Choosing a System : ISO 9000 : ISO 17025 : GLP
you make will have surprisingly little effect on the processes and
procedures that you need to put in place.
All standards and regulators demand a formally defined system of management. These systems
have many features in common.
organisations, regardless of regulatory requirements, need to have processes
for managing projects, priorities, resources, staff, materials, equipment,
In all cases clear process definitions provide the cornerstone for
demonstrating conformity to the relevant requirements. These process
definitions can then be referred to by all staff and external assessors
regardless of the particular focus of the assessment.
The choice ultimately
depends on the nature of the business, the demands of the clients and the
type of laboratory.
Choose for the Business, not for the Regulator
commercial situation, customer demands and the local regulatory environment
will ultimately define which management system has the most value for your
that the aim is to make your business more attractive to customers and more
successful for staff and stakeholders.
If you have
a well run business then complying with regulatory requirements should not be a
QUALITY FACTORS can explain the differences between the requirements
of each management system and how to make the most appropriate choice for