ISO 9001:2015, 9.1.3

This article provides a summary of the Analysis and Evaluation requirements as stated in the recently published Draft International Standard (DIS) version of ISO 9001:2015. The draft analysis and evaluation differences from ISO 9001:2008 are also identified.

ISO/DIS 9001:2015 Summary

 9.1.3 Analysis and Evaluation

Analyze and evaluate appropriate data and information arising from monitoring, measurement, and other sources. Use the output of this analysis and evaluation to:

  • demonstrate conformity of products and services to requirements
  • assess and enhance customer satisfaction
  • ensure conformity and effectiveness of quality management system
  • demonstrate that planning has been successfully implemented
  • assess the performance of processes
  • assess the performance of external providers
  • determine need or opportunities for improvements within quality management system

Use the results of the analysis and evaluation to provide inputs to management review.

Further analysis and evaluation 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

1. Clause Numbers
The draft standard has adopted the new clause structure required for all new and revised management system standards, and has placed Analysis and Evaluation under clause 9, Performance Evaluation.

The Analysis and Evaluation requirements of the draft standard are expressed in clause 9.1.3. The related requirements in ISO 9001:2008 are primarily in clause 8.4, Analysis of Data.

2. Successful Planning
A new requirement in clause 9.1.3 of the draft standard is to use the output of the analysis and evaluation to “demonstrate” that planning has been “successfully implemented”. Clause 8.4 of ISO 9001:2008 doesn’t mention use of the data analysis for planning purposes.

3. Process Performance
An expanded requirement in clause 9.1.3 of the draft standard compared to clause 8.4 in ISO 9001:2008 is to assess the “performance” of processes. Clause 8.4 refers to providing information on the characteristics and trends of processes and products.

4. Customer Satisfaction
Clause 8.4 in ISO 9001:2008 requires data to be analyzed to provide information on customer satisfaction. Clause 9.1.3 in the draft standard requires the analysis and evaluation be used to assess and enhance customer satisfaction.

In other words, use the analysis and evaluation to “assess and enhance” customer satisfaction, not just “provide information” on customer satisfaction.

5. Products and Services
Clause 8.4 in ISO 9001:2008 refers to analyzing data to provide information on conformity to product requirements. Clause 9.1.3 in the draft standard requires the analysis and evaluation be used to demonstrate conformity of products and services to requirements.

So, don’t just “provide information” on product conformity, use the analysis and evaluation to “demonstrate” conformity of both products “and services”.

6. External Providers
Clause 8.4 of ISO 9001:2008 requires data be analyzed to “provide information” on “suppliers”. Clause 9.1.3 in the draft standard requires the analysis and evaluation be used to “assess the performance” of “external providers”.

A supplier can be internal or external. An external provider is a supplier of products or services that is external to the organization.