SIR #: 10024
Standard: 2003 NELAC
Section: 220.127.116.11.2 (b)
Link to relevant standard
The above section requires documents to be reviewed "periodically". I have interpreted this to mean that NELAC wants the documents reviewed but requires the lab to establish the frequency. NELAC further supports this position by specifically requiring data integrity procedure to be reviewed annually (18.104.22.168). However, some assessors with whom I work take the position that since 22.214.171.124 requires labs to annually review the "suitability of procedures" and 126.96.36.199 requries labs to annually conducts audits on "all elements of the quality system" that these are inferred or indirect requirements to annually review all procedures. Since 188.8.131.52.2.b addresses the issue directly, I take the position that it prevails over any indirect or inferred interpretation of the standard. Agree? Disagree?
TNI FINAL RESPONSE:
(Quality Systems Expert Committee/NELAP Board, 10-25-08)
The Quality Systems Committee sees no conflict here. The internal audits must show compliance with the laboratories policies and procedures. This is a procedural review for compliance and suitability.
The periodic review of SOPs is set by the lab and does require that technical management review current procedures. This can be done with internal method audits. If the AB finds issues that would indicate that periodically has been stretched too long, then the AB could impose a finding that would require the timeframe be shortened.
Also, support procedures can be allowed to have longer periods between review, such as when changes are needed due to a change in laboratory practice.