TS 16949 requires internal laboratories to have a Laboratory Scope. There are specific requirenents for this. They are defined in the standard as;

A controlled document containing:

• specific tests, evaluations and calculations that the laboratory is qualified to perform
• a list of the equipment which it uses to perform the tests etc
• a list of methods and standards to which it performs the tests etc

For excellent systems, an organization would expand on this requirement and would develop a complete Laboratory Manual.  In addition to the required laboratory scope requirements, a Laboratory Manual would include documentation of:

• procedures for training and qualification of personnel performing specific laboratory functions

• procedures for communicating who is qualified to do which tests, evaluations and calculations

• procedures for handling and traceability of sample material while in the laboratory

• procedures for handling test data and test reports

• procedures for maintaining laboratory cleanliness

• procedures for equipment maintenance and calibration

• procedures for laboratory environmental controls

Laboratories are unique environments with unique needs and concerns.  Processes developed to meet the needs of a manufacturing type environment will not sufficiently cover the needs for an internal laboratory.

Therefore a laboratory manual which covers the specific needs and processes of the laboratory would be most effective in controlling the unique risks to the customer and to the organization that can come from laboratory processes.