Laboratory Systems

Home Integrated Processes Integrated Systems Laboratory Systems Client Services

Select below

Process Improvement

Why Focus on Processes?

Business Process
Definition & Development

Business Process Architecture

Radical Process &
 Productivity Improvement

New Product Introduction
& Project Management

Management Systems

Why Focus on
Management Systems

Quality Systems - ISO 9000

Management Systems

Excellence Model (EFQM)

Performance Measurement

Management Systems

Choosing the Right System

Find out more about

Services Provided

Consultant Profile

Application of 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.

For 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)

ISO 9000 :-  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.

ISO 17025 :- Is intended to apply to all types of laboratories that provide testing services, whether commercially or for their own parent organisation.

It is effectively in two parts. The first is equivalent to ISO 9000 in terms of the basic processes required to run any business.

The second 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.

GLP (Good 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.

The 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.

Choosing a System

QUALITY FACTORS  will guide you to the creation of  one single management system with an integrated set of processes that will add value to the business as well as meeting the requirements of management standards or regulatory requirements.              +44 (0) 7803 148397