Action Steps
The best contacts and resources to help you get it done

Download the requirements for the type of lab accreditation your lab wants

Depending on what kind of laboratory you have, you can pursue one of more than a dozen organizations to find the laboratory accreditation program that's right for your laboratory. Go to your accrediting body's website to get information you need for laboratory accreditation.

I recommend: The FDA offers medical laboratory accreditation for implantable medical devices. CLIA offers the leading clinical laboratory accreditation for processing human biomonitoring samples. You can pursue environmental laboratory accreditation through NELAC. Laboratories with more a more general scope might seek American Association for Laboratory Accreditation instead.

Develop the documentation you need to become an accredited lab

No matter which laboratory accreditation program you choose, you'll need to develop certain documents before you can apply to become an accredited laboratory.

I recommend: Get to work on your QMP, or Quality Management Plan. A QMP outlines your business's plan for following the requirements for accreditation for laboratory. Although your QMP should reflect the specific requirements you've found on your accrediting body's website, the EPA website has good resources to guide you through your first iteration of your QMP. Once you have your basic QMP, you'll need to fill in the blanks with specific Standard Operating Procedures, or SOPs. The SOPs should more completely address the accrediting body's concerns. You can find examples of SOPs for Good Clinical Laboratory Practices here.

Develop an electronic backup system in preparation for lab accreditation

Nearly every laboratory accreditation program requires you to have backup files of all of your laboratory data maintained offsite. This allows you to recover files, even if your laboratory suffers fire, flood, or vermin infestations.

I recommend: Data Deposit Box, MozyPro, and EVault represent only a tiny fraction of the online data backup options available. Each provides software that when installed in your computer, automatically uploads your computer's files to the server several times a day. You'll backup your files without ever having to think about it.

Find a consultant to help you wrap up your laboratory accreditation process

To prepare for lab accreditation, you simply need to prepare all of the procedural and management documents, and train your staff to understand those procedures. If you feel as if you're forgetting something, hire an accreditation consultant to give your laboratory a mock site visit and help you prepare for the real thing.

I recommend: Knapp Frazer Consulting helps laboratories gain CLIA certification. Laboratories seeking NELAC accreditation can choose from one of the NELAC recommended consultants. Consultants at FDAinspections.com can also help you prepare for your official onsite accreditation inspection.

Helpful advice for making the most of this Guide

• •  Devote some time to tailoring your QMP and SOPs to address the specific requirements of the accrediting body for which your business seeks lab accreditation.