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ISO 9001:2015 is here!

By Stephanie S. Skipper, Ticalion Quality Management Services – 10/14/2015

Organizations that are currently ISO 9001:2008 registered have just three years from the publication date of the new standard to transition their quality system or risk losing their registered status.

Will you be ready?

ISO standards are revised approximately every seven years but not all revisions are equal. Differences between the 9001:2000 and the 9001:2008 versions were relatively minor, but the 9001:2015 changes are major and comprehensive. The most significant of these changes include:

• Revision to the structure of the standard including changes in the titles and order of clauses and sub-clauses
• Introduction of context of the organization and requirements to base the quality management system around the context of the organization
• Focus of risk-based thinking and opportunity management
• Significant emphasis on top management engagement and leadership of the Quality Management System
• Expansion of documentation and record-keeping requirements
• Improved compatibility with other ISO standards
• Greater explicit focus on process approach
• Management of outsourced activities
• Stronger measuring and monitoring

Ticalion offers solutions to help companies effectively and efficiently manage the transition with a range of services to fit your needs. Our quality system professionals can:

• Perform a GAP analysis of your current quality management system to the new standard and provide a comprehensive report to guide your QMS upgrade
• Create and execute a quality plan to deploy QMS changes throughout your organization
• Provide training to help your leadership team understand their expanded role in the ISO 9001:2015 the quality management system
• Create a training plan, training materials and provide organizational training to help your entire team understand the requirements of your upgraded quality management system
• Perform post implementation readiness audit to assure that you are ready for your certification audit

Click here to request more information or call us at (410) 245-7237.

About Ticalion Quality Management Services
Ticalion provides expert quality system deployment and remediation services to meet requirements for FDA compliance and ISO registration.