ISO 9001:2015, 9.1.1

This article provides a summary of the General requirements section of Monitoring, Measurement, Analysis, and Evaluation as stated in the Draft International Standard (DIS) version of ISO 9001:2015. The changes from the related ISO 9001:2008 requirements are also identified.

ISO/DIS 9001:2015 Summary

9.1.1 General

Determine:

  • what needs to be monitored and measured
  • the methods for monitoring, measurement, analysis, and evaluation, as applicable, to ensure valid results
  • when the monitoring and measuring will be performed
  • when the results from monitoring and measurement will be analyzed and evaluated

Ensure that monitoring and measurement activities are implemented in accordance with determined requirements and retain documented information as evidence of the results. Evaluate the quality performance and effectiveness of the quality management system.

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

1. Clause Numbers

The general monitoring, measurement, and analysis requirements of the draft standard are now stated in clause 9.1.1, instead of clause 8.1 as in ISO 9001:2008. The draft standard has adopted the new clause structure required for all new and revised management system standards, which places these general requirements under clause 9, Performance Evaluation.

2. Monitor, Measure, and Analyze

The requirements in clause 9.1.1 of the draft ISO 9001:2015 are similar to the requirements stated in ISO 9001:2008, clause 8.1.

Clause 8.1 refers to monitoring, measurement, analysis, and “improvement” processes. The draft clause 9.1.1 refers to monitoring, measurement, analysis, and “evaluation” processes. The draft clause 9.1.3 described later in this newsletter includes requirements to analyze and evaluate the data and information arising from monitoring and measurement. Draft clauses 10.1 and 10.3 include requirements for improvements.

3. What and When

Clause 9.1.1 of the draft ISO 9001:2015 is more specific than clause 8.1 of ISO 9001:2008 in terms of what has to be determined. Clause 9.1.1 requires an organization to determine “what” needs to be monitored and measured, “when” the monitoring and measurement must be performed, and “when” the results must be analyzed and evaluated.  Additional analysis and evaluation requirements are in clause 9.1.3.

4. Valid Results

ISO 9001:2008, clause 8.1, says to determine the applicable methods and the extent of their use. Clause 9.1.1 of the draft ISO 9001:2015 says to determine the methods to ensure “valid results”.

5. Determined Requirements

ISO 9001:2008, clause 8.1, requires an organization to plan and implement its monitoring and measurement activities. Clause 9.1.1 of the draft ISO 9001:2015 adds that the monitoring and measurement activities must be implemented in accordance with the “determined requirements”.

6. Evidence of Results

Clause 9.1.1 of the draft ISO 9001:2015 adds a requirement to retain documented information (records) as “evidence of the results”.

7. Quality Performance

Clause 9.1.1 of the draft ISO 9001:2015 requires evaluation of the “quality performance” and the “effectiveness” of the quality management system. Clause 8.1 of ISO 9001:2008 refers to ensuring the “conformity” of the quality management system and continually improving its “effectiveness”.  The new requirement is to evaluate measurable quality results, not just ensure conformity to requirements.

8. Statistical Techniques
ISO 9001:2008, clause 8.1, requires an organization to determine the applicable methods, including “statistical techniques”.  The draft ISO 9001:2015 does not mention “statistical techniques”.