This is typically determined during the contract review; to meet a need, the laboratory must first understand what that need is.

In clause 5.4.2, ISO/IEC 17025 states that a laboratory “shall preferably use international/regional/national published standards.” The word “preferably” makes this an optional “shall.”A laboratory “shall ensure use of latest valid edition of standard (method/procedure) unless not appropriate or possible.” The word “unless” makes this a conditional requirement based on appropriateness, or an impossibility that should be well documented during the contract review.

(See the “Method validation” section below.)When a customer does not specify the method or procedure to be used, a laboratory “shall select an appropriate method/procedure.” Ideally, customers will know exactly what they require, but often they rely on the laboratory to have access to a subject matter expert.

validating pdf-84

This process is usually less involved than full validation, but it might involve many of the same considerations.

Method instructions provide the detail necessary to ensure that all personnel involved are executing a method or procedure in a consistent manner, specific to the laboratory’s equipment, environment, data collection methods, and training programs.

Among these are instructions for operating equipment, handling and preparing items to be tested or calibrated, and for any activity where the absence of instructions would jeopardize test and calibration results.

Methods, procedures, and instructions must be kept up to date (i.e., controlled) and available to the personnel for whom they are intended.

Allowable deviations from these can occur only under certain “documented” circumstances and the subsequent acceptance of them by the customer.

Laboratories are required to use methods or procedures that meet customer needs and are appropriate for the test or calibration.The sufficiency or “fitness for purpose” of a method or procedure is determined by the laboratory and is typically confirmed through performance.In life science laboratories, this process is called “method validation” and is covered in clause 5.4.5.Generally, a method is a commonly available published document that describes a measurement or testing technique, e.g., ASTM E18—“Standard test method for Rockwell hardness of metallic materials” or ASTM E4—“Force verification of testing machines.”Procedures can also be published documents that generally describe a number of steps to complete a task with specific outcomes, e.g., ASTM E18, Annex A—“Direct verification of Rockwell hardness machines,” or ASTM E4—“Force verification of testing machines by elastic calibration devices.”Laboratories may find it useful to separate these ideas; however, laboratories would most benefit from arriving at their own understanding and use of the terms “method” and “procedure.”The word “instruction” is used differently.It describes documents intended to ensure consistency.A customer “shall be informed as to the method or procedure chosen where the customer has not specified the method/procedure.” Again, the laboratory has a responsibility to first inquire about the customer’s need and then, if possible, recommend a method or procedure to meet that need.