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Standard Interpretation



Standard: 2003 NELAC
Section: 5.5.4.1.1
Link to relevant standard

REQUEST:

Are SOPs required for procedures not performed (e.g., "legal coc" 5.5.8.3.1 f) says "if required"; or subcontracting)

TNI FINAL RESPONSE:

(Quality Systems Expert Committee/NELAP Board, 10-27-08)

SOPs are not required for activities that the laboratory is not required to perform. The converse is obviously true, in that you must have an SOP if you perform, or are required to perform, these activities. The first paragraph of 5.5.4.1.1 states that SOPs must "accurately reflect all phases of current laboratory activities". Where an activity is not performed, such as legal Chain of Custody, the laboratory should not be required to have an SOP for what it doesn�t do. Compliance could be demonstrated if the lab's Quality Manual states 'We do not perform legal CoC, and will refuse any samples requiring legal CoC', although this is not mandatory.