ISO 9001:2015, 10.3

This article provides a summary of the ISO/DIS 9001:2015 requirements in Clause 10.3, Continual Improvement, and also identifies the changes from ISO 9001:2008.

10.3 Continual Improvement

The organization must continually improve the suitability, adequacy, and effectiveness of the quality management system.

Consider the outputs of analysis and evaluation and the outputs of management review to confirm if there are areas of underperformance or opportunities that must be addressed as part of continual improvement.

Where applicable, select and utilize applicable tools and methodologies for investigation of the causes of underperformance and for supporting continual improvement.

Further changes may be introduced in the FDIS version, as well as, the final published version of the ISO 9001:2015 standard.

Changes from ISO 9001:2008

Clause Numbers

ISO/DIS 9001:2015 has adopted the new Annex SL clause structure required for all new and revised management system standards. Annex SL has clause 10 as “Improvement”, clause 10.1 as “Nonconformity and Corrective Action” and clause 10.2 as “Continual Improvement”.

Since ISO/DIS 9001:2015 has added a “General” section as clause 10.1, “Nonconformity and Corrective Action” has been bumped to clause 10.2 and “Continual Improvement” to clause 10.3.

The continual improvement requirements in clause 8.5.1 of ISO 9001:2008 are now stated in clause 10.3 of the ISO/DIS 9001:2015 standard.

Underperformance and Opportunities

ISO/DIS 9001:2015 adds that the outputs of analysis and evaluation (clause 9.1.3) and the outputs of management review (clause 9.3) are to be considered to identify any areas of underperformance or opportunities that must be addressed as part of continual improvement.

The draft standard also adds that tools and methodologies should be used to investigate the cause of any underperformance and to support continual improvement.

Effectiveness of Quality Management System

Improving the “effectiveness” of the quality management system is a requirement of ISO 9001:2008, clause 8.5.1. The ISO/DIS 9001:2015 standard adds in clause 10.3 that the organization is to also improve the “suitability” and “adequacy” of the quality management system.

Clause 8.5.1 states that the quality management system is to be improved through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions, and management review. This statement is not carried over to clause 10.3 of the draft standard.

Changes from Annex SL Common Text

The requirement to continually improve the suitability, adequacy, and effectiveness of the quality management system is part of the common Annex SL text. The other requirements in clause 10.3 have been added by the draft ISO 9001:2015 standard.