Laboratory Requirements for the FDA LAAF Accreditation Program
What Is the FDA LAAF-Accreditation Program? Under the Federal Food, Drug and Cosmetic Act (FD&C Act), the Food and Drug Administration (FDA) has established the…
NELAC and NELAP – What Do These Acronyms Mean for the Environmental Laboratory?
What Is NELAC? NELAC stands for the National Environmental Laboratories Accreditation Conference. Established by the EPA in 1995 as a means to bring consistency in…
The Importance Of Bioburden Testing
Bioburden testing is a critical component for medical device manufacturing to ensure the safety of the product and the user. Why Is Bioburden Testing Important?…
APAC TEC1-002 Coil Guidance Document
ANAB is pleased to announce the publication of APAC TEC1-002 APAC Guidance on the Assessment of Metrological Traceability of Measurements Made with Multi-Turn Coils Used…
Implementing Beneficial Laboratory Practices
Implementing beneficial laboratory practices enhances confidence in the data generated by the laboratory, which helps bolster its reputation. Beneficial laboratory practices also improve productivity and…
The Anatomy of a Laboratory Assessment
An assessment is a demonstration by a body that specified requirements are fulfilled. Assessments are performed by technically competent assessors who evaluate the competence of…
Assessment and Audit Performance Techniques
Assessment and audit performance techniques include, but are not limited to, interviewing, audit sampling, communicating orally and in writing, and collecting objective evidence, all while…
Changes in the New ISO 15189:2022
The objective of ISO 15189:2022- Medical Laboratories – Requirements For Quality And Competence is to promote the welfare of patients and satisfaction of laboratory users…
New Prefixes in the SI: ronto, quecto, ronna, quetta
As of November 2022, in its first update to prefixes since 1991, the International System of Units (SI) now includes prefixes ronna, quetta, ronto, and…