ISO 9001 Note for Area 9

9 Performance evaluation

ISO 9001:2015 Requirement

Table of contents:

 9.1 Monitoring, measurement, analysis and evaluation

o 9.1.1 General
o 9.1.2 Customer satisfaction
o 9.1.3 Analysis and evaluation
 9.2 Internal audit
 9.3 Management review
o 9.3.1 General
o 9.3.2 Management review inputs
o 9.3.3 Management review outputs

9.1 Monitoring, measurement, analysis and evaluation

ISO 9001:2015 Requirement
Table of contents:

 9.1.1 General
 9.1.2 Customer satisfaction
 9.1.3 Analysis and evaluation

9.1.1 General
ISO 9001:2015 Requirement
The organization shall determine:

a) what needs to be monitored and measured;

b) the methods for monitoring, measurement, analysis, and evaluation needed to ensure valid results;

c) when the monitoring and measuring shall be performed;

d) when the results from monitoring and measurement will be analyzed and evaluated;

The organization shall evaluate the performance and effectiveness of the quality management system.

The organization shall retain appropriate documented information as evidence of the results.
(Mandatory documented information)
 What has changed from ISO 9001:2008
Requirements in this clause are similar to one stated in clause 8.1 (General - Measurement, analysis
and improvement) of ISO 9001:2008.
Significant change in the new standard is the need to keep the documented information as evidence.

9.1.2 Customer satisfaction

ISO 9001:2015 Requirement
The organization shall:

 monitor customers’ perceptions of degree to which their needs and expectations have been
fulfilled.
 determine the methods for obtaining, monitoring and reviewing this information.

Note: Examples of monitoring customer perceptions can include customer surveys, customer feedback on
delivered products and services, meeting with customers, market-share analysis, complaints, warranty
claims and dealer reports.
What has changed from ISO 9001:2008

This clause of the standard is similar to clause 8.2.1 (customer satisfaction) of ISO 9001:2008.

The focus of the previous version was on "meeting customer requirements", however this has now
shifted to "customer perception of meeting the needs and expectations". This is much deeper than just
meeting the requirements.

Notes
Examples of monitoring customer perceptions:

 customer surveys
 customer feedback on delivered products or services
 meetings with customers
 market-share analysis
 compliments
 warranty claims
 dealer reports
 9.1.3 Analysis and evaluation
ISO 9001:2015 Requirement
The organization shall analyze and evaluate appropriate data and information arising from monitoring
and measurement.

The results of analysis and evaluation shall be used to evaluate:

a) conformity of products and services;

b) the degree of customer satisfaction;
c) the performance and effectiveness of quality management system
d) if planning has been implemented effectively
e) the effectiveness of actions taken to address risks and opportunities
f) the performance of external providers
g) the need for improvements to the quality management system

NOTE: conformity of products and services(8.6), customer satisfaction(9.1.2), planning(6), address

risks and opportunities(6.1), performance of external providers(8.4), improvements(10)

Method to analyse data can include statistical techniques.

What has changed from ISO 9001: 2008

Just like clause 8.4 (Analysis of data) of ISO 9001:2008, this clause also requires organizations to
collect data and use that data to improve. Some of the changes in the use of data includes the use of
data to address risk and opportunities. This change can been seen across the standard where the need
of risk and opportunities has been included.

9.2 Internal audit

ISO 9001:2015 Requirement
9.2.1

The organization shall conduct internal audits at planned intervals to provide information on whether
the quality management system:

a) Conforms to the

 organization’s own requirements for its QMS;

 requirements of ISO 9001

b) Is effectively implemented and maintained

9.2.2

The organization must:

a) Plan, establish, implement, and maintain the audit program including

  frequency
 methods
 responsibilities
 planning requirements and reporting

, which shall take into consideration

 the importance of the processes

 changes affecting the organization and
 the results of previous audits

b) Define audit criteria and scope for each audit

c) Select auditors and conduct audits to ensure impartiality and objectivity of audit process

d) Ensure results of audits are reported to relevant management

e) Take necessary correction and corrective actions without undue delay

f) Retain evidence of audit program implementation and audit results (Mandatory documented
information)

What has changed from ISO 9001:2008

These requirements were earlier covered in 8.2.2 (Internal audit) of ISO 9001:2008.

Previous version required internal audits to conform to planned arrangements (in addition to the
international standard and QMS requirements established by the organization). The requirement to
conform with the planned arrangements has been dropped in this version.

Previously the audit program was required to be planned taking into consideration the status and
importance of the processes and the results of previous audit. In this version the word "status" has
been replaced with the "changes affecting the organization".

Previously the standard required to define the audit criteria, scope, frequency, and methods. This new
standard requires the audit frequency and methods to be considered in the planning stage and the
audit criteria and scope to be defined for "each audit".

Requirements related to follow-up activities including the verification of action and the reporting of
verification results have been dropped from this new standard.
 9.3 Management review
ISO 9001:2015 Requirement
Table of contents:

 9.3.1 General
 9.3.2 Management review inputs
 9.3.3 Management review outputs

9.3.1 General
ISO 9001:2015 Requirement
Top management shall review the organization's QMS at a planned interval to ensure its continuing

 suitability
 adequacy
 effectiveness and
 alignment with the strategic direction of the organization.

What has changed from ISO 9001:2008

Requirements related to Management Review were earlier covered in the clause 5.6 of ISO
9001:2008.

Ensuring alignment with the strategic direction has been added in this revised standard.

Some of the requirements in 5.6.1 of ISO 9001:2008 have been moved to 9.3.2 of ISO 9001:2015.
(e.g. assessing opportunities for improvement)

The previous version for the standard required the review to include the review of "quality policy" as
well. This requirement no longer exists in the new standard.

9.3.2 Management review inputs

ISO 9001:2015 Requirement
The management review shall be planned and carried out the management review taking into
consideration:

a) Status of actions from previous management reviews

b) Changes in external and internal issues relevant to QMS

c) Information on quality performance and effectiveness of the QMS, including trends in:

1) Customer satisfaction and feedback from interested parties

2) the extent to which quality objectives have been met
3) process performance and conformity
 4) Nonconformities and corrective actions
5) Monitoring and measurement results
6) Audit results
7) Performance of external providers

d) the adequacy of resources required for maintaining effective QMS

e) the effectiveness of actions taken to address risks and opportunities (see 6.1)

f) Opportunities for improvement

What has changed from ISO 9001:2008

Management review input requirements were earlier covered in clause 5.6.2 of ISO 9001:2008.

Preventive actions have been removed from the list of inputs, as the new standard does not use the
term preventive actions. Instead of "status of preventive and corrective actions" the new standard
mentions "nonconformities and corrective actions" as review input.

Instead of "customer feedback" as the management review input the new standard requires "the
trends in customer satisfaction".

Instead of "recommendations for improvement" the new standard requires "opportunities for
improvement" as the management review input.

Effectiveness of actions taken to address risks and opportunities has now been added to the list of
management review inputs.

9.3.3 Management review outputs

ISO 9001:2015 Requirement

The outputs from the management review must include decisions and actions related to:

a) opportunities for improvement

b) Any need for changes to QMS

c) resource needs

The organization shall retain documented information as evidence of the results of management
reviews.

What has changed from ISO 9001:2008

Management review output requirements were earlier covered under clause 5.6.3 of ISO 9001:2008.

Opportunities for improvement is now under both management review inputs and outputs.