Quality Management Organizations
The two quality management organizations profiled in this analysis are Q-Plus Labs located in Irvine, California and Quality Auditing LLC who has offices located in Los Angeles, California, Minneapolis, MN and New York City. Both can serve local and national markets given their organizational structures. Of the two, Quality Auditing LLC is the closest locally while also having the ability to operate nationally. For purposes of this analysis Q-Plus Labs is defined as the national quality management organization and Quality Auditing LLC as the local one.
Analysis of Quality Management Organizations
Beginning with Quality Auditing LLC, their main business is providing auditing and consulting for improving procedures and requirements definition, to ensure their clients pass quality management audits. The main part of this company's business is audit outsourcing, supply quality auditing, suppler quality management auditing and supply chain analysis. Managing quality at a strategic level is critical to ensure each aspect of suppliers, manufacturing, logistics and fulfillment stay within procedural audit parameters, especially in highly regulated industries including pharmaceutical drugs (Hagan, 1984). Quality Auditing LLC has extensive expertise in the following standards ISO 9001, ISO 13485, ISO 14001, as 9100, 21 CFR 211, 21 CFR 820, NAY-1, 10 and CFR 50. Taken together, these standards indicate the company can equally manage supplier and internal quality process control audits across a variety of industries. The extent to which any organization can attain ISO 9001 certification and consistently retain it is a primary indicator of how effectively they will be able to pass regulatory audits on a periodic basis while attaining the benefits of lean manufacturing as well (Psomas, Fotopoulos, Kafetzopoulos, 2011). What Quality Auditing LLC actively promotes is their ability to transform clients into more lean-based and highly effective platforms for future profitable growth. The combining and orchestration of these services are over time intended to change the culture of their clients' organizations into one that is more quality-focused. The ability of any organization t transform itself into a quality-driven enterprise is predicated on hwo well it interprets and implements quality management standards corporate-wide (Kujala, Lillrank, 2004). Quality Auditing LLC is designed as a business to deliver these benefits.
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