ISO 9000

ISO 9000 is a series of international quality standards, intended to ensure customer satisfaction through a self-managed, continuous improvement approach to product and service quality assurance.  ISO 9000 ties together good business practices and provides a management system that assures that those practices are performed consistently and in the spirit of continuous-improvement.

PRiMEX offers an accelerated, cost effective ISO 9000 certification program specifically designed for small to midsized companies.  The ISO 9000 is customized for each organization specific to their way of doing business and allows each company to pursue registration at their own pace.  The registration is not only a commitment to excellence, but lends credibility to a business.

Benefits:

	Increased productivity and quality – ISO 9000 Registration focuses on making your internal process visible, efficient, measurable and repeatable
	Expansion into international markets – ISO 9000 Registration allows you to compete in foreign markets.
	Increased customer satisfaction – ISO 9000 focuses on satisfying your clients by ensuring that your company delivers the highest quality products on time and continuously.
	Quality for government contracts or other business opportunities
	Improve employee performance

ISO 14001 is a voluntary international standard that defines the elements of an environmental management system (EMS) necessary for an organization to effectively manage its impact on the environment. Although conformance to the standard is voluntary, having an EMS in place can help a company add new customers and save money in other areas.

PRiMEX’s program is ideal for busy manufacturers. This program help companies become ISO 14001 compliant in four months-significantly faster than the usual schedule. During the program, PRiMEX will:

Training PRiMEX also offers ISO 14001 training including an overview, management review, aspects and impacts, applicable laws and regulations, procedure writing, internal auditing, lead auditing, and more.

 

ISO 13485

Provides a quality management systems model for the medical device industry to meet regulatory requirements.  ISO 13485 includes a process model similar to that of ISO 9001:2000 but requires additional documented procedures that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

Benefits

	Provides international recognition in compliance with the FDA Quality System Regulations
	Enables your organization to become more cost-effective.
	Improves internal communications, efficiency and resilience to change.
	Improves product and process quality and provides a basis for meeting regulatory requirements.
	Requires your organization to monitor and improve key business and customer satisfaction measures.
	Certification to ISO 13485 satisfies a significant portion of the EU Directive requirements for marketing medical devices in Europe.

Six Sigma is a highly disciplined process that helps us focus on developing and delivering near-perfect products and services.  The word is a statistical term that measures how far a given process deviates from perfection. With Six Sigma you can measure how many "defects" you have in a process, you can systematically figure out how to eliminate them and get as close to "zero defects" as possible.

Benefits

	Emphasis on bottom-line results
	Ensures improvements are permanent
	All aspects of business involved with Six Sigma processes
	Concentrate attention to achieve near-term successes
	Trains the right people on the right tool at the right time
	Executives visibly sustain the approach to ensure long-term results