9.

0 Performance Evaluation
The section on evaluation includes monitoring, measurement, and
analysis, internal audits, and management review.  Requirements for
monitoring, measurement, analysis, and evaluation are covered and you
will need to consider what needs to be measured, methods employed,
when data should be analyzed and reported on, and at what intervals.
Documented information that provides evidence of this must be
retained. There is now an emphasis on directly seeking out information
that relates to how customers view the organization. Organizations must
actively seek out information on customer perception. This can be
achieved in a number of ways including satisfaction surveys, analysis of
market share, and complaints lodged. There is now an explicit
requirement that organizations must show how the analysis and
evaluation of this data are used, especially with regards to the need for
improvements to the QMS. As with other ISO standards, Internal audits
must also be conducted. There are requirements relating to defining the
‘audit criteria’ and ensuring the results of the audits are reported to
‘relevant’ management’. Management reviews are required. Documented
information must be retained as evidence of management reviews.

9.1 Monitoring, measurement, analysis, and evaluation.

There is a new requirement to obtain information relating to customer

views and opinions of the organization. This requirement should not be
equated with the requirement for managing equipment for monitoring
and measuring from clause 7.1.5 of the standard. This is about a wider
aspect of monitoring and measuring. Information derived from
monitoring, measurement, and analysis represents inputs in the process
of improvement and management review. The organization needs to
determine what needs to be monitored and measured, how, and when, as
well as when the results will be analyzed. It is required to measure your
own performance as a supplier in order to get information about user’s
observations, and the extent to which you fulfilled their requirements.
Monitoring customer satisfaction levels must be constant activity in
order to determine trends, and because opinions about your
performance can change. Information about customer satisfaction can be
collected via phone, interview, or questionnaire, direct contact with the
user on the field, etc. Once the monitoring and measuring are performed
and the results are gathered, the organization needs to analyze the
results in order to evaluate the conformity of products and services,
degree of customer satisfaction, the performance of the QMS, the
effectiveness of actions taken to address risks and opportunities, the
performance of external providers, and need for improvements to the
QMS.

9.2 Internal Audit.

There continues to be a need to carry out internal audits and to do it

effectively. The goal of an internal audit is not to determine
nonconformity; its goal is to check whether your QMS:
a) complies with the requirements of ISO 9001 and the requirements of
your organization
b) is effectively implemented and maintained
There is no need for an internal audit procedure but it may be useful to
keep it. You do need to define audit criteria. There is more emphasis on
how they are done, how feedback should be taken, and audits being
corrected in a reasonable time to fix non-conformances identified.
Ensuring that all the right people are included in the audit outcome. At
the end of the audit, you will get audit results by evaluating the data you
collected during the audit. Audit results can be manifested as positive,
recommendations for improvements, and nonconformities (major and
minor). Verification of actions taken to fix the non-conformity may be
needed, and in that case, the next step is a follow-up audit. The audit
schedule must take customer feedback into account. The organization
can determine the technique of doing internal audits and the length of
the intervals between the two audits is up to you. They can decide how
the organization conforms to the requirement of QMS and that of ISO
9001. The organization can determine the manner by which it can
maintain the system. To conduct the audit the organization must:
1. Plan approach to internal audits based on the importance of the
processes.
2. For each audit, work out the scope of what will be covered. You
can’t audit 100% of the process, but you do need to cover
enough to be satisfied that the important issues have been
captured.
 3. Make sure the auditors are independent of the process under
audit.
4. Report all findings to the relevant managers so there aren’t any
surprises.
5. Ensure that the corrective actions from the audit are dealt with.
6. Retain the audit results in a document.

9.3 Management review.

A Management Review is a formal, structured meeting that involves top

management and takes place at regular intervals throughout the year.
They are a critical and required part of running an ISO 9001
Management System.

The purpose of a Management Review meeting is to review and evaluate

the effectiveness of your Management System, helping you to determine
its continued suitability and adequacy.  At least once a year, the top-level
management must review the QMS in order to determine its:
 Appropriateness – does it serve its purpose and satisfy the
needs of the organization?
 Adequacy – does the QMS conform to standard
requirements?
 Applicability – are activities performed according to
procedures?
 Effectiveness – does it accomplish the planned results?

This review must evaluate possibilities for improvement and needs for
changing the QMS, Quality Policy, and objectives. Considering the inputs
for the management review, such as the results of the previous
management reviews, changes in the context, customer satisfaction
survey results, performance of the QMS and suppliers, etc., the top
management must make decisions regarding opportunities for
improvement, need for changes in the QMS, and resources needed for
the upcoming period. A Management Review also ensures that all levels
of management are made aware of any changes, updates, revisions, etc.
to the day-to-day workings of the Management System itself. The
organization will need to decide when it will take place, what will be
discussed, and who should attend. You must document when the
meetings have occurred and what has been discussed. A Management
Review should cover the following topics:
 Discussion on the status of any issues from the previous
meeting.
 Changes to external and internal issues that affect the
Management System.
 Examination of the performance of the Management System.
 Review of available resources and their adequacy.
 Examination of how effective the actions are taken towards
identified risks and opportunities were.
 Identification of further opportunities for improvement.

The inputs to the Management review should be:

 Minutes of previous Management Review meeting
 Management System documentation
 Internal and External Audit Reports
 Relevant records (including customer feedback, corrective
action log, etc.)
 Register of Legal and other requirements
 Complaints analysis
 Corrective and preventive actions and close-out of Management
Information Reports
 Policies review

In order to keep improving your Management System, you need to be

looking for trends both inside and outside of the organization.  Consider
looking for trends in the following areas:
 The requirements of external interested parties
 Compliance to legislation, regulations, and other requirements
 Changes to products, services, and processes
 Customer satisfaction and complaint records
  Non-conformances and the effectiveness of any corrective
actions taken in response

The output to the management review includes decisions and actions

related to:
 Any opportunities for improvement within the organization
 Any changes to the Management System, processes, or policies
that are required
 Any revisions to company objectives or Key Performance
Indicators (KPIs)
 Any amendments to business plans or budgets
 Any changes to the resources that are needed for the smooth
running of the Management System

These types of changes affect day-to-day operations so it is important to

keep staff informed of these changes as this will ensure that your
Management System is operating effectively.