ISO 9001 2008, according to the www.iso.org website "represents fine-tuning, rather than a thorough overhaul. It introduces clarifications to the requirements existing in ISO 9001 2000, based on user experience over the last eight years, and changes that are intended to improve further compatibility with the ISO 14001 2004 standard for environmental management systems."
Significant changes from ISO 9001 2000 to ISO 9001 2008 include a more specific discussion regarding outsourced processes and according to praxiom.com "makes it clear that an outsourced process is still part of your QMS."
Additional changes are made clear in regard to documentation and management representatives. For example, in 9001 2000 many readers simply took it for granted that any and all external documentation should be identified/controlled. With 9001 2008 however it is made clear that quality representatives only need to identify/control the external documentation that is required for the planning and operation of a company's QMS.
In regard to management representatives, it was considered "legal" with 9001 2000 standards to authorize anyone, even if they worked outside of the company in question, to serve as the representative management. However, 9001 2008 specifies that "the management representative must be a member of the organization's own management."
As ISO 9001 2008 compliance continues to be "fine tuned" it can become more difficult to manage. However, with modern software solutions, ISO compliance can actually become easier to manage over time. MasterControl streamlines compliance with ISO standards, FDA regulations and additional rules legislated by national or international bodies.
MasterControl streamlines compliance with ISO 9001 2008 by controlling documentation, connecting that documentation to automated training solutions, streamlining process management (e.g., change control, CAPA, nonconformance events, audits, etc.) and by streamlining supplier and BOM (bill of materials) management processes.
Software validation for ISO 9001 2008, is one of the core factors that are considered in a highly regulated company that is considering the implementation of PLM, process or document control solutions. MasterControl provides validation tools, documentation and resources that help companies save significant amounts when performing validation regarding ISO 9001 2008 standards.
To learn more about MasterControl's solutions for ISO 9001 2008 compliance, please feel free to contact a MasterControl representative.