ISO 9001 Revision 2015, What You Need to Know

The ISO/DIS 9001 was approved on May 9, 2014 and published on May 16. Several changes have been made between the CD and DIS stage, including:

• Movement of process approach discussion to the Introduction; while essentially retaining the list of process requirements in the standard itself
• Re-inclusion of Plan-Do-Check-Act cycle in the Introduction
• Re-inclusion of several specific ‘calibration’ requirements
• Slight change from “goods and services” to “products and services”
• Expansion of design and development requirements from the abbreviated CD version

Many changes in the that were first drafted in the CD remain in the DIS including:

• New structure of the standard (per Annex SL)
• Inclusion of risk and risk-based thinking throughout the standard
• Migration to new terms such as “documented information”, “external provider/externally provided” and “products and services”
• Elimination of preventive action as a discrete activity

The release of the DIS in May 2014 keeps the release generally on schedule for the targeted late 2015 ISO publication.More detailed analysis of the DIS will be forthcoming, along with continued tracking to subsequent stages of FDIS and final ISO publication.Certified organizations will likely have up to a three year transition period from the date of ISO publication in order to migrate to the new version (i.e. 2015-2018). A detailed set of client information and transition planning will also be forthcoming as the revisions become more stable and certain.For more information on the update, please contact our NQA division at (800) 649-5289 or browse all other articles related to this topic at www.nqa-usa.com