ISO Quality Systems: Measuring up to Technical Standards 9001, 9002 and 9003
ISO (International Organization for Standardization) quality systems, or systems that adhere to quality standards agreed upon by various ISO bodies, are quality systems that generally garner a high amount of global esteem.
Why ISO?
For any business entity with a focus on technical products or services, compliance with ISO quality system standards and recommendations provides a variety of benefits:
• Benchmark Guide – Since technically oriented businesses (like most businesses) are busily invested in a tide of ongoing globalization, it makes sense that companies would begin to increase product specialization and seek partnerships (or contract relationships) with companies that may be located in another hemisphere or on another geographic continent. From external suppliers to CROs (contract research organizations) and from external manufacturers to clinical laboratories, it is essential that benchmark guides such as the ISO quality system standards exist for a company that may be headquartered in Hong Kong but is interested in doing business with a contract organization in Philadelphia.
• Differentiators – ISO certifications may also act as immediate and symbolic differentiators between one organization and another. For instance, two companies may have similar methodologies for achieving a high functioning quality system but customers and contract organizations are more likely to work with and/or support an organization with significant certifications and accreditations such as those associated with ISO.
• Tried and Tested – Since ISO standards have been tried and tested and essentially proven in a variety of technical environments, what have companies got to lose?
• Save Resources – According to an online article, “Most companies implementing ISO 9000 certification report increases in business process efficiencies, reductions in waste, and improved product quality.”1
What are ISO 9001, 9002 and 9003?
ISO standards 9001, 9002, and 9003 are simply three ways to define three types of quality system requirements. Essentially, the content expressed in these standards is similar but does vary in terms of breadth.
ISO 9001
The ISO 9001 quality system standards may be considered the “most rigorous” of all ISO quality standards but in reality are simply the broadest set of standards. For example, 9001 standards (last revised in 2000) are designed for companies that rely on processes that included the following:
• Design/Development
• Production
• Installation
• Service Provisions
ISO 9002
ISO 9002 quality system standards are narrower in breadth than those expressed in the 9001 documentation. For example, 9002 standards are designed for organizations that do not participate in the design and development of their products or services but do participate in production processes, installation processes and service processes.
ISO 9003
ISO 9003 is the narrowest set of quality system standards but is very useful for organizations that do NOT perform any of the following:
• Design/Development
• Control of Process
• Purchasing
• Service Provisions
Becoming ISO Certified
Companies interested in complying with ISO quality system standards and achieving ISO certification should document their quality system, implement their quality system and then contact an auditor who has been ISO accredited.
Automated Solutions
Companies that invest in automated software solutions designed for better quality system control and ISO compliance may also find that the benefits of ISO compliance can be magnified via intelligent automation solutions.
Conclusion
Achieving ISO compliance and certification can take significant amounts of time but should prove valuable for companies interested in successful global networking and high levels of customer satisfaction.
1 http://www.isixsigma.com/library/content/c000917b.asp
About the Author: Marci Crane is a copywriter for MasterControl in Salt Lake City, UT. For more information in regards to quality system management that complies with ISO standards, please feel free to contact a MasterControl representative.
More articles by mcrane@mastercontrol.com
Print Article | Download PDF | 66 views | Apr 17 2008
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