Iso 9000 Case Study

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The series of ISO 9000 quality management guidelines are based on eight quality management principles and are defined in ISO 9000:201 5, Quality management systems – Fundamentals and vocabulary. These quality management principles function as the core set of values that the board considers when they create and revise new international standards. Customer focus holds the highest priority on this list and is the foundation for the entire ISO 9000 set of guidelines. These principles define Customer focus as a commonsense value that should be recognized by any organization that wishes to succeed. Customers are the only source of income and, therefore, companies rely heavily on maintaining a steady flow of customers. In order to maintain this stream…show more content…
The 1st party audit begins with the company answering several fundamental questions to start the process of enabling themselves to be eligible for ISO 9000 certification. These questions identify the best people inside an organization to complete the audit properly. The best people for the job are those who are familiar with ISO 9000, know the difference between the different flavors of the various ISO guidelines, and know how to select the proper set of standards for their organization from the ISO 9000 family. For example, an organization that deals with producing medical equipment would have a different set of guidelines from an organization that produced lasers. The medical organization would need to identify which procedure standards they need to adapt to based on what functions their equipment will perform. The medical categories are split into an initial layer for each set of categories that medical equipment could fall into; such as general equipment, dentistry, sterilization and disinfection, laboratory medicine, pharmaceutics, and first aid, among others. Each subsection is further divided into the specific equipment protocols that could apply to each resource. In the general equipment subsection of the medical section, organizations can select a set of guidelines dedicated to a very specific device that can be produced. This list…show more content…
The ISO aims to align the plethora of different standards into one quality system that can handle many standards. In order to align the standards, ISO has to first move the standards towards more competence, consistency, and impartiality so that businesses who follow them can practice the three tenants more openly in their process (Diesing). The revisions that have been completed on the various ISO standards, specifically ISO 9000 and 9001, have allowed companies in any industry to easily adopt them, making them prime models for future revisions to other ISO standards and indicators of how these standards will change over time. These standards are increasingly moving away documentation heavy manuals that force companies to adhere to stacks of procedural manuals which prevent adaptation to new procedures. The recently revised standards embrace subjective definitions for how companies define field-specific terms and rely on measurement of progress more than how well a procedure is followed to determine the success of a company in producing quality products. Current ISO standards focus more on identifying the particular task or activity that presents problems or delays in an organization rather than the old methods that involved writing procedure manuals to attempt to limit unknown variables that could raise issues
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