Food Safety Magazine, February/March 2013

Accreditationan ILAC-recognized AB are accepted bygovernments and industries worldwide.Jesse Lamas Calvillo, laboratory managerfor AGQ Labs, Spain, says, “Internationalaccreditation not only assuresthe quality of data being emitted to ourclients from our laboratory, but benefitsthe company by guaranteeing uniformityof standards across the board on theworld stage. AGQ has seven laboratoriesthroughout the world, which allow us tooperate in over 20 countries, and ISO/IEC 17025 accreditation has been criticalwithin every one of those food safetymarkets. Beyond the more apparentbenefits of having an internationally recognizedaccreditation, being on the sameplaying field as national agrifood laboratoriesin Europe and abroad heightensour profile and lends credibility any timewe have to represent our clients in adispute.”Governmental regulatory agenciessuch as the Consumer Product SafetyCommission, the U.S. EnvironmentalProtection Agency and the NuclearRegulatory Commission require accreditationto verify the technical competenceof organizations like laboratories, inspectionbodies and/or certification agencies.Laboratories seeking accreditationfrom anILAC memberorganizationmustdemonstratethat theirtesting andcalibrationmethods areconducted inaccordancewith internationallyrecognizedstandards,and within the framework of ISO/IEC17025, General requirements for the competenceof testing and calibration laboratories.Figure 1: Certificate of AccreditationSystematic AssessmentThe first step in the accreditation processis for the laboratory to submit qualitymanagement system documentationto the AB, describing its managementand technical procedures for compliancewith ISO/IEC 17025. The documentationcomprises the laboratory’s qualitysystem manual, details on the laboratory’sequipment, a proposed scope ofaccreditation, list of test methodologiesand procedures, and capabilities forAnticipated Regulatory Changes Push for Accreditation StandardsAccording to the Food Safety Modernization Act (FSMA), FDA must establishmodel accreditation standards to ensure that accredited labs have the followingcontrols by 2013:• Methods to ensure that appropriate sampling and analytical procedures arefollowed• Certification of reports of analyses• Internal quality systems• Complaint-handling procedures• Training/experience requirementsOf course, these types of Good Laboratory Practices and controls are alreadycommon in many accredited laboratories currently operating throughout theworld. In fact, many of these would be eligible for accreditation under FSMA,which would cover government and private labs, both U.S. and foreign. Althoughnon-third party, in-house laboratories of food manufacturers are eligiblefor FSMA accreditation, FDA has not yet decided on this issue and has declinedto provide guidance at this time.However, the agency stated that to facilitate FDA assessment, a certificationbody could seek accreditation from an AB that is operating in accordance withISO/IEC 17011:2004, and that the certification bodies should have access toaccredited laboratory services needed to support the audit program functions(see www.fda.gov/RegulatoryInformation/Guidances/default.htm). Theselaboratories should conform to ISO/IEC 17025:2005.establishingand estimatingmeasurementuncertaintyfor thetesting to beperformed.After reviewingthisdocumentation,the ABconducts anon-site assessmentusing ateam of qualitysystem and technical experts matchedto the laboratory’s scope to confirmcompliance with the standard. For instance,a food laboratory may proposea scope of accreditation that includesbiological testing for Salmonella using theFDA-Bacteriological Analytical Manual,which outlines procedures for the detectionof pathogens such as Salmonella infood products. Another example couldbe the use of a regulatory method likeU.S. Department of Agriculture (USDA)-Microbiology Laboratory Guidebook(MLG) for the microbiological analysisof meat, poultry and egg products.Competency of the laboratory staff toperform the intended work and ongoingtraining is another critical area reviewedby the AB.Dr. Sri Ghanthan, a veteran IAS assessor,says, “Certainly the primary focus ofthe assessment team is to identify nonconformances.However, they might alsolook for ways to share knowledge aboutindustry best practices. In the food safetybusiness, it’s not enough to just meetthe standard[s]. Accreditation bodiesmust also see evidence of a laboratory’scommitment to continuous improvementof its processes, people and toolsas well as evidence of preventive actionsto proactively address potential problemareas. That means looking at the testingprocesses, interviewing people, determiningequipment capabilities and even theway samples are received, identified andstored. The goal of continuous improvementis to improve long-term efficiencyand accuracy.”26 F o o d S a f e t y M a g a z i n e