What are the Major Changes in Draft International Standard of ISO 9001:2015

CMMI FAQ 0

4th June, 2015

The revised standard of ISO 9001:2015 is due in Sept 2015. The standard is to incorporate the new “High Level Structure” as defined in the “Annex SL” of ISO 17021. The Draft International Version is currently available.

Major Highlights are as under:

• High Level Structure is used in text writing (i.e. clause sequence, common text and terminology)
• New clause sequence is adopted in new version which is consistent with Annex SL, highlighted in main body of the text (clause 1 to 10).
• No specific reference and text for possible exclusions of requirements
• No specific requirement and text for documented procedures and records. Both have been replaced throughout by the text documented information.
• Role of Management Representative Now the activities of Management Representative should be performed by one of group of Senior Management.
• No mention of a Quality Manual. Specific word Quality Manual is no-were mentioned in the Draft Standard.
• Quality policy / objectives compatible with strategic direction
• Integration of QMS requirements into business processes
• Change of term product to product and services. New term include all output categories i.e. hardware, services, software and processed materials
• Organization needs to determine the knowledge necessary for the operation of the QMS and its processes and to achieve conformity of process
• Risk-based thinking introduced in all clauses
• Organization needs to determine the risks to conformity of goods and services and to customer satisfaction and opportunities in place of preventive action

This is the Draft International Standard, there may be changes when the standard will be published in Sept 2015

Source: Information Collected from ISO website