Breaking down the lab accreditation process into manageable piecesLaboratory accreditation can open the doors for your analytical business. Every year, corporations and the government spend billions of dollars on environmental and clinical monitoring, and often times only an accredited lab can gain access to those projects.
For those new to the system, lab accreditation can be a daunting process full of bureaucracy and multitasking. To get accreditation for a laboratory you need to have certain things in place. Consider this:
1. No accrediting body will consider giving laboratory accreditation without a Quality Management Plan.
2. You need Standard Operating Procedures for all of your laboratory and management functions for any type of accreditation for laboratory.
3. You should create a system for record keeping and archiving as an accredited laboratory.
Download the requirements for the type of lab accreditation your lab wants
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 labNo matter which laboratory accreditation program you choose, you'll need to develop certain documents before you can apply to become an accredited laboratory.
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 accreditationNearly 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.
Find a consultant to help you wrap up your laboratory accreditation processTo 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.
- 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.
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