been revised to cover testing, calibration and sampling associated
with subsequent calibration and testing.
process approach now matches that of newer standards such
as ISO 9001 (quality management), ISO 15189 (quality of medical
laboratories) and ISO/IEC 17021-1 (requirements for audit and
The standard has now a stronger
focus on information technologies and incorporates the use
of computer systems, electronic records and the production of
electronic results and reports.
A new chapter introducesthe
concept of risk-based