News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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The A-to-Z of ISO 15189: How to Boost Your Lab’s Clinical and Financial Performance

Helping your lab meet tough international standards for technical quality
and competence in medical laboratory testing

Gregory-Cooper Caroline-Maurer


Julie Coffey, Staff Technologist and Quality Manager, Ontario Laboratory Accreditation

Gregory Cooper CLS, MHA, Principal, W. Gregory Cooper LLC, on behalf of the American Association for Laboratory Accreditation (A2LA)

Caroline Maurer, Director CAP15189, College of American Pathologists

(Moderator), THE DARK REPORT


Recorded LIVE Event – Order Audio NOW!

In the United States, interest in “ISO 15189: Medical Laboratories” is growing fast. Some of the nation’s most innovative clinical laboratory organizations are already accredited to ISO 15189 and report exciting benefits from this achievement.

The list of ISO 15189-accredited labs in the United States is impressive, ranging from health-system labs like Avera McKennan Laboratories to large commercial laboratories such as Laboratory Corporation of America (its Tampa, Florida lab division). Large or small, leaders from these labs are enthusiastic about the gains from ISO 15189 accreditation.

Now you and your lab team can learn all the essentials of ISO 15189 and how it can propel your laboratory-testing organization to higher levels of quality and operational excellence. This exceptional event from THE DARK REPORT and DARK DAILY lets you to hear directly from the three leading ISO 15189 accrediting bodies in North America—all at one time and in one place! Each organization offers a unique perspective and resources that will help your laboratory decide how to pursue ISO 15189 accreditation.

Our panel of experts explains why, since its introduction just seven years ago, ISO 15189 has emerged as the premier global quality-management system (QMS). Find out how ISO 15189 boosts the ability of every clinical lab and pathology group to meet and exceed changing international standards for technical quality and competence in medical laboratory testing.

ISO 15189 accreditation is important because it provides validation that your lab is competent to deliver accurate and reliable test results to patients and healthcare providers. It’s recognized by the thousands of employers, customers, payers, and even patients-themselves employees of ISO-compliant organizations-as validation of your laboratory’s quality and integrity.

This is the first audio conference that lets you hear from all three organizations in North America that offer ISO 15189 accreditation. Find out which one is right for your lab. Explore the criteria that you’ll need to consider before choosing an accrediting body. And, of course, what each of these organizations will require from you.

In addition, you’ll get practical advice and useful insights into the accreditation process. Each speaker will share lessons learned from their clients’ labs. You’ll come away with invaluable do’s and don’ts that will help your lab achieve full ISO 15189 accreditation.

Whether you’re a laboratory director, manager or administrator, quality manager or pathologist-anyone who needs to understand the key benefits of investing in ISO15189-this is one audio conference you won’t want to miss. Invest just 90 minutes of your time and get a comprehensive introduction to ISO 15189. Order Audio today.

And don’t forget that you can have everyone on your lab team participate with you. From just one order, you can all listen, learn, and get answers to your own specific questions on the importance of ISO15189 accreditation for your lab.



COST: $245 per audio recording

TO ORDER NOW: Click here or call 1-800-560-6363 toll-free


For one low price— just $245—you and your entire team can take part in this fast-paced, insightful audio conference.

Here’s just some of what you’ll learn during this in-depth 90-minute audio conference:

o  What ISO 15189 is and how it’s related to ISO 9001.

o  Why a quality management system (QMS) underpins all aspects of medical laboratory operations.

o  Essential characteristics to look for in an accrediting body.

o  Specific ways that ISO 15189 accreditation benefits your lab.

o  The definition of “mutual recognition arrangement” and how your lab can benefit from having one.

o  The amount of money and staff time typically required to achieve ISO 15189 accreditation.

o  The special tools and resources necessary to implement ISO 15189.

o  Important do’s and don’ts from the nation’s first ISO 15189-accredited laboratories.

o  Success stories from ISO 15189-accreditated labs.

o  How to get support and resources from your hospital’s administration.

o  Why acting now gives you a competitive advantage in the lab-testing marketplace.

…and much more!

How to Oegister:

1. Online
2. Call toll free: 800-560-6363.

Your audio conference order includes:

•A site license to attend the conference (invite as many people as you can fit around your speakerphone at no extra charge)

•A downloadable PowerPoint presentations from our speaker

•A full transcript emailed to you soon after the conference

ORDER AUDIO Now! Or for more information, call us toll-free at 800-560-6363

Distinguished Faculty:

Julie Coffey is a staff technologist and quality manager from the Ontario Laboratory Accreditation (OLA) division of QMP-LS in Ontario, which is a partner of the Institute for Quality Management in Healthcare (IQMH). She is a Medical Laboratory Technologist, certified Quality Auditor, and a certified Manager of Quality/Organizational Excellence. She has played a key role in the development of the OLA program and its requirements since its inception in 2000, and to date has coordinated and conducted more than 100 assessments of Ontario laboratories using the ISO 15189 standard. Ms. Coffey is the primary author of IQMH’s Decoding ISO 15189™ web-based educational series, and has written numerous articles for QMP-LS News on the implementation of a quality management system. She has given countless presentations on understanding OLA and ISO 15189.

Greg Cooper is a California-licensed Clinical Laboratory Scientist. He retired from Bio-Rad Laboratories in 2010 after 20 years of service as the Scientific Affairs Manager for the Quality Systems Division. At Bio-Rad, Mr. Cooper was responsible for the creation and development of Bio-Rad’s interlaboratory program, UNITY, and a new paradigm in quality control under development that earned him several patents. His work with Bio-Rad provided experience with domestic and international laboratory operations in most major markets. He also participated in the development of the first version of ISO 15189, which was published in 2003. In his career before Bio-Rad, Mr. Cooper was a chemistry department supervisor and laboratory manager. He is now principal owner of W. Gregory Cooper LLC, which advises medical laboratories on quality systems, and is involved in development of laboratory standards with the Clinical and Laboratory Standards Institute (CLSI). Mr. Cooper is chair of CLSI’s Evaluation Protocols Area Committee and a member of the CLSI Chairholder’s Council and the American Society of Quality. He serves as a medical laboratory assessor for the American Association for Laboratory Accreditation (A2LA). He has a Masters degree in healthcare administration.

Caroline Maurer is the Director of the College of American Pathologists 15189 Accreditation Program. Ms. Maurer was a key founder working with ISO Technical Committee 212 CAP liaison members in the development, launching and delivery of the first ISO 15189 Accreditation Program to the CAP customer base. She has more than 20 years of experience in healthcare as director of operations for the medical laboratory, diagnostic imaging and cardiology. She also has experience in operational improvement, systems integration and project management. She is a Medical Technologist with a Bachelors degree from Northern Illinois University and is certified as a Project Management Professional (PMP). Ms. Maurer serves on the College of American Pathologists CAP 15189 accreditation committee as staff liaison and is the CAP affiliate member liaison to the International Laboratory Accreditation Cooperation. She continues to contribute, with board certified pathologists of ISO TC 212, to the development and oversight of 15189 in the CAP accreditation process.

ACCENT® Continuing Education Credit
The American Association of Clinical Chemistry (AACC) designates this program for a maximum of 1.5 ACCENT® credit hours towards the AACC Clinical Chemist’s Recognition Award. AACC is an approved provider of continuing education for clinical laboratory scientists in the states of California, Florida, Louisiana, Montana, Nevada, North Dakota, Rhode Island, and West Virginia.