ISO 9001:2015, Clause 9.1

This article summarizes the ISO 9001:2015 requirements in clause 9.1, Monitoring, Measurement, Analysis, and Evaluation, plus its changes from ISO 9001:2008.

ISO 9001:2015, 9.1.1, General

Determine:

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

Evaluate the performance and effectiveness of the quality management system.

Retain appropriate documented information as evidence of the results.

Changes from ISO 9001:2008

1. Clause Numbers

The general monitoring, measurement, and analysis requirements are now stated in clause 9.1.1, instead of clause 8.1 as in ISO 9001:2008. The new standard uses 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 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 new clause 9.1.1 refers to monitoring, measurement, analysis, and “evaluation” processes.

Clause 9.1.3 described later in this article includes requirements to analyze and evaluate the data and information arising from monitoring and measurement. Clauses 10.1 and 10.3 also include requirements for improvements.

3. What and When

Clause 9.1.1 of 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 ISO 9001:2015 says to determine the methods to ensure “valid results”.

5. Quality Performance

Clause 9.1.1 of ISO 9001:2015 requires evaluation of the “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”.

6. Evidence of Results

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

7. Statistical Techniques

ISO 9001:2008, clause 8.1, requires an organization to determine applicable methods, including “statistical techniques”. ISO 9001:2015 only mentions “statistical techniques” in a Note under clause 9.1.3.

ISO 9001:2015, 9.1.2, Customer Satisfaction

  • Monitor customer perceptions of the degree to which their needs and expectations have been fulfilled
  • Determine the methods for obtaining, monitoring, and using this information

NOTE: Examples of monitoring customer perceptions can include customer surveys, customer feedback on delivered products or services, meetings with customers, market-share analysis, compliments, warranty claims, and dealer reports.

Changes from ISO 9001:2008

1. Clause Numbers

The Customer Satisfaction requirements are now stated in clause 9.1.2, instead of clause 8.2.1 as in ISO 9001:2008. The new standard has adopted the new clause structure required for all new and revised management system standards, which places Customer Satisfaction under clause 9, Performance Evaluation.

2. Performance Measurement

Clause 8.2.1 of ISO 9001:2008 states that customer satisfaction is one of the performance measurements of the quality management system. Clause 9.1.2 has dropped that statement. The new clause 9.3.2.c.1 in Management Review includes customer satisfaction as one of the performance items to be considered.

3. Information Sources

The information sources in the Note at clause 9.1.2 continue to include customer surveys, compliments, warranty claims, and dealer reports. Opinion surveys have been dropped.

Customer data on delivered products has become customer “feedback” on delivered products and “services”. Market-share analysis has replaced lost business analysis.

ISO 9001:2015, 9.1.3, Analysis and Evaluation

Analyze and evaluate appropriate data and information arising from monitoring and measurement. Use the results of the analysis to evaluate:

  • conformity of products and services
  • the degree of customer satisfaction
  • the performance and effectiveness of the quality management system
  • if planning has been effectively implemented
  • the effectiveness of actions taken to address risks and opportunities
  • the performance of external providers
  • the need for improvements within the quality management system

NOTE: Methods to analyze data can include statistical techniques.

Changes from ISO 9001:2008

1. Clause Numbers

ISO 9001:2015 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 new 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. Effective Planning

A new requirement in clause 9.1.3 is to use the results of the analysis to evaluate if planning has been effectively implemented. Clause 8.4 of ISO 9001:2008 doesn’t mention use of data analysis to evaluate planning.

3. Risks and Opportunities

A new requirement in clause 9.1.3 is to evaluate the effectiveness of the actions taken to address risks and opportunities. ISO 9001:2008 does not mention risks or opportunities.

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 requires the analysis and evaluation be used evaluate the “degree” of 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 requires the results of the analysis to be used to evaluate the conformity of 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 requires the results of the analysis be used to evaluate the “performance” of “external providers”.

An external provider is a supplier of products or services that is external to the organization. The provider could be a producer, distributor, retailer, or vendor.

ISO 9001:2015 Requirements and Transition Guidance

We offer a 2.0 day course on the new and changed ISO 9001:2015 requirements, plus guidance on how to successfully make the transition from ISO 9001:2008. To view the course description, or enroll in a class, go to this web page.