Next month, new regulations go into effect requiring testing laboratories to undergo periodic audits as a continuing condition to the CPSC’s acceptance of their accreditation. These audits, unlike the tax audits conducted by the IRS, examine management and technical requirements supporting a lab’s accreditation to test in accordance with the CPSA.
The audit consists of two parts: (i) an examination by the accreditation body to determine whether the lab continues to meet the conditions for accreditation (this phase is called a “reassessment”); and (ii) the resubmission to the CPSC of an application and supporting documents (accreditation certificate and scope document) for each standard as to which the lab seeks to retain its accredited status (this phase is called the “examination” portion). Each testing lab must be reassessed at the frequency established by its accreditation body. The CPSC has proposed regulations that would require labs to undergo the examination phase at least every two years but this requirement is not yet in effect.
The new regulations introduce the concept of a “quality manager”, defined as an individual who has “defined responsibility and authority for ensuring that the management system related to quality is implemented and followed at all times and has direct access to the highest level of management at which decisions are made on the [lab’s] policy or resources.” Under the new regulations, this person is responsible for initiating corrective action as required by the accreditation body and notifying the CPSC within five business days if the accreditation body decides to reduce, suspend or withdraw the lab’s accreditation.
These audit requirements, which will go into effect on July 23, 2012 and are codified at 16 CFR Part 1112, require labs to maintain records for the last three assessments and to make these records available to the CPSC upon request.
