ISO/IEC 17025 Accreditation a Necessity, Not an Option

McCrone Associates Class 5 Cleanroom

We have seen a change in needs of many of the industries we work with such that ISO/IEC 17025 accreditation for analytical testing and analysis is the expected norm, not an added value option. Regulations like the U.S. Food Safety Modernization Act require manufacturers to have testing and analyses conducted by an accredited laboratory, whether the lab is internal or external. Also, when exceptions occur, the regulations require that confirmation analyses are conducted by an accredited lab.

Recently, food industry clients have selected McCrone Associates because of our accreditation. Production line issues require timely resolution. The new requirements mandate forensic investigation prior to closure of the investigation, so a company doesn’t have an in-house laboratory, they need external assistance, and the regulations mandate that assistance be from an accredited laboratory.

McCrone Associates, Inc. was re-accredited by A2LA as meeting ISO/IEC 17025:2005 guidelines for its microanalysis and micro-spectroscopy methods in conformance with applicable U.S. FDA Good Manufacturing Practice, Good Laboratory Practice regulations per 21 CFR 58, 210, 211, and 820 for pharmaceuticals, medical devices, food and beverage, personal care products, plastics and polymers, metals and alloys, paints, pigments and coatings, glass vials and containers, and ceramics and composites. The accreditation is effective until September 30, 2018.

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