Regulations & Standards

We will now look at the regulations and standards pertaining to the three international quality assurance schemes related to laboratory testing. It is convenient to present these in two categories depending on the purpose or application of the laboratory testing.

Direct Impact on Health or Environment

The first category relates to applications of testing which have a direct impact on human and animal health or the environment, such as:

• Non-clinical studies to assess the safety of substances to human and animal health and to the environment
• Quality control of manufactured products to ensure conformance to appropriate specifications on products relating to human and animal health
• Clinical studies to assess efficacy of products relating to human and animal health

The requirements for these activities are usually incorporated into national legislation, and regulated by government authorities, or an organisation empowered by legislation. For the purpose of this program these will be referred to as regulations.

Indirect Impact on Health or Environment

The second category relates to applications of laboratory testing that do not directly impact human and animal health, or the environment. For the purpose of this program these requirements will be referred to as standards.