ISO 9001 has developed into the most significant standard in the field of quality management. The first edition was issued in 1987 and revised within the framework of a comprehensive review in 2000. Although certification is considered not relevant in the pharmaceutical industry because of the GMP regulations, as a matter of fact nearly all companies have checked their processes against the elements of ISO 9001.
In December the revised version was published. The changes are not of fundamental character, but when interpreting the standard, different interpretations occurred. The wish for a more precise wording and clarifications was now fulfilled. Furthermore, a better harmonisation with ISO 14001 (environmental management systems) was taken into account. With ICH Q10 "Pharmaceutical Quality System", among other things the elements of ISO 9001 were transferred into a pharmaceutical quality management system. The ICH Q10 is the subject of a Training Course in Barcelona.
On behalf of the European Compliance Academy