Featured Product
This Week in Quality Digest Live
Health Care Features
Jon Speer
Lessons from the medical device industry
Matthew M. Lowe
Three-quarters of life sciences CIOs and IT execs say security risks are main reason for opposing cloud technologies
Questions linger about FDA processes that seem to favor medical device companies
Matthew M. Lowe
Confronting the fear of being displaced by machines

More Features

Health Care News
ISO and WHO are working for universal access to quality health products that are all at once safe, effective, and affordable
Certification bodies can conduct food safety audits and issue certifications of foreign food facilities
Creates adaptive system for managing product development and post-market quality for devices with software elements
Transforming a dysfunctional industry
An invite from Alcon Laboratories
Intended to harmonize domestic and international requirements
The FDA wants medical device manufactures to succeed, new technologies in supply chain managment
Neuroscientists train a deep neural network to analyze speech and music
Pharma quality teams will have performance-oriented objectives as well as regulatory compliance goals

More News


Health Care

Five-Day Free Trial for Online Series "Decoding ISO 15189"

Interactive education modules help medical labs prepare for ISO 15189 accreditation

Published: Tuesday, April 26, 2011 - 11:11

(A2LA: Frederick, MD) -- The American Association for Laboratory Accreditation (A2LA), in partnership with the Institute for Quality Management in Healthcare (IQMH), is offering a five-day, free trial of the educational series “Decoding ISO 15189,” modules 8 and 11.

The interactive online education series helps medical laboratories kick-start their compliance to ISO 15189—“Medical laboratories—Particular requirements for quality and competence,” an international standard from the International Organization for Standardization (ISO).

The 15 modules take labs step-by-step through ISO 15189 requirements and provide them with the tools they need to prepare for their assessment visit. Decoding ISO 15189 includes dozens of coaching tips, useful tools such as workbooks, templates, and samples, and a downloadable library of PDFs.

The five-day trial allows medical laboratories to consider how Decoding ISO 15189 can help them prepare for their accreditation visit. The modules cover the following information:
• Module 8—Internal Audit and Management Review: Take a Close Look at Yourself
• Module 11—Laboratory Equipment: The Tools of Our Trade

ISO 15189 is quickly becoming the international standard of excellence for medical labs. ISO 15189 accreditation demonstrates to patients and medical practitioners that labs are following rigorous standards and processes when conducting medical tests. A patient’s prognosis and diagnosis is based largely on the results from such tests, making accuracy critical.

Decoding ISO 15189 can help medical labs:
Establish a plan of action. Modules will help laboratory staff decipher the requirements and translate them into an easy-to-follow plan of action.
Understand the requirements. The series includes detailed step-by-step workbooks, templates, samples, and downloadable PDFs to help labs begin implementing the ISO 15189 requirements.
Create a quality manual. Use sample templates and a detailed analysis of the requirements to create a quality manual.
Employ document control. Evaluate different approaches to document control, learn which documents need to be controlled, and establish a system to meet individual laboratory needs.
Be prepared for your assessment. Understand what assessment will require and have the required measures in place.

For details on accessing the five-day free trial for this educational opportunity, visit A2A’s website.


About The Author

A2LA’s picture


The American Association for Laboratory Accreditation (A2LA) is a nonprofit, nongovernmental, public service, membership society, which provides comprehensive services in laboratory accreditation and laboratory-related training. Accreditation and training services are available to any type of organization including testing labs, calibration labs, medical testing labs, inspection bodies, proficiency testing providers, reference material producers, and product certification bodies. Laboratory accreditation is based on internationally accepted criteria for competence (ISO/IEC 17025). A2LA is the largest multidiscipline accreditation body in the United States, and the second largest in the world.