Management Systems to Laboratories
The relevance of regulatory requirements and third party assessments clearly
depends on the nature of the business, the demands of the clients and the
type of laboratory.
laboratory organisations it also depends to some degree on geographical
location - in other words which standards are applied or demanded by the
home country of the business and the country of the client (e.g. FDA
requirements in the USA compared with GLP requirements in Europe)
Is intended to apply to all types of business whether providing commercial
products and services or a not-for-profit organisation such as charities. Its focus is on
customer satisfaction, the elimination of errors and continuous improvement.
It has no scientific or technical content.
Is intended to apply to all types of laboratories that provide testing
services, whether commercially or for their own parent organisation.
effectively in two parts. The first is equivalent to ISO 9000 in terms of
the basic processes required to run any business.
part is specific to laboratory management and contains the more technical
requirements that you would expect to meet in order to achieve accurate and
reliable scientific results for the testing carried out.
Laboratory Practice) :-
Is intended to apply to laboratories whose work relates to the
pharmaceutical and clinical environments. It focuses almost entirely on the
laboratory organisation, project management and technical requirements.
In the UK
and Europe a laboratory can only be formally assessed against GLP
requirements if its own activities or those of its clients fall within the
defined scope of GLP. Accreditation is not voluntary in the same way as it
can be for the ISO standards.
historical origins of GLP standards were a response to serious malpractice
in certain clinical testing laboratories. Because of this its approach (and
its interpretation) has been somewhat defensive. In other words:- "How can we
prove in a court of law at some future date that the work that we did was
competent and scientifically valid?"
As a result
it can be seen as the most bureaucratic of the Management Systems with a
strong focus on record keeping. The view of Quality Factors is that this is
more to do with interpretation than with the real requirements for good
laboratory management and good science.