking at all possible means to operate profitably. As demand for products and services drops and customers expect the lowest possible price, organizations are feeling urgent pressure to cut costs in response to lower revenues and decreased margins. However, many companies are missing the mark by cutting indiscriminately when they should be streamlining their business processes to become more efficient, enhance their business results, and achieve sustainable success.


Do You Work for ISO or Does ISO Work for You?

Did you ever wonder why ISO 9001 certification has not yet had a tangible impact on your company’s overall business performance? Does it feel like you are “working for ISO” as your organization expends a lot of effort and resources in order to avoid trouble with your registrar? If so, consider a holistic approach to managing quality by embracing the guidance given in ISO 9004—have “ISO work for you.”


Making Improvement Work: Using Process Management to Transform Your Performance Improvement Initiative

Oriel STAT A MATRIX presents a process management approach to help your organization “super charge” your process improvement initiative. If your organization already has a process improvement program, our approach will ensure better focus, alignment, and sustainability. If your organization is starting from scratch, our approach defines a road map for designing an effective process improvement program.


Achieving Lean Success: A Pathway for Implementation

How do you implement Lean to its fullest advantage? How do you know which approach to use and when to use it? How do you address the key drivers of waste?

 
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