5 Structural requirements

5.1 Legal Entity

The laboratory shall be a legal entity, or a defined part of a legal entity, that is legally responsible for its laboratory activities.

Note:
For the purposes of this document, a governmental laboratory is deemed to be a legal entity on the basis of its governmental status.

5.2 Management Responsibility

The laboratory shall identify management that has overall responsibility for the laboratory.

5.3 Laboratory Activities

The laboratory shall define and document the range of laboratory activities for which it conforms with this document. The laboratory shall only claim conformity with this document for this range of laboratory activities, which excludes externally provided laboratory activities on an ongoing basis.

5.4 Activity Requirements

Laboratory activities shall be carried out in such a way as to meet the requirements of this document, the laboratory’s customers, regulatory authorities, and organizations providing recognition. This shall include laboratory activities performed in all its permanent facilities, at sites away from its permanent facilities, in associated temporary or mobile facilities, or at a customer's facility.

5.5 Organization Structure

The laboratory shall:

  • Define the organization and management structure of the laboratory, its place in any parent organization, and the relationships between management, technical operations, and support services.
  • Specify the responsibility, authority, and interrelationship of all personnel who manage, perform, or verify work affecting the results of laboratory activities.
  • Document its procedures to the extent necessary to ensure the consistent application of its laboratory activities and the validity of the results.

5.6 Personnel Authority

The laboratory shall have personnel who, irrespective of other responsibilities, have the authority and resources needed to carry out their duties, including:

  • Implementation, maintenance, and improvement of the management system.
  • Identification of deviations from the management system or from the procedures for performing laboratory activities.
  • Initiation of actions to prevent or minimize such deviations.
  • Reporting to laboratory management on the performance of the management system and any need for improvement.
  • Ensuring the effectiveness of laboratory activities.

5.7 Management System

Laboratory management shall ensure that:

  • Communication takes place regarding the effectiveness of the management system and the importance of meeting customers' and other requirements.
  • The integrity of the management system is maintained when changes to the management system are planned and implemented.