Featured Product
This Week in Quality Digest Live
FDA Compliance Features
Kari Miller
An effective strategy requires recruiting qualified personnel familiar with the process and technology
Dario Lirio
Modernization is critical to enhance patient experience and boost clinical trial productivity
Alexander Khomich
Healthcare software opens up opportunities for clinics in both management and patient care
Gary Shorter
Pharma needs to adapt and evolve with the changing environment of life science data
Etienne Nichols
Quality management system regulation explained

More Features

FDA Compliance News
Delivers time, cost, and efficiency savings while streamlining compliance activity
First trial module of learning tool focuses on ISO 9001 and is available now
Free education source for global medical device community
Good quality is adding an average of 11 percent to organizations’ revenue growth
Further enhances change management capabilities
Creates adaptive system for managing product development and post-market quality for devices with software elements
VQIP allows for expedited review and importation for approved applicants that demonstrate safe supply chains
An invite from Alcon Laboratories
Intended to harmonize domestic and international requirements

More News

Quality Digest

FDA Compliance

ISO 15189 Medical Laboratory Accreditation from A2LA

Published: Tuesday, June 26, 2007 - 22:00

(A2LA: Frederick, Maryland) -- The American Association for Laboratory Accreditation began adding medical laboratories to its accreditation offerings on June 1, 2007. “We see strong demand for an internationally recognized accreditation program in the medical laboratory industry,” says Peter Unger, A2LA president. “We offer a distinct approach to laboratory accreditation that, to date, has not been established for the medical laboratory community in the U.S.”

In addition to examining the technical aspects of a medical laboratory’s operation, the A2LA accreditation process will include a review of its management system. “We hold ourselves to the same expectations for competency that we hold our applicants to,” says Unger. “That is, we operate a management system to ISO requirements which is evaluated by external parties, resulting in our international recognition.”

General criteria for A2LA accreditation of medical laboratories are contained in ISO 15189, "Medical Laboratories—Particular Requirements for Quality and Competence." A2LA accreditation attests that a medical laboratory has demonstrated:

  • Competency to perform specific testing procedures
  • That its quality management system is documented, is fully operational, and addresses and conforms to all elements of ISO 15189
  • Adherence to any additional requirements established by A2LA including measurement traceability and laboratory participation in ongoing proficiency testing

To assist laboratories in preparing for accreditation to ISO 15189, A2LA is offering commercially available training courses in preparation and implementation of the quality management system and technical aspects of the standard.

For more information, visit www.a2la.org.

Discuss

About The Author

Quality Digest’s picture

Quality Digest

For 40 years Quality Digest has been the go-to source for all things quality. Our newsletter, Quality Digest, shares expert commentary and relevant industry resources to assist our readers in their quest for continuous improvement. Our website includes every column and article from the newsletter since May 2009 as well as back issues of Quality Digest magazine to August 1995. We are committed to promoting a view wherein quality is not a niche, but an integral part of every phase of manufacturing and services.