Loading ...

White Papers and Market Updates

The New EU Medical Device Regulations: What You Need to Know

New quality system requirements, classification rules, and conformity assessment procedures - these are just a few of the hurdles that manufacturers must clear to sell devices in the EU now that the Medical Device Regulation (MDR) and In Vitro Diagnostic Devices Regulation (IVDR) have been published. This Market Update will help you familiarize yourself with the upcoming changes – and their potential impact on your business.

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.

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.

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.”

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.

Lean and Six Sigma Glossary of Terms

The Oriel STAT A MATRIX Lean Six Sigma Glossary is a comprehensive resource of easy-to-understand definitions for frequently used Six Sigma and Lean terms.

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.

Beyond the Voice of the Customer: How to Grow Your Company Using Customer Value Analysis

Understanding your customers’ perceptions of value can make your company a market leader. By using Customer Value Analysis to focus quality improvement efforts, your company can chart its course to sustainable growth.

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?

Our team is here to help. Call 1.888.532.6360 or contact us online ›