ISO 9001:2008—Hidden Business Opportunities

The ISO 9001:2000 Standard has been revised after eight years.  And the buzz is rapidly reaching a crescendo.  We continue to receive numerous emails and phone calls regarding the impact of the new release.  First, let me dispel any anxiety about the November 15, 2008 official “2008” release.  There are no new requirements.  The changes are largely interpretive, and focus on terminology clarifications.  The changes to the ISO 9001 amendment, however, will have considerable benefit.



As a back drop, keep in mind that ISO 9001 is not just an International Standard for a Quality Management System.  It is the world’s most recognized business management standard.  And it makes a strong business case.  It focuses attention on leadership, business planning, organizational business processes, your customers (internal and external), measurement and reporting, and continual improvement.  That translates to improved business results and a sustainable competitive advantage. 



Transitioning to ISO 9001:2008



The International Organization of for Standardization and the International Accreditation Forum have agreed to a smooth transition.  Both standards will remain current for two years—until November 15, 2010.  Registration of conformity to ISO 9001:2008 will be issued from November 15 on, and after a routine registrar surveillance audit, or a recertification audit against the new version.  Also, as of November 15, 2009, all new registrations and recertifications must be to ISO 9001:2008.



Two years after publication of ISO 9001:2008 (November 15, 2010), any certifications that are still to ISO 9001:2000 will no longer be valid.  This means that currently certified organizations in “surveillance mode” in 2008-2009 have until November 15, 2010 to be successfully certified to ISO 9001:2008.  We recommend a proactive approach.  If you can win in your marketplace every day—why put it off?



Overview of the Changes



The points of clarification focus on outsourcing, documentation, management representative, employee competence, design verification and validation, process monitoring, control of nonconforming product and corrective and preventive action.  But bear in mind, no “shalls” (requirements) were added or removed.



Examples of select changes include: In an attempt to clarify the term “outsourcing,” notes were added that require the organization to identify processes (and High risk work license voc the control of these) to be completed by an external party.  With respect to documentation, the changes focus on improving the compatibility between ISO 9001 and ISO 14001.



The only significant addition to the management representative sub clause was to require that the MR be a member of the organization’s management team.  This means a contracted person could serve in this role as long as he or she is also considered part of management.  The management representative does not have to be full-time.



With regard to competence of employees, a note was added to make training more pervasive throughout the organization.  Training applies to all employees directly or indirectly responsible for delivering a service or producing a product (everyone that is part of the quality chain).  A complete li[ ][ ], you should also explore ways to leverage your certificate to accelerate growth of sales.

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