ABSTRACT
There are many quality standards available that organizations can use to improve. These are in addition to those necessary for legal compliance, such as the U.S. Food and Drug Administration’s (FDA’s) Good Practices guidelines (GxPs). When I first started in the good laboratory practices (GLP) area and wanted to know more about the basics of quality principles, my first point of contact was with British Standard (BS) 5750, later known as ISO 5750. (I suppose the rest of the developed world could see a good system and decided to adopt the British system
in toto
as no major changes were made to the text.) These were general documents in much the same way as the U.K. GLP
Blue Book
; they provided outlines of what was required but no real details or interpretation. I knew by meeting people within the British Association for Research Quality Assurance (BARQA) that such networking was especially useful in interpreting guidelines. You could interpret the rules yourself, but what would be more useful would be some information from people who had interpreted the guidelines and been approved by some international third party such as Lloyd’s Register Quality Assurance
or SGS
, etc. The problem here for me was getting this information. Another area that concerned me was that I did not have any tools or basic understanding of what the foundations of quality systems were. I found that one avenue open was membership in the Institute of Quality Assurance. This provided the framework to build and advance my knowledge. My previous experience and qualifications allowed me initially to obtain the Licentiate grade of membership. This gave me access to the publications of the institute which, in itself, was worth the membership fee. By studying for the institute’s A3 examination in quality management, the foundations of all these quality ideas were revealed to me. Passing this examination gave me the advantage of the professional designation of membership in the Institute of Quality Assurance (MIQA). The major drawback with this approach was that the institute and the examples were engineering or manufacturing oriented, which was not really appropriate for the science-based, service-area requirements I had in mind.
