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McCrone Associates, Inc. (MA) management and personnel are committed to excellence in professional practices and providing reliable, defensible, and scientifically sound results to our clients. The goal of the quality management system is to establish formal policies and procedures to provide a quality assurance program consistent with recognized standards for quality assurance practices. MA is accredited to the requirements of ISO/IEC 17025:2005 and conforms with current Good Manufacturing Practices (cGMP’s 21 CFR Parts 210, 211 and 820). To maintain quality, excellence, and integrity; the quality management system will utilize test technologies and methods that are valid, dependable, reproducible, and adequate for the intended purpose. Sample preparation and particle isolation are performed in our ISO Class 5 cleanrooms, which are certified to ISO 14644 standards.
The MA quality management system (QMS) encompasses all sample receipt, sampling, sample handling, processing, analysis, and reporting activities. Management and personnel are responsible for ensuring that they understand and employ the quality management system in their daily work activities. The president, senior vice president, and department managers together with the quality managers ensure the quality system is applied uniformly throughout the organization. Quality assurance managers ensure quality requirements are defined, supported and maintained. Overall authority for the conduct of MA laboratory operations, including quality assurance efforts, remains with the president.
MA continually strives to improve its quality management system to ensure confidence in laboratory results. The effectiveness of the quality management system is monitored through audits and management reviews, and, when necessary, new policies, practices and procedures are developed and implemented. If conditions or situations having an adverse impact on the QMS are identified, appropriate changes are made and/or corrective actions are implemented.
MA is FDA registered (#1421090), GDUFA registered and DEA registered (#RM0182787) Schedule I-IV.